Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT05821218
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2023-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Sacroiliac Joints of People With Chronic Low Back Pain From a Chiropractic Perspective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-07-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-23', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg Check Test', 'timeFrame': '1 day', 'description': 'When a subject is lying prone or supine, emptying the pelvis, the feet are examined for the presence of a "short leg" or alignment asymmetry, often at the margin (heel-sole interface). Evidence has suggested that for most people, anatomical leg length disparity is not clinically relevant until the size reaches \\~20 mm (\\~3/4"). It is a clinical test commonly used by chiropractors'}, {'measure': 'Pressure Pain Threshold Measurement with Algometer', 'timeFrame': '1 day', 'description': 'Pressure algometry is a semi-quantitative method used to localize sensitive areas, trigger points, abnormal sensitivity on muscles and bones, and evaluate pressure pain sensitivity in tissues. The dial is calibrated to 2.5 kg in 25 g divisions. The pressure applied by continuously pressing the disc 35 against the skin is to advance the pointer on the dial clockwise through the metal piston.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': 'one day', 'description': 'Low back pain is one of the most common disorders that cause activity limitationIt has 16 questions and two subscales: physical activity and work. The physical activity section consists of 5 questions and the labor section consists of 11 questions. The questionnaire was a 7-point Likert type scale. In the answers given to the questionnaire, 0 points are given to the statement of "I don\'t agree at all" and 6 points to the statement of "I totally agree".'}, {'measure': 'Patrick FABER Test:', 'timeFrame': '1 day', 'description': 'The ipsilateral hip and knee joint of the participant in the supine position was flexed, and the heel was placed on the opposite knee. The test stresses the anterior sacroiliac ligaments and hip joint. It was accepted that the pain was felt in the sacroiliac joint region'}, {'measure': 'Gaenslen Test', 'timeFrame': '1 day', 'description': 'The participant was in the supine position on the examination table, with the lower extremity close to the evaluator hanging down from the bed, while the hip joint was brought to maximal hyperextension, while the hip and knee joints were passively brought to maximum flexion in the other lower extremity. The'}, {'measure': 'Compression Test', 'timeFrame': '1 day', 'description': 'The participant was positioned on their side, hips flexed to 45° and knees flexed to 90°. The evaluator applied a compression force from the superior iliac crest to the lower iliac crest behind the patient. This test stretches the posterior sacroiliac ligaments and compresses the anterior portion of the sacroiliac joint. The test was considered positive if there was pain in the sacroiliac joint.'}, {'measure': 'The straight leg raise test', 'timeFrame': '1 day', 'description': 'The straight leg raise test is known as the sciatic nerve stretch test. It has been reported that mobilization and stretching of the sciatic nerve occur from 30 degrees on.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sacroiliac'], 'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': 'Low back pain is a musculoskeletal problem that we commonly encounter in the clinic,which negatively affects the quality of life, reduces productivity and limits the ability to perform activities of daily living.', 'detailedDescription': 'The most common causes of low back pain are disc lesions and soft tissue injuries due to trauma, rheumatological disorders such as spondylosis, spinal stenosis and spondylolisthesis, ankylosing spondylitis and rheumatoid arthritis due to degenerative changes; osteoporosis, root disorders, and sacroiliac joint dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Bahçeşehir University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria;\n\n* Volunteer\n* Not undergoing surgery related to the lumbar region\n* Cases without lumbar steroid injection in the last 3 months\n* Not having visual and hearing loss\n* Having low back pain\n* Cases without neurological problems\n* Cases without tumor and infection in the lumbar region\n* Cases in which communication and cooperation are provided Exclusion criteria;\n* Not having a musculoskeletal or neuromuscular disease that limits mobility,\n* No upper extremity sequelae,\n* Not volunteering'}, 'identificationModule': {'nctId': 'NCT05821218', 'briefTitle': 'Evaluation of the Sacroiliac Joints of People With Chronic Low Back Pain From a Chiropractic Perspective', 'organization': {'class': 'OTHER', 'fullName': 'Bahçeşehir University'}, 'officialTitle': 'Evaluation of the Sacroiliac Joints of People With Chronic Low Back Pain From a Chiropractic Perspective', 'orgStudyIdInfo': {'id': 'Chiropractic Perspective'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'back pain group', 'description': 'back pain group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34353', 'city': 'Istanbul', 'state': 'None Selected', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'HAZAL genç, phd', 'role': 'CONTACT', 'email': 'hazaloksuz@gmail.com', 'phone': '05413204291'}], 'facility': 'HAZAL genç', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'HAZAL genç, PhD', 'role': 'CONTACT', 'email': 'hazaloksuz@gmail.com', 'phone': '05413204291'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bahçeşehir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erdal Beken', 'investigatorAffiliation': 'Bahçeşehir University'}}}}