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

NCT ID: NCT06552962

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2025-02-06

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.

Detailed Description

WBV exercise is a popular method to reduce pain intensity and improve function and quality of life.

is the method. WBV exercise is currently used as a treatment for patients with chronic low back pain. The effect of WBV exercise on the treatment of low back pain can be explained by activating the core muscles and increasing stabilization. Additionally, paravertebral muscle spasm occurs in most patients, and it is said that WBV can relieve pain by relaxing the paravertebral muscles. In addition, it is thought that it may reduce the associated spinal dysfunction and instability by improving the proprioception of the lumbosacral region. Although studies have begun with WBV in patient groups with chronic low back pain, the studies are limited.

Therefore, the optimal dosage has not yet been determined. It aims to compare its effect on strength, balance, proprioception, endurance, quality of life and viscoelastic properties of the lumbar region. Thus, WBV on the specified parameters It is aimed to reveal its effectiveness and contribute to the existing literature. Measurement with the MyotonPRO device, a newly widespread and expensive measuring device, will strengthen the objective and original aspect of the study. Lumbar stabilization exercises (LSE) try to correct the disorders by activating the trunk muscles. In this respect, it is widely used by physiotherapists in the treatment of low back pain. In our study, while lumbar stabilization exercises were applied to individuals in the control group; intervention The group will be given exercise accompanied by vibration. The effect of the added vibration on the exercises accepted in the literature will be examined. The effectiveness of WBV in patients with chronic non-specific low back pain will be evaluated by making the following measurements: MyotonPRO: 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.

Pain: Participants' pain intensity will be evaluated according to the Visual Analog Scale (VAS).

Function: The Oswestry Low Back Pain Disability Questionnaire measures the functioning of patients affected by low back pain.

It is an index consisting of 10 sections used for evaluation. Quality of Life: Measurement with Short Form SF-12, which is the abbreviated version of the SF-36 Quality of Life Scale will be done. Lower Extremity Muscle Strength: Myometer is a muscle strength measurement device. More objective than manual muscle testing provides data. Endurance: The endurance of the trunk muscles is measured by lateral bridging, Sorensen and trunk flexors endurance test.

will be measured. Balance: Dynamic balance will be measured with the Y balance test. Static Balance, Single Leg Stand Test will be done. This test is performed with eyes open and hands on hips. Proprioception: With the passive positioning technique, a certain angle is applied to the lumbar region as the patient's eyes are closed.

Position is given passively with the helper and then the patient is asked to do the same without support using the same extremity.

You are asked to find the angle. The difference between the angles is recorded with a goniometer.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Whole body vibration

Intervention Type: 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.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

lumbar stabilization exercises

Intervention Type: BEHAVIORAL

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

Interventions

Whole body vibration

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 Type: DEVICE

lumbar stabilization exercises

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istinye University

OTHER

Sponsor Role: collaborator

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Beyza Tanrıöğen

Research Assistant (MSc student)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yıldız Analay Akbaba, Phd

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Beyza Tanrıöğen, MSc (c)

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Istinye University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

İÜC-BT1

Identifier Type: -

Identifier Source: org_study_id