Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT05023005
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2021-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strain-Counterstrain Treatment of Piriformis Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D055958', 'term': 'Piriformis Muscle Syndrome'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D017699', 'term': 'Pelvic Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant will not know the true positioning for strain counterstrain treatment of piriformis muscle versus hamstring muscle.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two arms to the study: treatment and sham. The treatment group will receive strain-counterstrain for the piriformis muscle. The sham group will receive strain-counterstrain treatment for the hamstring muscle.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Algometer - Change in pressure pain threshold', 'timeFrame': 'Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.', 'description': 'Objective improvement in pressure/pain threshold'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Analog Scale', 'timeFrame': 'Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.', 'description': 'Subjective improvement in low back/leg pain'}, {'measure': 'Change in Oswestry Disability Index', 'timeFrame': 'Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated).', 'description': 'Assesses pain with doing different activities (sleeping, walking, sitting, etc), assesses ability to do activities of daily living'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain, Mechanical', 'Piriformis Syndrome', 'Somatic Dysfunction of Sacral Region (Finding)']}, 'descriptionModule': {'briefSummary': 'The purpose of this investigator-initiated study is to provide an efficient and non-invasive treatment option for pain caused by the piriformis muscle.', 'detailedDescription': 'There are two arms to the study: treatment and sham. The treatment group will receive strain-counterstrain for the piriformis muscle. The sham group will receive strain-counterstrain treatment for the hamstring muscle.\n\nThere will be two treatments, 1-2 weeks apart ideally.\n\nParticipants will fill out the Oswestry Disability Index Questionnaire before the first treatment and after the second treatment (which is 1-2 weeks after the first treatment).\n\nParticipants will also identify pain using the Visual Analog Scale (VAS) before and after each treatment. Participants will identify pain at rest prior to treatment using VAS. Participant will then identify pain at the start of treatment while pressure is applied to the piriformis muscle (4.5kg/cm2) and post treatment while pressure is applied to the piriformis muscle (4.5 kg/cm2).\n\nAn algometer will be used pre and post each treatment (2 treatments that are 1-2 weeks apart) to objectively measure any change in pain pressure threshold.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years of age\n* Tender point (or trigger point) in piriformis muscle determined by physical exam\n\nExclusion criteria:\n\n* Less than 45 degrees of active hip flexion, less than 5 degrees of active hip internal rotation or less than 30 degrees of active hip external rotation, on side of affected piriformis\n* Unable to lay prone\n* Non-English speaker\n* Inability to attend 2 sessions within the same month\n* Active cancer\n* Pregnant\n* Diagnosis of lumbar radiculopathy\n* Greater than grade 1 lumbar spondylolisthesis\n* Presence of lumbar region Pars Defect\n* Receiving massage, acupuncture, chiropractic treatments, osteopathic treatments during study period.'}, 'identificationModule': {'nctId': 'NCT05023005', 'briefTitle': 'Strain-Counterstrain Treatment of Piriformis Pain', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Strain-Counterstrain Treatment of Piriformis Pain', 'orgStudyIdInfo': {'id': '5210286'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Piriformis Strain-Counterstrain', 'description': 'The treatment group will receive strain-counterstrain for the piriformis muscle.', 'interventionNames': ['Other: Strain-Counterstrain treatment of piriformis muscle']}, {'type': 'SHAM_COMPARATOR', 'label': 'Hamstring Strain-Counterstrain', 'description': 'The sham group will receive strain-counterstrain treatment for the hamstring muscle.', 'interventionNames': ['Other: Strain-Counterstrain treatment of piriformis muscle']}], 'interventions': [{'name': 'Strain-Counterstrain treatment of piriformis muscle', 'type': 'OTHER', 'description': 'Participant will lay prone on table with affected leg close to edge of table. Piriformis muscle tender point is identified and palpated. Then patient leg is passively moved off table and passive hip flexion, abduction, and possible internal/external rotation is added to reduce tender point by 70% or more. This is done passively. This position is held for 90 seconds and then participant is passively returned back to neutral prone position with leg on table. Tender point is palpated again to reassess for change in pain (using subjective visual analog scale). An algometer is also used pre and post to assess objective change in pressure pain threshold.', 'armGroupLabels': ['Hamstring Strain-Counterstrain', 'Piriformis Strain-Counterstrain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mickey Lui, MD', 'role': 'CONTACT', 'phone': '909-558-1000'}], 'facility': 'Loma Linda University Health', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'centralContacts': [{'name': 'Roya Vahdatinia, DO', 'role': 'CONTACT', 'email': 'rvahdatinia@llu.edu', 'phone': '9095586202'}, {'name': 'Mickey Lui, DO', 'role': 'CONTACT', 'email': 'Mickey.Lui@va.gov', 'phone': '9095586202'}], 'overallOfficials': [{'name': 'Mickey Lui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}