Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 7:40 PM
Study NCT ID:
NCT07465068
Status:
COMPLETED
Last Update Posted:
2026-03-11
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Visceral Osteopathic Manual Therapy in Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individuals diagnosed with lumbar disc herniation, able to communicate in Turkish, literate, and able to accept verbal instructions, and over 18 years of age will be included in the study. Patients with spondylolisthesis and spinal steanosis, those with internal fixators, those with acute low back pain, those with traumatic injuries, those with a history of surgery, those with internal organ disease, patients over 70 years of age, and pregnant women will be excluded from the study. Patients will be randomly divided into two groups of 20 people each: treatment and control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-07', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-07', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'World Health Organization Quality of Life Instrument (WHOQOL):', 'timeFrame': 'The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.', 'description': "It is a scale developed by the World Health Organization (WHO) and used to assess health-related quality of life. This scale is a comprehensive tool for evaluating individuals' physical, psychological, social, and environmental health status. WHOQOL is used in many areas such as health service planning, health policy development, clinical research, and evaluating the effectiveness of health services.The higher the score, the higher the life satisfaction.\n\nThe Physical Health subscale has a minimum score of 7 and a maximum score of 35. The Psychological subscale has a minimum score of 6 and a maximum score of 30. The Social Relationships subscale has a minimum score of 3 and a maximum score of 15. The Environment subscale has a minimum score of 8 and a maximum score of 40."}, {'measure': 'Visual Analog Scale', 'timeFrame': 'The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.', 'description': 'The VAS (Variable Rate of Pain) is used to subjectively assess pain intensity, typically expressed on a scale of 0 to 10. 0 indicates the absence of pain, while 10 represents the most severe pain. This scale helps patients visually understand and express the intensity of their pain. A higher numerical value indicates a higher level of pain, while a lower numerical value suggests a more positive outcome for the patient.'}, {'measure': 'Quebec Functional Scale of Lower Back Pain', 'timeFrame': 'The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.', 'description': 'It is a scale used to assess the severity, impact, and functional capacity of lower back pain. It is based on patient reports and evaluates daily living activities, mobility, and quality of life. The minimum score is 20, and the maximum score is 100. Higher scores are associated with a higher percentage of disability.'}, {'measure': 'World Health Organization Quality of Life Instrument (WHOQOL):', 'timeFrame': 'The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.', 'description': "It is a scale developed by the World Health Organization (WHO) and used to assess health-related quality of life. This scale is a comprehensive tool for evaluating individuals' physical, psychological, social, and environmental health status. WHOQOL is used in many areas such as health service planning, health policy development, clinical research, and evaluating the effectiveness of health services."}], 'secondaryOutcomes': [{'measure': 'y balance test', 'timeFrame': 'The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.', 'description': 'It is a commonly used balance test and is used to assess the balance, core stability, and limb function of athletes. This test can help identify the risk of injury in athletes and track rehabilitation progress.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lumbar disc herniation', 'osteopathic manipulative treatment', 'Quality of life', 'visual analog scale', 'y balance test'], 'conditions': ['Disk Hernisi', 'Visseral Manuel Terapi']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the impact of adding visceral osteopathic manual therapy techniques to conservative physical therapy on the lives of individuals with lumbar disc herniation.', 'detailedDescription': 'Chronic lumbar disc herniation is a very common problem. The aim of our study is to evaluate the effectiveness of visceral manual therapy in addition to classical physical therapy applications used in the treatment of chronic lumbar disc herniation problems. For this purpose, 40 patients diagnosed with chronic lumbar disc herniation who applied to the clinic will be divided into 2 groups, with 20 participants in each group. Participants will be randomly assigned to two groups using a randomization method: Classical Treatment Group (n=20) and Classical Treatment + Visceral Osteopathic Manual Therapy (VOMT) Group (n=20). Sessions will be administered by the same physiotherapist, with a session duration of 30 minutes, every other day, for a total of 5 sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years of age\n* Having chronic lumbar disc herniation\n* Being able to communicate in Turkish\n* Being willing to participate in the study\n\nExclusion Criteria:\n\n* Spinal Slippage\n* Spinal Stenosis\n* Having an Internal Fixator Implanted\n* Having Acute Back Pain\n* Having a Traumatic Injury\n* Having Previous Surgery\n* Being Over 70 Years Old\n* Being Pregnant and Having Internal Organ Disease'}, 'identificationModule': {'nctId': 'NCT07465068', 'briefTitle': 'The Effect of Visceral Osteopathic Manual Therapy in Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Rumeli University'}, 'officialTitle': 'The Effect of Visceral Osteopathic Manual Therapy in Chronic Lumbar Disc Herniation', 'orgStudyIdInfo': {'id': 'IstanbulRumeliU-ftr-MHB-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1: FTR+ VOMT', 'description': 'Following conservative physical therapy, the FTR+VOMT group will receive visceral osteopathic manual therapy techniques including: CV4 Technique, Segmental Release, Hormonal Axis (Pituitary, Thyroid, Diaphragm), Liver and Stomach Mobilization, Pylor Sphincter and Ligament Hepato-gastricus Mobilization, Odi Sphincter Mobilization, Ilio-jejunum Sphincter Mobilization, Ilio-cecal Valve Mobilization, and Bowel and Colon Mobilization. These applications will be performed in 5 sessions, with one day in between. Each session will be 30 minutes long and performed by the same physiotherapist.', 'interventionNames': ['Other: osteopathic manual therapy']}, {'type': 'OTHER', 'label': 'group 2', 'description': 'Group 2 will receive the same conservative physical therapy treatments as the VOMT group, for the same duration, but will not include manual therapy.', 'interventionNames': ['Other: FTR']}], 'interventions': [{'name': 'osteopathic manual therapy', 'type': 'OTHER', 'description': 'Group 1 will receive conservative physical therapy including TENS current, heat agent, and additionally, VOMT techniques such as CV4 Technique, Segmental Release, Hormonal Axis (Pituitary-Thyroid-Diaphragm), Liver, Stomach, Pyloris Sphincter, Ligamentum Hepato-gastricus, Sphincter Odi, Sphincter Ilio-jejunum, Ilio-cecal Valve, Bowel and Colon Mobilization.', 'armGroupLabels': ['group 1: FTR+ VOMT']}, {'name': 'FTR', 'type': 'OTHER', 'description': 'Group 2 will only receive conservative physical therapy including TENS current and heat agents; none of the VOMT techniques will be applied.', 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27090', 'city': 'Gaziantep', 'state': 'şehitkamil', 'country': 'Turkey (Türkiye)', 'facility': 'Therapie KONZEPT', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing the data is not appropriate due to the personal data protection law.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Rumeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator physiotherapist', 'investigatorFullName': 'Mehmet Hakkı Boyu', 'investigatorAffiliation': 'Istanbul Rumeli University'}}}}