NCT06957951

Brief Summary

"This randomized controlled trial investigated the effects of conventional physiotherapy, core stabilization exercises, and WBV-supported core stabilization exercises on pain intensity, functional disability, quality of life, and sleep quality in male patients with lumbar disc herniation without neurological deficits."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

October 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

April 27, 2025

Last Update Submit

April 27, 2025

Conditions

Lumbar Disc HerniationLow Back Pain

Keywords

Whole-Body VibrationCore Stabilization ExercisesLow Back PainSleep QualityFunctional Disability

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity (VAS)

    Change in pain scores measured by Visual Analog Scale.

    4 weeks

  • Functional Disability (ODI)

    Change in disability scores measured by Oswestry Disability Index.

    4 weeks

  • Quality of Life (SF-36)

    Change in quality of life scores

    4 weeks

  • Sleep Quality (PSQI)

    Change in sleep quality scores.

    4 weeks

Study Arms (3)

Conventional Physiotherapy

ACTIVE COMPARATOR

Conventional Physiotherapy including hot pack, TENS, ultrasound, and education.

Other: Conventional Physiotherapy

Core Stabilization Exercises

ACTIVE COMPARATOR

Core stabilization exercises added to conventional physiotherapy.

Other: Conventional PhysiotherapyBehavioral: Core Stabilization Exercises

WBV-Supported Core Exercises

EXPERIMENTAL

Participants received conventional physiotherapy combined with core stabilization exercises performed on a whole-body vibration platform (30 Hz, low amplitude \~2 mm).

Other: Conventional PhysiotherapyBehavioral: WBV-Supported Core Exercises

Interventions

Conventional PhysiotherapyOTHER

Application of hot packs, TENS (transcutaneous electrical nerve stimulation), therapeutic ultrasound, and posture/activity education for low back pain management.

Conventional PhysiotherapyCore Stabilization ExercisesWBV-Supported Core Exercises
Core Stabilization ExercisesBEHAVIORAL

Supervised core stabilization exercises including planks, bird-dog, and pelvic bridging, targeting trunk muscle strength and stability.

Core Stabilization Exercises
WBV-Supported Core ExercisesBEHAVIORAL

Core stabilization exercises performed on a whole-body vibration platform (30 Hz frequency, low amplitude \~2 mm) during exercise execution to enhance neuromuscular stimulation.

WBV-Supported Core Exercises

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male gender
  • Age between 30 and 50 years
  • Diagnosis of lumbar disc herniation (L4-L5 or L5-S1)
  • No neurological deficits

You may not qualify if:

  • Prior lumbar surgery
  • Severe cardiopulmonary or musculoskeletal disorders
  • Uncontrolled systemic diseases
  • Participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Medical Faculty Physical Medicine and Rehabilitation Unit

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementLow Back PainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 27, 2025

First Posted

May 6, 2025

Study Start

October 15, 2023

Primary Completion

December 15, 2024

Study Completion

December 31, 2024

Last Updated

May 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)