Elsevier

The Spine Journal

Volume 11, Issue 7, July 2011, Pages 585-598
The Spine Journal

Clinical Study
Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial

https://doi.org/10.1016/j.spinee.2011.01.036Get rights and content

Abstract

Background context

Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interventions, for example, home exercise, remains inconclusive in CLBP populations.

Purpose

The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP.

Study design/setting

An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA.

Patient sample

Individuals, 18 to 65 years of age, who had a primary complaint of mechanical LBP of at least 6-week duration with or without radiating pain to the lower extremity were included in this trial.

Outcome measures

Patient-rated outcomes were pain, disability, general health status, medication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase.

Methods

This prospective randomized clinical trial examined the short- (12 weeks) and long-term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards.

Results

A total of 301 individuals were included in this trial. For all three treatment groups, outcomes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term.

Conclusions

For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for these individual outcomes.

Introduction

Evidence & Methods

Many nonsurgical interventions have been shown to make a small, but positive, impact on patients with chronic low back pain. This article compares three such interventions.

This is a prospective randomized clinical trial with 300 subjects having “mechanical back pain.” The authors found that supervised exercise aimed at trunk musculature provided better improvement in trunk strength than spinal manipulation or home exercise. Satisfaction was statistically better with the trunk strengthening program at some, but not all, data points. All other outcome measures, however, demonstrated no statistical differences between groups.

In a randomized clinical trial of this size, the chances of missing a major clinical superiority of one treatment are very small. The most impressive outcome appears to be the lack of clear and meaningful clinical advantage. In that respect, the study will likely be interpreted in different ways by different stakeholders. Some might focus on the demonstrable ability to increase trunk strength despite the failure of this outcome to translate into meaningful clinical differences. Others might be impressed by the unsupervised home exercise—a nearly “benign neglect” alternative—with little apparent clinical downside. Still others may cite the finding that popular chiropractic interventions produced similar outcomes despite a passive-patient approach. Previous work suggests that patient preference may be as important a clinical predictor as the actual intervention.

—The Editors

The impact of low back pain (LBP) is substantial with an estimated lifetime prevalence of up to 80% [1]. Moreover, 75% of back pain sufferers experience lingering problems 1 year after onset [2]. In the United States, the costs attributable to LBP continue to increase and are now estimated to exceed $100 billion annually [3]. The societal cost of LBP is more than financial, with many patients developing psychological distress and illness behaviors, which can be as disabling as the LBP itself [4].

There is no established standard care for chronic LBP (CLBP), but several conservative therapies have demonstrated benefit, including different forms of intensive supervised exercise and spinal manipulative therapy (SMT) [5], [6], [7], [8], [9]. Less costly and time-consuming self-care interventions, such as home exercise, have been shown to be effective for acute and subacute LBP; however, the evidence to support their use for CLBP remains inconclusive [10].

The purpose of this randomized clinical trial was to examine the relative short- and long-term efficacy of high-dose, supervised low-tech trunk exercise and chiropractic SMT for the treatment of LBP of at least 6-week duration and to compare the two interventions to a short course of home exercise.

Section snippets

Design

This study used a mixed-methods approach. The design was a prospective, observer-blinded, parallel-group, randomized clinical trial. A multifaceted qualitative study was also conducted alongside the randomized study. The trial was conducted at the Wolfe-Harris Center for Clinical Studies at the Northwestern Health Sciences University in Bloomington, MN, USA. The study was approved by the institutional review boards of the Northwestern Health Sciences University, the Minneapolis Medical Research

Results

A total of 630 individuals were evaluated for the study, of which 301 were randomized. A summary of patient recruitment, participation, and attrition during the study is shown in Fig. 1. Overall, adherence to study interventions was high with 96% of the SMT group, 86% of the SET group, and 96% of the HEA group attending the predefined compliance threshold (80% of their treatment visits). Table 1 shows the demographic and baseline clinical characteristics of all randomized participants.

Principal findings

This study demonstrated that CLBP patients who received supervised trunk exercise were most satisfied with care during the treatment and follow-up periods and experienced the greatest gains in trunk strength and endurance at the end of treatment. Both the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group over the two other groups, but the differences were

Conclusions

For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups for patient-rated pain, disability, global improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for those outcomes. To

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  • Cited by (0)

    FDA device/drug status: not applicable.

    Author disclosures: GB: Nothing to disclose. MJM: Nothing to disclose. RLE: Nothing to disclose. CAS: Nothing to disclose. YB: Nothing to disclose. KHS: Nothing to disclose. RHG: Consulting: Pfizer (B); Speaking/Teaching Arrangements: Merck (B), Takeda (B); Scientific Advisory Board: Pfizer (B); Research Support (Investigator Salary): Roche (B); Grants: National Institute on Aging (B). EFO: Nothing to disclose. TAG: Royalties: MSD (F); Fellowship Support: Synthes (F), Stryker (F), Abbot (F), MSD (F). EET: Royalties: Medtronic (F); Consulting: Medtronic (F); Speaking/Teaching Arrangements: Stryker (B); Trips/Travel: Medtronic (A); Scientific Advisory Board: United Health Care (B); Fellowship Support: Medtronic (E, Paid to institution/employer), Synthes Spine (E, Paid to institution/employer), Zimmer Spine (C, Paid to institution/employer).

    The disclosure key can be found on the Table of Contents and at www.TheSpineJournalOnline.com.

    Trial Registration: ClinicalTrials.gov NCT00269347.

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