Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Guru Gobind Singh Indraprastha University, New Delhi, India.
Department of Physiotherapy, Gurugram University, GURGAON, India.
Trials. 2024 Sep 2;25(1):580. doi: 10.1186/s13063-024-08430-0.
Individuals with spinal cord injury (SCI) often suffer from neuropathic pain which is often disabling and negatively affects function, participation, and quality of life (QoL). Pharmacological treatments lack efficacy in neuropathic pain reduction hence studying alternatives to drug treatment is necessary. Preclinical evidence of various aerobic exercises has shown positive effects on neuropathic pain but scientific studies investigating its effect in the SCI human population are limited.
This study is a double-blind, parallel, two-group, randomized controlled trial with an interventional study design that aims to evaluate the effectiveness of aerobic exercise program on neuropathic pain and quality of life (QoL) in individuals with chronic paraplegia. Thirty individuals with chronic paraplegia with the neurological level of injury from T2 to L2 will be recruited from the rehabilitation department at a super specialty hospital based on the inclusion criteria. Using a 1:1 allocation ratio, the participants will be randomly assigned to one of the two groups. The intervention group will perform high-intensity interval training (HIIT) aerobic exercise using an arm ergometer based on their peak heart rate, and the control group will perform free-hand arm aerobic exercise. In both groups, the intervention will be delivered as 30-min sessions, four times a week for 6 weeks.
International Spinal Cord Injury Pain Basic Data Set Version 3.0 will be used for diagnosing and assessing neuropathic pain and its interference with day-to-day activities, mood, and sleep. The International Spinal Cord Society (ISCoS) QoL basic data set will be used to assess QoL, and 6-min push test distance will be used to assess peak heart rate and aerobic capacity.
The effectiveness of the aerobic exercise program will be assessed based on the changes in neuropathic pain score and its interference with day-to-day activities, mood, sleep, QoL, and aerobic capacity after 3 weeks mid-intervention and after 6 weeks post-intervention. The trial will provide new knowledge about the effectiveness of the aerobic exercise program in improving neuropathic pain and QoL in individuals with chronic paraplegia.
Clinical Trials Registry-India CTRI/2023/08/056257. Registered on 8 August 2023.
脊髓损伤（SCI）患者常患有神经性疼痛，这种疼痛常常使人丧失能力，并对功能、参与度和生活质量（QoL）产生负面影响。药物治疗在减轻神经性疼痛方面效果有限，因此有必要研究药物治疗以外的替代方法。各种有氧运动的临床前证据表明其对神经性疼痛有积极影响，但研究 SCI 人群中这种影响的科学研究有限。
这是一项双盲、平行、两臂、随机对照试验，采用干预性研究设计，旨在评估有氧运动方案对慢性截瘫患者神经性疼痛和生活质量（QoL）的有效性。将根据纳入标准从一家专科医院的康复科招募 30 名损伤神经节段为 T2 至 L2 的慢性截瘫患者。采用 1:1 分配比例，将参与者随机分配到两组中的一组。干预组将根据峰值心率使用手臂测功计进行高强度间歇训练（HIIT）有氧运动，对照组将进行徒手手臂有氧运动。在两组中，干预将以 30 分钟的课程进行，每周 4 次，持续 6 周。
国际脊髓损伤疼痛基本数据集版本 3.0 将用于诊断和评估神经性疼痛及其对日常活动、情绪和睡眠的干扰。国际脊髓学会（ISCoS）QoL 基本数据集将用于评估 QoL，6 分钟推测试距离将用于评估峰值心率和有氧运动能力。
将根据 3 周中期干预和 6 周后干预后神经性疼痛评分及其对日常活动、情绪、睡眠、QoL 和有氧运动能力的干扰变化来评估有氧运动方案的有效性。该试验将提供关于有氧运动方案在改善慢性截瘫患者神经性疼痛和 QoL 方面的有效性的新知识。
印度临床试验注册中心 CTRI/2023/08/056257。于 2023 年 8 月 8 日注册。
