Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05660005
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2022-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self Myofascial Release in Individuals With Piriformis Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055958', 'term': 'Piriformis Muscle Syndrome'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D012585', 'term': 'Sciatica'}], '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': '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel group study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '4 weeks', 'description': 'The severity of sciatic pain extending along the hip and leg was questioned with the Visual Analog Scale (VAS). The assessment was based on a horizontal 10 cm scale from 1 (least pain) to 10 (the worst pain ever)'}], 'secondaryOutcomes': [{'measure': 'Extension Range of motion of the hip angle', 'timeFrame': '4 weeks', 'description': 'Extension ROM was measured while the individual was in the pronee position, the pivot point of the goniometer at the trochanter major, the moving arm aligned on the lateral midline of the femur, and the stable arm aligned parallel to the ground.'}, {'measure': 'Flexion Range of motion of the hip angle', 'timeFrame': '4 weeks', 'description': 'Flexion ROM was measured while the individual was in the supine position, the pivot point of the goniometer at the trochanter major, the moving arm aligned on the lateral midline of the femur, and the stable arm aligned parallel to the ground.'}, {'measure': 'Adduction Range of motion of the hip angle', 'timeFrame': '4 weeks', 'description': 'Adduction ROM were evaluated in the supine position, with the pivot point on the anterior projection of the trochanter major, the stable arm parallel to the anterior superior of the spina iliaca, and the moving arm on the anterior midline of the femur. Femur approached to the midline'}, {'measure': 'Abduction Range of motion of the hip angle', 'timeFrame': '4 weeks', 'description': 'Abduction and adduction ROM were evaluated in the supine position, with the pivot point on the anterior projection of the trochanter major, the stable arm parallel to the anterior superior of the spina iliaca, and the moving arm on the anterior midline of the femur. During the evaluation of abduction, attention was paid to the absence of external rotation of the hip and the absence of internal rotation of the hip in adduction.'}, {'measure': 'External Rotation Range of motion of the hip angle', 'timeFrame': '4 weeks', 'description': 'The measurement was taken in a prone position, with the knees flexed to 90°, pivot point on the tibial tubercle, with the stable arm perpendicular to the ground and the mobile arm following the tibial crista. During the evaluation, attention was paid to the absence of hip adduction and abduction movement. Knee turned externally'}, {'measure': 'Internal Rotation Range of motion of the hip angle', 'timeFrame': '4 weeks', 'description': 'The measurement was taken in a prone position, with the knees flexed to 90°, pivot point on the tibial tubercle, with the stable arm perpendicular to the ground and the mobile arm following the tibial crista. During the evaluation, attention was paid to the absence of hip adduction and abduction movement. Knee turned internally'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Piriformis syndrome', 'Pain', 'hip', 'range of motion', 'sciatica'], 'conditions': ['Piriformis Muscle Syndrome']}, 'descriptionModule': {'briefSummary': 'Piriformis syndrome is pain that extends from the hip to the knee, caused by the pressure of the piriformis muscle in the hip on the sciatic nerve. There is no valid protocol for the treatment of this syndrome. Physiotherapists generally use hip strengthening exercises and modalities for pain. In this study, in addition to the classical treatment, we will give two different programs consisting of self-myofascial relaxation and stretching exercises to two different groups for 4 weeks as home exercise. We will question the level of pain that people felt in the hip before starting the exercises and at the 4th week after starting the exercises and measured the hip joint range of motion.', 'detailedDescription': 'Piriformis syndrome (PS) is a condition caused by compression of the sciatic nerve, causing pain, tingling, and numbness. Although conservative treatment includes hip muscle strengthening and stretching, there is no proven treatment method in the literature.\n\nThis study will be conducted to investigate the effect of stretching and myofascial release added to standard physiotherapy treatment in piriformis syndrome.\n\nThis prospective, randomized controlled study will be planned to completed with 64 individuals between the ages of 20-40. Participants will be randomized into the Piriformis Muscle Stretch Group (PiM-S) and Piriformis Muscle Self Myofascial Release Group (PiM-SMR). Both groups will be included in a home program of muscle strengthening exercises for 4 weeks. And groups will be subjected to perform stretching and self-myofascial relaxation exercises, respectively, in addition to the home exercise program. The primary outcome of the study is pain intensity, and the secondary outcome is determined as the range of motion (ROM) of the hip.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants\n* Aged 20 to 40 years\n* Presented leg or hip posterior compartment pain\n* Diagnosed with chronic PS and without any other source of pain\n\nExclusion Criteria:\n\n* Any pathology or acute injury around the hip, sacroiliac joint, or lumbar spine;\n* Limb length discrepancy,\n* Recent buttock trauma,\n* Deep gluteal syndrome,\n* Extrapelvic compression of the sciatic nerve or sacral plexus ischiogluteal/ischiofemoral bursitis or impingement, Upper hamstring tendinitis,\n* Fibromyalgia, myofascial pain syndrome\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05660005', 'briefTitle': 'Self Myofascial Release in Individuals With Piriformis Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effect of Self Myofascial Release and Stretching Exercises in Individuals With Piriformis Syndrome', 'orgStudyIdInfo': {'id': 'E.10304 / 29.03.2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Piriformis Muscle Stretching', 'description': 'Stretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants. With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position. Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week.', 'interventionNames': ['Other: Muscle Stretching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Piriformis Muscle Self Myofascial Release', 'description': 'The patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body. They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball. Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight. There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions).', 'interventionNames': ['Other: Self Myofascial Release']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'The individuals who refused to apply stretching or releasing included to the control group. They perform only home exercises of hip strengthening', 'interventionNames': ['Other: home exercises']}], 'interventions': [{'name': 'Muscle Stretching', 'type': 'OTHER', 'otherNames': ['Piriformis Muscle Stretching'], 'description': 'Stretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants. With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position. Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week.', 'armGroupLabels': ['Piriformis Muscle Stretching']}, {'name': 'Self Myofascial Release', 'type': 'OTHER', 'description': 'The patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body. They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball. Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight. There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions).', 'armGroupLabels': ['Piriformis Muscle Self Myofascial Release']}, {'name': 'home exercises', 'type': 'OTHER', 'description': 'The exercise brochure consists of 5 different exercises that include isometric and isotonic strengthening of the hip and surrounding muscles. Isometric contraction of gluteus maximus, hip march, external/internal rotation of hips with theraband, 4 sided straight leg raises were the exercises and prescribed 5 days a week, 10 repetitions, 3 sets. All participants were advised to use analgesics determined by the physician in case of unbearable pain and to apply a hot pack for 10-20 minutes before sessions.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34810', 'city': 'Istanbul', 'state': 'Beykoz', 'country': 'Turkey (Türkiye)', 'facility': 'Gizem Ergezen', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Gizem Ergezen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}, {'name': 'Mustafa Sahin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'gizem ergezen', 'investigatorAffiliation': 'Medipol University'}}}}