Whole-Body Vibration and Balneotherapy in Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUludag University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of radicular pain or radiculopathy
Spondylolisthesis, spinal stenosis, vertebral infection, or cauda equina syndrome
Vertebral fracture, axial spondyloarthritis
History of lumbar spine surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Balneotherapy
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Balneotherapy and Standard Exercise GroupExperimental treatment 1 intervention
Group B: Balneotherapy and Whole-Body Vibration Exercise GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pittsburgh Sleep Quality Index (PSQI)
SQI will be used to evaluate subjective sleep quality across 7 components. Higher total scores indicate poorer sleep quality.
Time frame
Baseline and after 3 weeks of intervention2
Functional disability measured by Oswestry Disability Index
Time frame
Baseline and after 3 weeks of intervention3
Modified Schober Test
Time frame
Baseline and after 3 weeks4
Timed Up and Go (TUG) Test
Time frame
Baseline and after 3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Uludag University
Lead sponsor
Mustafa Kemal University
Sponsor institution
Source ClinicalTrials.gov