Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT05915858
Status:
UNKNOWN
Last Update Posted:
2023-06-23
First Post:
2023-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Energy Technique and Stretching Exercise in Working Pregnant Women With Piriformis Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055958', 'term': 'Piriformis Muscle Syndrome'}], 'ancestors': [{'id': 'D020426', 'term': 'Sciatic 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': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric pain rating scale', 'timeFrame': '6months', 'description': 'Measurement of pain intensity was done by using numeric pain rating scale.it is reliable and valid.subjects were explained about the scale and instructed to indicate the intensity of current,best and worst pain on a scale of zero(no pain) to ten(worst pain)'}], 'secondaryOutcomes': [{'measure': 'Measurements of pain Intensity', 'timeFrame': '6months', 'description': 'measurement were taking at pre intervention and post intervention after the end of second week intervention.(10) Lower extremity functional scale Lower extremity functional scale is a questionnaire containing twenty question about persons ability to perform everyday task.The LEFS can be used by clinician as a measure of patients initial function,ongoing progress and out come as well as to set functional goals.\n\nThe LEFS has maximum scores of 80 points where lower the score greater disability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle energy technique,stretching exercise, pain rom'], 'conditions': ['Piriformis Syndrome']}, 'descriptionModule': {'briefSummary': 'Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Muscle energy technique is one of manual technique in which the muscle uses its own energy in the form of isometric contraction to relax the muscle by the autogenic inhibition of reciprocal inhibition. Reciprocal inhibition in muscle energy technique was succeeded in relieving pain and improves flexibility.', 'detailedDescription': 'Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Muscle energy technique is one of manual technique in which the muscle uses its own energy in the form of isometric contraction to relax the muscle by the autogenic inhibition of reciprocal inhibition. Reciprocal inhibition in muscle energy technique was succeeded in relieving pain and improves flexibility. Stretching exercises improves physical performance ability, prevents injury, reduces muscle pain and increases flexibility. Both muscle energy technique and stretching has shown significant improvement in reducing pain and lower extremity function and increase range of motion.\n\nRandomized clinical trial will be conducted. Sample size of 30 patients will be taken. Non probability convenient sampling will be used.A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups, to either the muscle energy technique group or stretching exercises group.Treatment will be given twice a week for twelve treatment session..Numeric pain rating scale will be used to measure the intensity of pain,Lower extremity functional scale will be used to access lower extremity function. Standard goniometer is used to measure hip joint range of motion.All participants in both groups will be evaluated before and after treatment programme.Total duration of study will be six months.Data will be analyzed by using SPSS 25. Key words Muscle energy technique,Stretching exercises,Piriformis syndrome,Pain,Range of motion'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Female 25-45age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 25-45 years .\n* Tenderness of piriformis muscle.\n* Chronic non-specific low back pain patients.\n* Women in second trimester of pregnancy\n* Multiparous women\n* SLR positive below 60 degrees .\n* VAS score: 6-10\n* Internal rotation of hip less than 45 degrees.\n\nExclusion Criteria:\n\n* SLR negative test\n* Skin allergy\n* Pre-eclampsia\n* Gestational diabetes mellitus\n* Clinical diagnosis of osteoarthritis or history of fracture of lower extremities'}, 'identificationModule': {'nctId': 'NCT05915858', 'briefTitle': 'Muscle Energy Technique and Stretching Exercise in Working Pregnant Women With Piriformis Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Muscle Energy Technique and Stretching Exercise on Pain, Hip Joint Range of Motion and Function in Working Pregnant Women With Piriformis Syndrome', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/23/0518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'muscle energy technique', 'description': 'muscle energy technique', 'interventionNames': ['Other: muscle energy technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stretching exercise', 'description': 'stretching exercises along with piriformis stretch', 'interventionNames': ['Other: stretching exercise']}], 'interventions': [{'name': 'muscle energy technique', 'type': 'OTHER', 'description': 'Group 1: Group 2:\n\nMuscle energy technique (Reciprocal inhibition) Stretching exercises Static stretching 2 weeks (twelve treatment session) patient supine, the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra-lateral knee (the leg on the side to be treated is crossed over the other, straight leg).\n\n* The angle of hip flexion should not exceed 60 degree.\n* The practitioner places one hand on the contra-lateral ASIS to prevent pelvis motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis for 7-10 seconds.', 'armGroupLabels': ['muscle energy technique']}, {'name': 'stretching exercise', 'type': 'OTHER', 'description': 'Following the contraction the practitioner eases the treated side leg into adduction until a sense of resistance is noted; this is held for 10-30 seconds. 2 week (twelve treatment session) practitioner manual stretches the piriformis:\n\n* The patient lies in supine position the affected leg is placed into flexion at hip and knee so that the foot rests on the table lateral to the contra-lateral knee.\n* The practitioner places one hand over the contra-lateral ASIS to stabilize the pelvis during the exercise and passively abducts and internally rotates the hip medially till the pain is bearable.\n* The process is repeated 3-5 times with a 30', 'armGroupLabels': ['stretching exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54660', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Shafaq Naaeem, ms-whpt', 'role': 'CONTACT', 'email': 'shafaqshazib@gmail.com', 'phone': '03249567534'}], 'facility': 'Lady Willington', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'hafiza neelam, MS', 'role': 'CONTACT', 'email': 'hafiza.neelam@riphah.edu.pk', 'phone': '03204097476'}, {'name': 'Shfaq Naeem, MS*', 'role': 'CONTACT', 'email': 'shafaqshazib@gmail.com', 'phone': '03249567535'}], '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'}}}}