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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014