Manipulative and Massage Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome
Not Applicable
- Conditions
- Fibromyalgia
- Registration Number
- NCT02864524
- Lead Sponsor
- Universidad de Almeria
- Brief Summary
Objective: Compare degree of improvement can reach patients diagnosed with fibromyalgia syndrome, by treatment with Manipulative and Massage Techniques versus an exercise program for lower thoracic and cervical spine.
Study Design: A single-blind randomized controlled trial was conducted on patients with fibromyalgia syndrome (FMS).
Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving manipulative and massage therapy, or to a control group for exercise program.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Diagnosed Fibromyalgia Syndrome.
- Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
- Agreement to attend evening therapy sessions.
- Non-practice of regular physical activity.
Exclusion Criteria
- A history of surgery.
- The presence of comorbid conditions (e.g., morbid obesity, inflammatory diseases, irritable bowel syndrome and interstitial cystitis).
- A history of whiplash injury.
- Severe physical disability.
- Uncontrolled endocrine disorders (e.g., hyperthyroidism, diabetes).
- Illness (e.g., schizophrenia or substance abuse).
- The use of medication other than as-needed analgesics (excluding long-term narcotics).
- Malignancy.
- Psychiatric disorders.
- A score of ≥ 9 points in the Beck depression inventory.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain Intensity Changes from Baseline, and 5 weeks A 10-point numerical scale (0 = no pain, 10: very severe pain)
- Secondary Outcome Measures
Name Time Method Schöber Test Changes from Baseline, and 5 weeks Pittsburgh Quality of Life Questionnaire Changes from Baseline, and 5 weeks McGill Pain Questionnaire Changes from Baseline, and 5 weeks Quality of Life Questionnaire (SF-36) Changes from Baseline, and 5 weeks Fibromyalgia Impact Questionnaire (FIQ) Changes from Baseline, and 5 weeks Fatigue Impact Scale (FIS) Changes from Baseline, and 5 weeks Beck Depression Inventory Changes from Baseline, and 5 weeks Pressure Algometry Changes from Baseline, and 5 weeks Hospital Anxiety and Depression Scale (HADS) Changes from Baseline, and 5 weeks
Trial Locations
- Locations (1)
Adelaida María Castro-Sánchez
🇪🇸Almeria, Spain
Adelaida María Castro-Sánchez🇪🇸Almeria, Spain