- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04759404
The Effect of Deep Oscillation and Myofascial Relaxation With Chronic Nonspecific Low Back Pain
The Effect of Deep Oscillation and Myofascial Relaxation on Pain, Functionality and Quality of Life in Individuals With Chronic Nonspecific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to the data determined by the World Health Organization (WHO), one of the diseases that 80% of people encounter throughout their lives is low back pain. Nonspecific low back pain is defined as low back pain of unknown cause, which can be diagnosed, and cannot be attributed to a known specific disease (eg infection, structural deformity, inflammatory disorder, tumor, osteoporosis, fracture, radicular syndrome or cauda equina syndrome).
In addition, low back pain problem is divided into three groups according to the duration of the pain as acute (<6 weeks), subacute (6-12 weeks) and chronic (> 12 weeks) low back pain. Chronic low back pain, which constitutes one third of all back problems, is known as moderate back pain that lasts more than 12 weeks and continues one year after the onset of acute pain. A definite etiological factor can be defined in only 15% of low back pain. It is known that individuals' sociodemographic characteristics, psychosocial factors, occupational factors, erroneous posture postures and recurrent microtraumas can cause back pain. In addition to these, when looking at the studies conducted, it is seen that spasm in lumbar muscles, loss of flexibility and increase in lumbal lordosis cause low back pain.
Low back pain can be treated with pharmacological and non-pharmacological methods. Non-pharmacological methods include various treatments such as physiotherapy, psychological therapy and acupuncture; Pharmacological treatment methods include anti-inflammatory drugs, opioids and antidepressants. It is suggested that pharmacological treatment methods have a short-term effect on low back pain and create a placebo effect in individuals. Studies have shown that physiotherapy programs that include treatment methods such as exercise, Tai Chi, yoga, acupuncture, pilates, core stabilization exercises, Transcutaneous Electrical Nerve Stabilization (TENS) are effective in reducing muscular spasm and pain.
Myofascial release is a manual treatment method that involves low pressure, long-term stretching of the soft tissue in the painful area to restore the normal length of the facial tissue, reduce pain and increase functionality. It has been shown that myofascial relaxation therapy, which is applied in musculoskeletal disorders and observed to provide relaxation by stimulating the neuromuscular system, has been shown to reduce back pain and increase the flexibility of the lumbar muscles.
Deep oscillation therapy, which increases tissue nutrition and has an anti-inflammatory effect as a result of electrostatic currents that cause a gentle and deep effective fluctuation in the tissue, provides a positive effect on pain reduction and also on muscle relaxation. In deep oscillation treatment, the body tissue of the individual is used as an electrode, while the probe used by the physiotherapist for the area to be applied is used as another electrode. Although there are no studies determining the effects of deep oscillation therapy on the lumbar region muscles, it was seen that deep oscillation application had an acute effect on muscle relaxation in the comparison of deep oscillation and ultrasound treatments performed due to the decrease in the flexibility of the hamstring muscles.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bayrampaşa
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Istanbul, Bayrampaşa, Turkey, 34040
- Private Mediworld Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being diagnosed with Chronic Low Back Pain
- Getting 4 and above in the Roland Morris Disability Questionnaire
- Being 18 years or older
- Agree to voluntarily participate in the study
Exclusion Criteria:
- Having an acute infection
- Having a heart disease or pacemaker
- Hypersensitivity to electrostatic waves
- Having an infectious skin condition
- Having vertebrobasilar insufficiency
- Having knee pain complaints
- Being diagnosed with coronavirus
- Physical therapy for back pain in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
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Active Comparator: Deep Oscillation Group
Individuals in the deep oscillation group will be treated by the researcher.
During the application, individuals will be positioned face down on the stretcher.
After the powder is applied to the lumbar region, deep oscillation treatment with a frequency of 80% -100% with a frequency of 145-150 Hz for the first 10 minutes and 55-60 Hz for 5 minutes will be applied with the Physiomed Deep Oscilation device.
Each individual will be given a home exercise program (stretching and strengthening for waist, back and abdominal) consisting of stretching and strengthening.
Individuals will be asked to come to the center where the research will take place, for a total of six sessions for two weeks, three times a week.
|
Deep oscillation to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
|
|
Active Comparator: Myofascial Release Group
Individuals in the myofascial relaxation group will be treated by the researcher.
During the application, individuals will lie face down on the stretcher.
Myofascial release therapy will be applied in the lumbar region and each individual will be given home exercise (stretching and strengthening for waist, back and abdominal).
Individuals will be asked to come to the center where the research will be conducted for a total of six sessions for two weeks, three times a week.
|
Myofascial release to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Roland Morris Disability Questionnaire
Time Frame: change between baseline and first and 2 weeks
|
the total score is between 0 and 24, and the higher the score, the more disability
|
change between baseline and first and 2 weeks
|
|
Visual Analog Scale
Time Frame: change between baseline and first and 2 weeks
|
pain sensation is determined from 0 to 10. 0 is low pain, 10 is high pain
|
change between baseline and first and 2 weeks
|
|
Oswestry Disability Index
Time Frame: change between baseline and first and 2 weeks
|
The highest score is "100", the lowest is "0".
The higher the total score, the higher the disability value.
|
change between baseline and first and 2 weeks
|
|
The Pittsburgh Sleep Quality Index
Time Frame: change between baseline and first and 2 weeks
|
A total score higher than five indicates a poor sleep quality.
|
change between baseline and first and 2 weeks
|
|
Short Form-36
Time Frame: change between baseline and first and 2 weeks
|
Scores for each subtitle are coded and converted into a scale between 0-100 points.
The best health indicator is 100 points.
|
change between baseline and first and 2 weeks
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1505183
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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