Interactive Web-based Program and CBT-coaching With Physiotherapy for Patients With Chronic Musculoskeletal Pain
Individualised Interactive Web-based Self-help Program and CBT-coaching in Combination With Physiotherapy for Patients With Persistent Musculoskeletal Pain
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedSeptember 23, 2016
September 1, 2016
1.8 years
September 10, 2014
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-perceived workability.
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.
Baseline, After intervention (16 weeks), 12 month
Secondary Outcomes (1)
Health related quality of life
Baseline, After intervention (16 weeks), 12 month
Other Outcomes (2)
Self-efficacy in relation to pain
Baseline, After intervention (16 weeks), 12 month
Pain intensity
Baseline, after intervention (16 weeks), 12 month
Study Arms (2)
Web-prog, followed by CBT + PT
EXPERIMENTALThis 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.
Base, followed by Web + CBT + PT
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Luleå Tekniska Universitetlead
- County Council of Norrbotten, Swedencollaborator
Study Sites (1)
Luleå university of Technology
Luleå, Norrbotten County, 97187, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mai Lindstrom, Dean
Luleå University of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior lecturer
Study Record Dates
First Submitted
September 10, 2014
First Posted
March 4, 2015
Study Start
September 1, 2014
Primary Completion
June 1, 2016
Study Completion
February 1, 2017
Last Updated
September 23, 2016
Record last verified: 2016-09