Composite Regional Centre for Skill Development, Rehabilitation, and Empowerment of Persons with Disabilities, Lucknow, Uttar Pradesh, 226017, India.
Department of Physiotherapy, Integral University, Kursi Road, Lucknow, Uttar Pradesh, 226026, India.
Trials. 2023 May 9;24(1):319. doi: 10.1186/s13063-023-07316-x.
BACKGROUND: The role of pain sensitivity in the development and maintenance of chronic pain states, impaired executive functioning, and patient recovery is being investigated. Conditioned pain modulation (CPM) is widely used to measure musculoskeletal pain associated with central sensitization (CS). Despite the recommendations of many reviews and clinical practice guidelines that exercise programs reduce pain and disability, the overall confidence in these results is considered "critically low." The "active ingredient" of exercise programs and the dominant factor influencing CPM remain largely unknown. The objectives of this trial are to determine: • If different exercises cause different results on the CPM in a subgroup of people with chronic low back pain (CLBP) who are labeled as having CS pain, • If a program of exercise interventions for 12 weeks would alter executive functioning, quality of life (QoL), disability, and pain in persons with CLBP. • The relationship between patient characteristics, executive functions, CPM, and QoL METHODS: The trial is a randomized, controlled, multi-center study with four experimental groups and one healthy control group. Both the researchers and the people in the study will be blinded to the results. This paper describes the protocol for a trial examining the effects of 12-week individualized, twice-weekly exercise sessions lasting 30 to 60 min in persons with CLBP, who are positive for CS. Participants will be randomized to receive either patient education with motor control exercises (MCE), superficial strengthening (SS), aerobic exercises (AE), or patient education alone. Another group comprised of healthy volunteers will serve as controls. The primary outcomes are changes in CPM outcomes as measured by the cold pressor test (CPT). The secondary objectives are to evaluate executive functioning, pain, disability, quality of life, and spine muscle strength. The outcomes will be measured at 3 months and at a 6-month follow-up. DISCUSSION: The outcomes of the study will help in gaining more information and evidence about exercise-induced analgesia from the perspective of CPM. Measuring exercise outcomes will aid in scientifically prescribing exercise prescriptions in people with CLBP. The study outcomes will also assist in identifying the characteristics of individuals who will respond or respond indifferently to exercises. Investigating the relationship between the study's various outcomes could provide information for future trials. TRIAL REGISTRATION: Clinical Trials Registry of India (CTRI) identifier: CTRI/2022/03/041143. Registered on 16 March 2022.
背景:疼痛敏感性在慢性疼痛状态、执行功能障碍和患者康复的发展和维持中的作用正在研究中。条件性疼痛调制(CPM)广泛用于测量与中枢敏化(CS)相关的肌肉骨骼疼痛。尽管许多综述和临床实践指南建议运动方案可以减轻疼痛和残疾,但这些结果的整体置信度被认为“非常低”。运动方案的“有效成分”和影响 CPM 的主要因素在很大程度上仍然未知。本试验的目的是确定:
方法:该试验是一项随机、对照、多中心研究,有四个实验组和一个健康对照组。研究人员和研究对象都对结果不知情。本文描述了一项试验方案,该试验检查了为期 12 周的个体化、每周两次、每次 30 至 60 分钟的运动方案对 CS 阳性的 CLBP 患者的影响。参与者将被随机分配接受患者教育加运动控制练习(MCE)、浅表强化(SS)、有氧运动(AE)或仅接受患者教育。另一组由健康志愿者组成,作为对照组。主要结果是通过冷加压试验(CPT)测量的 CPM 结果的变化。次要目标是评估执行功能、疼痛、残疾、生活质量和脊柱肌肉力量。结果将在 3 个月和 6 个月的随访时进行测量。
讨论:该研究的结果将有助于从 CPM 的角度获得更多关于运动诱导镇痛的信息和证据。测量运动结果将有助于在 CLBP 患者中科学地开出运动处方。研究结果还将有助于确定对运动有反应或无反应的个体的特征。研究该研究各种结果之间的关系可以为未来的试验提供信息。
试验注册:印度临床试验注册处(CTRI)标识符:CTRI/2022/03/041143。于 2022 年 3 月 16 日注册。
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