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Effect of Specific Acupuncture Therapy Combined with Rehabilitation Training on Incomplete Spinal Cord Injury: A Randomized Clinical Trial.

ABSTRACT: Acupuncture therapies were used to treat spinal cord injury (SCI) and its complications. To assess the effect of a specific acupuncture therapy combined with rehabilitation training for inpatients with incomplete SCI, we conducted an assessor-blinded, randomized controlled clinical trial in the Department of Rehabilitation Medicine Center in West China Hospital, Sichuan University. Seventy-two participants diagnosed with incomplete SCI were randomly assigned into 3 groups of 24 patients each, with data collection completed in December, 2019. Participants were randomly assigned (1 : 1 : 1) to 3 groups to receive treatment for 4 weeks, 5 times/week of acupuncture for Continuous Acupuncture Treatment (CAT) group, 3 times/week for Intermittent Acupuncture Treatment (IAT) group, and no acupuncture for Control group; all 3 groups received routine rehabilitation training. The primary outcome was the change of American Spinal Injury Association (ASIA) motor score from baseline to week 4. Secondary outcomes included sensory score, Modified Barthel Index (MBI). At week 4, CAT group had a higher motor score and MBI score increase than the control group (mean difference 10.52, 17.36; p < 0.001, p < 0.01, respectively). CAT group had more increase in motor score and MBI than IAT group (mean difference 5.55, 14.77; p < 0.05, p < 0.05, respectively). But the difference among groups in the increase of sensory score was not statistically significant. Acupuncture resulted in a higher motor score and MBI after 4 weeks. And the dosage of 5/week led to more improvement in motor score and MBI than that of 3/week. The results suggested that a dosage of 5/week of acupuncture is safe and more effective for SCI than 3/week. But further research is needed to determine the best intervention dosage, long-term efficacy, and underlying mechanism. This trial is registered with ChiCTR1900021530.

SUBMITTER: Xiong F

PROVIDER: S-EPMC8720606 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIn recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the user-to-robot adaptation mechanisms responsible for functional improvement are still not adequately unveiled. This study aimed to (1) assess the safety and feasibility of using the HANK exoskeleton for walking rehabilitation, and (2) investigate the effects on walking function after a training program with it.MethodsA randomized controlled trial was conducted including a cohort of 23 patients with less than 1 year since injury, neurological level of injury (C2-L4) and severity (American Spinal Cord Injury Association Impairment Scale [AIS] C or D). The intervention was comprised of 15 one-hour gait training sessions with lower limb exoskeleton HANK. Safety was assessed through monitoring of adverse events, and pain and fatigue through a Visual Analogue Scale. LEMS, WISCI-II, and SCIM-III scales were assessed, along with the 10MWT, 6MWT, and the TUG walking tests (see text for acronyms).ResultsNo major adverse events were reported. Participants in the intervention group (IG) reported 1.8 cm (SD 1.0) for pain and 3.8 (SD 1.7) for fatigue using the VAS. Statistically significant differences were observed for the WISCI-II for both the "group" factor (F = 16.75, p < 0.001) and "group-time" interactions (F = 8.87; p < 0.01). A post-hoc analysis revealed a statistically significant increase of 3.54 points (SD 2.65, p < 0.0001) after intervention for the IG but not in the CG (0.7 points, SD 1.49, p = 0.285). No statistical differences were observed between groups for the remaining variables.ConclusionsThe use of HANK exoskeleton in clinical settings is safe and well-tolerated by the patients. Patients receiving treatment with the exoskeleton improved their walking independence as measured by the WISCI-II after the treatment.

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Effect of Specific Acupuncture Therapy Combined with Rehabilitation Training on Incomplete Spinal Cord Injury: A Randomized Clinical Trial.

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