A Pilot Randomized, Controlled Trial of the Effectiveness of Pain Neuroscience Education on Pain Intensity, Patients' Attitudes and Beliefs About Pain, Disability and Quality of Life After Arthroscopic Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Kinesiophobia
研究概览
简要总结
The aim of this study was to evaluate the effects of a 8-week pain neuroscience education programme compared to a biomedical education programme on the rehabilitation of patients who undergo arthroscopic rotator cuff repair. Outcome measures included pain intensity, patients' attitudes and beliefs about pain, disability and quality of life.
详细描述
This was a single-blinded, randomized parallel study. Twenty- nine patients who undergo arthroscopic rotator cuff repair took part in a multimodal physiotherapy programme and were allocated to two groups. Patients in the experimental group - PNE (n= 16) received multimodal physiotherapy along with pain neuroscience education, and the control group- PME (n=13) received multimodal physiotherapy along with biomedical education. The multimodal treatment included 1-hour sessions 3 times per week for 8 weeks (24 sessions). In addition, the education component (PNE, PME) consisted of 4 education sessions of 30 minutes duration, on a one-to-one basis, once per week at the start of the programme.
Physiotherapists involved in the delivery of the interventions were previously trained on both, the theoretical and practical aspects related to the protocols of multimodal physiotherapy and specially on the education component.
Outcome measures included pain intensity (pain intensity numerical rating score), catastrophizing, kinesiophobia, disability and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People aged 30 to 59 years with shoulder pain for more than three months, with torn rotator cuff repaired by arthroscopy.
排除标准
- •Subjects unable to understand, read or speak Spanish, or participated in a programme for psychological management of chronic pain, or presented with generalised pain.
结局指标
主要结局
Kinesiophobia
时间窗: From baseline to the end of intervention (8 weeks)
Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK-11), a 44-point self-administered instrument with MCID established at 6.0 points
Change Pain intensity: visual analogue scale
时间窗: From baseline to the end of intervention (8 weeks)
The visual analogue scales is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a point in a straight horizontal line of fixed length, usually 10 cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best). The Minimal Clinically Important Difference (MCID) in subjects with shoulder pain is 2.2 cm.
Pain catastrophizing
时间窗: From baseline to the end of intervention (8 weeks)
Pain catastrophic was assessed using the Patient Catastrophizing Scale (PCS), a 52-point self-administered instrument with MCID of 4.5 points.
Disability
时间窗: From baseline to the end end of intervention (8 weeks)
The degree of disability was assessed with the QuickDASH questionnaire, a self-administered instrument which expresses the degree of disability as a percentage on a scale of 0-100%, with MCID of 8% in subjects with shoulder pain.
Health-related quality of life: 5-dimension EuroQol questionnaire
时间窗: From baseline to the end of intervention (8 weeks)
The health-related quality of life was assessed with the 5-dimension EuroQol questionnaire, with MCID established on a scale of 0.03-0.52 in the population with musculoskeletal pain.
次要结局
未报告次要终点
研究者
Jorge Fuentes
Principal investigator
Universidad Católica del Maule