NCT07752199

Brief Summary

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 3, 2026

Last Update Submit

August 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Oswestry Disability Index (ODI) Score

    Baseline and Week 3 (end of intervention)

Secondary Outcomes (4)

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

    Baseline and Week 3 (end of intervention)

  • Health-related quality of life (SF-12)

    Baseline and Week 3

  • Change in Infrared Thermographic Temperature Parameters

    Baseline, Week 1, and Week 3

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

    Baseline and Week 3

Study Arms (2)

Arm 1

EXPERIMENTAL

Manual Therapy + Neural Mobilization

Behavioral: Neural MobilizationBehavioral: Manual Therapy

Arm 2

SHAM COMPARATOR

Manual Therapy + Sham Neural Mobilization

Behavioral: Sham Neural MobilizationBehavioral: Manual Therapy

Interventions

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.

Arm 1

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

Arm 2
Manual TherapyBEHAVIORAL

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).

Arm 1Arm 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

Location

Related Publications (3)

  • Basson A, Olivier B, Ellis R, Coppieters M, Stewart A, Mudzi W. The Effectiveness of Neural Mobilization for Neuromusculoskeletal Conditions: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Sep;47(9):593-615. doi: 10.2519/jospt.2017.7117. Epub 2017 Jul 13.

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  • Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Physical Therapist

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 7, 2026

Study Start

April 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations