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Effects of non-surgical decompression therapy in addition to routine physical therapy on pain, range of motion, endurance, functional disability and quality of life versus routine physical therapy alone in patients with lumbar radiculopathy; a randomized controlled trial
Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Hanif A
BMC Musculoskeletal Disorders 2022 Mar 16;23(255):Epub
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Lumbar radiculopathy is an extensively common complaint reported by patients of low back pain (LBP), resulting in several impairments. A comparatively novel technique, non-surgical spinal decompression (NSD), is introduced, which uses a sensitive computerized feedback mechanism and decompresses the spinal nerve roots through segmental distraction. The objective of this study was to determine the effects of NSD therapy in addition to routine physical therapy on pain, lumbar range of motion (ROM), functional disability, back muscle endurance (BME), and quality of life (QOL) in patients with lumbar radiculopathy. METHODS: A total of sixty patients with lumbar radiculopathy were randomly allocated into two groups, an experimental (n = 30) and a control (n = 30) group, through a computer-generated random number table. Baseline values were recorded before providing any treatment by using a visual analogue scale (VAS), Urdu version of Oswestry Disability Index (ODI-U), Modified-Modified Schober's Test (MMST), prone isometric chest raise test, and Short Form 36-Item Survey (SF-36) for measuring the pain at rest, functional disability, lumbar ROM, BME, and QOL, respectively. All patients received twelve treatment sessions over 4 weeks, and then all outcome measures were again recorded. RESULTS: By using the ANCOVA test, a statistically significant (p < 0.05) between-group improvement was observed in VAS, ODI-U, BME, lumbar ROM, role physical (RP), and bodily pain (BP) domains of SF-36, which was in favour of NSD therapy group. The between-group difference was 1.07 +/- 0.32 cm (p < 0.001) for VAS, 5.65 +/- 1.48 points (p < 0.001) for ODI-U, 13.93 +/- 5.85 s (p = 0.002) for BME, 2.62 +/- 0.27 cm (p < 0.001) for lumbar flexion, 0.96 +/- 0.28 (p < 0.001) for lumbar extension, 5.77 +/- 2.39 (p = 0.019) for RP and 6.33 +/- 2.52 (p = 0.016) for BP domain of SF-36. For these outcomes, a medium to large effect size (d = 0.61 to 2.47, 95% CI 0.09 to 3.14) was observed. CONCLUSION: It was concluded that a combination of non-surgical spinal decompression therapy with routine physical therapy is more effective, statistically and clinically, than routine physical therapy alone in terms of improving pain, lumbar range of motion, back muscle endurance, functional disability, and physical role domain of quality of life, in patients with lumbar radiculopathy, following 4 weeks of treatment. TRIAL REGISTRATION: WHO Iranian registry of clinical trials (IRCT20190717044238N1) Dated: 23.12.2019.

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