Effects of Whole Body Vibrationin in Patients With Non-Specific Low Back Pain

NCT06552962 | Completed

• 1 other identifier: İÜC-BT1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

After acute low back pain, one third of patients have chronic low back pain. A sedentary lifestyle is a leading cause of mechanical stress-related low back pain and exacerbates chronic low back pain. Balance disorders, postural adjustment disorder, abnormal spinal movements and related muscle imbalance are observed in individuals with chronic low back pain. Conservative treatment is mostly used in treatment. Langevin et al. stated that an abnormal and irregular thoracolumbar connective tissue structure is observed in chronic and recurrent low back pain. It has been said that physiotherapy and rehabilitation methods such as exercise therapy, massage, chiropractic and acupuncture provide changes in the biomechanical components of the affected connective tissue such as stiffness, viscoelasticity and density. Over the past 20 years, exercises with Whole Body Vibration (WBV) have begun to be used as an effective method for reducing pain. Exercises performed with WBV are thought to improve neuromuscular activation and increase muscle strength and joint stabilization. In non-specific chronic low back pain, increased tone is observed in the superficial back muscles. And based on this study, no study has been found examining the effect of vibratory exercise intervention on the tone of superficial back muscles that go into spasm due to pain. In this study, lumbar stabilization exercises, one of the most effective exercise methods in chronic low back pain, will be applied and exercises performed with vibration will have an additional effect. It is aimed to reveal whether it creates or not. MyotonPRO (myometer) is a digital palpation device that can measure the viscoelastic properties of myofascial tissue. In measurements made with patients with chronic low back pain and healthy controls, While lumbar myofascial tissue elasticity was significantly low in patients; The tone of the lumbar extensor muscles was found to be significantly higher. However, this measurement has not been made before in studies conducted with WBV, which is one of the methods used to reduce pain in individuals with chronic low back pain. The aim of this study is to reveal the effect of exercises performed with WBV on the myofascial tissue of the lumbar region and the tone of the superficial back muscles, on pain, function, muscle strength, balance, proprioception and endurance parameters compared to the group exercising only.

Conditions

Low Back Pain; Low Back Pain, Mechanical; Low Back Pain, Postural; Low Back Pain, Recurrent

Keywords

whole body vibration; biomechanical structures; low back pain; core stabilisation; lumbar myofascia

Outcome Measures

Primary Outcomes (1)

• MyotonPRO myofascial palpation device

  The measurement will be made in the prone position, without active muscle contraction. Lumbar paraspinal muscle measurement will be made from a point one finger to the right/left of the L4 level. F - Natural Oscillation Frequency \[Hz\], characterizing Tone or Tension S - Dynamic Stiffness \[N/m\] D - Logarithmic Decrement \[relative unit\], characterizing Elasticity R - Mechanical Stress Relaxation Time \[ms\] C - Ratio of Relaxation and Deformation time \[relative unit\], characterizing Creep

  6 weeks

Secondary Outcomes (8)

• Pain severity for lower back (Visual analog scale)

  6 weeks

• Low Back Function Assesment

  6 weeks

• Quality of Life (SF-12 SHORT FORM)

  6 weeks

• Lower Extremity Muscle Strength

  6 weeks

• Abdominals, side abdominals and back extenstors Endurance

  6 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The experimental group will have the same lumbar stabilization exercises performed on the whole body vibration device twice a week for 6 weeks. The frequency of the device will be set to 30 Hz. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment.

Device: Whole body vibration

Control Group

ACTIVE COMPARATOR

Within the scope of the research, individuals with chronic non-specific low back pain will be randomized and divided into two separate groups. Lumbar stabilization exercises will be applied to the control group twice a week for 6 weeks. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment.

Behavioral: lumbar stabilization exercises

Interventions

Whole body vibration DEVICE

The aim of this study is to reveal the effect of exercises performed with WBV on the myofascial tissue of the lumbar region and the tone of superficial back muscles, as well as to investigate the effects on pain, function, muscle strength, balance, proprioception and endurance parameters, compared to the exercise-only group.

Intervention Group

lumbar stabilization exercises BEHAVIORAL

The control group will undergo lumbar stabilization exercises twice a week for 6 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with Non-Specific low back pain by a physician,
• Having a complaint of non-specific low back pain for at least 3 months,
• Being 18 years or older,
• Volunteer,
• Not having any diagnosed cardiac disease,
• Not having any diagnosed neuromuscular disease,
• Pain level should be at least 3 according to VAS,
• Not having received physiotherapy or rehabilitation in the last 3 months
• Individuals who meet the above criteria will be included in the study.

You may not qualify if:

• Diagnosed stomach, kidney, liver, pancreas and bladder problems,
• Presence of mental or cognitive problems,
• History of surgery for low back pain,
• Pain level is 8 or above according to Visual Analogue Scale,
• Use of painkillers during treatment,
• Acute and severe musculoskeletal pain,
• Radiculopathy,
• Malignancy,
• Pregnancy,
• Pace maker users,
• Epilepsy,
• Individuals meeting the above criteria will be excluded from the study.

Sponsors & Collaborators

• Istanbul University: lead
• Istinye University: collaborator

Study Sites (1)

Istinye University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yıldız Analay Akbaba, Phd

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Beyza Tanrıöğen, MSc (c)

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study was designed as a double-blind randomize-controlled study in which the participant and the evaluator were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant (MSc student)

Model Details: Within the scope of the research, individuals with chronic non-specific low back pain will be randomized and divided into two separate groups. The control group will undergo lumbar stabilization exercises twice a week for 6 weeks. The experimental group will have the same lumbar stabilization exercises performed on the whole body vibration device twice a week for 6 weeks. The frequency of the device will be set to 30 Hz. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 14, 2024
• Study Start: July 25, 2024
• Primary Completion: November 20, 2024
• Study Completion: February 6, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)