Tegner Heidi, Esbensen Bente Appel, Henriksen Marius, Bech-Azeddine Rachid, Lundberg Mari, Nielsen Louise, Rolving Nanna
Department of Occupational Therapy and Physiotherapy, Rigshospitalet, Valdemar Hansens Vej 13, 2600, Glostrup, Denmark.
Centre for Rheumatology and Spine Diseases, Rigshospitalet, Valdemar Hansens Vej 13, 2600, Glostrup, Denmark.
Trials. 2020 Sep 15;21(1):791. doi: 10.1186/s13063-020-04719-y.
Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life.
The study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient's self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery.
We hypothesize that, compared with the "usual care group", GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient's self-efficacy for exercise and quality of life.
www.clinicaltrials.gov NCT04103970 , Registered on 24 September 2019.
接受腰椎融合术（LSF）的慢性下腰痛患者身体活动不足，因此存在健康状况不佳的风险。在术后康复中，需要认识到身体活动的障碍。这项随机对照试验（RCT）的主要目的是研究由分级活动和疼痛教育（GAPE）组成的早期积极干预对接受LSF手术患者群体久坐行为的影响。次要目的是研究GAPE对残疾、疼痛、运动恐惧、运动自我效能感和健康相关生活质量的影响。
该研究是一项RCT，计划纳入144例因腰椎退变导致下腰痛而接受1-2节段LSF手术的患者。患者将被随机分配接受常规护理或常规护理加GAPE。GAPE包括在10周内由物理治疗师指导的9次个人治疗课程。总体目的是通过对患者进行疼痛教育，并基于认知行为视角，逐步增强患者身体活动的自我效能感并减少运动恐惧，从而减少久坐行为。物理治疗师将与患者合作规划干预措施。基于半结构化访谈和对患者家中情况的观察，他们将设定个性化的功能目标。主要结局将是久坐行为的减少，通过在基线（术前）以及术后3个月和12个月使用加速度计进行测量。次要结局将包括残疾、疼痛、运动恐惧、运动自我效能感和生活质量。次要结局数据将在基线（术前）以及术后3个月、6个月和12个月收集。
我们假设，与“常规护理组”相比，GAPE将主要导致久坐行为显著减少，其次是残疾、疼痛强度和运动恐惧的降低；此外，它将提高患者的运动自我效能感和生活质量。
www.clinicaltrials.gov NCT04103970，于2019年9月24日注册。
