Lumbar Disc HerniationWBV-LDHNCT06957951
Effectiveness of WBV-Supported Core Training on Lumbar Disc Herniation
A study testing Conventional Physiotherapy, Core Stabilization Exercises and WBV-Supported Core Exercises in people with Lumbar Disc Herniation and Low Back Pain, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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." Read more about this study
- Who is it for?
- Ages 30 to 50 years, men only
- Conditions the study is for
- Lumbar Disc Herniation, Low Back Pain
- What is being tested?
- Conventional Physiotherapy, Core Stabilization Exercises and WBV-Supported Core Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- • Male gender
- Age between 30 and 50 years
- Diagnosis of lumbar disc herniation (L4-L5 or L5-S1)
- No neurological deficits
Who cannot join
- • Prior lumbar surgery
- Severe cardiopulmonary or musculoskeletal disorders
- Uncontrolled systemic diseases
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Medical Faculty Physical Medicine and Rehabilitation Unit
Erzurum
About this study
Official title: 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."
Read the 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)."
- Conditions
- Lumbar Disc Herniation, Low Back Pain
- Being tested
- Conventional Physiotherapy, Core Stabilization Exercises, WBV-Supported Core Exercises
- Keywords
- Whole-Body Vibration, Core Stabilization Exercises, Low Back Pain, Sleep Quality, Functional Disability
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
Application of hot packs, TENS (transcutaneous electrical nerve stimulation), therapeutic ultrasound, and posture/activity education for low back pain management.
Core Stabilization ExercisesBehavioural
Supervised core stabilization exercises including planks, bird-dog, and pelvic bridging, targeting trunk muscle strength and stability.
WBV-Supported Core ExercisesBehavioural
Core stabilization exercises performed on a whole-body vibration platform (30 Hz frequency, low amplitude ~2 mm) during exercise execution to enhance neuromuscular stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Conventional Physiotherapy including hot pack, TENS, ultrasound, and education. Receives: Other: Conventional Physiotherapy |
| Core Stabilization Exercises | Active comparator | Core stabilization exercises added to conventional physiotherapy. Receives: Other: Conventional Physiotherapy; Behavioral: 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). Receives: Other: Conventional Physiotherapy; Behavioral: WBV-Supported Core Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS)
Change in pain scores measured by Visual Analog Scale.
Measured: 4 weeks
Functional Disability (ODI)
Change in disability scores measured by Oswestry Disability Index.
Measured: 4 weeks
Quality of Life (SF-36)
Change in quality of life scores
Measured: 4 weeks
Sleep Quality (PSQI)
Change in sleep quality scores.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start15 Oct 2023
- Primary completion15 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Erzurum Technical University, Ataturk University
- Responsible party
- Principal investigator, Esedullah Akaras, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957951
- Sponsor's protocol ID
- ETU-WBV-LDH-2023
- Acronym
- WBV-LDH
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of WBV-Supported Core Training on Pain, Function, and Sleep in Lumbar Disc Herniation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06957951
- Acronym / sponsor ID
- WBV-LDH / ETU-WBV-LDH-2023
- Conditions
- Lumbar Disc Herniation, Low Back Pain
- Keywords
- Whole-Body Vibration, Core Stabilization Exercises, Low Back Pain, Sleep Quality, Functional Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Erzurum Technical University, Ataturk University
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyConventional Physiotherapy including hot pack, TENS, ultrasound, and education. |
| Core Stabilization Exercises | Active comparator | Other: Conventional Physiotherapy, Behavioral: Core Stabilization ExercisesCore stabilization exercises added to conventional physiotherapy. |
| WBV-Supported Core Exercises | Experimental | Other: Conventional Physiotherapy, Behavioral: WBV-Supported Core ExercisesParticipants received conventional physiotherapy combined with core stabilization exercises performed on a whole-body vibration platform (30 Hz, low amplitude ~2 mm). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Male gender
Key exclusion criteria (4 listed)
- • Prior lumbar surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PhysiotherapyApplication of hot packs, TENS (transcutaneous electrical nerve stimulation), therapeutic ultrasound, and posture/activity education for low back pain management. | Other | Conventional Physiotherapy, Core Stabilization Exercises, WBV-Supported Core Exercises |
| Core Stabilization ExercisesSupervised core stabilization exercises including planks, bird-dog, and pelvic bridging, targeting trunk muscle strength and stability. | Behavioural | Core Stabilization Exercises |
| WBV-Supported Core ExercisesCore stabilization exercises performed on a whole-body vibration platform (30 Hz frequency, low amplitude ~2 mm) during exercise execution to enhance neuromuscular stimulation. | Behavioural | WBV-Supported Core Exercises |
Primary outcome
Pain Intensity (VAS)
Time frame: 4 weeks
Change in pain scores measured by Visual Analog Scale.
Functional Disability (ODI)
Time frame: 4 weeks
Change in disability scores measured by Oswestry Disability Index.
Quality of Life (SF-36)
Time frame: 4 weeks
Change in quality of life scores
Sleep Quality (PSQI)
Time frame: 4 weeks
Change in sleep quality scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy, Core Stabilization Exercises and WBV-Supported Core Exercises in people with Lumbar Disc Herniation and Low Back Pain, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (VAS) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.