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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Deep Oscillation Treatment
Myofascial Release Treatment
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, muscle relaxation, quality of life, vibration, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private Mediworld Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Deep Oscillation Group

Myofascial Release Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Roland Morris Disability Questionnaire
the total score is between 0 and 24, and the higher the score, the more disability
Visual Analog Scale
pain sensation is determined from 0 to 10. 0 is low pain, 10 is high pain
Oswestry Disability Index
The highest score is "100", the lowest is "0". The higher the total score, the higher the disability value.
The Pittsburgh Sleep Quality Index
A total score higher than five indicates a poor sleep quality.
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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2021
Last Updated
August 9, 2022
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT04759404
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, muscle relaxation, quality of life, vibration, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The individuals are randomly allocated into deep oscillation, myofascial relaxation and control groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep Oscillation Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Myofascial Release Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Deep Oscillation Treatment
Intervention Description
Deep oscillation to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
Intervention Type
Other
Intervention Name(s)
Myofascial Release Treatment
Intervention Description
Myofascial release to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
Primary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire
Description
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
Title
Visual Analog Scale
Description
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
Title
Oswestry Disability Index
Description
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
Title
The Pittsburgh Sleep Quality Index
Description
A total score higher than five indicates a poor sleep quality.
Time Frame
change between baseline and first and 2 weeks
Title
Short Form-36
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leyla Ataş Balcı, Assist Prof
Organizational Affiliation
Bahçeşehir University
Official's Role
Study Director
Facility Information:
Facility Name
Private Mediworld Medical Center
City
Istanbul
State/Province
Bayrampaşa
ZIP/Postal Code
34040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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