NCT07203560

Brief Summary

The objective of this randomized controlled trial was to investigate the effects of neurodynamic mobilization on pain intensity, normal joint motion, neurodynamics, functional level, and disability in patients with lumbar disc herniation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 17, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

low back painsciaticaDisability EvaluationMusculoskeletal Manipulations

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Patients' rest and activity pain levels was assessed via a visual analog scale (VAS). Participants were asked to mark the intensity of pain they felt on a 10-centimeter (cm) horizontal line (0 indicates no pain, 10 indicates intolerable pain). The point marked on the line was measured with a ruler and the VAS value was recorded in cm

    Pain was assessed at baseline (before treatment) and at the end of 4 weeks of treatment (post-treatment)

Secondary Outcomes (3)

  • ROM

    Rom was assessed at baseline (before treatment) and at the end of 4 weeks of treatment (post-treatment).

  • Neurodynamic Mobility - Slump Test

    These were assessed at baseline (before treatment) and at the end of 4 weeks of treatment (post-treatment).

  • Neurodynamic Mobility - Sit and Reach Test

    Baseline (before treatment) and at the end of 4 weeks of treatment (post-treatment)

Study Arms (2)

Neurodynamic Mobilization + Conventional Therapy (Experimental Group)

EXPERIMENTAL

Participants received the conventional physiotherapy program plus neurodynamic mobilization administered by a physical therapist. Treatment was given 5 days a week for 4 weeks, for a total of 20 sessions.

Other: Neurodynamic MobilizationOther: Conventional Physiotherapy

Conventional Therapy (Control Group)

ACTIVE COMPARATOR

Individuals in control group received hot therapy (Hotpack, 20 minutes), Conventional Tens (60 Hz, 60 msec, 20 minutes) and Therapeutic Ultrasound (1.5 w/cm2, 10 minutes). Patients were given an exercise program to do at home and the treatment was given 5 days a week for 4 weeks, for a total of 20 sessions, to all patients in the study.

Other: Conventional Physiotherapy

Interventions

In the experimental group, neurodynamic mobilization was applied in addition to the conventional physiotherapy program. For the neurodynamic mobilization tibial nerve neural mobilization was performed. For neural mobilization of the tibial nerve, the patient was placed in the side-lying position with the hip in 90° flexion, knee flexion and ankle dorsi flexion. In this position, the ankle and hip positions were maintained, and knee extension was performed. When the symptoms were at a level that would not disturb the patient, it was held for 5 seconds, and knee flexion was performed by plantar flexion of the ankle. This practice was performed twice a week with 10 repetitions by a physiotherapist. The same neurodynamic mobilization exercise was recommended to the patients in the neuromobilization group as a home program with 10 repetitions twice a day.

Neurodynamic Mobilization + Conventional Therapy (Experimental Group)

All participants received hot pack therapy (20 minutes), conventional TENS (60 Hz, 60 msec, 20 minutes), therapeutic ultrasound (1.5 W/cm², 10 minutes), and a prescribed home exercise program, delivered 5 days per week for 4 weeks (20 sessions in total).

Conventional Therapy (Control Group)Neurodynamic Mobilization + Conventional Therapy (Experimental Group)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 60 years
  • Diagnosed with lumbar disc herniation at one or more of the L3-L4, L4-L5
  • L5-S1 levels with prolapsed, protruding, or extruding disc confirmed by MRI
  • Presence of low back pain for at least 6 weeks.

You may not qualify if:

  • Spinal stenosis
  • Previous lumbar surgery or medical treatment for disc herniation
  • Pregnancy
  • Severe osteoporosis
  • Diabetes mellitus
  • Severe neurological deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Department of Physical Therapy and Rehabilitation

Ankara, Çankaya, 06690, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementLow Back PainSciatica

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and SymptomsSciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgia

Study Officials

  • Gurkan Gunaydin

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, parallel-group randomized controlled trial. Control group received a conventional physiotherapy program; intervention group received the same program plus neurodynamic mobilization. Treatments were delivered over 4 consecutive weeks. Outcomes included pain, ROM, neurodynamic mobility, functional status and disability.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 17, 2025

First Posted

October 2, 2025

Study Start

June 4, 2018

Primary Completion

May 10, 2019

Study Completion

May 10, 2019

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations