Chronic Low-back PainNCT05302882
Evaluation of The Immediate Effect of Myofascial Release Application in Patients With Chronic Low Back Pain
A study testing Myofascial release and Classical massage in people with Chronic Low-back Pain, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP). Materials and methods: Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Myofascial release and Classical massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2021to 27 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 20 and 55 years;
- low back pain lasting more than 3 months;
- stable clinical status;
- no cognitive and mental problems;
- self-expression ability;
- volunteering to participate in the study.
Who cannot join
- problems of cooperation;
- malignancy or infection;
- acute fractures;
- occlusive edema;
- osteoporosis;
- advanced degenerative joint problems;
Show all 10Show fewer
- acute rheumatologic conditions;
- cortisone therapy;
- use of blood thinners;
- skin problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of The Immediate Effect of Myofascial Release Application on Pain, Flexibility and Trunk Mobility in Patients With Chronic Low Back Pain
Purpose: To determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP).
Materials and methods: Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Visual Analogue Scale (VAS) was used for pain assessment. Sit-Reach Test for flexibility evaluation and Straight Leg Raising Test with goniometric measurement for hamstring flexibility were used. Modified Schober Test was applied to evaluate trunk mobility. Comparison of the pre- and post-treatment evaluation data of the individuals in the same group was made using the "Wilcoxen Sum Rank Test", one of the non-parametric tests. Comparison of pre- and post-treatment evaluation data of both groups was performed using the non-parametric evaluation "Mann-Whitney U Test".
Read the detailed description
It was aimed to determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP). Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Visual Analogue Scale (VAS) was used for pain assessment. Sit-Reach Test for flexibility evaluation and Straight Leg Raising Test with goniometric measurement for hamstring flexibility were used. Modified Schober Test was applied to evaluate trunk mobility. Comparison of the pre- and post-treatment evaluation data of the individuals in the same group was made using the "Wilcoxen Sum Rank Test", one of the non-parametric tests. Comparison of pre- and post-treatment evaluation data of both groups was performed using the non-parametric evaluation "Mann-Whitney U Test".
- Conditions
- Chronic Low-back Pain
- Being tested
- Myofascial release, Classical massage
- Keywords
- Myofascial release, Chronic low back pain, Flexibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial releaseBehavioural
The physiotherapist placed both palms on the two right and left ribs at the T12 level and applied continuous stretching to the superior for 2 minutes. After this application, the physiotherapist placed one hand on the sacrum with the other hand on T12 with his hands crossed, and applied rhythmically 2 seconds of stretching and 2 seconds of relaxation for a total of 2 minutes. Then, myofascial release was terminated by applying deep compression to the paraspinal muscles with palms for 2 minutes on the right and 2 minutes on the left side, respectively.
Classical massageBehavioural
Classical massage was applied to the lumbar region for 9 minutes. Classical massage was applied with the patient in the prone position. A small amount of solid vaseline was taken and a gentle stroke was applied for 1 minute to spread it sufficiently to the lumbar region. Then, superficial stroking was applied to the right paraspinal region for 1 minute from distal to proximal by the physiotherapist. After the same procedure was performed on the right paraspinal region for 1 minute. Then, both hands were placed on the right and left paraspinal region and friction was applied for 2 minutes. Afterwards, the patient's right paraspinal region was kneeding for 1 minute and then the same procedure was applied to the left paraspinal region for 1 minute. As the last procedure, the fingertips of both hands were placed on the right and left paraspinal region and the classical massage was completed by performing 2 minutes of deep euphlorage from the L5-S1 level to the T12 level.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Myofascial release was applied to the experimental group Receives: Behavioral: Myofascial release |
| Control Group | Active comparator | Classical massage was applied to the control group Receives: Behavioral: Classical massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Pain Score
The VAS is a widely used scale for pain assessment in daily practice. VAS, with 0-10 numbers on it and they are asked to give a value between these numbers. 0: I have no pain, 10: I have very severe pain
Measured: Baseline, immediately after the intervention
Change in The Straight Leg Raise Test Score
test was used to assess hamstring flexibility. While the patient is in the supine position, the physiotherapist makes passive hip flexion with the knee straight and the measurement is made with a goniometer.
Measured: Baseline, immediately after the intervention
Change in The Modified Schober Test Score
Test is an assessment method that measures lumbar flexion flexibility. The lumbosacral junction and 10 cm above were marked when the person was in an upright position. Then third mark was placed 5 cm below the lumbosacral junction. After anterior flexion as far forward as possible, the distance between the highest and lowest marks was measured.
Measured: Baseline, immediately after the intervention
Change in Sit and Reach Test Score
test was used for flexibility evaluation. While the patient was performing maximum trunk flexion in the knee extension, the distance between the fingertip and the box aganist the sole of the foot was measured as +/- centimeters
Measured: Baseline, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start5 Mar 2021
- Primary completion30 Apr 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Çetinkaya, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302882
- Sponsor's protocol ID
- acetinkaya
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boff TA, Pasinato F, Ben AJ, Bosmans JE, van Tulder M, Carregaro RL. Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial. Physiotherapy. 2020 Jun;107:71-80. doi: 10.1016/j.physio.2019.11.002. Epub 2019 Nov 18.
PubMed 32026838Lohr C, Medina-Porqueres I. Immediate effects of myofascial release on neuromechanical characteristics in female and male patients with low back pain and healthy controls as assessed by tensiomyography. A controlled matched-pair study. Clin Biomech (Bristol). 2021 Apr;84:105351. doi: 10.1016/j.clinbiomech.2021.105351. Epub 2021 Apr 5.
PubMed 33848704Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.
PubMed 28441294Cetinyol O, Saka S, Cetinkaya A. Acute effects of myofascial release technique on flexibility and pain: Outcome for chronic low back pain. J Bodyw Mov Ther. 2025 Mar;41:194-198. doi: 10.1016/j.jbmt.2024.11.035. Epub 2024 Nov 18.
PubMed 39663087
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Immediate Effect of Myofascial Release Application on Pain, Flexibility and Trunk Mobility in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05302882
- Acronym / sponsor ID
- acetinkaya
- Conditions
- Chronic Low-back Pain
- Keywords
- Myofascial release, Chronic low back pain, Flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 31 Mar 2022 (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.
Purpose: To determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP).
Materials and methods: Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Visual Analogue Scale (VAS) was used for pain assessment. Sit-Reach Test for flexibility evaluation and Straight Leg Raising Test with goniometric measurement for hamstring flexibility were used. Modified Schober Test was applied to evaluate trunk mobility. Comparison of the pre- and post-treatment evaluation data of the individuals in the same group was made using the "Wilcoxen Sum Rank Test", one of the non-parametric tests. Comparison of pre- and post-treatment evaluation data of both groups was performed using the non-parametric evaluation "Mann-Whitney U Test".
Detailed description
It was aimed to determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP). Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Visual Analogue Scale (VAS) was used for pain assessment. Sit-Reach Test for flexibility evaluation and Straight Leg Raising Test with goniometric measurement for hamstring flexibility were used. Modified Schober Test was applied to evaluate trunk mobility. Comparison of the pre- and post-treatment evaluation data of the individuals in the same group was made using the "Wilcoxen Sum Rank Test", one of the non-parametric tests. Comparison of pre- and post-treatment evaluation data of both groups was performed using the non-parametric evaluation "Mann-Whitney U Test".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Myofascial releaseMyofascial release was applied to the experimental group |
| Control Group | Active comparator | Behavioral: Classical massageClassical massage was applied to the control group |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age between 20 and 55 years;
- low back pain lasting more than 3 months;
- stable clinical status;
- no cognitive and mental problems;
- self-expression ability;
Key exclusion criteria (10 listed)
- problems of cooperation;
- malignancy or infection;
- acute fractures;
- occlusive edema;
- osteoporosis;
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 |
|---|---|---|
| Myofascial releaseThe physiotherapist placed both palms on the two right and left ribs at the T12 level and applied continuous stretching to the superior for 2 minutes. After this application, the physiotherapist placed one hand on the sacrum with the other hand on T12 with his hands crossed, and applied rhythmically 2 seconds of stretching and 2 seconds of relaxation for a total of 2 minutes. Then, myofascial release was terminated by applying deep compression to the paraspinal muscles with palms for 2 minutes on the right and 2 minutes on the left side, respectively. | Behavioural | Experimental Group |
| Classical massageClassical massage was applied to the lumbar region for 9 minutes. Classical massage was applied with the patient in the prone position. A small amount of solid vaseline was taken and a gentle stroke was applied for 1 minute to spread it sufficiently to the lumbar region. Then, superficial stroking was applied to the right paraspinal region for 1 minute from distal to proximal by the physiotherapist. After the same procedure was performed on the right paraspinal region for 1 minute. Then, both hands were placed on the right and left paraspinal region and friction was applied for 2 minutes. Afterwards, the patient's right paraspinal region was kneeding for 1 minute and then the same procedure was applied to the left paraspinal region for 1 minute. As the last procedure, the fingertips of both hands were placed on the right and left paraspinal region and the classical massage was completed by performing 2 minutes of deep euphlorage from the L5-S1 level to the T12 level. | Behavioural | Control Group |
Primary outcome
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, immediately after the intervention
The VAS is a widely used scale for pain assessment in daily practice. VAS, with 0-10 numbers on it and they are asked to give a value between these numbers. 0: I have no pain, 10: I have very severe pain
Change in The Straight Leg Raise Test Score
Time frame: Baseline, immediately after the intervention
test was used to assess hamstring flexibility. While the patient is in the supine position, the physiotherapist makes passive hip flexion with the knee straight and the measurement is made with a goniometer.
Change in The Modified Schober Test Score
Time frame: Baseline, immediately after the intervention
Test is an assessment method that measures lumbar flexion flexibility. The lumbosacral junction and 10 cm above were marked when the person was in an upright position. Then third mark was placed 5 cm below the lumbosacral junction. After anterior flexion as far forward as possible, the distance between the highest and lowest marks was measured.
Change in Sit and Reach Test Score
Time frame: Baseline, immediately after the intervention
test was used for flexibility evaluation. While the patient was performing maximum trunk flexion in the knee extension, the distance between the fingertip and the box aganist the sole of the foot was measured as +/- centimeters
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 31 Mar 2022.
- Results publication: PubMed 32026838Boff TA, Pasinato F, Ben AJ, Bosmans JE, van Tulder M, Carregaro RL. Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial. Physiotherapy. 2020 Jun;107:71-80. doi: 10.1016/j.physio.2019.11.002. Epub 2019 Nov 18.
- Results publication: PubMed 33848704Lohr C, Medina-Porqueres I. Immediate effects of myofascial release on neuromechanical characteristics in female and male patients with low back pain and healthy controls as assessed by tensiomyography. A controlled matched-pair study. Clin Biomech (Bristol). 2021 Apr;84:105351. doi: 10.1016/j.clinbiomech.2021.105351. Epub 2021 Apr 5.
- Results publication: PubMed 28441294Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.
- Derived from this study: PubMed 39663087Cetinyol O, Saka S, Cetinkaya A. Acute effects of myofascial release technique on flexibility and pain: Outcome for chronic low back pain. J Bodyw Mov Ther. 2025 Mar;41:194-198. doi: 10.1016/j.jbmt.2024.11.035. Epub 2024 Nov 18.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release and Classical massage in people with Chronic Low-back Pain, run by Halic 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 6 inclusion and 10 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 31 Mar 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?
Change in Visual Analog Scale (VAS) Pain Score (time frame: Baseline, immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302882, which also lists 4 linked publications.
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 31 Mar 2022.