Trial record 2 of 16 for:    michaelson

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
  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
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 April 16, 2014