Clinical trial NCT04759404: The Effect of Deep Oscillation and Myofascial Relaxation With Chronic Nonspecific Low Back Pain
Official title: The Effect of Deep Oscillation and Myofascial Relaxation on Pain, Functionality and Quality of Life in Individuals With Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
muscle relaxation
quality of life
vibration
sleep
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The individuals are randomly allocated into deep oscillation, myofascial relaxation and control groups
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: change between baseline and first and 2 weeks
measure: Visual Analog Scale
timeFrame: change between baseline and first and 2 weeks
measure: Oswestry Disability Index
timeFrame: change between baseline and first and 2 weeks
measure: The Pittsburgh Sleep Quality Index
timeFrame: change between baseline and first and 2 weeks
measure: Short Form-36
timeFrame: change between baseline and first and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Private Mediworld Medical Center
state: Bayrampaşa
Study officials:
affiliation: Bahçeşehir University
name: Leyla Ataş Balcı, Assist Prof
role: STUDY_DIRECTOR
References: