The Effect of Visceral Osteopathic Manual Therapy in Lumbar Disc Herniation

NCT07465068 | Completed DMC

• 1 other identifier: IstanbulRumeliU-ftr-MHB-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disk Hernisi; Visseral Manuel Terapi

Keywords

lumbar disc herniation; osteopathic manipulative treatment; Quality of life; visual analog scale; y balance test

Outcome Measures

Primary Outcomes (4)

• World Health Organization Quality of Life Instrument (WHOQOL):

  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

  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

  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):

  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 Outcomes (1)

• y balance test

  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.

Study Arms (2)

group 1: FTR+ VOMT

ACTIVE COMPARATOR

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.

Other: osteopathic manual therapy

group 2

OTHER

Group 2 will receive the same conservative physical therapy treatments as the VOMT group, for the same duration, but will not include manual therapy.

Other: FTR

Interventions

osteopathic manual therapy OTHER

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.

group 1: FTR+ VOMT

FTR OTHER

Group 2 will only receive conservative physical therapy including TENS current and heat agents; none of the VOMT techniques will be applied.

group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years of age
• Having chronic lumbar disc herniation
• Being able to communicate in Turkish
• Being willing to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Rumeli University: lead

Study Sites (1)

Therapie KONZEPT

Gaziantep, şehitkamil, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 11, 2026
• Study Start: April 10, 2025
• Primary Completion: June 28, 2025
• Study Completion: July 3, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)