Whole-Body Vibration and Balneotherapy in Chronic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Balneology Whole Body Vibration Water Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Balneotherapy

Intervention Type 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 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.

Group Type EXPERIMENTAL

Balneotherapy

Intervention Type 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.

Whole-Body Vibration Exercise

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No