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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04759404
Other study ID # 1505183
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2021
Est. completion date May 15, 2021

Study information

Verified date August 2022
Source Bahçesehir University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In our study, it was aimed to investigate the effects of deep oscillation and myofascial release on pain, functionality and quality of life in individuals with chronic nonspecific low back pain. 72 individuals who voluntarily agree to participate in the study will be included. Participants will be randomly divided into three groups, the deep oscillation group, myofascial release and the control group. Home exercises including stretching and strengthening for waist, back and abdominals will be given to all groups. However, in addition to the deep oscillation group, deep oscillation will be applied to the lumbar region and myofascial relaxation will be applied to the lumbar region for the myofascial group. 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. Participants' pain will be evaluated with Visual Analog Scale, disability status with Oswestry Disability Index, sleep quality with Pittsburgh Sleep Quality Index, and quality of life with Short Form-36 before and after the first treatment in the first treatment. Statistical analysis to be used in our research will be done with the Statistical Package for the Social Sciences 20.0 package program.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date May 15, 2021
Est. primary completion date March 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Deep Oscillation Treatment
Deep oscillation to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
Myofascial Release Treatment
Myofascial release to the lumbar region and stretching and strengthening exercise for waist, back and abdominal

Locations

Country Name City State
Turkey Private Mediworld Medical Center Istanbul Bayrampasa

Sponsors (1)

Lead Sponsor Collaborator
Bahçesehir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Roland Morris Disability Questionnaire the total score is between 0 and 24, and the higher the score, the more disability change between baseline and first and 2 weeks
Primary Visual Analog Scale pain sensation is determined from 0 to 10. 0 is low pain, 10 is high pain change between baseline and first and 2 weeks
Primary Oswestry Disability Index 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
Primary The Pittsburgh Sleep Quality Index A total score higher than five indicates a poor sleep quality. change between baseline and first and 2 weeks
Primary Short Form-36 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
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