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NCT Number: NCT07067489

Whole-Body Vibration and Balneotherapy in 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.

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Key information

Conditions

Balneology Behavior Exercise Motor Activity Water Whole Body Vibration

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. Functional disability measured by Oswestry Disability Index

    Time frame: Baseline and after 3 weeks of intervention

  3. Modified Schober Test

    Time frame: Baseline and after 3 weeks

  4. Timed Up and Go (TUG) Test

    Time frame: Baseline and after 3 weeks

  5. 30-Second Chair Stand Test

    Time frame: Baseline and after 3 weeks

  6. Functional Reach Test

    Time frame: Baseline and after 3 weeks

  7. Roland-Morris Disability Questionnaire

    Time frame: Baseline and after 3 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Selim Mahmut GÜNAY, Asst Prof

CONTACT

[email protected]

+90 0224 295 0844

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Acronym: Whole-Body Vib

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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