Whole-Body Vibration and Balneotherapy in Chronic Low Back Pain (Whole-Body Vib)

April 29, 2026 updated by: Selim Mahmut GÜNAY, Uludag University

The Effect of Whole-Body Vibration Exercises Combined With Balneotherapy on Pain, Function, and Sleep Quality in Patients With Chronic Low Back Pain

This randomized controlled clinical trial aims to investigate the effects of whole-body vibration (WBV) exercises combined with balneotherapy on pain, physical function, sleep quality, and daily activity levels in individuals with chronic low back pain.

A total of 60 volunteers aged 18 to 65 who have been diagnosed with chronic low back pain by a physical medicine and rehabilitation specialist and who meet the eligibility criteria will be included. Participants will be randomly assigned to two groups. Both groups will receive balneotherapy five days a week for three weeks. After balneotherapy, the first group will perform standard stretching, strengthening, and aerobic exercises designed for low back pain. The second group will receive the same exercise program in combination with WBV exercises using a vibration platform. WBV sessions will include static and dynamic exercises with specific frequency and amplitude settings.

All participants will be evaluated at baseline and after three weeks using validated measures, including pain intensity (Visual Analog Scale), spinal mobility (Modified Schober Test), balance and reach (Functional Reach Test), physical performance (Sit-to-Stand and Timed Up and Go Tests), disability (Oswestry Disability Index, Roland-Morris Questionnaire), and sleep quality (Pittsburgh Sleep Quality Index).

The study seeks to determine whether combining WBV with balneotherapy can provide additional benefits over standard exercise alone in managing chronic low back pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary consent to participate in the study
  • Age between 18 and 65 years
  • Having chronic low back pain lasting at least 3 months or recurring at least 3 times per week
  • Diagnosis of chronic low back pain by a physical medicine and rehabilitation specialist
  • Normal neurological examination findings (no abnormal lower extremity reflexes or anesthesia)

Exclusion Criteria:

  • Presence of radicular pain or radiculopathy
  • Spondylolisthesis, spinal stenosis, vertebral infection, or cauda equina syndrome
  • Vertebral fracture, axial spondyloarthritis
  • History of lumbar spine surgery
  • Inflammatory rheumatic disease, psychiatric or neurological disorders
  • Uncontrolled hypertension, decompensated organ failure, or malignancy
  • Pregnancy or breastfeeding
  • Use of systemic steroids in the last 3 months
  • Major trauma or surgery within the past 6 months
  • Receiving physical therapy or physical modalities within the past 6 months
  • Any health condition that prevents participation in balneotherapy or exercise programs

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Balneotherapy and Standard Exercise Group
Participants in this group will receive 20-minute balneotherapy sessions five days per week for three weeks. Following a 30-40 minute rest, they will perform a standardized exercise program targeting chronic low back pain. The program includes stretching, strengthening, range of motion, and stabilization exercises focused on the lumbar spine, hips, and lower extremities. Exercises will be performed in 2 sets of 8-10 repetitions. Sessions will be supervised by a physiotherapist.
Behavioral: Balneotherapy
Participants receive 20-minute balneotherapy sessions involving full-body immersion in thermal-mineral spring water at a therapeutic spa facility. Sessions are conducted five days per week over a three-week period. Water temperature and mineral content are standardized according to institutional protocols. The intervention is designed to provide analgesic, anti-inflammatory, and muscle-relaxant effects through thermally induced vasodilation and neuromuscular modulation.
Experimental: Balneotherapy and Whole-Body Vibration Exercise Group
Participants in this group will also receive 20-minute balneotherapy sessions five days per week for three weeks. After a 30-40 minute rest, they will first complete the same standardized exercise program as the first group. Then, they will perform whole-body vibration (WBV) exercises on a vibration platform (Compex Winplate). The WBV session will include static squats, dynamic squats, bridge exercises, dynamic weight shifting, and toe raises, performed at 30-40 Hz frequency and 2-4 mm amplitude for 40-60 seconds per set, with 2 sets per session and 3-minute rest intervals.
Behavioral: Balneotherapy
Participants receive 20-minute balneotherapy sessions involving full-body immersion in thermal-mineral spring water at a therapeutic spa facility. Sessions are conducted five days per week over a three-week period. Water temperature and mineral content are standardized according to institutional protocols. The intervention is designed to provide analgesic, anti-inflammatory, and muscle-relaxant effects through thermally induced vasodilation and neuromuscular modulation.
Behavioral: Whole-Body Vibration Exercise
Participants perform whole-body vibration (WBV) exercises using the "Compex Winplate" platform (Uniphy Elektromedizin GmbH & CoKG), certified under ISO 9001:2000 and DIN EN ISO 13485:2003. The exercise protocol includes static squats, dynamic squats, bridge exercises, dynamic weight shifting, and toe raises. Vibration is applied at a frequency of 30-40 Hz and amplitude of 2-4 mm for 40-60 seconds per set, with two sets per session and a 3-minute rest between sets. WBV is applied following a standardized exercise program, and the full intervention is delivered five days per week for three weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and after 3 weeks of intervention
SQI will be used to evaluate subjective sleep quality across 7 components. Higher total scores indicate poorer sleep quality.
Baseline and after 3 weeks of intervention
Functional disability measured by Oswestry Disability Index
Time Frame: Baseline and after 3 weeks of intervention
Baseline and after 3 weeks of intervention
Modified Schober Test
Time Frame: Baseline and after 3 weeks
Baseline and after 3 weeks
Timed Up and Go (TUG) Test
Time Frame: Baseline and after 3 weeks
Baseline and after 3 weeks
30-Second Chair Stand Test
Time Frame: Baseline and after 3 weeks
Baseline and after 3 weeks
Functional Reach Test
Time Frame: Baseline and after 3 weeks
Baseline and after 3 weeks
Roland-Morris Disability Questionnaire
Time Frame: Baseline and after 3 weeks
Baseline and after 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uludag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/8-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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