Back to resultsDevelopment of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise and education
Education
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, chronic pain, physical, exercise, activity, education
Eligibility Criteria
Inclusion Criteria:
- Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years.
Exclusion Criteria:
- Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period
Sites / Locations
- Alingsas Primary Health Care
- Göteborg Primary Health Care
- Uddevalla Primary Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Exercise and education
Education only
Outcomes
Primary Outcome Measures
Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)
Secondary Outcome Measures
Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue
Full Information
NCT ID
NCT00545649
First Posted
October 16, 2007
Last Updated
October 16, 2007
Sponsor
Göteborg University
Collaborators
The Swedish Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00545649
Brief Title
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
Official Title
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Göteborg University
Collaborators
The Swedish Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment.
Detailed Description
164 patients with fibromyalgia and chronic widespread pain were randomized to an exercise-education group or to education-only group. The study period was 20 week. The primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact Questionnaire. Several other self-administered instruments were included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, chronic pain, physical, exercise, activity, education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Exercise and education
Arm Title
2
Arm Type
Active Comparator
Arm Description
Education only
Intervention Type
Behavioral
Intervention Name(s)
Exercise and education
Intervention Type
Behavioral
Intervention Name(s)
Education
Primary Outcome Measure Information:
Title
Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)
Time Frame
2004-2007
Secondary Outcome Measure Information:
Title
Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue
Time Frame
2004-2007
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years.
Exclusion Criteria:
Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisa Mannerkorpi, Ass prof
Organizational Affiliation
Göteborg University, Institute of Medicine, Department of Rheumatology and Inflammation Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kaisa Mannerkorpi, Ass prof
Organizational Affiliation
Göteborg University, Institute of Medicine, Department of Rheumtology and Inflammation Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alingsas Primary Health Care
City
Alingsas
Country
Sweden
Facility Name
Göteborg Primary Health Care
City
Göteborg
Country
Sweden
Facility Name
Uddevalla Primary Health Care
City
Uddevalla
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
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