- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06957951
- Original Trial
Effectiveness of WBV-Supported Core Training on Lumbar Disc Herniation (WBV-LDH)
April 27, 2025 updated by: Esedullah Akaras, Gazi University
Effectiveness of WBV-Supported Core Training on Pain, Function, and Sleep in Lumbar Disc Herniation: A Randomized Controlled Trial
"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."
Study Overview
Status
Completed
Conditions
Detailed Description
"This study aimed to compare the effects of whole-body vibration (WBV)-supported core exercises, standard core exercises, and conventional physiotherapy on pain, disability, quality of life, and sleep quality among male patients aged 30-50 years with lumbar disc herniation without neurological deficits.
Participants were randomly allocated to one of three groups and underwent 12 sessions over 4 weeks.
The outcomes assessed were pain (VAS), disability (ODI), quality of life (SF-36), and sleep quality (PSQI)."
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzurum, Turkey
- Atatürk University Medical Faculty Physical Medicine and Rehabilitation Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Male gender
- Age between 30 and 50 years
- Diagnosis of lumbar disc herniation (L4-L5 or L5-S1)
- No neurological deficits
Exclusion Criteria:
• Prior lumbar surgery
- Severe cardiopulmonary or musculoskeletal disorders
- Uncontrolled systemic diseases
- Participation in another clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Physiotherapy
Conventional Physiotherapy including hot pack, TENS, ultrasound, and education.
|
Application of hot packs, TENS (transcutaneous electrical nerve stimulation), therapeutic ultrasound, and posture/activity education for low back pain management.
|
|
Active Comparator: Core Stabilization Exercises
Core stabilization exercises added to conventional physiotherapy.
|
Application of hot packs, TENS (transcutaneous electrical nerve stimulation), therapeutic ultrasound, and posture/activity education for low back pain management.
Supervised core stabilization exercises including planks, bird-dog, and pelvic bridging, targeting trunk muscle strength and stability.
|
|
Experimental: WBV-Supported Core Exercises
Participants received conventional physiotherapy combined with core stabilization exercises performed on a whole-body vibration platform (30 Hz, low amplitude ~2 mm).
|
Application of hot packs, TENS (transcutaneous electrical nerve stimulation), therapeutic ultrasound, and posture/activity education for low back pain management.
Core stabilization exercises performed on a whole-body vibration platform (30 Hz frequency, low amplitude ~2 mm) during exercise execution to enhance neuromuscular stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity (VAS)
Time Frame: 4 weeks
|
Change in pain scores measured by Visual Analog Scale.
|
4 weeks
|
|
Functional Disability (ODI)
Time Frame: 4 weeks
|
Change in disability scores measured by Oswestry Disability Index.
|
4 weeks
|
|
Quality of Life (SF-36)
Time Frame: 4 weeks
|
Change in quality of life scores
|
4 weeks
|
|
Sleep Quality (PSQI)
Time Frame: 4 weeks
|
Change in sleep quality scores.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2023
Primary Completion (Actual)
December 15, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
April 27, 2025
First Submitted That Met QC Criteria
April 27, 2025
First Posted (Actual)
May 6, 2025
Study Record Updates
Last Update Posted (Actual)
May 6, 2025
Last Update Submitted That Met QC Criteria
April 27, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETU-WBV-LDH-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.