Low Back PainNCT04759404
The Effect of Deep Oscillation and Myofascial Relaxation With Chronic Nonspecific Low Back Pain
A study testing Deep Oscillation Treatment and Myofascial Release Treatment in people with Low Back Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Deep Oscillation Treatment and Myofascial Release Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 15 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Mediworld Medical Center
Istanbul, Bayrampaşa, 34040
About this study
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
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.
- Conditions
- Low Back Pain
- Being tested
- Deep Oscillation Treatment, Myofascial Release Treatment
- Keywords
- low back pain, muscle relaxation, quality of life, vibration, sleep
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Oscillation TreatmentOther
Deep oscillation to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
Myofascial Release TreatmentOther
Myofascial release to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
| Study group | Role | What they receive |
|---|---|---|
| Deep Oscillation Group | Active comparator | 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. Receives: Other: Deep Oscillation Treatment |
| Myofascial Release Group | Active comparator | 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. Receives: Other: Myofascial Release Treatment |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Questionnaire
the total score is between 0 and 24, and the higher the score, the more disability
Measured: change between baseline and first and 2 weeks
Visual Analog Scale
pain sensation is determined from 0 to 10. 0 is low pain, 10 is high pain
Measured: change between baseline and first and 2 weeks
Oswestry Disability Index
The highest score is "100", the lowest is "0". The higher the total score, the higher the disability value.
Measured: change between baseline and first and 2 weeks
The Pittsburgh Sleep Quality Index
A total score higher than five indicates a poor sleep quality.
Measured: change between baseline and first and 2 weeks
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.
Measured: change between baseline and first and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 Feb 2021
- Primary completion8 Mar 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The individuals are randomly allocated into deep oscillation, myofascial relaxation and control groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Beyza ŞAHİN, Bahçeşehir University
- Investigators
- Leyla Ataş Balcı, Assist Prof, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759404
- Sponsor's protocol ID
- 1505183
- Status last verified
- Aug 2022
- First submitted
- 15 Feb 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04759404
- Acronym / sponsor ID
- 1505183
- Conditions
- Low Back Pain
- Keywords
- low back pain, muscle relaxation, quality of life, vibration, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The individuals are randomly allocated into deep oscillation, myofascial relaxation and control groups
| Arm | Type | Receives |
|---|---|---|
| Deep Oscillation Group | Active comparator | Other: Deep Oscillation TreatmentIndividuals 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. |
| Myofascial Release Group | Active comparator | Other: Myofascial Release TreatmentIndividuals 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. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Having an acute infection
- Having a heart disease or pacemaker
- Hypersensitivity to electrostatic waves
- Having an infectious skin condition
- Having vertebrobasilar insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Oscillation TreatmentDeep oscillation to the lumbar region and stretching and strengthening exercise for waist, back and abdominal | Other | Deep Oscillation Group |
| Myofascial Release TreatmentMyofascial release to the lumbar region and stretching and strengthening exercise for waist, back and abdominal | Other | Myofascial Release Group |
Primary outcome
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
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyla Ataş Balcı, Assist Prof study director
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Oscillation Treatment and Myofascial Release Treatment in people with Low Back Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Disability Questionnaire (time frame: change between baseline and first and 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.