Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-03 @ 1:09 PM
Study NCT ID:
NCT02706418
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2016-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Massage Therapy as a 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2016-02-26', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants experiencing improvements in the symptoms of Carpal Tunnel Syndrome as assessed by the Boston Carpal Tunnel Questionnaire (BCTQ), change from baseline in the symptom severity scores at 4 weeks.', 'timeFrame': '4 weeks.'}]}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': "Once participants have been recruited, their grip strength shall be tested and they will all complete baseline questionnaires to assess functional status and symptom severity.\n\nFollowing the recruitment stage, participants will be asked to attend Medway Maritime Hospital once a week for four weeks, to receive the massage protocol. At the first session participants shall be asked to rate their pain (NPRS), before receiving a massage treatment. This will be followed by instructions on how to perform self-massage, which they will be asked to complete daily over the four-week period, and record in a diary. At the remaining three sessions, participants shall just complete the NPRS prior to receiving the massage treatment.\n\nAfter four weeks the group will be reassessed at the same Orthopaedic Clinic they attended prior to recruitment. They will be asked to complete a final pain score, record any changes in their condition, repeat the initial symptom questionnaire, and finally preform a grip strength test. The duration of four weeks was chosen as this is the time-frame within which the specific massage protocol advises a 'significant symptom improvement' should be seen."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or above.\n* Pain paraesthesia and/or hypoesthesia in the hand, in the area innervated by the median nerve.\n* Participants must have a clinical diagnosis of Carpal Tunnel Syndrome (CTS).\n* Participant must be able to comply with the study procedures.\n* Participant must have attended the Medway Maritime Hospital (Kent), for assessment of the present condition.\n* Participant is willing and able to give informed consent for participation in the study.\n* Participant must not be contra-indicated for the receipt of massage.\n* Participants must be able to speak and read English fluently.\n\nExclusion Criteria:\n\n* Participants who are receiving any additional treatment for their carpal tunnel pain that is not part of standard care (topical pain relief, bracing).\n* Participants that have had any surgery on the anatomical sites relevant to the condition and/or treatment (neck, shoulder, arm, wrist, hand).\n* Participants that have any suggestion of an additional condition related to carpal tunnel pain (i.e. previous trauma, pregnancy, etc).\n* Planning to undertake any activities or lifestyle changes which may affect their levels of carpal tunnel pain (e.g. changing/ceasing occupation, alternative symptom therapy, adopting/ceasing a hobby).'}, 'identificationModule': {'nctId': 'NCT02706418', 'briefTitle': 'Clinical Massage Therapy as a Treatment for Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Jing Advanced Massage Training'}, 'officialTitle': 'A Standardised Massage Protocol as an Effective Treatment for Chronic Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'CTS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinical Massage Therapy', 'interventionNames': ['Procedure: Clinical Massage Therapy']}], 'interventions': [{'name': 'Clinical Massage Therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Clinical Massage Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ME7 5NY', 'city': 'Gillingham', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Medway Maritime Hospital', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jing Advanced Massage Training', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medway NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}