Effects of Exercise and Cognitive Behavioural Therapy on Pain Perception and Related Biomediators in Fibromyalgia Patients - A Pilot Study
- Conditions
- M79.7Fibromyalgia
- Registration Number
- DRKS00004902
- Lead Sponsor
- Dept. Rehabilitation Medicine, Hannover Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 68
Female with 18 – 70 years old of age
- Patients understand German Language.
- American College of Rheumatology (ACR) criteria for fibromyalgia (Wolfe et al, 1990) is confirmed by physicians at Deparment of Rehabilitation Medicine, Hannover Medical School
- Patient has abnormal function of liver.
- Patient is pregnant.
- Patient discontinues aerobic exercise and CBT/patient education program 2 months ago
- Patient with endocrine or clinically significant chronic disease, such as diabetes, inflammatory bowel disease or organic brain disorders
- Patient has a recent or past history of psychiatric disorders, e.g. major depressive disorder, alcohol dependence, substance abuse, schizophrenic or paranoid disorders, personality disorder or somatoform disorders.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity that is measured by visual anaologue scale which is consisted of scale from 0(No pain) to 10 (The worst pain). This scale is assessed before treatment, after 12 weeks of treatment and after 6 months of the last treatment
- Secondary Outcome Measures
Name Time Method Questionnaires:<br>- fibromyalgia impact questionnaires (self administered)<br>Hospital Anxiety and Depression Score (self-administered),<br>SF-12 (self administered), <br>pain-related biomediators (interleukins) from serum are measured before treatment, after 12 weeks of treatment and after 6 months of the last treatment.<br>