Objectifying Performance Assessments and Personalized Rehabilitation Trajectories to Improve Return to Work in Patients With Persistent Spinal Pain Syndrome Type II: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 8
- 主要终点
- Work ability
研究概览
简要总结
A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work (RTW) compared with usual care.
详细描述
A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work compared with usual care.
The primary scientific objective is to examine whether the ability to work in PSPS-T2 patients after SCS implantation is different with a personalized biopsychosocial rehabilitation program specifically targeting RTW, compared to usual care. The secondary objective of the study is to examine if a personalized biopsychosocial rehabilitation program specifically targeting RTW, compared to usual care, is different in improving functional capacity, improving work status and participation, obtaining pain relief, increasing health-related quality of life, increasing functioning and physical activity, improving sleep quality, decreasing kinesiophobia, increasing self-management, decreasing anxiety and depression and decreasing healthcare expenditure.
Patients will be randomly allocated (1:1 ratio) to a personalized rehabilitation program or usual care using random, permuted blocks of 2 or 4 patients stratified by investigational site and the duration of sick leave. Participants randomly allocated to the usual care intervention will undergo the usual care trajectory. This program is delivered at each of the participating centres. Patients will follow the usual care as it is implemented in Belgian hospitals, after SCS implantation. Participants randomly allocated to the personalized biopsychosocial return to work program will receive an individualized 14-week rehabilitation program. Therapy is provided at each implantation centres and will start 6 weeks after definitive SCS implantation. Within a 14-week period, patients in this group receive treatment sessions from trained physiotherapists, occupational therapists and psychologists. All therapists will be trained by experts in the different therapy modalities.
Outcome assessments will take place at baseline, immediately before the intervention, immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent Spinal Pain Syndrome Type II (PSPS-T2)
- •Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment.
- •Dutch speaking persons
- •Patient has been informed of the study procedures and has given written informed consent
- •Patient willing to comply with study protocol including attending the study visits
排除标准
- •Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
- •Pregnancy
结局指标
主要结局
Work ability
时间窗: The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Work ability, evaluated with the Work Ability Index
次要结局
- Physical activity(The change between the baseline screening and the evaluation immediately after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Sleep quality(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Kinesiophobia(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Anxiety and depression(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Functional capacity evaluation(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Functional disability(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Work status and participation(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Overall pain intensity with Visual Analogue Scale (VAS)(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Health related quality of life(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
- Healthcare utilisation(The change in healthcare utilisation starting from the the baseline screening up to 12 months after the intervention.)
- Patients' individual competencies for self-management(The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.)
研究者
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel