Spinal Manipulation, Medication, or Home Exercise With Advice for Acute and Subacute Neck Pain
FREEAbstract
Background:
Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain.
Objective:
To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term.
Design:
Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770)
Setting:
1 university research center and 1 pain management clinic in Minnesota.
Participants:
272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks.
Intervention:
12 weeks of SMT, medication, or HEA.
Measurements:
The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks.
Results:
For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome.
Limitations:
Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature.
Conclusion:
For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points.
Primary Funding Source:
National Center for Complementary and Alternative Medicine, National Institutes of Health.
Context
Persons with acute or subacute neck pain often turn to chiropractors and other practitioners of spinal manipulation for pain relief.
Contribution
This trial demonstrates that 12 weeks of spinal manipulation therapy (SMT) led to greater pain relief than medication up to 1 year after treatment. However, trial participants had as much pain relief with home exercise with advice (HEA) as with SMT over the same period.
Caution
Participants were unblinded to interventions.
Implication
For relief of acute or subacute neck pain, SMT and HEA seemed to be similarly effective and both were more effective than medication.
—The Editors
Neck pain is a prevalent condition that nearly three quarters of persons experience at some point in their lives (1, 2). One of the most commonly reported symptoms in primary care settings (3, 4), neck pain results in millions of ambulatory health care visits each year and increasing health care costs (5–8). Although it is not life-threatening, neck pain can have a negative effect on productivity and overall quality of life (1, 9–11).
Chiropractors, physical therapists, osteopaths, and other health care providers commonly apply spinal manipulation, a manual therapy, for neck pain conditions (12), and home exercise programs and medications are also widely used (13). Recent Cochrane reviews (13, 14) report insufficient evidence to assess the effectiveness of commonly used medications or home exercise programs for the treatment of acute neck pain. The evidence for spinal manipulation is similarly limited, with only low-quality evidence supporting its use for neck pain of short duration (15).
Our goal was to test the hypothesis that spinal manipulation therapy (SMT) is more effective than medication or home exercise with advice (HEA) for acute and subacute neck pain.
Methods
Setting
The trial was conducted from 2001 to 2007 in Minneapolis, Minnesota. Eligibility screening, randomization, and short-term data collection occurred at a university-affiliated research center; long-term data collection took place by mail. A university-affiliated outpatient clinic provided SMT and instruction for home exercise. Medical treatment was provided at a pain management clinic. The institutional review boards of Northwestern Health Sciences University and Hennepin County Medical Center approved our study, and all participants gave written informed consent.
Participants
Participants were recruited by using mailings targeted to persons with neck pain who were registered with Blue Cross/Blue Shield Minnesota and through newspaper and radio advertisements. Interested persons were screened for eligibility at 2 baseline appointments by clinicians who were blinded to the randomization schedule. Inclusion criteria were age 18 to 65 years; primary symptom of mechanical, nonspecific neck pain equivalent to grades I or II according to the Bone and Joint Decade 2000–2010 Task Force on Neck Pain and Its Associated Disorders classification (16, 17); current neck pain of 2 to 12 weeks' duration; and a neck pain score of 3 or greater on a scale of 0 to 10. Participants were asked to refrain from seeking additional treatment for neck pain from nonstudy health care providers during the 12-week intervention.
Exclusion criteria were cervical spine instability, fracture, neck pain referred from peripheral joints or viscera, progressive neurologic deficits, existing cardiac disease requiring medical treatment, blood clotting disorders, diffuse idiopathic hyperostosis, inflammatory or destructive tissue changes of the cervical spine, infectious disease or other severe disabling health problems, substance abuse, pregnancy or breastfeeding, previous cervical spine surgery, and pending or current litigation. In addition, participants were excluded if they had received any of the study treatments in the past 3 months.
Randomization and Interventions
Participants were randomly assigned at the second baseline appointment by using permutated blocks of different sizes (18). The randomization schedule was prepared off-site by the study statistician before enrollment and was concealed from the investigators, treatment providers, and research staff by using consecutively numbered, sealed, opaque envelopes. As participants became eligible, envelopes were opened in consecutive order by a research staff member in the presence of the participant.
The intervention protocol was tested in a pilot study by our research team (19). Maximum treatment duration was 12 weeks. Treatment providers were trained in the study intervention protocols and were required to document treatment activities in standardized clinical records, which were routinely monitored by research staff to ensure protocol adherence.
SMT Group
Six chiropractors with a minimum of 5 years' experience served as the primary providers of treatment. Visits lasted 15 to 20 minutes and included a brief history and examination of the cervical and thoracic spine. The primary focus of treatment was manipulation of areas of the spine with segmental hypomobility by using diversified techniques, including low-amplitude spinal adjustments (a high-velocity type of joint thrust manipulation) and mobilization (a low-velocity type of joint oscillation) (20). The specific spinal level to be treated and the number of treatment sessions over the 12 weeks was left to the discretion of the provider, based on manual palpation of the spine and associated musculature and the participant's response to treatment (21). Adjunct therapy common to clinical practice included limited light soft-tissue massage, assisted stretching, and hot and cold packs to facilitate the manipulation treatment. Advice to stay active or modify activity was recommended as needed.
Medication Group
A licensed medical physician provided care to participants, with the focus of treatment on prescription medication. Visits lasted 15 to 20 minutes and included a brief history and examination. The first line of therapy was nonsteroidal anti-inflammatory drugs, acetaminophen, or both (22, 23). Participants who did not respond to or could not tolerate first-line therapy received narcotic medications. Muscle relaxants were also used. Advice to stay active or modify activity was issued as needed. The choice of medications and number of visits was made by the physician on the basis of the participant's history and response to treatment.
HEA Group
Home exercise with advice was provided in two 1-hour sessions, 1 to 2 weeks apart, at the university-affiliated outpatient clinic. Six therapists provided instruction to participants. The primary focus was simple self-mobilization exercise (gentle controlled movement) of the neck and shoulder joints, including neck retraction, extension, flexion, rotation, lateral bending motions, and scapular retraction, with no resistance (Supplement). The delivery method was 1-on-1, and the program was individualized to each participant's abilities, tolerance, and activities of daily living. Participants were instructed to do 5 to 10 repetitions of each exercise up to 6 to 8 times per day. A booklet (24) and laminated cards of prescribed exercises were provided. Sessions were supplemented with information about the basic anatomy of the cervical spine and advice, including postural instructions and practical demonstrations of lifting, pushing, pulling, and other daily actions.
Outcomes and Measurements
We collected participant demographic and clinical characteristics at the initial baseline appointment by using self-report questionnaires, clinical history, and physical examinations. Self-reported outcomes (such as pain) were measured 6 times during the 12-week treatment period (at the 2 baseline appointments and 2, 4, 8, and 12 weeks after randomization). Outcomes were also collected twice during the posttreatment period (at weeks 26 and 52) by using a mailed questionnaire. All self-report questionnaires were completed by participants independent of influence from investigator, study staff, or treatment provider. Participants were asked in each questionnaire if anyone had attempted to influence their responses. Objective measures of cervical spine motion were measured at 4 and 12 weeks by 7 trained examiners who were masked to treatment assignment (25). Blinding was maintained by systematically instructing participants not to reveal treatment information and by ensuring that examiners had no exposure to activities in the outpatient clinics.
We chose participant-rated pain as the primary outcome measure a priori and used an 11-box numerical rating scale (range, 0 [no symptoms] to 10 [highest severity of pain]) (26–29). Secondary outcomes included the Neck Disability Index (30), global improvement (31–33), medication use (34), satisfaction with care (25, 34), the Short Form-36 Health Survey (SF-36) (35), and cervical spine motion (measured with a CA 6000 Spine Motion Analyzer [Orthopedic Systems, Union City, California]) (36, 37).
Before random assignment, participants were asked in the self-report questionnaire how they expected their neck pain to change in response to treatment, with choices of much better, better, no change, worse, and much worse. Participants were also asked to report additional health care use visits to nonstudy providers in the self-report questionnaires at all time points.
Participants were asked standardized questions at each treatment visit to assess side effects since the last visit, and responses were documented in the clinical record.
Statistical Analysis
Our sample size calculation was based on an ability to detect a 0.8-point difference between the highest and lowest group means in participant-rated neck pain (the primary outcome) at the end of 12 weeks of treatment. This difference was informed by previous neck pain trials conducted by our group (19, 25) and the ability to detect a small to medium effect size. We used an SD of 1.8 for our pain scale on the basis of our pilot study and estimates from the literature (25, 38). With a power of 0.90 and a 3-group design tested at an α level of 0.05 (2-tailed test), 75 participants per group were required (SPSS SamplePower 1.0, International Business Machines, Armonk, New York). To allow for a loss to follow-up rate of up to 15%, we aimed to recruit 90 participants per group for a total of 270 participants.
In primary analyses, we evaluated changes in neck pain between baseline and week 12 and performed longitudinal analyses by using data from weeks 2, 4, 8, and 12 (short-term outcome). In secondary (exploratory) analyses of both primary and secondary outcomes, we evaluated changes in participant-rated outcomes between baseline and weeks 2, 4, 8, 12, 26, and 52 and performed longitudinal analyses by using data from weeks 2, 4, 8, 12, 26, and 52 (long-term outcome). Both analyses were conducted by using linear mixed-model analysis with the MIXED procedure in SAS, version 9.1 (SAS Institute, Cary, North Carolina), with baseline values as outcomes (39–42). Clinical and demographic variables showing group differences at baseline were used as covariates in the analysis if they were at least moderately correlated with changes in outcomes (43, 44).
The study database was prepared by data managers who were blinded to study allocation. The intention-to-treat principle was adhered to by including all participants with baseline data in the analyses, regardless of loss to follow-up. To protect against increased risk for type I errors, we used the Fisher (protected) least-significant-difference test (45, 46). The mixed-model analysis included all participants who had at least baseline assessments. In the event of missing data, the reasons were explored and the pattern of the missing data was determined to select the best method of data imputation. The original analyses were then repeated as sensitivity analyses with fully imputed data by using the MI procedure in SAS, to assess the effect of the missing data (47–51). No prespecified thresholds for clinically important group differences were set because none has been established in the literature. To facilitate interpretation of the magnitude of group differences, responder analyses were conducted by group for pain reduction (absolute risk reduction) of 50%, 75%, and 100% (including 95% CIs) at the end of treatment and at 26- and 52-week follow-up (52–55).
Role of the Funding Source
Our trial was funded by the National Center for Complementary and Alternative Medicine, National Institutes of Health. The funding source had no role in the study design, collection, analysis, data interpretation, or writing of this article.
Results
We evaluated 504 persons for eligibility, of whom 272 were randomly assigned: 90 to the medication group, 91 to the SMT group, and 91 to the HEA group. The Figure summarizes recruitment, participation, and attrition.
Participants were lost to follow-up if they did not provide data at each time point. Patients who discontinued treatment had the opportunity to provide follow-up data. HEA = home exercise with advice; SMT = spinal manipulation therapy.
Table 1 summarizes the demographic and clinical characteristics of the randomly assigned participants. Potentially important between-group differences were noted for sex, duration of neck pain, pain during the night, and expectation of change in neck pain. Table 2 provides details of the 3 study interventions.
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Primary Outcomes
Improvement in participant-rated pain significantly differed with SMT compared with medication at 12 weeks (0.94 greater reduction in pain [95% CI, 0.37 to 1.51]; P = 0.001) and in longitudinal analyses that incorporated pain ratings every 2 weeks from baseline to 12 weeks (0.55 greater reduction in pain [CI, 0.10 to 1.00]; P = 0.017). At 12 weeks, a significantly higher absolute proportion of the SMT group experienced reductions of pain of at least 50% (Table 3). Differences in participant-rated pain improvement between the SMT and HEA groups were smaller and not statistically significant. Differences between the HEA and medication groups were also not statistically significant, although a higher absolute proportion of the HEA group experienced reductions in pain of at least 75% at 12 weeks compared with the medication group.
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Longer-term analyses showed similar findings. At 26 and 52 weeks, participant-rated pain improvement favored SMT over medication, but not SMT over HEA or HEA over medication, compared with baseline. A higher absolute proportion in the SMT group than in the medication group experienced reductions of pain of at least 50% at 26 but not 52 weeks. Those proportions did not differ at any time in comparisons of SMT and HEA, and a higher absolute proportion in the HEA group than in the medication group experienced reductions of pain of at least 75% at 26 but not 52 weeks.
Adjustment for baseline imbalances in sex, cause of pain, and depression did not change the group differences in pain outcomes.
Secondary Outcomes
Group differences in most secondary outcomes were similar to those of the primary outcomes (Appendix Tables 1, 2, 3, and 4). Spinal manipulation therapy was superior to medication at the end of treatment and during follow-up in terms of global improvement, participant satisfaction, and SF-36–assessed physical but not mental function; SMT was also superior to medication in measures of long-term medication use (1.26 fewer days per week of use at week 52 [CI, 0.53 to 1.99 days]; P < 0.001).
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The SMT and HEA groups performed similarly on most of the secondary outcomes, although SMT performed better than HEA for satisfaction with care in both the short and long term. Home exercise with advice was superior to medication in both the short and long term for satisfaction with care and for long-term medication use (1.00 fewer days per week of use at week 52 [CI, 0.27 to 1.73 days]; P = 0.008).
Appendix Table 4 shows changes in cervical spine motion after 4 and 12 weeks. Overall, the greatest changes in cervical spine motion were observed in the HEA group. Results of the group differences in 3-dimensional cervical spine motion patterns will be reported elsewhere.
One of the participants indicated that someone tried to influence his responses. Because this was a week-52 questionnaire collected by mail independent of study staff, it was probably not of consequence.
Missing Data Analysis
Among the 272 participants, 219 (80.5%) provided data on neck pain at every visit. We considered loss to follow-up to be nonrandom for 12 participants, 6 of whom never commenced treatment (all in the medication group) and 6 of whom stopped participating in the study after they received treatment (2 in the medication group, 1 in the SMT group, and 3 in the HEA group). We first imputed values to the missing responses of these 12 participants by using the mean percentage reduction from baseline at all time points specific to the group to which they belonged. Then, we imputed the rest of the missing data during treatment and the 2 posttreatment follow-up time points by using the SAS multiple imputation strategy, on the assumption that the data were missing at random. The results of the analyses with imputed values changed the estimates of group differences very little, and all statistically significant differences remained the same.
Nonstudy Treatments
During the 12-week intervention, 4 participants (3 in the medication group and 1 in the HEA group) reported visits to other health care providers for their neck pain. By week 52, about equal numbers of persons in each treatment group sought additional health care after completing the treatment phase (18 in the SMT group, 14 in the medication group, and 17 in the HEA group).
Adverse Events
No serious adverse events were reported in the study. Expected, nonserious adverse events that are typical to these treatments did occur and were all transient in nature, requiring little or no change to activity levels. Forty percent of the SMT group and 46% of the HEA group reported adverse events, primarily musculoskeletal pain. Paresthesia, stiffness, headache, and crepitus were less frequent (Appendix Table 5). Sixty percent of participants in the medication group reported side effects, the most common being gastrointestinal symptoms and drowsiness. Dry mouth, cognitive disturbances, rash, congestion, and disturbed sleep were less commonly reported.
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Discussion
In the absence of available criteria for what constitute clinically important group differences, several factors should be considered in aggregate. This includes the statistical significance of the results of our primary efficacy analysis, as well as those of the responder and secondary outcomes analyses. The durability of the treatment effect, the safety and tolerability of the interventions, and the participant's ability and willingness to adhere to treatment should also be taken into account (56).
In this trial of SMT versus medication or HEA for the treatment of acute and subacute neck pain, SMT seemed more effective than medication according to various measures of neck pain and function. However, SMT demonstrated no apparent benefits over HEA. Spinal manipulation therapy and HEA led to similar short- and long-term outcomes, but participants who received medication seemed to fare worse, with a consistently higher use of pain medication for neck pain throughout the trial's observation period. The performance of the HEA group, which has the potential for cost savings over both SMT and medication interventions, is noteworthy.
Participants and clinicians consider the potential for side effects when making treatment decisions. Although the frequency of reported side effects was similar among the 3 groups (41% to 58%), the nature of the side effects differed, with participants in the SMT and HEA groups reporting predominantly musculoskeletal events and those in the medication group reporting side effects that were more systemic in nature. Of note, participants in the medication group reported higher levels of medication use after the intervention.
Most participants had subacute neck pain that lasted more than 4 weeks, beyond the time when pain will probably resolve spontaneously, and evidence suggests that one half of persons with nonspecific neck pain continue to have neck pain 1 year after the original report (57). Although our trial did not have a placebo group, the observed results are unlikely to be due to natural history alone.
To date, few clinical trials have assessed the effectiveness of noninvasive interventions for acute and subacute neck pain not associated with whiplash; therefore, no evidence-informed first-line therapy for this type of neck pain has been established (12, 13).
We searched MEDLINE, EMBASE, CINAHL, and the Cochrane Library, using the terms spinal manipulation and neck pain, to identify all randomized trials published from 1960 to 2011 that evaluated SMT for acute or subacute neck pain. We found 3 trials (58–61). Our trial is most similar to that of Hoving and colleagues (58, 59), in which 75% of patients had neck pain of less than 12 weeks' duration. Six weeks of manual therapy (mainly spinal mobilization) was compared with usual medical care (advice, home exercise, and medication). The investigators found manual therapy to be superior to medical care, with reductions in pain and disability similar to what we observed at 8 weeks but less than what we observed at 12 weeks. Pool and colleagues (60) compared 6 weeks of manual therapy (up to 6 sessions) with 6 weeks of a behavioral-graded activity program (maximum of 18 sessions of 30 minutes each). At 3 months, the behavioral-graded activity program demonstrated slightly larger reductions in pain and disability than manual therapy; however, the magnitude of improvements in the behavioral program was similar to that found for SMT in our trial. Finally, Cleland and colleagues (61) found thrust mobilization and manipulation to be more effective than nonthrust manual treatment in patients with subacute neck pain. When considered in the context of the existing evidence, our results suggest that SMT and HEA both constitute viable treatment options for managing acute and subacute mechanical neck pain.
Our study has several strengths, including a rigorous concealed randomization procedure, use of recommended reliable outcome measures, masked objective outcomes assessors, and long-term postrandomization follow-up (6 and 12 months.) It also has limitations. First, participants and providers could not be blinded because of the nature of the treatments received and delivered. Second, no criteria are available to define clinically important group differences for the different outcomes. Finally, our study does not differentiate between the specific effects of treatment and the contextual (nonspecific) effects, including participant–provider interactions and expectations. This study was intended to be pragmatic in nature and to answer clinical questions regarding commonly used treatment approaches by approximating how they are delivered in practice.
For participants with acute and subacute neck pain, SMT was more effective than management with medication in both the short and long term; however, a few sessions of supervised instruction in HEA resulted in similar outcomes at most time points.
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Author, Article, and Disclosure Information
Gert Bronfort,
From Northwestern Health Sciences University, Pain Management and Rehabilitation Center, and Berman Center for Outcomes and Clinical Research at the Minneapolis Medical Research Foundation, Minneapolis, Minnesota.
Acknowledgment: The authors thank the study staff for dedicating substantial time and energy to ensure successful completion of the trial, as well as Brent Leininger, DC, and Jennifer Hart, MS, for their technical assistance in preparing this manuscript.
Grant Support: By the National Institutes of Health's National Center for Complementary and Alternative Medicine (grant R01 AT000707).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-0299.
Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Bronfort (e-mail, gbronfort@nwhealth.
Corresponding Author: Gert Bronfort, DC, PhD, Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 West 84th Street, Bloomington, MN 55431; e-mail, gbronfort@nwhealth.
Current Author Addresses: Drs. Bronfort and Evans: Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 West 84th Street, Bloomington, MN 55431.
Dr. Anderson: Medical Pain Management, 5775 Wayzata Boulevard, Suite 110, St. Louis Park, MN 55416.
Mr. Svendsen: 900 Forest Avenue, Birmingham, MI 48009.
Mr. Bracha: Division of Health Policy and Clinical Effectiveness, Cincinnati Children's Hospital, 3333 Burnet Avenue, MLC 5040, Cincinnati, OH 45229.
Dr. Grimm: Berman Center for Outcomes and Clinical Research, 825 South 8th Street, Suite 440, Minneapolis, MN 55404.
Author Contributions: Conception and design: G. Bronfort, R. Evans, R.H. Grimm.
Analysis and interpretation of the data: G. Bronfort, R. Evans, K.H. Svendsen, Y. Bracha, R.H. Grimm.
Drafting of the article: G. Bronfort, R. Evans, Y. Bracha, R.H. Grimm.
Critical revision of the article for important intellectual content: G. Bronfort, R. Evans, Y. Bracha, R.H. Grimm.
Final approval of the article: G. Bronfort, R. Evans, A.V. Anderson, Y. Bracha, R.H. Grimm.
Provision of study materials or patients: A.V. Anderson.
Statistical expertise: G. Bronfort, K.H. Svendsen, Y. Bracha, R.H. Grimm.
Obtaining of funding: G. Bronfort, R. Evans, R.H. Grimm.
Administrative, technical, or logistic support: G. Bronfort, R. Evans.
Collection and assembly of data: R. Evans, A.V. Anderson.
Authors Response
In response to Dr. Ernst, our study was a pragmatic trial designed to assess the comparative effectiveness of three commonly used management options for neck pain. The design was chosen to represent as closely as possible what happens in the real world clinical setting in which treatment is tailored to individual patients.(1) Pragmatic trials are not meant to control for placebo and non-specific effects (different environments, time spent with patients, etc). Control of such effects requires an explanatory or fastidious trial. As described in the discussion section of our paper, both comparative effectiveness and fastidious trial designs are important but address very different research questions. We made no claim that any of the study treatments was superior to placebo or that the outcomes could not partially be explained by treatment related nonspecific effects.
We disagree with Mr. Guy Chapman regarding the documented risk of significant adverse outcomes related to cervical spine manipulation. The best available evidence regarding the relationship between spinal manipulation and vertebral artery dissection comes from several large case-control studies.(2,3) These show that while there is an association between visits to chiropractors and the subsequent development of vertebral vascular stroke, this type of stroke is extremely rare. Importantly, the risk is no greater than if patients seek care from their family medical physicians who are very unlikely to apply spinal manipulation.
References:
1. Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, Schwartz JS. Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med. 2009 Aug 4;151(3):206-9. Epub 2009 Jun 30
2. Smith WS,Johnston SC,Skalabrin EJ,et al. Spinal manipulative therapy is an independent risk factor for vertebral artery dissection. Neurology 2003;60: 1424 – 8.
3. Cassidy JD, Boyle E, Côté P, He Y, Hogg-Johnson S, Silver FL, Bondy SJ. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover study. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S176-83.
Conflict of Interest:None declared
Re:Uncritical interpretation of flawed study
It seems to me that the most important finding is: "No important differences in pain were found between SMT and HEA at any time point."
As the study identifies, HEA involved a significantly lower average involvement from providers (under one fifth of the number of sessions, and mainly provided by telephone not in the office, if I read it correctly).
Given this fact, and the documented risk of significant adverse outcomes due to vertebral artery dissection in SMT, the principal conclusion from this work must be that home exercise with advice offers safety and cost benefits which convincingly establish its superiority over manipulation therapy in patients with neck pain.
Conflict of Interest:None declared
Re:Uncritical interpretation of flawed study
I can only agree with Professor Ernst. This was a very flawed study, especially in design. With such a small sample, when the question of interest is the comparison between manipulation and home exercise, with or without analgesia, the obvious design is factorial. The primary randomisation between these two would therefore have achieved a direct comparison between them (inevitably unblinded) with the analgesic comparison blinded.
The definition of outcomes is also poor. There are many validated pain scores which could have been used, and apparently were not.
There is no evidence of "intention to treat" analysis and "loss to follow-up" defined as any failure to attend at any time is very wasteful of volunteer subjects.
Jennifer Baker (MSc in medical statistics, MBBS)
Conflict of Interest:None declared
Re:Cervical spine manipulation may have significant risk.
The National Institute of Health public information description of chiropractic on their National Center of Complementary and Alternative Medicine site states: "Side effects from spinal manipulation can include temporary headaches, tiredness, or discomfort in the parts of the body that were treated. There have been rare reports of serious complications such as stroke, but whether spinal manipulation actually causes these complications is unclear. Safety remains an important focus of ongoing research."
The cause is unclear. The notion that a practitioner of neurology or imaging specialist sees a patient with a vertebral artery abnormality and contemporaneous symptom onset and therefore assumes a cause/effect relationship with spinal manipulation is as erroneous an assumption as the criticisms of the article for claims beyond significant weaknesses in the study. Published accounts of cases of this type are equally biased in the cause/effect conclusions, especially those from Ernst, which are often cited as facts in other publications. It is amazing that the papers get published without further restrictions of these erroneous opinions by reviewers. Believe it or not, it is often harder in the reputable chiropractic journals to slip these kinds of opinions by reviewers than in some medical journals. It is like the idea is popular so publish it, even without adequate evidence to make such a statement.
There may or may not be a cause and effect relationship. The fact is that we don't know for sure. Another glaring fact is that the risks for cervical spine manipulation is so much less than almost any medical intervention such as injections or surgical procedures, that this argument is very one sided, if an individual is to choose one versus the other.
After 31 years of practicing chiropractic and likely a few hundred thousand cervical spine adjustments given without serious adverse affects, I am very confident that this procedure is relatively risk free in relation to serious complications.
Conflict of Interest:None declared
Single Blind Research Study on SMT Completed. Positive Outcome
The practitioner can't be blinded. The manipulation is either performed or it is not. However, the subject can be blinded. This was the subject of my Master's Thesis. The subject volunteers with neck pain were placed under twilight sedation. Some were manipulated, some were not. The manipulated subjects had a dramatic and statistically significant improved outcome. Objectively by improved range of motion. Improved and lengthened muscle resting length. Diminution of active trigger points. Improved inter segmental mobility both by motion palpating and radiography.. Objectively by improved visual analog scale scores. Simple but elegant study. Dr Ron Grassi.,DC,MS,ACFEI. Jupiter, Fl.
Conflict of Interest:None declared
Who is hurting who?
I am a chiropractic physician by Illinois Law and have been in practice for 35 years. During that time I have adjusted over 20,000 new patients. As a Gonstead practitioner, I have therefore performed literally millions of specific spinal adjustments to the cervical spine without one adverse reaction. Not one! That's got nothing to do with luck; it's a matter of skill built over an entire career and I remain proud of that statistic to this day.
Just as there are surgeons that have no business being anywhere near a patient with anything sharp, there are chiropractors that should not be adjusting patient's necks primarily because they are simply not good at it. The spinal adjustment is an art form that is perfected over time like any other fine motor skill set. Any chiropractor worth his salt knows that it's all about the suttle nuances relative to the vector, velocity and force of thrust required to restore the function of the intervertebral motor unit. What makes chiropractic unique is our ability to reduce and hopefully eliminate the fixation that develops at the leve of the facet joint and decompress the nerve root. In essense I feel we are "fixation breakers" for lack of a better term and with the exception of osteopathy, no other profession does that. I feel strongly that this is the very genesis of osteoarthritis in the spine and develops when no correction is implimented from the start. When joints stop being joints they lose their primary function and that begins the path to anykylosis.
Yesterday Medscape published an article stating that pain medication kills 40 patients a day is this country as an adverse side effect. To me death is an unacceptable side effect but maybe I'm being too critical. To any medical professional who is critical of the spinal adjustment, I suggest you clean up your own house first. The incidence of death related to adjusting the spine is unheard of so again, who is hurting who?
The medical model of matching a drug to the symptom seems to have run its course. When the World Health Organization rates us # 37 on a global scale you have to wonder what happened. Maybe the medical profession is not as great as they think they are. We were the most expensive though. When the CDC starts warning all medical doctors that over prescribing antibiotics has now created resistance to these medications you have to take notice. What does the public do now when they might really need them? When 40 patients a day die in this country from adverse reactions to pain medication only an idiot would not realize the horribe risks of medications that were handed out like candy. You have created a culture that has become increasingly dependent on drugs for everything and they (the public) have forgotten how to stay well all by themselves. Then again, what would a medical doctor do without his prescription pad? Parenthetically, the word doctor in the old latin means "to teach". With the average medical office visit taking 10 minutes I have to wonder how much "teaching" actually goes on. Health care reform has to start somewhere so I suggest we teach the patient what health really means and that has nothing to do with a drug. That is exactly what I have done for the last 35 years of my career. So far so good.
Conflict of Interest:None declared
Cervical spine manipulation may have significant risk.
The Annals of Internal Medicine is among the most frequently cited medical journals. The journal has a duty to publish articles that advance science and promote good medical care. The recent publication of an article and an editorial about the use of chiropractic spine manipulation as a treatment for neck pain appears to have failed in this regard (1,2). Worse yet, the article was immediately reported by The New York Times (3), which extolled the efficacy of spinal manipulation for neck pain, thus compounding the damage done by the publishing of the article.
The value of a proposed medical treatment is always a function of its efficacy and its risks. A risk of manipulation of the cervical spine is cervical arterial dissection. The article fails to mention any risk at all. The editorial characterizes such events as being rare, a statement which cannot be supported by the literature. The literature is in the process of calibrating that risk which may be much higher than has previously been recognized.
Vascular imaging has improved remarkably over the past twenty years, allowing for the accurate, non-invasive diagnosis of cervical artery dissection. With the new imaging capabilities, many radiologists, neurologists and neurosurgeons have seen patients with dissection where the injury appears to have been caused by spinal manipulation. This is documented in a number of articles that are easily found by scholastic search engines.
A very recent article reports a series of 13 patients treated at a single institution over the course of four years, with cervical dissection related to chiropractic manipulation. Twelve of the patients presented with acute neurological symptoms. Three of them were permanently disabled and one died. Their mean age was 44 years; most of them were in the primes of their lives. (4)
These cases of dissection post chiropractic manipulation are only now being fully recognized because of better imaging capabilities and no study to date has definitively quantified the risk. The fact that one institution could see 13 patients within 4 years suggests that the risk may be very significant indeed.
It was irresponsible to publish the Bronfort article without reference to the risk involved. The editorial that accompanied the article should have indicated that the risk of dissection is currently unknown. The literature on the subject is clearly evolving. The risk of cervical artery dissection as a complication of cervical spine manipulation may be much higher than was previously realized.
References
1. Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH. Spinal Manipulation, Medication, or Home Exercise With Advice for Acute and Subacute Neck Pain: A Randomized Trial. Ann Intern Med 156:1-10, January 3, 2012.
2. Walker BF, French SD. Editorial: Pain in the Neck: Many (Marginally Different) Treatment Choices. Ann Intern Med 156:52-53, January 3, 2012.
3. O'Connor A. For Neck Pain, Chiropractic and Exercise Are Better Than Drugs. New York Times, January 3, 2012.
4. Albuquerque FC, Hu YC, Dashti SR, Abla AA, Clark JC, Alkire B, Theodore N, McDougall CG. Craniocervical arterial dissections as sequelae of chiropractic manipulation: patterns of injury and management. J Neurosurg 115:1197-1205, December 2011.
Conflict of Interest:None declared
Results from a high quality randomized controlled trial, which are not immediately applicable in clinical practice
In a recent randomized trial (RCT), subacute and chronic neck pain patients were treated with spinal manipulation (SM), home exercise (primarily stretching) and postural instructions (HE), or medication (primarily NSAID, opioid analgesics and muscle relaxants), and were followed-up for 52 weeks. Results suggest that, from week 12 onwards, the evolution of pain and most secondary outcomes in the SM and HE groups were similar, and slightly worse among patients on medication.
We would like to congratulate the authors and point out that these results are not immediately applicable in clinical practice, since:
1. As the authors acknowledge, the lack of a placebo group makes it impossible to rule out the possibility that unspecific factors may account for the effectiveness attributed to each form of treatment.1 For instance, the mean amount of minutes patients spent with therapists was 67,5-96 in the medication group, 120 in the HE group, and 229.5-306 in the SMT group;1 previous RCTs in which low back pain patients received medication, education and physical therapy, showed that procedures involving longer contact between patients and therapists lead to slightly better results.
2. These results were sensitive to the cut-off limit for "clinical relevance". At 26 weeks, when cut-off point was set at 50% of baseline score, the largest proportion of patients experiencing "relevant improvement" was observed among those treated with SM. However, when cut- off point was set at 75%, the highest proportion was found among patients treated with HE.1 It might be interesting to reanalyze these results using the minimal clinically important change (MCIC) as the cut-off point.3,4 The MCIC for this type of patients ranges between 1.5-2.5 VAS points,3,4 and is lower for those with less intense baseline pain and subacute (vs. chronic) patients.3
3. Differences between groups were small, especially between HE and SMT, whereas the latter required twice as much therapists' time. Therefore, data on cost/effectiveness would help translate these results into recommendations for routine clinical practice.
References
1.Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH. Spinal manipulation, medication or home exercise with advice for acute and subacute neck pain. Ann Intern Med 2012;156:1-10
2.Albadalejo C, Kovacs FM, Royuela A, del Pino R, Zamora J et al. The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care. A cluster randomized trial. Spine 2010;35:483-496
3.Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Tom?s M, Mir MA, Cano A, Muriel A, Zamora J, Gil del Real MT, Gestoso M, Mufraggi N. Minimum detectable and minimal clinically important changes for pain in patients with nonspecific neck pain. BMC Musculoskeletal Disorders 2008, 9:43 doi:10.1186/1471-2474-9-43. http://www.biomedcentral.com/1471- 2474/9/43.
4.Pool JJM, Ostelo RWJG, Hoving JL, Bouter LM, de Vet, HCW. Minimal clinically important change of the neck disability index and the numerical rating scale for patients with neck pain. Spine 2007;32:3047-3051
Conflict of Interest:None declared
Dangers of Spinal Manipulation Therapy (SMT) for Meck Pain
The authors conclude that SMT was superior to medication and home exercise for acute and subacute neck pain. They make no mention (even in the heading "Adverse Events") of the very serious complications of SMT of the neck including: vertebral artery injury, stroke, and/or death. There are many citations of these events in the recent literature and there have been many lawsuits against the practitioners of SMT. Physicians need to be warned of these dangers to inform their patients about manipulative therapy.
Conflict of Interest:None declared
Re:Re:Re:Uncritical interpretation of flawed study
Despite a lack of scientific underpinnings for the therapeutic mechanism of spinal manipulation, it seems to be a very effective placebo. There is strong science behind the placebo effect. It should not be underestimated as a potential therapy for susceptible patients.
Conflict of Interest:None declared
Re:Re:Uncritical interpretation of flawed study
Anyone who makes a statement ( 'Spinal manipulation should be banned as a form of "medical treatment."). displays a basic lack of knowledge about the subject.
Osteopathic physicians have been mainpulating cervical spines for over 120 years without one confirmed neck injury or related CVA, etc. A few injuries have been attributed to Chiropractors or MDs who may have not used discretion or proper evaluation but this also appears to be a rare event. As observed by some commentators, surgical and medical approaches are not without injury.
I have been using Myofascial Release Manipulation, (non-forceful procedures releasing myofascial trigger points without resort to neddling or injections) for nearly 60 years including 20 years in the USAF Medical Corps and have never encountered any problems other than relief of pain and spasm with many patients even into their 8th and 9th decades of life who had otherwise given up hope of relief. I frequently have been a resource of last resort when all else had failed. As a result of my approaches, patients were returned to work sooner and usually at less cost to the patient or insurance company and with shorter periods of disability (including patients with.... so-called Fibromyalgia ......with added low dose supplimental antidepressants.)
Regardless of what field of medicine one practices, one should be familiar enough with unused theraputic approaches before making "un-informed decisions."
Conflict of Interest:None declared
recurring issue with study design and caution
I agree wtih the three comments submitted thusfar, wishing to point out that the incidence of CVA after SMT is extremely rare.
The study design misses an entire dimension, as do so many:
What does the illness mean to the patient?
I find that self-awareness is very helpful*. Otherwise, these are mere mechanics.
Mark Antony LaPorta, MD FACP
*Certainly my colleagues are aware of Aristotle's dictum.
Conflict of Interest:None declared
Correct information about chiropractic treatments
I would like to say that this was a good starting point for future research. I would like to comment that chiropractors are required to maintain current malpractice in all 50 states. The previous post was entirely incorrect.
The risk of stroke from manipulation has been stated to be 1 in 10 million. This can occur from an osteopath, chiropractor or an MD. The chiropractic profession has been around for over 115 years. It has been classified as one of the safest forms of healthcare. (Including cervical manipulation) There are over 300 chiropractic techniques to treat a patient and only a small handful require a rotary manipulation.
Each year over 100,000 people in the US die due to medical error. Instead of attacking each profession it's important to realize we are all committed to helping our patients. The study below was one of several that revealed we can ALL do better.
In April 2011, a study released in the journal Health Affairs found that one third of hospital visits will lead to hospital related injuries, and as many as 90 percent of hospital errors are missed by current surveillance systems.
Forty-four percent of the errors identified were preventable, Dorrill said.
Conflict of Interest:None declared
Re:Spinal manipulation should be banned as a form of "medical treatment."
"I have worked in orthopedics for over 15 years and have referred hundreds of cases to a chiropractor near us. He has helped not all of the cases, but he has helped most of them feel better when the medical community could not. I have had several very in depth conversations with this chiropractor and I fully trust referring some of my patients to him. I have referred for cervical, thoracic, and lumbar spinal manipulation therapy. Several studies have been done on the chance of vertebral artery dissection and the highest chance that I have found published in literature is 1 out of approximately 2 million adjustments. If a complication experienced at this rate is too high, no prescriptions, surgeries or over the counter medications should be used because the risk is too great. In the medical field, the field that we both work in, it would be nearly impossible to have a treatment or medication that experiences this low of a complication rate. Based on this rationale, it would be impossible to suggest any form of treatment because the risk is too great. There are numerous medications that carry very serious side effects, but the reward is considered greater than the risk. If 1,999,999 people are helped by chiropractic and one person experiences a vertebral artery dissection, that would be defined as an acceptable risk by any health care provider or researcher. For example, many of the common spinal surgeries that are performed carry a much higher risk. It is in the patient's best interest that they receive whatever care they need, whether it is medical or some form of alternative care such as chiropractic. This is the reason that integrative health clinics are becoming so popular. It limits the amount of competition between providers so that the patient can get the help they need." Sources: Terrett AGJ: Current Concepts in Vertebrobasilar Complications following Spinal Manipulation. West Des Moines, IA: NCMIC Group, Inc., 2001 Klougart N, Leboeuf-Yde C, Rasmussen LR: Safety in chiropractic practice part I: The occurrence of cerebrovascular accidents after manipulation to the neck in Denmark from 1978-1988. J Manipulative Physiol Ther 1996; 19;371. Haldeman S, Carey P, Townsend M, Papadopoulos C: Arterial dissections following cervical manipulation: the chiropractic experience. CMAJ 2001;165:905.
Spinal manipulation should be banned as a form of "medical treatment."
In my twenty seven years of neurological practice, I recall at least six cases in which chiropractic spinal manipulation caused major neurological damage. I saw my first case over thirty years ago. It involved a man in his thirties who complained of a "crick" in his neck. As his chiropractor performed neck manipulation, he experienced severe left neck pain, headache, nausea, dizziness and blindness of the entire right visual fields of both eyes. A CT brain scan revealed a large stroke involving the left occipital lobe. An arteriogram demonstrated a damaged left vertebral artery with clot formation. The chiropractor's neck thrust resulted in a traumatic tear and dissection of the left vertebral artery high within the left neck, setting up a clot, which dislodged and traveled up into the brain blocking the blood flow to the brain's left occipital lobe.
Most of these cases end up in the hospital Emergency Room and are taken care of by stroke specialists. In the ER, the physician should ask, "Has a chiropractor popped your neck within the past several days?" If the answer is "yes," the diagnosis becomes highly suspect, to be confirmed by the exam and diagnostic studies.
Here's the rub, the stroke may not occur immediately. The clot may not dislodge for hours or for several days. The patient doesn't have a clue that the neck manipulation performed days ago could be responsible for his/her stroke. If the ER doctor doesn't ask, then the chiropractor gets off scott free. No one is aware of how the stroke really occurred, not the patient, not the ER doctor and not the chiropractor.
How many patients present to the ER with a stroke and the doctor fails to ask, "Has your chiropractor popped you neck recently?" My guess is that it occurs frequently and the chiropractor goes his merry way, unaware of what happened to the patient after he/she had a neck-popping.
In my experience in both Georgia and Florida, the State Chiropractic Boards are made up of chiropractors who allowed chiropractors to practice without malpractice insurance. Attorneys generally will not take a case if the defendant has no malpractice insurance. The young man, mentioned above, couldn't find an attorney who would take his case because the chiropractor had no malpractice insurance.
If you need references or studies to back up the claims that chiropractic spinal manipulation causes stroke, I recommend Googling "Chiropractic Spinal Manipulation and Stroke" and check Dr Steven Barrette's "Chiropractor's Dirty Secret," a review of the literature.
Bottom line: Never allow a chiropractor perform cervical spinal manipulation on you. The risk of stroke, herniated disc with nerve root or spinal cord compression, is far too great to justify the claimed benefit.
Conflict of Interest:None declared
Uncritical interpretation of flawed study
Bronfort et al. recently reported a trial intended “to determine the efficacy of spinal manipulation therapy (SMT), medication and home exercise with advice (HEA)” for neck pain. They concluded that “SMT was more effective than medication” and that “HEA resulted in similar outcomes” as SMT (1).
In my opinion, this study has the following flaws: The comparisons between the SMT or HEA and the medication group are of questionable validity. The latter group was treated in a different setting with medications that were only loosely described (e.g., unspecified doses and durations). Six participants in the medication group actually received no treatment.
The comparison between the SMT and the HEA groups is also problematic. There was no attempt to control for placebo effects, and the patient-therapist contact time differed considerably between groups. While the SMT group had an average of 15 “hands on” treatment sessions of 15 to 20 minutes each, the HEA group had two 1-hour sessions of instructions. Moreover, non-specific effects of patient-therapist interactions involving touch, verbal and non-verbal communications, could have affected the outcome.
In my view, reasonable conclusions from the reported data are that different therapeutic settings can lead to different outcomes, and that, despite strong non-specific effects, SMT is not better than HEA.
Reference List
1. Bonfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH. Spinal manipulation, medication or home exercise with advice for acute and subacute neck pain. A randomized trial. Ann Intern Med. 2012;156:1-10.
Conflict of Interest:None declared