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

This study is currently recruiting participants.

Verified March 2013 by Luleå Tekniska Universitet

Sponsor:

Collaborator:

Norrbottens county council

Information provided by (Responsible Party):

Peter Michaelson, Luleå Tekniska Universitet

ClinicalTrials.gov Identifier:

NCT01475591

First received: November 1, 2011

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Purpose

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.

Condition	Intervention
Musculoskeletal Pain	Behavioral: Web-based multimodal rehabilitation based on cognitive based principles

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by Luleå Tekniska Universitet:

Primary Outcome Measures:

Work ability [ Time Frame: 4 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain rating [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Pain-rating is measured on a visual analog-scale
Self-efficacy in relation to workability [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Self-efficacy in relation to work-ability is measured by a questionnarie
General health [ Time Frame: 12 month ] [ Designated as safety issue: No ]
General health is measured with SF-36 and EQ-5D.
Functional status [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Functional status is measured with Pain disability index.

Estimated Enrollment:	200
Study Start Date:	October 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

Eligibility

Ages Eligible for Study:	18 Years to 63 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475591

Contacts

Contact: Peter Michaelson, PhD

+46-727294981

peter.michaelson@ltu.se

Locations

Sweden
Primary health care centers in Norrbotten county council	Recruiting
Luleå, Norrbotten, Sweden
Contact: Margareta Eriksson, PhD margareta.eriksson@nll.se

Sponsors and Collaborators

Luleå Tekniska Universitet

Norrbottens county council

Investigators

Principal Investigator:

Gunvor Gard, Professor

Luleå University of Technology

More Information

No publications provided

Responsible Party:	Peter Michaelson, Senior lecturer, Luleå Tekniska Universitet
ClinicalTrials.gov Identifier:	NCT01475591 History of Changes
Other Study ID Numbers:	REHSAM_NLL_LTU
Study First Received:	November 1, 2011
Last Updated:	March 4, 2013
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Luleå Tekniska Universitet:

persistent neuromusculoskeletal pain
neck
shoulder
back-area

risk
longlasting
pain syndrome

ClinicalTrials.gov processed this record on May 19, 2013

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