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Completed

NCT Number: NCT07752199

Effects of Neural Mobilization Combined With Manual Therapy on Infrared Thermography, Inflammatory Markers and Clinical Outcomes in Patients With Lumbar Disc Herniation: A Randomized Controlled Clinical Trial

The objective of this randomized controlled clinical trial is to evaluate whether manual therapy combined with neural mobilization can improve pain, functional impairment, quality of life, inflammatory markers, and infrared thermographic findings in patients with lumbar disc herniation. The study subjects consist of 72 patients with lumbar disc herniation (aged 18-65 years, with unilateral lumbar radicular symptoms).

The primary questions it aims to address are:

1. In patients with lumbar disc herniation, is manual therapy combined with neural mobilization more effective than manual therapy alone in relieving pain and improving functional impairment? 2. Can manual therapy combined with neural mobilization improve patients' quality of life, inflammation-related markers (IL-6 and TNF-α), and body temperature changes detected by infrared thermography?

The researchers compared:

* Experimental group: manual therapy combined with neural mobilization (36 cases) * Control group: manual therapy with sham neural mobilization (36 cases)

to determine whether adding neural mobilization can provide additional therapeutic effects, including better pain relief, functional recovery, and improvement in related physiological indicators.

Participants will:

* Receive a 3-week course of treatment, totaling approximately 11 sessions. * Undergo standardized manual therapy, including lumbar mobilization and soft tissue therapy, to help relieve pain and improve mobility. * Receive additional treatment according to group assignment: * The experimental group will receive sciatic nerve mobilization through gentle, controlled leg movements to improve nerve function and reduce nerve sensitivity. * The control group will receive lumbar traction therapy to relieve lumbar stress. * Be assessed before and after treatment, including pain scores, functional impairment scores (ODI), quality of life surveys (SF-12), infrared thermography examinations, and blood tests for inflammatory markers.

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Key information

Conditions

Herniated Disc Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sciatica Due to Intervertebral Disc Disorder Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Participants will be eligible for inclusion if they meet the following criteria:

Adults aged 18-65 years. Diagnosis of lumbar disc herniation based on clinical symptoms and imaging findings.

Presence of unilateral lumbar radiculopathy. Persistent symptoms despite initial conservative management. Ability to participate in the intervention protocol. Provided written informed consent before study enrollment.

Exclusion criteria

-

Participants will be excluded if they meet any of the following criteria:

Requirement for surgical intervention for lumbar disc herniation. Serious spinal conditions, including spinal infection, tumor, or fracture. Severe systemic diseases or acute inflammatory conditions. Pregnancy or breastfeeding. Receipt of other interventions that may affect study outcomes during the study period.

Treatment and study plan

Neural Mobilization

Behavioral

Neural mobilization will be performed using neurodynamics techniques, aiming to improve neural activity and reduce neural mechanosensitivity. The intervention will be conducted over a period of three weeks.

Sham Neural Mobilization

Behavioral

The posture and duration of pseudo neural stretching therapy do not produce the expected neurodynamic effects.

Manual Therapy

Behavioral

Participants in both groups will receive standardized manual therapy targeting the lumbar spine. The intervention includes lumbar posterior-to-anterior (PA) mobilization and soft tissue mobilization techniques applied to the lumbar paraspinal muscles, gluteal muscles, piriformis, and proximal hamstrings. Manual therapy will be performed within a tolerable range without provoking symptom exacerbation and will be administered every other day for 3 weeks (a total of 11 sessions).

Primary outcomes

  1. Change in Oswestry Disability Index (ODI) Score

    Time frame: Baseline and Week 3 (end of intervention)

Secondary outcomes

  1. Change in Pain Intensity Measured by Visual Analog Scale (VAS)

    Time frame: Baseline and Week 3 (end of intervention)

  2. Health-related quality of life (SF-12)

    Time frame: Baseline and Week 3

  3. Change in Infrared Thermographic Temperature Parameters

    Time frame: Baseline, Week 1, and Week 3

  4. Change in Serum Inflammatory Biomarkers (IL-6 and TNF-α)

    Time frame: Baseline and Week 3

Sponsors and collaborators

Lead sponsor

Longhua Hospital

Other

Registry information

Official study title

Effects of Neural Mobilization Combined With Manual Therapy on Functional Outcomes and Exploratory Infrared Thermographic Changes in Patients With Lumbar Disc Herniation: A Randomized Sham-Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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