Spinal Manipulation and Home Exercise With Advice for Subacute and Chronic
Back-related Leg Pain: A Trial With Adaptive Allocation
SOURCE: Annals of Internal Medicine 2014 (Sep 16); 161 (6): 381—391
Gert Bronfort, DC, PhD; Maria A. Hondras, DC, MPH;
Craig A. Schulz, DC, MS; Roni L. Evans, DC, PhD;
Cynthia R. Long, PhD; and Richard Grimm, MD, PhD
University of Minnesota,
Northwestern Health Sciences University, and
Berman Center for Outcomes and Clinical Research at
the Minneapolis Medical Research Foundation,
Minneapolis, Minnesota, and
Palmer Center for Chiropractic Research,
Davenport, Iowa.
BACKGROUND: Back-related leg pain (BRLP) is often disabling and costly, and there is a paucity of research to guide its management.
OBJECTIVE: To determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with BRLP.
DESIGN: Controlled pragmatic trial with allocation by minimization conducted from 2007 to 2011.
(ClinicalTrials.gov: NCT00494065).
SETTING: 2 research centers (Minnesota and Iowa).
PATIENTS: Persons aged 21 years or older with BRLP for least 4 weeks.
INTERVENTION: 12 weeks of SMT plus HEA or HEA alone.
MEASUREMENTS: The primary outcome was patient-rated BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks. Blinded objective tests were done at 12 weeks.
RESULTS: Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over home exercise and advice (HEA) (difference, 10 percentage points [95% CI, 2 to 19]; P=0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P=0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.
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LIMITATION: Patients and providers could not be blinded.
CONCLUSION: For patients with back-related leg pain (BRLP), SMT plus home exercise and advice (HEA) was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.
From the FULL TEXT Article:
Background
Back-related leg pain (BRLP) is an important symptom commonly associated with pervasive low back pain (LBP) conditions and, despite its socioeconomic effect, has been generally understudied. With poorer prognosis and quality of life, persons with BRLP have greater pain severity and incur more work loss, medication use, surgery, and health-related costs than those with uncomplicated LBP. [1–6]
Most patients with BRLP are treated with prescription medications and injections, although little to no evidence supports their use. [7, 8] Surgical approaches are also commonly applied, although there is only some evidence for short-term effectiveness compared with less invasive treatments. [9] Concerns are mounting about the overuse, costs, and safety of these conventional medical treatments [10–18], warranting identification of more conservative treatment options. Spinal manipulative therapy (SMT), exercise, and education promoting self-management are increasingly recommended as low-risk strategies for BRLP. [19] Although limited, evidence shows that these conservative approaches can be effective. [20–26] A recent systematic review by our group showed that SMT is superior to sham SMT for acute BRLP in the short and long term; however, the evidence for subacute and chronic BRLP is inconclusive, and high-quality research is needed to inform clinical and health policy decisions. [20] The underlying mechanisms of SMT seem to be multifactorial, including improvement in spinal stiffness, muscle recruitment, and synaptic efficacy of central neurons. [27, 28]
The purpose of this study was to test the hypothesis that the addition of SMT to home exercise and advice (HEA) would be more effective than HEA alone for patients with subacute and chronic BRLP.
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