Whole-Body Vibration and Balneotherapy in Chronic Low Back Pain

NCT07067489 | Recruiting

• 1 other identifier: 2025/8-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Water; Exercise; Balneology; Whole Body Vibration

Outcome Measures

Primary Outcomes (7)

• Pittsburgh Sleep Quality Index (PSQI)

  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

  Baseline and after 3 weeks of intervention

• 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 Reach Test

  Baseline and after 3 weeks

• Roland-Morris Disability Questionnaire

  Baseline and after 3 weeks

Study Arms (2)

Balneotherapy and Standard Exercise Group

EXPERIMENTAL

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

Balneotherapy and Whole-Body Vibration Exercise Group

EXPERIMENTAL

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; Behavioral: Whole-Body Vibration Exercise

Interventions

Balneotherapy BEHAVIORAL

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.

Balneotherapy and Standard Exercise Group; Balneotherapy and Whole-Body Vibration Exercise Group

Whole-Body Vibration Exercise BEHAVIORAL

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.

Balneotherapy and Whole-Body Vibration Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University

Bursa, Nilüfer, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Dilekci E, Ozkuk K, Kaki B. The short-term effects of balneotherapy on pain, disability and fatigue in patients with chronic low back pain treated with physical therapy: A randomized controlled trial. Complement Ther Med. 2020 Nov;54:102550. doi: 10.1016/j.ctim.2020.102550. Epub 2020 Sep 4.

  PMID: 33183668 BACKGROUND

• Blanco-Gimenez P, Vicente-Mampel J, Gargallo P, Baraja-Vegas L, Bautista IJ, Ros-Bernal F, Barrios C. Clinical relevance of combined treatment with exercise in patients with chronic low back pain: a randomized controlled trial. Sci Rep. 2024 Jul 24;14(1):17042. doi: 10.1038/s41598-024-68192-2.

  PMID: 39048701 BACKGROUND

• Remer F, Keilani M, Kull P, Crevenna R. Effects of whole-body vibration therapy on pain, functionality, postural stability, and proprioception in patients with subacute and chronic non-specific low back pain: a systematic review. Wien Med Wochenschr. 2025 Feb;175(1-2):20-40. doi: 10.1007/s10354-023-01026-4. Epub 2023 Nov 24.

  PMID: 37999785 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Balneology

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Selim Mahmut GÜNAY, Asst Prof

CONTACT

+90 0224 295 0844; selimmg@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst prof

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 16, 2025
• Study Start: July 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-07

Locations

TU (1)