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Clinical Trial Details — Status: Suspended

Administrative data

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

Study information

Verified date September 2023
Source Universidad de Almeria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesio Taping and Inhibitory Treatment Techniques
Kinesio Taping on trapezius, infraspinatus, and paravertebral muscles Inhibitory Treatment Techniques: Release Technique of the trapezius muscle. Release Technique for scalene muscles. Technique suboccipital inhibition. Technique hands crossed for induction dorsal superficial fascia.
Exercise and Electrical Stimulation Therapy
Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.

Locations

Country Name City State
Spain Adelaida María Castro-Sánchez Almería

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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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