Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-02 @ 11:45 AM
Study NCT ID:
NCT05680493
Status:
UNKNOWN
Last Update Posted:
2023-01-11
First Post:
2022-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'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': 'D000079245', 'term': 'Dry Needling'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'participants'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized control trial which will consist of two groups, control and experimental'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-26', 'studyFirstSubmitDate': '2022-12-26', 'studyFirstSubmitQcDate': '2022-12-26', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': '4 weeks', 'description': 'visual analogue scale'}, {'measure': 'functional disability', 'timeFrame': '4 weeks', 'description': 'functional disability will be measured through oswestry disability index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study will compare the effect of dry needling and manual pressure in patients having low back pain in terms of pain and disability. There will be two groups ; experimental and control. Half of study group will receive dry needling session along with hot pack. Half of study group will receive manual pressure technique along with hot pack.', 'detailedDescription': 'The study is Randomized Control Trail , which is being conducted in fauji foundation hospital and Foundation University College Of Rehabilitation (oct 2022-feb 2023) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. sample will be collected through pilot study .\n\nboth groups will recieve conventional physiotherapy protocol (hot pack) Assessment will be done on baseline, and 4th week .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:-\n\n* age between 30-60\n* pateint with subacute and chronic low back pain at least last 6 months.\n* pateint with active MTrps.\n\nExclusion Criteria:\n\n* patient with fibromyalgia\n* pregnant females\n* patient with chronic diseases (osteoporosis, lungs disease and diabetes)\n* patient with musculoskeletal injuries\n* patient that are using any medication to relief pain like analgesic or muscle relaxants\n* Any treatment for back pain in same period of research.\n* patient having any radiculopathies or discogenic low back pain'}, 'identificationModule': {'nctId': 'NCT05680493', 'briefTitle': 'Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain', 'orgStudyIdInfo': {'id': 'FUI/CTR/2022/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry needling', 'description': 'Total 12 sessions of trigger point dry needling at lumbar muscles with Hot pack,with 3 sessions per week', 'interventionNames': ['Procedure: Dry needling', 'Procedure: Heat therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'manual pressure release', 'description': 'Hot pack for 15 min then manual pressure release', 'interventionNames': ['Procedure: Manual pressure release', 'Procedure: Heat therapy']}], 'interventions': [{'name': 'Manual pressure release', 'type': 'PROCEDURE', 'description': 'lengthens the muscle up to the increasing resistance, then gradually applies gentle pressure on MTrp until fingers feels a definite increase in tissue resistance (first barrier). Pressure would maintain until clinician sense relief of tension', 'armGroupLabels': ['manual pressure release']}, {'name': 'Dry needling', 'type': 'PROCEDURE', 'description': 'A filiform needle is inserted at 45 degree in to trigger point and then twirl the needle up and down to release trigger point', 'armGroupLabels': ['Dry needling']}, {'name': 'Heat therapy', 'type': 'PROCEDURE', 'description': 'Hydro collator pack will be placed on affected area for relaxation and pain relief for 15 min', 'armGroupLabels': ['Dry needling', 'manual pressure release']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Foundation University College of Physical Therapy', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}