Whole-Body Vibration and Balneotherapy in Chronic Low Back Pain

Not Applicable

Recruiting

• Conditions: Whole Body Vibration; Exercise; Balneology; Water

• Registration Number: NCT07067489
• Lead Sponsor: Uludag University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	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.
Modified Schober Test	Baseline and after 3 weeks
Timed Up and Go (TUG) Test	Baseline and after 3 weeks
30-Second Chair Stand Test	Baseline and after 3 weeks
Functional disability measured by Oswestry Disability Index	Baseline and after 3 weeks of intervention
Functional Reach Test	Baseline and after 3 weeks
Roland-Morris Disability Questionnaire	Baseline and after 3 weeks

Trial Locations

Locations (1)

Bursa Uludag University; 🇹🇷 Bursa, Nilüfer, Turkey