NCT07588919

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable low-back-pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 9, 2026

Last Update Submit

May 9, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    30 minute

Secondary Outcomes (5)

  • Muscle Tone

    30 minute

  • Muscle Stiffness

    30 minute

  • Pressure pain threshold

    30 minute

  • Flexibility

    30 minute

  • Global Change Scale (GCS)

    30 minute

Study Arms (2)

Real neural mobilization

EXPERIMENTAL
Other: Sciatic neural mobilization

Sham neural mobilization

SHAM COMPARATOR
Other: Sham sciatic neural mobilization

Interventions

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.

Real 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.

Sham neural mobilization

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

YUNUS EMRE TÜTÜNEKEN, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Assistant Professor

Study Record Dates

First Submitted

May 9, 2026

First Posted

May 15, 2026

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05