Fibromyalgia Clinical Trial
Official title:
Benefits of Kinesio Taping and Inhibitory Treatment Techniques in Patients With Fibromyalgia Syndrome
NCT number | NCT02859467 |
Other study ID # | UAL-496 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | June 2024 |
Verified date | September 2023 |
Source | Universidad de Almeria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: Compare the benefits of Kinesio Taping and Inhibitory Treatment Techniques for Cervical, Thoracic and Lumbar Spine in Patients with Fibromyalgia Syndrome (FMS). Study Design: A single-blind randomized controlled trial was conducted on patients with FMS. Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving kinesio taping and inhibitory treatment techniques, or to a control group for exercises and electrical stimulation therapy.
Status | Suspended |
Enrollment | 64 |
Est. completion date | June 2024 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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); 6) 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Adelaida María Castro-Sánchez | Almería |
Lead Sponsor | Collaborator |
---|---|
Universidad de Almeria |
Spain,
Castro-Sanchez AM, Mataran-Penarrocha GA, Arroyo-Morales M, Saavedra-Hernandez M, Fernandez-Sola C, Moreno-Lorenzo C. Effects of myofascial release techniques on pain, physical function, and postural stability in patients with fibromyalgia: a randomized controlled trial. Clin Rehabil. 2011 Sep;25(9):800-13. doi: 10.1177/0269215511399476. Epub 2011 Jun 14. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. | Changes from Baseline, and 10 weeks | |
Secondary | Quality of Life (SF-36) | Changes from Baseline, and 10 weeks | ||
Secondary | Pittsburgh Quality of Sleep Questionnaire | Changes from Baseline, and 10 weeks | ||
Secondary | Beck Inventory for Depression | Changes from Baseline, and 10 weeks | ||
Secondary | Fibromyalgia Impact Questionnaire (FIQ) | Changes from Baseline, and 10 weeks | ||
Secondary | Hospital Anxiety Depression Scale (HADS) | Changes from Baseline, and 10 weeks | ||
Secondary | State-Trait Anxiety Inventory (STAI) | Changes from Baseline, and 10 weeks | ||
Secondary | McGill Pain Questionnaire | Changes from Baseline, and 10 weeks | ||
Secondary | Fatigue Impact Scale | Changes from Baseline, and 10 weeks | ||
Secondary | Pain Pressure | Changes from Baseline, and 10 weeks | ||
Secondary | Schöber Test | Changes from Baseline, and 10 weeks | ||
Secondary | Widespread pain index | Changes from Baseline, and 10 weeks | ||
Secondary | Symptom severity score | Changes from Baseline, and 10 weeks | ||
Secondary | Measurement Finger-Floor | symptom severity scale |
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