Low Back PainNCT07588919
Sciatic Neural Mobilization in Lumbar-Related Leg Pain
A study testing Sciatic neural mobilization in people with Low Back Pain and Leg Pain and/or Back Pain, run by Istinye University.
Trial summary
Low back pain is one of the most prevalent musculoskeletal disorders worldwide and significantly reduces individuals' quality of life, functional capacity, and productivity. Lumbar-related leg pain (LRLP) is observed in a substantial proportion of patients with low back pain and is associated with neurodynamic… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain, Leg Pain and/or Back Pain
- What is being tested?
- Sciatic neural mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Oct 2026
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having low back pain accompanied by radiating leg pain (radicular or pseudoradicular pain) for at least 3 weeks
- Demonstration of peripheral nerve sensitivity through clinical evaluation and neurodynamic tests
- Pain intensity of at least 3 on the Visual Analog Scale (VAS)
- Ability to understand verbal and written Turkish instructions
- Providing signed informed consent
Who cannot join
- Presence of surgical indication due to acute disc herniation or advanced lumbar disc pathology
- History of spinal surgery or spinal trauma
- Low back pain associated with other pathologies (e.g., rheumatic diseases, multiple sclerosis, malignancy)
- Instability conditions such as spondylolysis and spondylolisthesis
- Pregnancy
- Obesity (BMI ≥ 30 kg/m²)
- Orthopedic problems or chronic diseases that may limit exercise participation
- Physiotherapy or steroid injection treatment within the last 3 months
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: Immediate Effects of Sciatic Neural Mobilization on Balance and Proprioception in Patients With Low Back Pain and Radiating Leg Pain: A Prospective Randomized Clinical Trial
Low back pain is one of the most prevalent musculoskeletal disorders worldwide and significantly reduces individuals' quality of life, functional capacity, and productivity. Lumbar-related leg pain (LRLP) is observed in a substantial proportion of patients with low back pain and is associated with neurodynamic dysfunctions arising from peripheral nerve sensitization. Although the effects of neural mobilization on pain and functional outcomes have been investigated in the literature, studies examining its short-term effects on balance and proprioception remain limited. Therefore, this study aims to determine the immediate effects of sciatic nerve neural mobilization on balance and proprioception in individuals with LRLP exhibiting peripheral nerve sensitivity.
The study will be designed as a prospective, randomized, controlled clinical trial. Participants will be recruited from individuals presenting to the Istinye University Health Practice and Research Center Hospital who meet the inclusion criteria. Following random allocation, 52 participants will be assigned either to the intervention group (neural mobilization) or the sham group (sham mobilization). In addition to a single-session standard conventional physiotherapy program, each group will receive its respective intervention protocol. Assessments will be conducted at two time points: before treatment and immediately after treatment.
Static and dynamic balance as well as proprioception will be evaluated using the ProKin balance system; muscle mechanical properties will be assessed using the MyotonPRO device; pain threshold will be measured with an algometer; and flexibility will be evaluated using the sit-and-reach test.
- Conditions
- Low Back Pain, Leg Pain and/or Back Pain
- Being tested
- Sciatic neural mobilization, Sham sciatic neural mobilization
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic neural mobilizationOther
Participants in the intervention group will receive sciatic neural mobilization in addition to a single-session standard conventional physiotherapy program. The conventional treatment program will consist of hot pack application, transcutaneous electrical nerve stimulation (TENS), and exercises aimed at improving lumbar muscle activation, flexibility, and proprioceptive awareness. Sciatic neural mobilization will be performed based on controlled neural sliding and tensioning principles along the sciatic nerve, with the aim of enhancing neural mobility, improving neurodynamic mechanisms, and supporting neuromuscular control. All interventions will be administered by experienced physiotherapists according to standardized protocols.
Sham sciatic neural mobilizationOther
Participants in the sham group will receive the same single-session standard conventional physiotherapy program as the intervention group. In addition, sham sciatic neural mobilization will be applied. In the sham intervention, procedures similar to those used in the intervention group will be performed at a minimal level without producing therapeutic neural tension or sliding effects. This approach is intended to distinguish the specific effects of the intervention from placebo effects. All procedures will be carried out by experienced physiotherapists in accordance with standardized protocols.
| Study group | Role | What they receive |
|---|---|---|
| Real neural mobilization | Experimental | Not described Receives: Other: Sciatic neural mobilization |
| Sham neural mobilization | Sham comparator | Not described Receives: Other: Sham sciatic neural mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance
Static balance will be assessed using the ProKin Balance Assessment System. The ProKin system is a computer-assisted evaluation device equipped with an integrated force platform and motion sensors that objectively measure postural stability, weight distribution, and balance control. During the static balance assessment, participants will stand on a stable platform and will be instructed to maintain a steady posture for 30 seconds under both eyes-open and eyes-closed conditions. Parameters, including sway area and center of pressure path length will be recorded.
Measured: 30 minute
Dynamic Balance
Dynamic balance will also be evaluated using the ProKin Balance Assessment System. The assessment will be performed on a movable platform, where participants will be instructed to maintain balance by targeting the center point with visual feedback. During the evaluation, variables such as platform tilt angle, movement duration, and stability index will be recorded.
Measured: 30 minute
Proprioception
Proprioception will be assessed using the ProKin Balance Assessment System through the evaluation of lower extremity joint position sense. Participants will be asked to complete the circular trajectory determined by the device, and proprioceptive performance will be recorded accordingly.
Measured: 30 minute
Secondary outcomes (5)
Muscle Tone
Lumbar erector spinae muscle tone will be assessed using the MyotonPRO device. Muscle tone represents the natural oscillation frequency of the muscle at rest and reflects the passive tension state of the muscle tissue. Higher frequency values indicate increased resting muscle tension and altered neuromuscular regulation.
Measured: 30 minute
Muscle Stiffness
Lumbar erector spinae muscle stiffness will be evaluated using the MyotonPRO device. Muscle stiffness refers to the resistance of muscle tissue to external mechanical deformation and provides information regarding the biomechanical properties of the muscle. Increased stiffness values may indicate impaired tissue flexibility and altered viscoelastic behavior.
Measured: 30 minute
Pressure pain threshold
Pressure pain threshold will be assessed using a digital algometer applied bilaterally over the lumbar erector spinae muscle at the L3 level. The device objectively measures the minimum pressure perceived as painful, providing a reliable evaluation of mechanical pain sensitivity and alterations in nociceptive processing in individuals with low back pain.
Measured: 30 minute
Flexibility
Lumbar and hamstring flexibility will be evaluated using the Sit and Reach test with a standardized measurement box. Participants will perform controlled forward trunk flexion while maintaining full knee extension. The maximum reaching distance achieved will be recorded in centimeters, providing a reliable assessment of posterior chain flexibility and lumbopelvic mobility.
Measured: 30 minute
Global Change Scale (GCS)
The GCS will be used to assess the patient's perceived improvement following treatment and their level of satisfaction in comparison with their pre-treatment condition. Patients will be asked to rate the perceived effect of the treatment using a 5-point Likert scale as follows: "-2" (much worse), "-1" (worse), "0" (no change), "+1" (better), and "+2" (much better).
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588919
- Sponsor's protocol ID
- 20
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Sciatic Neural Mobilization on Balance and Proprioception in Patients With Low Back Pain and Radiating Leg Pain: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07588919
- Acronym / sponsor ID
- 20
- Conditions
- Low Back Pain, Leg Pain and/or Back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 15 May 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.
Low back pain is one of the most prevalent musculoskeletal disorders worldwide and significantly reduces individuals' quality of life, functional capacity, and productivity. Lumbar-related leg pain (LRLP) is observed in a substantial proportion of patients with low back pain and is associated with neurodynamic dysfunctions arising from peripheral nerve sensitization. Although the effects of neural mobilization on pain and functional outcomes have been investigated in the literature, studies examining its short-term effects on balance and proprioception remain limited. Therefore, this study aims to determine the immediate effects of sciatic nerve neural mobilization on balance and proprioception in individuals with LRLP exhibiting peripheral nerve sensitivity.
The study will be designed as a prospective, randomized, controlled clinical trial. Participants will be recruited from individuals presenting to the Istinye University Health Practice and Research Center Hospital who meet the inclusion criteria. Following random allocation, 52 participants will be assigned either to the intervention group (neural mobilization) or the sham group (sham mobilization). In addition to a single-session standard conventional physiotherapy program, each group will receive its respective intervention protocol. Assessments will be conducted at two time points: before treatment and immediately after treatment.
Static and dynamic balance as well as proprioception will be evaluated using the ProKin balance system; muscle mechanical properties will be assessed using the MyotonPRO device; pain threshold will be measured with an algometer; and flexibility will be evaluated using the sit-and-reach test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real neural mobilization | Experimental | Other: Sciatic neural mobilization |
| Sham neural mobilization | Sham comparator | Other: Sham sciatic neural mobilization |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having low back pain accompanied by radiating leg pain (radicular or pseudoradicular pain) for at least 3 weeks
- Demonstration of peripheral nerve sensitivity through clinical evaluation and neurodynamic tests
- Pain intensity of at least 3 on the Visual Analog Scale (VAS)
- Ability to understand verbal and written Turkish instructions
- Providing signed informed consent
Key exclusion criteria (8 listed)
- Presence of surgical indication due to acute disc herniation or advanced lumbar disc pathology
- History of spinal surgery or spinal trauma
- Low back pain associated with other pathologies (e.g., rheumatic diseases, multiple sclerosis, malignancy)
- Instability conditions such as spondylolysis and spondylolisthesis
- Pregnancy
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 |
|---|---|---|
| Sciatic neural mobilizationParticipants in the intervention group will receive sciatic neural mobilization in addition to a single-session standard conventional physiotherapy program. The conventional treatment program will consist of hot pack application, transcutaneous electrical nerve stimulation (TENS), and exercises aimed at improving lumbar muscle activation, flexibility, and proprioceptive awareness. Sciatic neural mobilization will be performed based on controlled neural sliding and tensioning principles along the sciatic nerve, with the aim of enhancing neural mobility, improving neurodynamic mechanisms, and supporting neuromuscular control. All interventions will be administered by experienced physiotherapists according to standardized protocols. | Other | Real neural mobilization |
| Sham sciatic neural mobilizationParticipants in the sham group will receive the same single-session standard conventional physiotherapy program as the intervention group. In addition, sham sciatic neural mobilization will be applied. In the sham intervention, procedures similar to those used in the intervention group will be performed at a minimal level without producing therapeutic neural tension or sliding effects. This approach is intended to distinguish the specific effects of the intervention from placebo effects. All procedures will be carried out by experienced physiotherapists in accordance with standardized protocols. | Other | Sham neural mobilization |
Primary outcome
Static Balance
Time frame: 30 minute
Static balance will be assessed using the ProKin Balance Assessment System. The ProKin system is a computer-assisted evaluation device equipped with an integrated force platform and motion sensors that objectively measure postural stability, weight distribution, and balance control. During the static balance assessment, participants will stand on a stable platform and will be instructed to maintain a steady posture for 30 seconds under both eyes-open and eyes-closed conditions. Parameters, including sway area and center of pressure path length will be recorded.
Dynamic Balance
Time frame: 30 minute
Dynamic balance will also be evaluated using the ProKin Balance Assessment System. The assessment will be performed on a movable platform, where participants will be instructed to maintain balance by targeting the center point with visual feedback. During the evaluation, variables such as platform tilt angle, movement duration, and stability index will be recorded.
Proprioception
Time frame: 30 minute
Proprioception will be assessed using the ProKin Balance Assessment System through the evaluation of lower extremity joint position sense. Participants will be asked to complete the circular trajectory determined by the device, and proprioceptive performance will be recorded accordingly.
5 secondary outcomes
Muscle Tone
Time frame: 30 minute
Muscle Stiffness
Time frame: 30 minute
Pressure pain threshold
Time frame: 30 minute
Flexibility
Time frame: 30 minute
Global Change Scale (GCS)
Time frame: 30 minute
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 15 May 2026.
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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 study testing Sciatic neural mobilization in people with Low Back Pain and Leg Pain and/or Back Pain, run by Istinye University.
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 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: opening soon, as of the sponsor's last update on 15 May 2026. 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. Some participants in this study may receive a placebo. 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?
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 YUNUS EMRE TÜTÜNEKEN, PhD (+905435912455, emre.tutuneken@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance (time frame: 30 minute). 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 15 May 2026.