Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 6:35 PM
Study NCT ID:
NCT07062692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Dry Needling Versus Manual Trigger Point Release on Active Rhomboid Trigger Points
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric pain rating scale (NPRS)', 'timeFrame': '2 Weeks', 'description': 'A subjective pain assessment tool where patients rate their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain).'}, {'measure': 'Goniometer', 'timeFrame': '2 Weeks', 'description': 'The goniometer is a handheld device with a protractor and movable arms used to precisely measure joint range of motion in degrees.'}, {'measure': 'DASH Questionnaire', 'timeFrame': '2 Weeks', 'description': 'The DASH Questionnaire is a 30-item self-report tool assessing upper extremity function and symptoms in daily activities, scored from 0 (no disability) to 100 (severe disability).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhomboid Trigger Points'], 'conditions': ['Trigger Point Pain, Myofascial']}, 'descriptionModule': {'briefSummary': 'This study compares dry needling and manual trigger point release for treating active rhomboid trigger points in 48 patients, assessing pain, ROM, and function. It addresses a gap in evidence for optimal pain management in upper back myofascial pain. Findings will guide clinical practice for more effective, evidence-based interventions.', 'detailedDescription': 'This randomized controlled trial (RCT) investigates the effectiveness of dry needling versus manual trigger point release in treating active rhomboid trigger points. The study aims to compare the effect of two interventions on pain, range of motion (ROM), and functional outcomes in patients with rhomboid muscle pain.\n\nParticipants: 48 individuals (aged 20-60) with clinically confirmed active rhomboid trigger points.\n\nInterventions:\n\nGroup 1: Dry needling therapy.\n\nGroup 2: Manual trigger point release. Both groups receive adjunct therapies (ultrasound, cold packs, and home exercises).\n\nOutcome Measures: Pain (Numeric Pain Rating Scale), ROM (goniometer), and function (DASH Questionnaire).\n\nDuration: 2-week intervention with follow-ups at 1 and 2 weeks.\n\nSignificance: The study addresses a gap in evidence for rhomboid trigger point treatments, guiding clinical decisions for pain management. Results may optimize therapeutic approaches for upper back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of a clinically confirmed active trigger point in the rhomboid muscle based on established criteria (e.g., palpable tight band, local tenderness, referred pain pattern).\n* Pain Level: Moderate to severe pain intensity (e.g., 4 or higher on a Visual Analog Scale or Numeric Pain Rating Scale).\n* Duration of Symptoms: pain for at least 4 weeks.\n\nExclusion Criteria:\n\n* Patient with conditions that may contribute to neck and subscapular pain other than rhomboid:\n* fibromyalgia\n* Rheumatic and inflammatory disease\n* Recent Surgery\n* Diabatic\n* Cervical radiculopathy and nerve entrapment\n* Pregnancy\n* Malignancy'}, 'identificationModule': {'nctId': 'NCT07062692', 'briefTitle': 'Effectiveness of Dry Needling Versus Manual Trigger Point Release on Active Rhomboid Trigger Points', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effectiveness of Dry Needling Versus Manual Trigger Point Release on Active Rhomboid Trigger Points', 'orgStudyIdInfo': {'id': 'REC-01017 Khaist Yousafzai'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dry needling trigger release therapy', 'description': 'This group will undergo dry needling trigger release therapy. Total of 2 sessions (one per week) followed by home based exercises plan. Treatment protocol of both groups will include Therapeutic ultrasound, Cold pack application and Home based exercise plan.', 'interventionNames': ['Other: dry needling trigger release therapy']}, {'type': 'EXPERIMENTAL', 'label': 'MANUAL TRIGGER POINT RELEASE', 'description': 'Manual trigger release will be given to the other group. Total of 2 sessions (one per week) followed by same home based exercises plan will be given to the both groups. Treatment protocol of both groups will include Therapeutic ultrasound, Cold pack application and Home based exercise plan.', 'interventionNames': ['Other: MANUAL TRIGGER POINT RELEASE']}], 'interventions': [{'name': 'dry needling trigger release therapy', 'type': 'OTHER', 'description': 'The dry needling intervention involved inserting sterile filiform needles directly into active rhomboid trigger points for 1-2 sessions (1 session/week) to elicit local twitch responses and relieve tension.', 'armGroupLabels': ['dry needling trigger release therapy']}, {'name': 'MANUAL TRIGGER POINT RELEASE', 'type': 'OTHER', 'description': 'The manual trigger point release intervention involved applying sustained pressure to active rhomboid trigger points followed by passive stretching to release muscle tension and improve mobility.', 'armGroupLabels': ['MANUAL TRIGGER POINT RELEASE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18800', 'city': 'Chakdara', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Riphah International University, Malakand', 'geoPoint': {'lat': 34.66156, 'lon': 72.03235}}], 'centralContacts': [{'name': 'Amna Anum, mS', 'role': 'CONTACT', 'email': 'amna.anum@riphah.edu.pk', 'phone': '03324896605'}], 'overallOfficials': [{'name': 'Amna Anum, ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}