Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-18 @ 9:14 PM
Study NCT ID:
NCT05429957
Status:
COMPLETED
Last Update Posted:
2022-12-09
First Post:
2022-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-06-20', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic pain impact questionnaire', 'timeFrame': '8th week', 'description': 'The Pelvic Pain Impact Questionnaire evaluates the pelvic pain impact on life. It has patient generated language, is easily managed and scored, has psychometric properties and it is appropriate for clinical settings and research across primary, secondary and tertiary care. The ten-item questionnaire consist of 8 Likert questions and 2 additional, non-scored questions'}, {'measure': 'Numerical Pain Rating Scale', 'timeFrame': '8th week', 'description': 'The Numerical Pain Rating Scale (NPRS) is a particular measure in which people rate their pain on an 11-point numerical scale. The scale is comprised of 0 (no pain at all) to 10, 0 show no pain at all and 10 indicate worst imaginable pain'}], 'secondaryOutcomes': [{'measure': 'Pain disability index', 'timeFrame': '8th week', 'description': 'The Pain Disability Index is a seven-item survey to investigate functional disability. Every question utilizes an ordinal scale going from 0 to 10, 0 indicates no disability and 10 means worst disability. Scores can be added to represent a combined score of worldwide disability ranging from 0 to 70 ,where higher scores indicate greater disability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic Pain', 'Female', 'Exercise'], 'conditions': ['Pelvic Pain', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '29757068', 'type': 'BACKGROUND', 'citation': 'Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14.'}, {'pmid': '30349698', 'type': 'BACKGROUND', 'citation': 'Chong OT, Critchley HO, Williams LJ, Haraldsdottir E, Horne AW, Fallon M. The impact of meridian balance method electro-acupuncture treatment on chronic pelvic pain in women: a three-armed randomised controlled feasibility study using a mixed-methods approach. Br J Pain. 2018 Nov;12(4):238-249. doi: 10.1177/2049463718776044. Epub 2018 May 14.'}, {'pmid': '32979978', 'type': 'BACKGROUND', 'citation': 'Horne AW, Vincent K, Hewitt CA, Middleton LJ, Koscielniak M, Szubert W, Doust AM, Daniels JP; GaPP2 collaborative. Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2020 Sep 26;396(10255):909-917. doi: 10.1016/S0140-6736(20)31693-7.'}, {'pmid': '32654406', 'type': 'BACKGROUND', 'citation': "Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, Standards in Urogynaecology, Women's Health. A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2021 Mar;128(4):628-634. doi: 10.1111/1471-0528.16412. Epub 2020 Sep 1."}, {'pmid': '34128995', 'type': 'BACKGROUND', 'citation': 'Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.'}, {'pmid': '30703061', 'type': 'BACKGROUND', 'citation': 'Nygaard AS, Stedenfeldt M, Oian P, Haugstad GK. Characteristics of women with chronic pelvic pain referred to physiotherapy treatment after multidisciplinary assessment: a cross-sectional study. Scand J Pain. 2019 Apr 24;19(2):355-364. doi: 10.1515/sjpain-2018-0308.'}]}, 'descriptionModule': {'briefSummary': 'The aim of study is to find out the effects of muscle energy technique versus aerobic exercises on pain and disability in patients with chronic pelvic pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Pelvic pain is more common in female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women with chronic pelvic pain of \\>6 months' duration and the cause of their pain is unknown\n* CPP was located within the true pelvis (between and below the anterior iliac crests)\n* Average score of at least 4 out of 10 (0-10) on a numeric rating scale\n* moderate to severe pain on pelvic pain impact questionnaire\n\nExclusion Criteria:\n\n* History of cancer\n* Pregnancy at the time of inclusion\n* Known pelvic pathology (eg, endometriosis, ovarian cyst, fibroid \\>3cm)\n* Intraabdominal and pelvic surgery within the last six months\n* chronic or recurrent gastro-intestinal disease including irritable bowel syndrome\n* Received any physiotherapy treatment within the previous month"}, 'identificationModule': {'nctId': 'NCT05429957', 'briefTitle': 'Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/22/0516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscle Energy Technique', 'description': 'Muscle Energy Technique of Iliopsoas, Piriformis, Quadratus Lumborum and Erector Spinae muscle', 'interventionNames': ['Other: Muscle Energy Technique']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercises', 'description': 'aerobic exercises (walking on the treadmill)', 'interventionNames': ['Other: Aerobic Exercises']}], 'interventions': [{'name': 'Muscle Energy Technique', 'type': 'OTHER', 'description': 'Muscle energy technique (Post Isometric relaxation) three times per week for 8 weeks.\n\n* MET of the Iliopsoas\n* MET of Piriformis muscle\n* MET of Quadratus Lumborum muscle\n* MET of Erector Spinae muscle', 'armGroupLabels': ['Muscle Energy Technique']}, {'name': 'Aerobic Exercises', 'type': 'OTHER', 'description': 'Aerobic exercise (treadmill walking) three times per week for 8 weeks\n\n* Warm-up phase: in which each patient alternately steps their legs forward, backward, and sideways in each direction for 5 min\n* Active phase: Treadmill speed was 3km/hour for 5 weeks and progress to 4km/hour after 5 weeks for 20 min.\n* Cool down phase: During a cool down period take a deep breath with both arms overhead and exhale while bringing the arms down, shaking out the legs and arms for 5 min.', 'armGroupLabels': ['Aerobic Exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54550', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Jinnah Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Hafiza Neelam, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}