Lumbar Disc HerniationPhase 1/2FDTNCT06886334
Flexion-Distraction Technique
A Phase 1/2 study testing exercise and mobilization in people with Lumbar Disc Herniation, run by Istanbul Medipol University Hospital.
Trial summary
The aim of this study is to compare the effects of conventional physical therapy and flexion-distraction (Cox technique) on pain, functional capacity, and quality of life in patients with lumbar disc herniation (LDH) receiving non-surgical treatment. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- exercise and mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2025to 1 May 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between 30-60 years of age
- Having a diagnosis of L4-L5 lumbar disc herniation
- Not having undergone surgical intervention
- Having no cognitive impairment or intellectual disability
- Providing voluntary participation and written consent
Who cannot join
- Having previously undergone surgical operation in the lumbar region
- Having an oncological diagnosis
- Pregnancy
- Presence of severe physical or psychological disorders that would prevent completion of the study
- Participation in another active physical therapy program
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effects of Conventional Physical Therapy and Flexion-Distraction Technique on Pain, Functional Capacity, Activities of Daily Living, and Range of Motion in Patients with Lumbar Disc Herniation: a Randomized Controlled Trial
The aim of this study is to compare the effects of conventional physical therapy and flexion-distraction (Cox technique) on pain, functional capacity, and quality of life in patients with lumbar disc herniation (LDH) receiving non-surgical treatment. The study will include two groups: one group will receive conventional physical therapy (ultrasound, transcutaneous electrical nerve stimulation (TENS), heat application, and home exercises), while the other group will receive heat application, the Cox technique, and home exercises. The effectiveness of these two methods will be compared to determine the most appropriate approach for LDH treatment.
The study will include individuals aged 30-60 diagnosed with L4-L5 disc herniation who apply to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital and Nilüfer Spine Health Center. Two groups of 34 participants each will be formed, and randomization will be based on the participants' preferred treatment center. The groups will be named the conventional physical therapy group (CPTG) and the Cox technique treatment group (CTTG).
Read more
Assessment parameters will include pain (visual analog scale (VAS) and algometry), range of motion (digital goniometer), functional capacity (Oswestry Disability Index - ODI), and quality of life (SF-36 Quality of Life Scale). Evaluations will be conducted by the same expert physiotherapist.
The treatment protocols are as follows:
Conventional Physical Therapy Group (CPTG): Ultrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks.
Flexion-Distraction Group (Cox Technique) (CTTG): In addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes.
Both groups will perform pelvic tilt, hip flexor stretching, hamstring stretching, cat-camel, bridge, and straight leg raise exercises, each repeated ten times.
The sample size was determined based on a study by Martinez et al., and a total of 68 participants will be included. Power analysis using the G*Power 3.1 program calculated the minimum sample size as 68.
Data will be analyzed using SPSS 25.0 software. Normal distribution will be evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric or non-parametric tests will be applied accordingly. Differences between groups will be analyzed using an independent samples t-test or the Mann-Whitney U test. Correlation analyses will be performed using Pearson or Spearman methods, and regression analyses will be applied to examine variable relationships.
The results of this study will contribute to determining the most effective conservative treatment approach for LDH patients by comparing the effectiveness of conventional physical therapy and the Cox technique.
Read the detailed description
The aim of this study is to compare the effects of conventional physical therapy and flexion-distraction (Cox technique) on pain, functional capacity, and quality of life in patients with lumbar disc herniation (LDH) receiving non-surgical treatment. One group will receive conventional physical therapy (ultrasound, transcutaneous electrical nerve stimulation (TENS), heat application, and home exercises), while the other group will receive heat application, the Cox technique, and home exercises. The effectiveness of these two methods will be evaluated to determine the most appropriate approach for LDH treatment.
LDH is a condition in which damage to the disc structures compresses the nerve roots, causing pain, numbness, and movement limitations in the lower back and legs. Non-surgical methods are generally the first choice in treatment and have shown successful results. Conventional physical therapy methods are effective in pain management and functional improvement and are widely used to reduce muscle spasms and inflammation. Ultrasound provides thermal and mechanical effects on deep tissues, while TENS stimulates nerves to relieve pain. Heat application helps muscle relaxation and increases blood circulation.
Flexion-distraction (Cox technique) is a manual therapy method that aims to widen the spinal canal and reduce nerve compression. This technique increases the flexibility of spinal segments, alleviating pain and improving functional capacity. Randomized controlled studies have shown that this method is effective in LDH patients. However, studies directly comparing the Cox technique with conventional physical therapy are limited.
This study will include individuals aged 30-60 diagnosed with L4-L5 disc herniation who apply to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital and Nilüfer Spine Health Center. Two groups of 34 participants each will be included, and randomization will be based on the participants' preferred treatment center. The groups will be named the conventional physical therapy group (CTG) and the Cox technique treatment group (CTG).
Assessment parameters will include pain measurement using the visual analog scale (VAS) and algometry. Range of motion will be determined using a digital goniometer, functional capacity will be assessed with the Oswestry Disability Index (ODI), and quality of life will be measured with the SF-36 Quality of Life Scale. Evaluations will be conducted by the same expert physiotherapist.
The treatment protocols are as follows:
- Conventional Physical Therapy Group (CTG): Ultrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks.
- Flexion-Distraction Group (Cox Technique) (CTG): In addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes.
Both groups will perform pelvic tilt, hip flexor stretching, hamstring stretching, cat-camel, bridge, and straight leg raise exercises, each repeated ten times.
The sample size was determined based on a study by Martinez et al., and a total of 68 participants will be included. Power analysis using the G*Power 3.1 program calculated the minimum sample size as 68.
Data will be analyzed using SPSS 25.0 software. Normal distribution will be evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric tests will be used for normally distributed data, while non-parametric tests will be applied otherwise. Differences between groups will be analyzed using an independent samples t-test or the Mann-Whitney U test. Correlation analyses will be performed using Pearson or Spearman methods, and regression analyses will be applied to examine variable relationships.
The results of this study will contribute to determining the most effective conservative treatment approach for LDH patients by comparing the effectiveness of conventional physical therapy and the Cox technique.
- Conditions
- Lumbar Disc Herniation
- Being tested
- exercise, mobilization
- Keywords
- Pain, Range of Motion, Flexion-Distraction Technique, Conventional Physical Therapy
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Ultrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks.
mobilizationOther
In addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy Group (CPTG) | Active comparator | A treatment protocol of ultrasound, TENS, hot pack, and exercises will be applied 3 times weekly for 4 weeks. Ultrasound (4 minutes per side) uses high-frequency waves for deep tissue healing. TENS (100 Hz, 20 minutes) delivers electrical currents to block pain signals. Hot packs (15 minutes) increase circulation and relax muscles. Exercises include Pelvic Tilt, Hip Flexor Stretch, Hamstring Stretch, Cat-Camel, Bridge, and Straight Leg Raise, aimed at improving flexibility, strength, and pain relief. Receives: Other: exercise |
| Flexion-Distraction Group (Cox Technique) (CTG): | Experimental | n addition to hot packs (15 minutes) and exercises, the flexion-distraction (Cox) technique will be used for 10 minutes. Developed in 1973, this chiropractic method uses a specialized table to decompress the spine, improve mobility, and reduce pain. Exercises include Pelvic Tilt, Hip Flexor Stretch, Hamstring Stretch, Cat-Camel, Bridge, and Straight Leg Raise, targeting flexibility, strength, and pain relief. Hot packs increase circulation and relax muscles. Both treatments are applied 3 times weekly for 4 weeks, ensuring consistent therapeutic benefits. Receives: Other: mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective pain
Measurements will be taken in two ways:
Visual Analog Scale (VAS):
The VAS scale will be used to assess low back pain in individuals with LDH. Participants will mark their pain level on a 10 cm line, where 0 represents "no pain" and 10 represents "very severe pain".
Measured: through study completion, an average of 6 months
range of motion
Measurements will be taken using the Baseline goniometer, a digital goniometer. A digital goniometer is a tool used to precisely measure the range of motion of joints. It offers greater accuracy compared to traditional goniometers and displays measurements on a digital screen. Research shows that measurements taken with a digital goniometer provide more consistent results compared to traditional methods. The flexion, extension, lateral flexion, and rotation degrees of the lumbar region will be measured.
Measured: through study completion, an average of 6 months
objective pain
Algometer:
Measurements will be taken using the Baseline dolorimeter, a device that applies pressure to measure pain threshold. The algometer determines the pressure point at which the patient feels pain, assessing pain tolerance and threshold. Measurements will be taken from the right and left sides of the affected spinal segment
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
Functional capacity
Functional capacity will be evaluated using the Oswestry Disability Index (ODI). The ODI is a questionnaire scale designed to assess the impact of low back pain on daily life. It consists of 10 items, each scored from 0 to 5. The total score reflects the patient's functional capacity. The ODI is a widely used and highly valid scale for evaluating the functional status of patients with low back pain
Measured: through study completion, an average of 6 months
Daily living activities
Daily living activities will be evaluated using the SF-36 Quality of Life Scale. The SF-36 is a questionnaire designed to assess individuals' overall health status and quality of life, covering both physical and mental health dimensions. It consists of 36 questions, and separate scores are calculated for each dimension. The SF-36 is widely used for quality of life assessment in various populations, and its reliability and validity have been well-established.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start2 Apr 2025 (estimated)
- Primary completion3 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Conventional Physical Therapy Group (CTG): Ultrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks. 2. Flexion-Distraction Group (Cox Technique) (CTG): In addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulay karacaoglu, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886334
- Sponsor's protocol ID
- E-10840098-202.3.02-7694
- Acronym
- FDT
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Conventional Physical Therapy and Flexion-Distraction Technique on Pain, Functional Capacity, Activities of Daily Living, and Range of Motion in Patients with Lumbar Disc Herniation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06886334
- Acronym / sponsor ID
- FDT / E-10840098-202.3.02-7694
- Conditions
- Lumbar Disc Herniation
- Keywords
- Pain, Range of Motion, Flexion-Distraction Technique, Conventional Physical Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Apr 2025 (estimated)
- Primary completion
- 3 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 20 Mar 2025 (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.
The aim of this study is to compare the effects of conventional physical therapy and flexion-distraction (Cox technique) on pain, functional capacity, and quality of life in patients with lumbar disc herniation (LDH) receiving non-surgical treatment. The study will include two groups: one group will receive conventional physical therapy (ultrasound, transcutaneous electrical nerve stimulation (TENS), heat application, and home exercises), while the other group will receive heat application, the Cox technique, and home exercises. The effectiveness of these two methods will be compared to determine the most appropriate approach for LDH treatment.
The study will include individuals aged 30-60 diagnosed with L4-L5 disc herniation who apply to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital and Nilüfer Spine Health Center. Two groups of 34 participants each will be formed, and randomization will be based on the participants' preferred treatment center. The groups will be named the conventional physical therapy group (CPTG) and the Cox technique treatment group (CTTG).
Assessment parameters will include pain (visual analog scale (VAS) and algometry), range of motion (digital goniometer), functional capacity (Oswestry Disability Index - ODI), and quality of life (SF-36 Quality of Life Scale). Evaluations will be conducted by the same expert physiotherapist.
The treatment protocols are as follows:
Conventional Physical Therapy Group (CPTG): Ultrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks.
Flexion-Distraction Group (Cox Technique) (CTTG): In addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes.
Both groups will perform pelvic tilt, hip flexor stretching, hamstring stretching, cat-camel, bridge, and straight leg raise exercises, each repeated ten times.
The sample size was determined based on a study by Martinez et al., and a total of 68 participants will be included. Power analysis using the G*Power 3.1 program calculated the minimum sample size as 68.
Data will be analyzed using SPSS 25.0 software. Normal distribution will be evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric or non-parametric tests will be applied accordingly. Differences between groups will be analyzed using an independent samples t-test or the Mann-Whitney U test. Correlation analyses will be performed using Pearson or Spearman methods, and regression analyses will be applied to examine variable relationships.
The results of this study will contribute to determining the most effective conservative treatment approach for LDH patients by comparing the effectiveness of conventional physical therapy and the Cox technique.
Detailed description
The aim of this study is to compare the effects of conventional physical therapy and flexion-distraction (Cox technique) on pain, functional capacity, and quality of life in patients with lumbar disc herniation (LDH) receiving non-surgical treatment. One group will receive conventional physical therapy (ultrasound, transcutaneous electrical nerve stimulation (TENS), heat application, and home exercises), while the other group will receive heat application, the Cox technique, and home exercises. The effectiveness of these two methods will be evaluated to determine the most appropriate approach for LDH treatment.
LDH is a condition in which damage to the disc structures compresses the nerve roots, causing pain, numbness, and movement limitations in the lower back and legs. Non-surgical methods are generally the first choice in treatment and have shown successful results. Conventional physical therapy methods are effective in pain management and functional improvement and are widely used to reduce muscle spasms and inflammation. Ultrasound provides thermal and mechanical effects on deep tissues, while TENS stimulates nerves to relieve pain. Heat application helps muscle relaxation and increases blood circulation.
Flexion-distraction (Cox technique) is a manual therapy method that aims to widen the spinal canal and reduce nerve compression. This technique increases the flexibility of spinal segments, alleviating pain and improving functional capacity. Randomized controlled studies have shown that this method is effective in LDH patients. However, studies directly comparing the Cox technique with conventional physical therapy are limited.
This study will include individuals aged 30-60 diagnosed with L4-L5 disc herniation who apply to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital and Nilüfer Spine Health Center. Two groups of 34 participants each will be included, and randomization will be based on the participants' preferred treatment center. The groups will be named the conventional physical therapy group (CTG) and the Cox technique treatment group (CTG).
Assessment parameters will include pain measurement using the visual analog scale (VAS) and algometry. Range of motion will be determined using a digital goniometer, functional capacity will be assessed with the Oswestry Disability Index (ODI), and quality of life will be measured with the SF-36 Quality of Life Scale. Evaluations will be conducted by the same expert physiotherapist.
The treatment protocols are as follows:
- Conventional Physical Therapy Group (CTG): Ultrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks.
- Flexion-Distraction Group (Cox Technique) (CTG): In addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes.
Both groups will perform pelvic tilt, hip flexor stretching, hamstring stretching, cat-camel, bridge, and straight leg raise exercises, each repeated ten times.
The sample size was determined based on a study by Martinez et al., and a total of 68 participants will be included. Power analysis using the G*Power 3.1 program calculated the minimum sample size as 68.
Data will be analyzed using SPSS 25.0 software. Normal distribution will be evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric tests will be used for normally distributed data, while non-parametric tests will be applied otherwise. Differences between groups will be analyzed using an independent samples t-test or the Mann-Whitney U test. Correlation analyses will be performed using Pearson or Spearman methods, and regression analyses will be applied to examine variable relationships.
The results of this study will contribute to determining the most effective conservative treatment approach for LDH patients by comparing the effectiveness of conventional physical therapy and the Cox technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1. Conventional Physical Therapy Group (CTG): Ultrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks. 2. Flexion-Distraction Group (Cox Technique) (CTG): In addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes.
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy Group (CPTG) | Active comparator | Other: exerciseA treatment protocol of ultrasound, TENS, hot pack, and exercises will be applied 3 times weekly for 4 weeks. Ultrasound (4 minutes per side) uses high-frequency waves for deep tissue healing. TENS (100 Hz, 20 minutes) delivers electrical currents to block pain signals. Hot packs (15 minutes) increase circulation and relax muscles. Exercises include Pelvic Tilt, Hip Flexor Stretch, Hamstring Stretch, Cat-Camel, Bridge, and Straight Leg Raise, aimed at improving flexibility, strength, and pain relief. |
| Flexion-Distraction Group (Cox Technique) (CTG): | Experimental | Other: mobilizationn addition to hot packs (15 minutes) and exercises, the flexion-distraction (Cox) technique will be used for 10 minutes. Developed in 1973, this chiropractic method uses a specialized table to decompress the spine, improve mobility, and reduce pain. Exercises include Pelvic Tilt, Hip Flexor Stretch, Hamstring Stretch, Cat-Camel, Bridge, and Straight Leg Raise, targeting flexibility, strength, and pain relief. Hot packs increase circulation and relax muscles. Both treatments are applied 3 times weekly for 4 weeks, ensuring consistent therapeutic benefits. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between 30-60 years of age
- Having a diagnosis of L4-L5 lumbar disc herniation
- Not having undergone surgical intervention
- Having no cognitive impairment or intellectual disability
- Providing voluntary participation and written consent
Key exclusion criteria (5 listed)
- Having previously undergone surgical operation in the lumbar region
- Having an oncological diagnosis
- Pregnancy
- Presence of severe physical or psychological disorders that would prevent completion of the study
- Participation in another active physical therapy program
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 |
|---|---|---|
| exerciseUltrasound (4 minutes), TENS (100 Hz, 20 minutes), heat application (15 minutes), and home exercises will be applied. Treatment will be conducted three times a week for four weeks. | Other | Conventional Physical Therapy Group (CPTG) |
| mobilizationIn addition to heat application (15 minutes) and home exercises, the Cox technique will be used. The patient will be placed face down on a specialized table, and traction will be applied to the lumbar spine for 10 minutes. | Other | Flexion-Distraction Group (Cox Technique) (CTG): |
Primary outcome
subjective pain
Time frame: through study completion, an average of 6 months
Measurements will be taken in two ways: Visual Analog Scale (VAS): The VAS scale will be used to assess low back pain in individuals with LDH. Participants will mark their pain level on a 10 cm line, where 0 represents "no pain" and 10 represents "very severe pain".
range of motion
Time frame: through study completion, an average of 6 months
Measurements will be taken using the Baseline goniometer, a digital goniometer. A digital goniometer is a tool used to precisely measure the range of motion of joints. It offers greater accuracy compared to traditional goniometers and displays measurements on a digital screen. Research shows that measurements taken with a digital goniometer provide more consistent results compared to traditional methods. The flexion, extension, lateral flexion, and rotation degrees of the lumbar region will be measured.
objective pain
Time frame: through study completion, an average of 6 months
Algometer: Measurements will be taken using the Baseline dolorimeter, a device that applies pressure to measure pain threshold. The algometer determines the pressure point at which the patient feels pain, assessing pain tolerance and threshold. Measurements will be taken from the right and left sides of the affected spinal segment
2 secondary outcomes
Functional capacity
Time frame: through study completion, an average of 6 months
Daily living activities
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing exercise and mobilization in people with Lumbar Disc Herniation, run by Istanbul Medipol University Hospital.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gulay yalcin (00905376342600, karacaoglugulay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective pain (time frame: through study completion, an average of 6 months). The study lists 3 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 20 Mar 2025.