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

September 22, 2016 updated by: Peter Michaelson, Luleå Tekniska Universitet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Norrbotten
      • Luleå, Norrbotten, Sweden
        • Primary health care centers in Norrbotten county council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Multimodal rehabilitation
The arm intervention is just multimodal rehabilitation.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Work ability
Time Frame: 4 month
4 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain rating
Time Frame: 12 month
Pain-rating is measured on a visual analog-scale
12 month
Self-efficacy in relation to workability
Time Frame: 12 month
Self-efficacy in relation to work-ability is measured by a questionnarie
12 month
General health
Time Frame: 12 month
General health is measured with SF-36 and EQ-5D.
12 month
Functional status
Time Frame: 12 month
Functional status is measured with Pain disability index.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luleå Tekniska Universitet

Collaborators

Norrbottens County Council

Investigators

  • Principal Investigator: Gunvor Gard, Professor, Luleå University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 16, 2011

First Posted (Estimate)

November 21, 2011

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REHSAM_NLL_LTU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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