Spinal Manipulation, Medication, or Home Exercise With Advice for Acute and Subacute Neck Pain: A Randomized Trial

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Spinal Manipulation, Medication, or Home Exercise With Advice for Acute and Subacute Neck Pain:  A Randomized Trial

Gert Bronfort, DC, PhD; Roni Evans, DC, MS; Alfred V. Anderson, DC, MD;
Kenneth H. Svendsen, MS; Yiscah Bracha, MS; and Richard H. Grimm, MD, MPH, PhD

Northwestern Health Sciences University,
Pain Management and Rehabilitation Center,
Minneapolis, Minnesota, USA.
gbronfort@nwhealth.edu



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.


From the FULL TEXT Article:

Introduction

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.


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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