- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06552962
Effects of Whole Body Vibrationin in Patients With Non-Specific Low Back Pain
Effects of Whole Body Vibration on Pain, Function and Viscoelasticity in Patients With Non-Specific Low Back Pain
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey, 34010
- Istinye University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
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The control group will undergo lumbar stabilization exercises twice a week for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MyotonPRO myofascial palpation device
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain severity for lower back (Visual analog scale)
Time Frame: 6 weeks
|
Participants' pain intensity will be evaluated according to Visual Analog Scale.
The score is from 0 to 10.
The pain level increases from 0 to 10.
|
6 weeks
|
|
Low Back Function Assesment
Time Frame: 6 weeks
|
The Oswestry Low Back Pain Disability Questionnaire is a 10-part index used to assess the functioning of patients affected by low back pain.
|
6 weeks
|
|
Quality of Life (SF-12 SHORT FORM)
Time Frame: 6 weeks
|
Measurement will be made with Short Form SF-12, which is the shortened version of the SF-36 Quality of Life Scale.
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6 weeks
|
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Lower Extremity Muscle Strength
Time Frame: 6 weeks
|
Myometer is a muscle strength measurement device.
Provides more objective data than manual muscle testing.
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6 weeks
|
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Abdominals, side abdominals and back extenstors Endurance
Time Frame: 6 weeks
|
The endurance of the trunk muscles will be measured by lateral bridging, Sorensen and trunk flexors endurance test.
|
6 weeks
|
|
Dynamic Balance
Time Frame: 6 weeks
|
Dynamic balance will be measured with the Y balance test.
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6 weeks
|
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Lumbar Proprioception
Time Frame: 6 weeks
|
With the passive positioning technique, a certain angle is applied to the lumbar region with the patient's eyes closed. The position is given passively and then the patient is asked to find the same angle without support, using the same extremity. The difference between the angles is recorded with a goniometer [29] |
6 weeks
|
|
Static Balance
Time Frame: 6 weeks
|
Static Balance and Single Leg Standing Test will be performed.
This test is performed with eyes open and hands on hips.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Yıldız Analay Akbaba, Phd, Istanbul University - Cerrahpasa
- Principal Investigator: Beyza Tanrıöğen, MSc (c), Istanbul University - Cerrahpasa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- İÜC-BT1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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