Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT02859467
Status:
SUSPENDED
Last Update Posted:
2023-09-21
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinesio Taping and Inhibitory Treatment Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Changes from Baseline, and 10 weeks', 'description': 'A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (SF-36)', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Pittsburgh Quality of Sleep Questionnaire', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Beck Inventory for Depression', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Hospital Anxiety Depression Scale (HADS)', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'McGill Pain Questionnaire', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Fatigue Impact Scale', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Pain Pressure', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Schöber Test', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Widespread pain index', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Symptom severity score', 'timeFrame': 'Changes from Baseline, and 10 weeks'}, {'measure': 'Measurement Finger-Floor', 'timeFrame': 'symptom severity scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical Therapy Modalities', 'Exercise', 'Electrical Stimulation Therapy', 'Bandages'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '27377815', 'type': 'BACKGROUND', '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.'}, {'pmid': '27296946', 'type': 'BACKGROUND', '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.'}, {'pmid': '27055444', 'type': 'BACKGROUND', '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.'}, {'pmid': '27014012', 'type': 'BACKGROUND', '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.'}, {'pmid': '27008285', 'type': 'BACKGROUND', '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.'}, {'pmid': '25457196', 'type': 'BACKGROUND', '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.'}, {'pmid': '23768283', 'type': 'BACKGROUND', '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.'}, {'pmid': '21673013', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21234327', 'type': 'BACKGROUND', '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.'}, {'pmid': '27473164', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Objective: Compare the benefits of Kinesio Taping and Inhibitory Treatment Techniques for Cervical, Thoracic and Lumbar Spine in Patients with Fibromyalgia Syndrome (FMS).\n\nStudy Design: A single-blind randomized controlled trial was conducted on patients with FMS.\n\nSetting: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Fibromyalgia Syndrome.\n* Limitation of usual activities due to pain on at least 1 day in the previous 30 days.\n* Agreement to attend evening therapy sessions.\n* Non-practice of regular physical activity.\n\nExclusion Criteria:\n\n* A history of surgery.\n* The presence of comorbid conditions (e.g., morbid obesity, inflammatory diseases, irritable bowel syndrome and interstitial cystitis).\n* A history of whiplash injury.\n* Severe physical disability.\n* uncontrolled endocrine disorders (e.g., hyperthyroidism, diabetes); 6) illness (e.g., schizophrenia or substance abuse).\n* The use of medication other than as-needed analgesics (excluding long-term narcotics).\n* Malignancy.\n* Psychiatric disorders.\n* A score of ≥ 9 points in the Beck depression inventory.'}, 'identificationModule': {'nctId': 'NCT02859467', 'briefTitle': 'Kinesio Taping and Inhibitory Treatment Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Almeria'}, 'officialTitle': 'Benefits of Kinesio Taping and Inhibitory Treatment Techniques in Patients With Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': 'UAL-496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinesio Taping and Inhibitory Treatment Techniques', 'description': 'During each session participants will receive the application kinesio taping in trapezius, infraspinatus and paravertebral muscles.\n\nInhibitory Treatment Techniques:\n\n* Release Technique of the trapezius muscle.\n* Release Technique for scalene muscles.\n* Technique suboccipital inhibition.\n* Technique hands crossed for induction dorsal superficial fascia.', 'interventionNames': ['Other: Kinesio Taping and Inhibitory Treatment Techniques']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise and Electrical Stimulation Therapy', 'description': 'Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.', 'interventionNames': ['Other: Exercise and Electrical Stimulation Therapy']}], 'interventions': [{'name': 'Kinesio Taping and Inhibitory Treatment Techniques', 'type': 'OTHER', 'description': 'Kinesio Taping on trapezius, infraspinatus, and paravertebral muscles\n\nInhibitory Treatment Techniques:\n\n* Release Technique of the trapezius muscle.\n* Release Technique for scalene muscles.\n* Technique suboccipital inhibition.\n* Technique hands crossed for induction dorsal superficial fascia.', 'armGroupLabels': ['Kinesio Taping and Inhibitory Treatment Techniques']}, {'name': 'Exercise and Electrical Stimulation Therapy', 'type': 'OTHER', 'description': 'Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.', 'armGroupLabels': ['Exercise and Electrical Stimulation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04120', 'city': 'Almería', 'country': 'Spain', 'facility': 'Adelaida María Castro-Sánchez', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Almeria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Adelaida María Castro-Sánchez', 'investigatorAffiliation': 'Universidad de Almeria'}}}}