- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859467
Kinesio Taping and Inhibitory Treatment Techniques
Benefits of Kinesio Taping and Inhibitory Treatment Techniques in Patients With Fibromyalgia Syndrome
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Almería, Spain, 04120
- Adelaida María Castro-Sánchez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Kinesio Taping and Inhibitory Treatment Techniques
During each session participants will receive the application kinesio taping in trapezius, infraspinatus and paravertebral muscles. Inhibitory Treatment Techniques:
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Kinesio Taping on trapezius, infraspinatus, and paravertebral muscles Inhibitory Treatment Techniques:
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Active Comparator: Exercise and Electrical Stimulation Therapy
Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.
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Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity
Time Frame: Changes from Baseline, and 10 weeks
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A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
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Changes from Baseline, and 10 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Quality of Life (SF-36)
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Pittsburgh Quality of Sleep Questionnaire
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Beck Inventory for Depression
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Hospital Anxiety Depression Scale (HADS)
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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State-Trait Anxiety Inventory (STAI)
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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McGill Pain Questionnaire
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Fatigue Impact Scale
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Pain Pressure
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Schöber Test
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Widespread pain index
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Symptom severity score
Time Frame: Changes from Baseline, and 10 weeks
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Changes from Baseline, and 10 weeks
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Measurement Finger-Floor
Time Frame: symptom severity scale
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symptom severity scale
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Castro-Sanchez AM, Mataran-Penarrocha GA, Granero-Molina J, Aguilera-Manrique G, Quesada-Rubio JM, Moreno-Lorenzo C. Benefits of massage-myofascial release therapy on pain, anxiety, quality of sleep, depression, and quality of life in patients with fibromyalgia. Evid Based Complement Alternat Med. 2011;2011:561753. doi: 10.1155/2011/561753. Epub 2010 Dec 28.
- Liptan G, Mist S, Wright C, Arzt A, Jones KD. A pilot study of myofascial release therapy compared to Swedish massage in fibromyalgia. J Bodyw Mov Ther. 2013 Jul;17(3):365-70. doi: 10.1016/j.jbmt.2012.11.010. Epub 2013 Jan 3.
- Yuan SL, Matsutani LA, Marques AP. Effectiveness of different styles of massage therapy in fibromyalgia: a systematic review and meta-analysis. Man Ther. 2015 Apr;20(2):257-64. doi: 10.1016/j.math.2014.09.003. Epub 2014 Oct 5.
- Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
- Saral I, Sindel D, Esmaeilzadeh S, Sertel-Berk HO, Oral A. The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial. Rheumatol Int. 2016 Oct;36(10):1379-89. doi: 10.1007/s00296-016-3473-8. Epub 2016 Apr 7.
- Ericsson A, Palstam A, Larsson A, Lofgren M, Bileviciute-Ljungar I, Bjersing J, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves physical fatigue in women with fibromyalgia: a randomized controlled trial. Arthritis Res Ther. 2016 Jul 30;18:176. doi: 10.1186/s13075-016-1073-3.
- Fernandez-de-Las-Penas C, Arendt-Nielsen L. Myofascial pain and fibromyalgia: two different but overlapping disorders. Pain Manag. 2016 May;6(4):401-8. doi: 10.2217/pmt-2016-0013. Epub 2016 Jun 14.
- Mendonca ME, Simis M, Grecco LC, Battistella LR, Baptista AF, Fregni F. Transcranial Direct Current Stimulation Combined with Aerobic Exercise to Optimize Analgesic Responses in Fibromyalgia: A Randomized Placebo-Controlled Clinical Trial. Front Hum Neurosci. 2016 Mar 10;10:68. doi: 10.3389/fnhum.2016.00068. eCollection 2016.
- Coppieters I, Cagnie B, Nijs J, van Oosterwijck J, Danneels L, De Pauw R, Meeus M. Effects of Stress and Relaxation on Central Pain Modulation in Chronic Whiplash and Fibromyalgia Patients Compared to Healthy Controls. Pain Physician. 2016 Mar;19(3):119-30.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAL-496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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