Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-22 @ 8:51 AM
Study NCT ID:
NCT02611193
Status:
UNKNOWN
Last Update Posted:
2015-11-20
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-18', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Boston Carpal Tunnel Questionnaire', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'self-administered questionnaire for the assessment of severity of symptoms and functional status in patients who have carpal tunnel syndrome. It has two distinct scales : a symptom-severity scale (11\n\n\\- Page 2 of 3 \\[DRAFT\\] - items) and a functional-status scale (8 items). It has been validated and demonstrated to show good responsiveness and reliability in evaluating outcome after carpal tunnel release. The Spanish version has been validated'}], 'secondaryOutcomes': [{'measure': 'Change in DASH Outcome Measure', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '30-item, self-report questionnaire designed to measure physical function and symptoms in people with a musculoskeletal disorder of the upper limb. It showed a large degree of responsiveness after CTS treatment and the Spanish version has been validated'}, {'measure': 'Change in Visual Analog Scale for pain', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'VAS has eleven points from 0 to 10, being 0 no pain at all, and 10 the worst pain could ever be imagined'}, {'measure': 'Change in EuroQol-5D scale', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': "Quality-of-life's measure instrument which consists of a combination of a 5 items questionnaire and a Visual analogue scale. Both validity and responsiveness have been demonstrated in patients with chronic pain, and it has been evaluated in patients with CTS symptoms. The Spanish version has been validated"}, {'measure': 'Change in strength (Dynamometer)', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'Measuring pulp pinch strength with digits I and II'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of CTS. Study design: Two-groups randomized single-blind interventional study.', 'detailedDescription': "Background: Carpal Tunnel Syndrome (CTS) is the most common compressive neuropathy in the upper limb. It considerably impairs patient's quality of life and generates important social consequences due to the lost of productivity and the cost of treatments. Both surgical and conservative treatment are utilized for CTS management. Manipulative treatment is a conservative, non-drug and cheap management option which can be proposed, but by now, treatment guidelines and reviews do not recommend it due to lack of evidence to assess his efficacy.\n\nHypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of CTS.\n\nStudy design: Two-groups randomized single-blind interventional study. Methods: Sixty-six patients reporting CTS symptoms that are confirmed by clinical exam and nerve conduction studies will be included. Participants will be randomized in two arms, one receiving manipulative treatment and one receiving simulated manipulative treatment (1/week for 4 weeks). The main outcome measures will be the DASH questionnaire, the Boston Carpal Tunnel Syndrome Questionnaire, patient estimate on Visual Analog Scale for pain and the EuroQol-5D scale. All outcomes measures will be administrated to participants before the first manipulation, after the last session (4 weeks) and 12 weeks after the baseline measure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of canal tunnel syndrome (CTS) : pain, numbness, paresthesia, diminished grip strength\n* Electromyography confirming CTS\n\nExclusion Criteria:\n\n* Previous surgical procedure for CTS in the same wrist\n* Possible secondary CTS : hypothyroidism, diabetes mellitus, pregnancy, rheumatologic diseases, neck or shoulder complaints,\n* Hand and wrist pathological conditions as previous disease, intervention, traumatism, anatomic abnormalities in shape or size.'}, 'identificationModule': {'nctId': 'NCT02611193', 'briefTitle': 'Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}, 'officialTitle': 'Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MOM-STC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manipulative treatment', 'description': 'Manipulative Treatment', 'interventionNames': ['Procedure: Manipulative treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Simulated manipulative treatment', 'description': 'Simulated manipulative treatment', 'interventionNames': ['Procedure: Simulated manipulative treatment']}], 'interventions': [{'name': 'Manipulative treatment', 'type': 'PROCEDURE', 'description': 'Manipulative treatment as described by the GBMOIM (Grupo Barcelona de Medicina Ortopédica y Manual) will be perform with extension of the transverse carpal ligament maneuver and fascia release maneuver', 'armGroupLabels': ['Manipulative treatment']}, {'name': 'Simulated manipulative treatment', 'type': 'PROCEDURE', 'description': 'Simulated Manipulative Treatment', 'armGroupLabels': ['Simulated manipulative treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julia Schmitt', 'role': 'CONTACT', 'email': 'juliaschmitt81@gmail.com'}], 'overallOfficials': [{'name': 'Julia Schmitt, PM&RResident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Arnau de Vilanova, Valencia, Spain'}, {'name': 'Julio Domenech, MD-PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Arnau de Vilanova, Valencia, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD-PhD', 'investigatorFullName': 'Julio Domenech', 'investigatorAffiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}}}}