Clinical Trial: Interactive Web-based Program and CBT-coaching With Physiotherapy for Patients With Chronic Musculoskeletal Pain

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Individualised Interactive Web-based Self-help Program and CBT-coaching in Combination With Physiotherapy for Patients With Persistent Musculoskeletal Pain

Brief Summary: 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.

Detailed Summary:

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.

Exclusion criteria:

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.

Ethical considerations The Ethical application has been from the
Sponsor: Luleå Tekniska Universitet

Current Primary Outcome: Self-perceived workability. [ Time Frame: 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.


Original Primary Outcome: Self-perceived workability. [ Time Frame: Baseline, After intervention (16 weeks), 12 month ]

Self-perceived workability. This will be assessed by 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.


Current Secondary Outcome: Health related quality of life [ Time Frame: Baseline, After intervention (16 weeks), 12 month ]

Health related quality of life will be measured using the RAND-36 questionnarie.


Original Secondary Outcome: Same as current

Information By: Luleå Tekniska Universitet

Dates:
Date Received: September 10, 2014
Date Started: September 2014
Date Completion: February 2017
Last Updated: September 22, 2016
Last Verified: September 2016