Individualised Interactive Web-based Self-help Program and CBT-coaching in Combination With Physiotherapy for Patients With Persistent Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Self-perceived workability.
研究概览
简要总结
The aim of the study is to evaluate the effects of a the multimodal treatment with a web-based self-help program with cognitive behavioral therapy coaching and individual tailored physiotherapy on workability, health behavior and pain symptoms for persons with persistent pain.
详细描述
Purpose The aim of the study is to evaluate the effects of a the multimodal treatment with a web-based self-help program with cognitive behavioral therapy (CBT) coaching and individual tailored physiotherapy on workability, health behavior and pain symptoms for persons with persistent pain.
Design In this study, we will apply a Single Subject Experimental Design (SSED) with a six week baseline phase, a 16 week intervention phase and a six week follow-up phase after twelve month. Outcome measurements will be performed regularly during all phases.
Participants Approximately 12 participants, fulfilling inclusion and exclusion criteria will be included in the study.
Inclusion criteria:
Persons, with persistent or recurrent pain from the neck-shoulder or back, with a duration for at least three months, aged 18-63 years, scoring ≥ 90 on Linton´s questionnaire, indicating risk for continuous sick leave and development of persistent pain, who are disposable for labor market at least 25% are eligible for the study. The participants have to be fluent in the Swedish language.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons, with persistent or recurrent pain from the neck-shoulder or back, with a duration for at least three months,
- •aged 18-63 years,
- •scoring ≥ 90 on Linton´s questionnaire (indicating risk for continuous sick leave and development of persistent pain),
- •who are disposable for labor market at least 25% are eligible for the study.
- •They have to be fluent in the Swedish language.
排除标准
- •Patients with dementia and/or restricted cognitive functioning.
- •Persons with depression and/or anxiety. The latter will be screened with the Hospital Anxiety Depression Scale questionnaire.
- •Terminally ill patients,
- •comorbidity which might prevent treatment participation and ongoing causal treatment,
- •identified drug abuse,
- •retirement pension and ongoing pregnancy,
- •patients lacking internet attached computers in their home.
研究组 & 干预措施
Web-prog, followed by CBT + PT
This arm of the single system experimental design starts with a baseline phase of 8 weeks where the subjects are introduced into to the interactive web-based self-help program. The baseline-period is followed by the intervention period which consists of a continued use of the interactive web-based self-help program, now with with cognitive behavioral therapy coaching in combination with individually tailored physiotherapy according to the person's needs for 16 weeks.
干预措施: Base, followed by Web + CBT + PT (Behavioral)
Base, followed by Web + CBT + PT
The intervention consists of a interactive web-based selfadministrated program with cognitive behavioral therapy coaching in combination with tailored physiotherapy according to the person's needs for 16 weeks.
干预措施: Web-prog, followed by CBT + PT (Behavioral)
结局指标
主要结局
Self-perceived workability.
时间窗: Baseline, After intervention (16 weeks), 12 month
Self-perceived workability. This will be assessed using the self-rated questionnaire Work Ability Index, which is a reliable and valid questionnaire addressing a persons perceived work capacity. By complementing outcome variables as Days of sick leave/activity compensation with Work Ability Index we will minimize the risk of a type II-error due to local labor market conditions.
次要结局
- Health related quality of life(Baseline, After intervention (16 weeks), 12 month)
研究者
Peter Michaelson
Senior lecturer
Luleå Tekniska Universitet