- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465068
The Effect of Visceral Osteopathic Manual Therapy in Lumbar Disc Herniation
The Effect of Visceral Osteopathic Manual Therapy in Chronic Lumbar Disc Herniation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
şehitkamil
-
Gaziantep, şehitkamil, Turkey (Türkiye), 27090
- Therapie KONZEPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 18 years of age
- Having chronic lumbar disc herniation
- Being able to communicate in Turkish
- Being willing to participate in the study
Exclusion Criteria:
- Spinal Slippage
- Spinal Stenosis
- Having an Internal Fixator Implanted
- Having Acute Back Pain
- Having a Traumatic Injury
- Having Previous Surgery
- Being Over 70 Years Old
- Being Pregnant and Having Internal Organ Disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group 1: FTR+ VOMT
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.
|
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.
|
|
Other: group 2
Group 2 will receive the same conservative physical therapy treatments as the VOMT group, for the same duration, but will not include manual therapy.
|
Group 2 will only receive conservative physical therapy including TENS current and heat agents; none of the VOMT techniques will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
World Health Organization Quality of Life Instrument (WHOQOL):
Time Frame: 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.
|
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. The 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. |
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.
|
|
Visual Analog Scale
Time Frame: 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.
|
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.
|
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.
|
|
Quebec Functional Scale of Lower Back Pain
Time Frame: 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.
|
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.
|
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.
|
|
World Health Organization Quality of Life Instrument (WHOQOL):
Time Frame: 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.
|
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 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
y balance test
Time Frame: 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.
|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulRumeliU-ftr-MHB-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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