Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care

Musculoskeletal Pain Clinical Trial

Official title:

Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475591
• Other study ID #: REHSAM_NLL_LTU
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: September 22, 2016
• Start date: October 2011
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: Luleå Tekniska Universitet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The aim is to evaluate effects of early individually tailored web-based multimodal rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary health care. The aim is also to study if this early web-based pain rehabilitation program is more cost-effective than only multimodal rehabilitation. Randomization will be done at each primary health care centre after screening to 1) Multimodal pain rehabilitation with web-based education and coaching support or 2) multimodal pain rehabilitation. The investigators suggest a clear rehabilitation chain where a web-based program is developed,evaluated and ready to implement if it shows positive effects on work-ability and/or is cost-effective. The research and implementation will be performed in a close cooperation with Luleå University of Technology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 63 Years

Eligibility

Inclusion Criteria:

• With persistent neuromusculoskeletal pain from the neck/shoulder/back-area and/or fibromyalgia and a screening

• > 90 on Lintons´ questionnaire, The Örebro Musculoskeletal Pain Questionnaire (Linton & Halldén., 1998; Hockings et.al., 2008)

• Fluent in Swedish language

• Working, or in disposition to at least 25%

Exclusion Criteria are persons with:

• Dementia

• Restricted cognitive functioning

• Comorbidity which might prevent treatment participation

• Identified abuse, retirement pension

• Ongoing causal treatment

• Pregnancy

• Patients lacking internet attached computers in their home

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Behavioral:
• Web-based multimodal rehabilitation based on cognitive based principles
The patient will be randomized to either the interventions group (multimodal pain rehabilitation with an added web-based multimodal rehabilitation with CBT-influences) or a control group (multimodal pain rehabilitation).

Locations

Country	Name	City	State
Sweden	Primary health care centers in Norrbotten county council	Luleå	Norrbotten

Sponsors (2)

Lead Sponsor	Collaborator
Luleå Tekniska Universitet	Norrbottens County Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work ability		4 month	No
Secondary	Pain rating	Pain-rating is measured on a visual analog-scale	12 month	No
Secondary	Self-efficacy in relation to workability	Self-efficacy in relation to work-ability is measured by a questionnarie	12 month	No
Secondary	General health	General health is measured with SF-36 and EQ-5D.	12 month	No
Secondary	Functional status	Functional status is measured with Pain disability index.	12 month	No