CClinicalTrials.gg
CompletedNCT04759404Updated Aug 11, 2022

The Effect of Deep Oscillation and Myofascial Relaxation With Chronic Nonspecific Low Back Pain

An interventional study of Deep Oscillation Treatment and Myofascial Release Treatment in Low Back Pain, sponsored by Bahçeşehir University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-11.

Sponsored by Bahçeşehir University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Low Back Pain

Keywords

  • low back pain
  • muscle relaxation
  • quality of life
  • vibration
  • sleep
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 72 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Bahçeşehir University is the lead sponsor of 117 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • 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.

    Other: Deep Oscillation Treatment

  • 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.

    Other: Myofascial Release Treatment

  • No intervention
    Control Group

Interventions

  • OtherDeep Oscillation Treatment

    Deep oscillation to the lumbar region and stretching and strengthening exercise for waist, back and abdominal

  • OtherMyofascial Release Treatment

    Myofascial release to the lumbar region and stretching and strengthening exercise for waist, back and abdominal

06

What researchers measure

Primary outcomes

  1. Roland Morris Disability Questionnaire

    the total score is between 0 and 24, and the higher the score, the more disability

    Time frame: change between baseline and first and 2 weeks

  2. Visual Analog Scale

    pain sensation is determined from 0 to 10. 0 is low pain, 10 is high pain

    Time frame: change between baseline and first and 2 weeks

  3. Oswestry Disability Index

    The highest score is "100", the lowest is "0". The higher the total score, the higher the disability value.

    Time frame: change between baseline and first and 2 weeks

  4. The Pittsburgh Sleep Quality Index

    A total score higher than five indicates a poor sleep quality.

    Time frame: change between baseline and first and 2 weeks

  5. 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.

    Time frame: change between baseline and first and 2 weeks

07

Study locations

1 site
  • Private Mediworld Medical Center
    Istanbul, Bayrampaşa 34040, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04759404
Lead sponsor
Bahçeşehir University
Responsible party
Ebru Beyza ŞAHİN (Physical Therapist, Bahçeşehir University) — Principal investigator
First posted
Feb 18, 2021
Start date
Feb 15, 2021
Primary completion
Mar 8, 2021
Completion
May 15, 2021
Last update
Aug 11, 2022

Study contacts

Leyla Ataş Balcı, Assist Prof
study director · Bahçeşehir University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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