Chronic Low-back Pain (cLBP)NCT07915817
Effects of Myofascial Techniques on Chronic Low Back Pain
A study testing Local Myofascial Release, Superficial Back Line Myofascial Release and Conservative treatment in people with Chronic Low-back Pain (cLBP), run by Kirsehir Ahi Evran Universitesi.
Trial summary
Participants with chronic low back pain will be randomly allocated to three groups: conservative treatment, conservative treatment plus local myofascial release, or conservative treatment plus superficial back line myofascial release. All groups will receive treatment three times weekly for six weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Local Myofascial Release, Superficial Back Line Myofascial Release and Conservative treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years.
- Presence of mechanically induced low back pain.
- Willingness to participate in the study.
- No neurological, rheumatological, or advanced degenerative spinal pathology.
- No lumbar surgery within the previous three months.
- No history of serious systemic diseases, such as advanced cardiovascular, neurological, or metabolic disorders.
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- Sufficient cognitive ability to understand and follow the treatment procedures. Exclusion Criteria
- Pregnancy.
- Active infection or malignancy.
- Severe osteoporosis.
- Spinal instability.
- History of lumbar surgery.
- Severe neurological deficits, such as substantial motor loss or progressive neurological symptoms.
- Ongoing intensive physical therapy or manual therapy.
- Psychiatric or cognitive disorders that may prevent participation in the study.
Who cannot join
None listed.
About this study
Official title: Myofascial Approaches in Chronic Low Back Pain: Effects of Local Application and Superficial Back Line Techniques on Clinical Outcomes
Participants with chronic low back pain will be randomly allocated to three groups: conservative treatment, conservative treatment plus local myofascial release, or conservative treatment plus superficial back line myofascial release. All groups will receive treatment three times weekly for six weeks. The conservative treatment program will include stretching, strengthening, and postural exercises. Myofascial release will be performed using a roller bar, with controlled rhythmic pressure applied for 30-60 seconds per region, totaling 10-15 minutes per session, according to individual tolerance. Age, height, weight, and body mass index will be recorded. Outcomes will include pain intensity (Visual Analog Scale), pressure pain threshold (digital algometer), range of motion (goniometer), static and dynamic balance (Biodex Balance System), and functional disability (Oswestry Disability Index). All outcomes will be assessed before and after the intervention.
Read the detailed description
Chronic low back pain is a common musculoskeletal condition that can negatively affect physical function, postural control, mobility, and quality of life. In addition to conventional exercise-based interventions, myofascial release techniques have been used to address soft tissue restrictions and improve musculoskeletal function. However, the effects of applying myofascial release locally to the lumbar region compared with applying it along the Superficial Back Line have not been sufficiently clarified in individuals with chronic low back pain.
The aim of this study is to investigate and compare the effects of local lumbar myofascial release and Superficial Back Line myofascial release, when combined with conservative treatment, on pain intensity, pressure pain threshold, lumbar range of motion, static and dynamic balance, and functional disability in individuals with chronic low back pain.
Participants diagnosed with chronic low back pain will be randomly allocated to one of three intervention groups: (1) conservative treatment alone, (2) conservative treatment combined with local lumbar myofascial release, and (3) conservative treatment combined with myofascial release applied along the Superficial Back Line. All interventions will be administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
The conservative treatment program will be applied to all three groups and will consist of stretching, strengthening, and postural exercises designed to address the physical limitations associated with chronic low back pain. Participants in the second group will additionally receive local myofascial release targeting the lumbar region. Participants in the third group will receive myofascial release along the Superficial Back Line, targeting the posterior myofascial structures according to the intervention protocol.
Myofascial release will be performed using a roller bar. Controlled and rhythmic pressure will be applied for approximately 60 seconds per treatment region. The total duration of the myofascial release application will be approximately 10-15 minutes per session, depending on the treatment protocol and individual participant tolerance.
Demographic and anthropometric characteristics, including age, height, and body weight, will be recorded, and body mass index will be calculated.
Clinical outcomes will be evaluated before and after the six-week intervention period. Pain intensity will be assessed using the Visual Analog Scale (VAS), while pressure pain threshold will be measured using a digital algometer. Lumbar range of motion will be evaluated using a goniometer. Static and dynamic balance will be assessed using the Biodex Balance System. Functional disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI).
The changes in clinical outcomes within each group and the differences between the three intervention groups will be analyzed to determine whether adding local lumbar myofascial release or Superficial Back Line myofascial release to conservative treatment provides additional benefits. The study will also compare the effects of the two myofascial approaches to determine whether the location and extent of myofascial application influence clinical outcomes in individuals with chronic low back pain.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Local Myofascial Release, Superficial Back Line Myofascial Release, Conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Myofascial ReleaseDevice
Myofascial release targeting only the lumbar region will be performed in addition to conservative treatment.
Superficial Back Line Myofascial ReleaseDevice
Myofascial release will be applied along the entire superficial back line in addition to conservative treatment.
Conservative treatmentOther
Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Sham comparator | Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated. Receives: Other: Conservative treatment |
| Local Myofascial Release | Experimental | Myofascial release targeting only the lumbar region will be performed in addition to conservative treatment. Receives: Device: Local Myofascial Release; Other: Conservative treatment |
| Superficial Back Line Myofascial Release | Experimental | Myofascial release will be applied along the entire superficial back line in addition to conservative treatment. Receives: Device: Superficial Back Line Myofascial Release; Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity from Baseline to Week 6
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain intensity on a 10-cm line, with 0 indicating no pain and 10 indicating the worst imaginable pain. The change in pain intensity from baseline to the end of the intervention will be evaluated.
Measured: Baseline and Week 6
Secondary outcomes (3)
Change in Balance Performance from Baseline to Week 6
Balance performance will be assessed using [Biodex Blance System]. Changes in balance performance from baseline to the end of the intervention will be evaluated.
Measured: Baseline and Week 6
Change in Functional Disability from Baseline to Week 6
Functional disability will be assessed using [Oswerty Disability Index]. Changes in functional disability scores from baseline to the end of the intervention will be evaluated.
Measured: Baseline and Week 6
Change in Lumbar Range of Motion from Baseline to Week 6
Lumbar range of motion will be assessed using [goniometer]. Changes in lumbar range of motion from baseline to the end of the intervention will be evaluated in degrees.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Samed DALAKÇI, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915817
- Sponsor's protocol ID
- samed.dalakci
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofascial Approaches in Chronic Low Back Pain: Effects of Local Application and Superficial Back Line Techniques on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07915817
- Acronym / sponsor ID
- samed.dalakci
- Conditions
- Chronic Low-back Pain (cLBP)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 Nov 2026 (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.
Participants with chronic low back pain will be randomly allocated to three groups: conservative treatment, conservative treatment plus local myofascial release, or conservative treatment plus superficial back line myofascial release. All groups will receive treatment three times weekly for six weeks. The conservative treatment program will include stretching, strengthening, and postural exercises. Myofascial release will be performed using a roller bar, with controlled rhythmic pressure applied for 30-60 seconds per region, totaling 10-15 minutes per session, according to individual tolerance. Age, height, weight, and body mass index will be recorded. Outcomes will include pain intensity (Visual Analog Scale), pressure pain threshold (digital algometer), range of motion (goniometer), static and dynamic balance (Biodex Balance System), and functional disability (Oswestry Disability Index). All outcomes will be assessed before and after the intervention.
Detailed description
Chronic low back pain is a common musculoskeletal condition that can negatively affect physical function, postural control, mobility, and quality of life. In addition to conventional exercise-based interventions, myofascial release techniques have been used to address soft tissue restrictions and improve musculoskeletal function. However, the effects of applying myofascial release locally to the lumbar region compared with applying it along the Superficial Back Line have not been sufficiently clarified in individuals with chronic low back pain.
The aim of this study is to investigate and compare the effects of local lumbar myofascial release and Superficial Back Line myofascial release, when combined with conservative treatment, on pain intensity, pressure pain threshold, lumbar range of motion, static and dynamic balance, and functional disability in individuals with chronic low back pain.
Participants diagnosed with chronic low back pain will be randomly allocated to one of three intervention groups: (1) conservative treatment alone, (2) conservative treatment combined with local lumbar myofascial release, and (3) conservative treatment combined with myofascial release applied along the Superficial Back Line. All interventions will be administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
The conservative treatment program will be applied to all three groups and will consist of stretching, strengthening, and postural exercises designed to address the physical limitations associated with chronic low back pain. Participants in the second group will additionally receive local myofascial release targeting the lumbar region. Participants in the third group will receive myofascial release along the Superficial Back Line, targeting the posterior myofascial structures according to the intervention protocol.
Myofascial release will be performed using a roller bar. Controlled and rhythmic pressure will be applied for approximately 60 seconds per treatment region. The total duration of the myofascial release application will be approximately 10-15 minutes per session, depending on the treatment protocol and individual participant tolerance.
Demographic and anthropometric characteristics, including age, height, and body weight, will be recorded, and body mass index will be calculated.
Clinical outcomes will be evaluated before and after the six-week intervention period. Pain intensity will be assessed using the Visual Analog Scale (VAS), while pressure pain threshold will be measured using a digital algometer. Lumbar range of motion will be evaluated using a goniometer. Static and dynamic balance will be assessed using the Biodex Balance System. Functional disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI).
The changes in clinical outcomes within each group and the differences between the three intervention groups will be analyzed to determine whether adding local lumbar myofascial release or Superficial Back Line myofascial release to conservative treatment provides additional benefits. The study will also compare the effects of the two myofascial approaches to determine whether the location and extent of myofascial application influence clinical outcomes in individuals with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Sham comparator | Other: Conservative treatmentPatients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated. |
| Local Myofascial Release | Experimental | Device: Local Myofascial Release, Other: Conservative treatmentMyofascial release targeting only the lumbar region will be performed in addition to conservative treatment. |
| Superficial Back Line Myofascial Release | Experimental | Device: Superficial Back Line Myofascial Release, Other: Conservative treatmentMyofascial release will be applied along the entire superficial back line in addition to conservative treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged 18-65 years.
- Presence of mechanically induced low back pain.
- Willingness to participate in the study.
- No neurological, rheumatological, or advanced degenerative spinal pathology.
- No lumbar surgery within the previous three months.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Local Myofascial ReleaseMyofascial release targeting only the lumbar region will be performed in addition to conservative treatment. | Device | Local Myofascial Release |
| Superficial Back Line Myofascial ReleaseMyofascial release will be applied along the entire superficial back line in addition to conservative treatment. | Device | Superficial Back Line Myofascial Release |
| Conservative treatmentPatients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated. | Other | Conservative treatment, Local Myofascial Release, Superficial Back Line Myofascial Release |
Primary outcome
Change in Pain Intensity from Baseline to Week 6
Time frame: Baseline and Week 6
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain intensity on a 10-cm line, with 0 indicating no pain and 10 indicating the worst imaginable pain. The change in pain intensity from baseline to the end of the intervention will be evaluated.
3 secondary outcomes
Change in Balance Performance from Baseline to Week 6
Time frame: Baseline and Week 6
Change in Functional Disability from Baseline to Week 6
Time frame: Baseline and Week 6
Change in Lumbar Range of Motion from Baseline to Week 6
Time frame: Baseline and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Local Myofascial Release, Superficial Back Line Myofascial Release and Conservative treatment in people with Chronic Low-back Pain (cLBP), run by Kirsehir Ahi Evran Universitesi.
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 15 inclusion and 0 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 Pain Intensity from Baseline to Week 6 (time frame: Baseline and Week 6). 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 4 Nov 2026.