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ABSTRACT: 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 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. Limitation: Patients and providers could not be blinded. Conclusion: For patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks. Primary Funding Source: U.S. Department of Health and Human Services.
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ABSTRACT: Neck pain, common among the elderly population, has considerable implications on health and quality of life. Evidence supports the use of spinal manipulative therapy and exercise to treat neck pain; however, no studies to date have evaluated the effectiveness of these therapies specifically in seniors. To assess the relative effectiveness of spinal manipulative therapy (SMT) and supervised rehabilitative exercise (SRE), both in combination with and compared to home exercise (HE) alone for neck pain in individuals aged 65 years or older Study Design/Setting. Randomized clinical trial PATIENT SAMPLE: Individuals 65 years of age or older with a primary complaint of mechanical neck pain, rated ≥ 3 (0-10) for 12 weeks or longer in duration. Patient self-report outcomes were collected at baseline and 4, 12, 26, and 52 weeks after randomization. The primary outcome was pain, measured by an 11- box numerical rating scale. Secondary outcomes included disability (Neck Disability Index), general health status (Medical Outcomes Study SF-36), satisfaction (7-point scale), improvement (9-point scale), and medication use (days per week). This study was funded by the U.S. Department of Health and Human Services, Health Resources and Services Administration. Linear mixed model analyses were used for comparisons at individual time points and for short- and long-term analyses. Blinded evaluations of objective outcomes were performed at baseline and 12 weeks. Adverse event data were collected at each treatment visit. 241 participants were randomized, with 95% reporting primary outcome data at all time points. After 12 weeks of treatment, the SMT with home exercise group demonstrated a 10 percentage point greater decrease in pain compared to the home exercise alone group, and 5 percentage point change over supervised plus home exercise. A decrease in pain favoring supervised plus home exercise over home exercise alone did not reach statistical significance. Compared to the home exercise alone group, both combination groups reported greater improvement at week 12 and more satisfaction at all time points. Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with home exercise group was superior to the home exercise alone group in both the short- and long-term. No serious adverse events were observed as a result of the study treatments. SMT with home exercise resulted in greater pain reduction after 12 weeks of treatment compared to both supervised plus home exercise, and home exercise alone. Supervised exercise sessions added little benefit to the home exercise alone program.
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