Whole-Body Vibration and Balneotherapy in Chronic Low Back Pain

Official title

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

Overview

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.

Interventions

• 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 sta

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Bursa Uludag University — Bursa

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07067489 · 2025/8-3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗