Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-01-27 @ 2:27 PM
Study NCT ID:
NCT03169218
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2017-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D020423', 'term': 'Median Neuropathy'}], 'ancestors': [{'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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088762', 'term': 'Mirror Movement Therapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To evaluate catastrophism associated with pain.', 'timeFrame': 'Day 0 of the study', 'description': 'Evaluation through Pain Catastrophizing Scale This questionnaire is self-administered'}], 'primaryOutcomes': [{'measure': 'To evaluate changes on pain', 'timeFrame': 'Changes in 8 weeks', 'description': 'Evaluation on pain through McGill Pain Questionnaire This questionnaire is self-administered.'}], 'secondaryOutcomes': [{'measure': 'To evaluate changes on the function of the upper limb.', 'timeFrame': 'Changes in 8 weeks', 'description': 'Evaluation on function through disabilities of the arm, shoulder and hand questionnaire (DASH)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adult', 'Chronic pain', 'Entrapment neuropathy. Carpal tunnel', 'Exercise therapy', 'Humans', 'Neuronal plasticity', 'Mirror neurons', 'Pain/cognitive aspects', 'Physiotherapy', 'Somatosensory cortex'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Lázaro C, Fèlix B, Torrubia R, Baños JE. The development of a Spanish questionnaire for assessing pain: preliminary data concerning reliability and validity. Eur J Psychol assesment. 1994;10(2):145-51.'}, {'pmid': '19007576', 'type': 'BACKGROUND', 'citation': 'Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.'}, {'pmid': '17040628', 'type': 'BACKGROUND', 'citation': 'Hervas MT, Navarro Collado MJ, Peiro S, Rodrigo Perez JL, Lopez Mateu P, Martinez Tello I. [Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness]. Med Clin (Barc). 2006 Sep 30;127(12):441-7. doi: 10.1157/13093053. Spanish.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate pain and function after mirror therapy as well as level of catastrophism in bilateral carpal tunnel syndrome patients', 'detailedDescription': 'The sample calculation was performed based on the previous pilot study, in which 10 subjects were included. Through this study, a statistically significant effect on the variables analyzed was demonstrated. Therefore, it was determined to duplicate the initial sample to confirm the effect previously studied, assuming losses of 20%. Thus, the value of n for the clinical trial is 20 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be signed the informed consent.\n* Bilateral carpal tunnel syndrome: clinic and electromiography positive.\n* Aged between 18 and 65 years\n\nExclusion Criteria:\n\n* Patients undergoing surgical intervention of carpal tunnel syndrome in one of two hands\n* Unilateral carpal tunnel syndrome\n* Patients with chronic pain and / or previous injury (wrist tumor, lymphedema ...) in either hand\n* Patients with systemic diseases (diabetes, thyroid ...)\n* Patients with pharmacological treatment to take analgesia for any other chronic pathologies\n* Subjects who have suffered from a neurological disease that affects the musculoskeletal system\n* Mental illness that prevents the compression and / or realization of the study\n* Patients with tattoos, scars and / or marks on any of the hands or distal forearm area\n* Pregnant women and minors'}, 'identificationModule': {'nctId': 'NCT03169218', 'acronym': 'MTSTC', 'briefTitle': 'Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Manises'}, 'officialTitle': 'Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom (MTSTC)', 'orgStudyIdInfo': {'id': 'HManises'}, 'secondaryIdInfos': [{'id': '2015/0277', 'type': 'OTHER', 'domain': 'CEIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror therapy group', 'description': 'Mirror therapy group: exercises looking at the reflection in the mirror of the hand moving', 'interventionNames': ['Other: Mirror therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo group: exercises performed with the mirror turned to avoid the reflection of the hand and looking at the hand that did not remain hidden.', 'interventionNames': ['Other: Placebo group']}], 'interventions': [{'name': 'Mirror therapy', 'type': 'OTHER', 'otherNames': ['Mirror visual feedback', 'Mirror box therapy'], 'description': 'The treatment proposed for the mirror group consisted of 8 weeks of treatment, performing a series of exercises 2 times a day / 4 times a week. The first 4 weeks the treatment was done in the hospital next to the physiotherapist for 2-3 days a week, and the next 4 weeks the patient performed the exercises following the same guidelines at home.', 'armGroupLabels': ['Mirror therapy group']}, {'name': 'Placebo group', 'type': 'OTHER', 'description': 'The treatment was the same than proposed in inference group but with a mirror covered to avoid the reflexion on the hand and looking at the hand that did not remain hidden.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46940', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital de Manises', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Sonia Monterde, PT, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olga Del Pozo Blanco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario La Fe', 'class': 'OTHER'}, {'name': 'University Rovira i Virgili', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Olga Del Pozo Blanco', 'investigatorAffiliation': 'Hospital de Manises'}}}}