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

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ClinicalTrials.gov Identifier: NCT01475591
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : September 23, 2016
Norrbottens County Council
Information provided by (Responsible Party):
Peter Michaelson, Luleå Tekniska Universitet

Brief 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.

Condition or disease Intervention/treatment
Musculoskeletal Pain Behavioral: Web-based multimodal rehabilitation based on cognitive based principles

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care
Study Start Date : October 2011
Primary Completion Date : June 2014
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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).

Primary Outcome Measures :
  1. Work ability [ Time Frame: 4 month ]

Secondary Outcome Measures :
  1. Pain rating [ Time Frame: 12 month ]
    Pain-rating is measured on a visual analog-scale

  2. Self-efficacy in relation to workability [ Time Frame: 12 month ]
    Self-efficacy in relation to work-ability is measured by a questionnarie

  3. General health [ Time Frame: 12 month ]
    General health is measured with SF-36 and EQ-5D.

  4. Functional status [ Time Frame: 12 month ]
    Functional status is measured with Pain disability index.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475591

Primary health care centers in Norrbotten county council
Luleå, Norrbotten, Sweden
Sponsors and Collaborators
Luleå Tekniska Universitet
Norrbottens County Council
Principal Investigator: Gunvor Gard, Professor Luleå University of Technology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Michaelson, Senior lecturer, Luleå Tekniska Universitet
ClinicalTrials.gov Identifier: NCT01475591     History of Changes
Other Study ID Numbers: REHSAM_NLL_LTU
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by Peter Michaelson, Luleå Tekniska Universitet:
persistent neuromusculoskeletal pain
pain syndrome

Additional relevant MeSH terms:
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms