- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07588919
Sciatic Neural Mobilization in Lumbar-Related Leg Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: YUNUS EMRE TÜTÜNEKEN, PhD
- Phone Number: +905435912455
- Email: emre.tutuneken@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real neural mobilization
|
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 Comparator: Sham neural mobilization
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 minute
|
|
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.
|
30 minute
|
|
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.
|
30 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Tone
Time Frame: 30 minute
|
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.
|
30 minute
|
|
Muscle Stiffness
Time Frame: 30 minute
|
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.
|
30 minute
|
|
Pressure pain threshold
Time Frame: 30 minute
|
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.
|
30 minute
|
|
Flexibility
Time Frame: 30 minute
|
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.
|
30 minute
|
|
Global Change Scale (GCS)
Time Frame: 30 minute
|
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).
|
30 minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20 (Sophies Minde Ortopedi AS)
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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