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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

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

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
Intervention / Treatment
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

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

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)

July 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

July 3, 2025

First Submitted That Met QC Criteria

July 14, 2025

First Posted (Actual)

July 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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