Disk HernisiNCT07465068
The Effect of Visceral Osteopathic Manual Therapy in Lumbar Disc Herniation
A study testing osteopathic manual therapy and FTR in people with Disk Hernisi and Visseral Manuel Terapi, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disk Hernisi, Visseral Manuel Terapi
- What is being tested?
- osteopathic manual therapy and FTR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 3 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Having chronic lumbar disc herniation
- Being able to communicate in Turkish
- Being willing to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Visceral Osteopathic Manual Therapy in Chronic Lumbar Disc Herniation
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.
Read the detailed description
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.
- Conditions
- Disk Hernisi, Visseral Manuel Terapi
- Being tested
- osteopathic manual therapy, FTR
- Keywords
- lumbar disc herniation, osteopathic manipulative treatment, Quality of life, visual analog scale, y balance test
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manual therapyOther
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.
FTROther
Group 2 will only receive conservative physical therapy including TENS current and heat agents; none of the VOMT techniques will be applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: FTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start10 Apr 2025
- Primary completion28 Jun 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disk HernisiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Rumeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Hakkı Boyu, Istanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465068
- Sponsor's protocol ID
- IstanbulRumeliU-ftr-MHB-1
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing the data is not appropriate due to the personal data protection law.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visceral Osteopathic Manual Therapy in Chronic Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07465068
- Acronym / sponsor ID
- IstanbulRumeliU-ftr-MHB-1
- Conditions
- Disk Hernisi, Visseral Manuel Terapi
- Keywords
- lumbar disc herniation, osteopathic manipulative treatment, Quality of life, visual analog scale, y balance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Rumeli UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1: FTR+ VOMT | Active comparator | Other: osteopathic manual therapyFollowing 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 2 | Other | Other: FTRGroup 2 will receive the same conservative physical therapy treatments as the VOMT group, for the same duration, but will not include manual therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years of age
- Having chronic lumbar disc herniation
- Being able to communicate in Turkish
- Being willing to participate in the study
Key exclusion criteria (8 listed)
- Spinal Slippage
- Spinal Stenosis
- Having an Internal Fixator Implanted
- Having Acute Back Pain
- Having a Traumatic Injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteopathic manual therapyGroup 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 1: FTR+ VOMT |
| FTRGroup 2 will only receive conservative physical therapy including TENS current and heat agents; none of the VOMT techniques will be applied. | Other | group 2 |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No. Sharing the data is not appropriate due to the personal data protection law.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic manual therapy and FTR in people with Disk Hernisi and Visseral Manuel Terapi, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.