Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-03 @ 7:27 PM
Study NCT ID:
NCT04645758
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2020-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Analyse the Immediate Effect of Dry Needling and Extra Corporeal Shock Wave Therapy on Hand Grip Strength
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2020-12-02', 'unreleaseDate': '2020-12-03'}, {'resetDate': '2020-12-30', 'releaseDate': '2020-12-03'}], 'estimatedResultsFirstSubmitDate': '2020-12-02'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'M.M.K outcome blind assessor'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned to two groups in parallel for the duration of the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-29', 'studyFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2020-11-22', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hand Grip Strength', 'timeFrame': 'Post 1 hours of Intervention in both groups', 'description': 'Measurement of Hand Grip Strength with Jamar Dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry needling', 'Extra corporeal Shockwave therapy', 'Hand Grip Strength', 'Post 1 hour'], 'conditions': ['Muscle Weakness Condition']}, 'descriptionModule': {'briefSummary': 'An argument to analyse the Immediate effect of dry needling or extra corporeal shock wave therapy on hand grip strength in normal healthy individuals with a hypothesis of dry needling or shock wave on forearm muscles have influence on the hand grip strength.', 'detailedDescription': 'After written consent obtained from all the participants randomization and allocation will be done with sealed non transparent envelopes and participants will be assign to two groups Dry needling(DN) and Extra corporeal shock wave therapy (ESWT).Pre and post data of hand grip strength measured with Jamar hand dynamometer.Post data shall be collected precisely after 1 hr of intervention from both groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No pain on the visual analog scoring scale of 100 mm scale,\n* Muscle power of 4+ on oxford manual muscle testing of forearm and wrist extrinsic and intrinsic muscles\n* Full range of motion in all dominant upper extremity joints.\n\nExclusion Criteria:\n\n* History of previous fractures of the dominant upper extremity,\n* Teno-synovitis of flexor tendons ,\n* Dequervains synovitis,\n* Left hand dominance.'}, 'identificationModule': {'nctId': 'NCT04645758', 'briefTitle': 'A Study to Analyse the Immediate Effect of Dry Needling and Extra Corporeal Shock Wave Therapy on Hand Grip Strength', 'organization': {'class': 'OTHER', 'fullName': 'Comprehensive Rehabilitation Centre, Medina, Saudi Arabia'}, 'officialTitle': 'The Immediate Effects of Dry Needling and Extra Corporeal Shockwave Therapy on Hand Grip Strength.A Randomised Controlled Trail.', 'orgStudyIdInfo': {'id': 'Rct001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dry Needling Group or (DN)', 'description': 'Dry needling for 5 mins on the flexor group of muscles of dominant forearm.', 'interventionNames': ['Combination Product: Dry needling and Extra corporeal Shock wave therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extra corporeal Shockwave therapy Group or (ESWT)', 'description': 'Delivering of Shock wave pulses of 1250 at the energy intensity of 0.58 mj/mm2 on the flexor group of muscles of dominant forearm', 'interventionNames': ['Combination Product: Dry needling and Extra corporeal Shock wave therapy']}], 'interventions': [{'name': 'Dry needling and Extra corporeal Shock wave therapy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Dry needle/Acupuncture needle.Shock wave therapy'], 'description': '5 mins of dry needling and 1250 pulses of shockwave therapy on dominant forearm muscles', 'armGroupLabels': ['Dry Needling Group or (DN)', 'Extra corporeal Shockwave therapy Group or (ESWT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42381', 'city': 'Madinah', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Mohammed A Khan', 'role': 'CONTACT', 'email': 'amjadkhan.mmkk@gmail.com', 'phone': '0508921749'}, {'name': 'Rayan M Al-Fadani, BPT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ibrahim H Al-Tobaigy, BPT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mujahid M Khoja, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohammed A Khan, BPT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abdullah M Al-Shenqiti, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tarek M El-Gohary, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Comprehensive Rehabilitation Centre', 'geoPoint': {'lat': 24.46861, 'lon': 39.61417}}], 'centralContacts': [{'name': 'Mohammed A Khan, BPT', 'role': 'CONTACT', 'email': 'amjadkhan.mmkk@gmail.com', 'phone': '00966508921749'}, {'name': 'Rayan M Fadani, BPT', 'role': 'CONTACT', 'email': 'dr.rayanalfadani@gmail.com', 'phone': '00966500600065'}], 'overallOfficials': [{'name': 'Rayan M Al-Fadani, BPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Comprehensive rehabilitation centre, Medina Al Munawwarah, Saudi Arabia.'}, {'name': 'Abdullah M Al-Shenqiti, PhD,PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taibah University of Medical Rehabilitation Sciences'}, {'name': 'Tarek M El-Gohary, PhD,PT', 'role': 'STUDY_CHAIR', 'affiliation': 'Taibah University of Medical Rehabilitation Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results of Hand grip strength pre and post intervention.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comprehensive Rehabilitation Centre, Medina, Saudi Arabia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Physical therapy and Rehabilitation.', 'investigatorFullName': 'Rayan Mohammed Al Fadani', 'investigatorAffiliation': 'Comprehensive Rehabilitation Centre, Medina, Saudi Arabia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-12-02', 'type': 'RELEASE'}, {'date': '2020-12-03', 'type': 'UNRELEASE'}, {'date': '2020-12-03', 'type': 'RELEASE'}, {'date': '2020-12-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rayan Mohammed Al Fadani, Head of the Department of Physical therapy and Rehabilitation., Comprehensive Rehabilitation Centre, Medina, Saudi Arabia'}}}}