Mechanical Low Back PainNCT07193251
Connective Tissue Massage and Core Training in Mechanical Low Back Pain
A study testing Core Stabilization Exercises and Connective tissue massage in people with Mechanical Low Back Pain, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study will investigate the effects of connective tissue massage combined with core stabilization exercises in patients with mechanical low back pain. Participants will be assigned to two groups: one will receive core stabilization exercises with connective tissue massage, while the other… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Core Stabilization Exercises and Connective tissue massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to Dec 2025
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be 20-55 years of age.
- Participants will have a clinician-confirmed diagnosis of mechanical low back pain and will be referred by specialists in Physical Medicine and Rehabilitation.
- Participants will have adequate cognitive ability to follow assessments and the treatment protocol and will agree to attend supervised sessions (2×/week for 8 weeks) and to perform daily home exercises.
- Participants will provide informed consent prior to any study procedures
Who cannot join
- Participants will be excluded if they have a history of lumbar spine surgery.
- Participants will be excluded for conditions affecting the lumbar region, including inflammatory arthritis, tumor, or infectious diseases.
- Participants will be excluded if they present congenital anomalies of the lumbosacral region or secondary orthopedic problems that could interfere with the study.
- Participants will be excluded if they have neurological disorders (e.g.,Parkinson's disease, Alzheimer's disease, multiple sclerosis) or systemic diseases such as diabetes mellitus.
- Any medical condition judged by the investigators to preclude safe participation or adherence to the protocol will lead to exclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Biruni University
Istanbul
Burcu AKKURT, PhD, +9005536046713, burcu.akkurt@fbu.edu.tr
Burcu AKKURT, PhD
About this study
Official title: The Effects of Connective Tissue Massage Combined With Core Stabilization Exercises on Pain, Functionality, and Endurance in Mechanical Low Back Pain
This randomized controlled study will investigate the effects of connective tissue massage combined with core stabilization exercises in patients with mechanical low back pain. Participants will be assigned to two groups: one will receive core stabilization exercises with connective tissue massage, while the other will receive only core stabilization exercises. Pain will be evaluated using the Visual Analog Scale, functionality will be assessed with the Oswestry Disability Index, and endurance will be measured with static and dynamic curl-up, static back endurance, and side bridge tests. Quality of life will be assessed with the SF-36, and instrumental daily living activities will be evaluated with the Lawton \& Brody Scale. The results will demonstrate whether adding connective tissue massage to core stabilization exercises will provide additional benefits in pain reduction, functional improvement, endurance, and quality of life compared to exercises alone.
Read the detailed description
This randomized controlled clinical trial will evaluate the effects of connective tissue massage (CTM) combined with core stabilization exercises (CSEs) on pain, functionality, endurance, and quality of life in patients with mechanical low back pain. A total of 29-30 participants aged 20 to 55 years who will be diagnosed with mechanical low back pain will be recruited. Participants will be randomized into two groups:
Experimental group: will receive core stabilization exercises plus connective tissue massage.
Control group: will receive only core stabilization exercises.
All interventions will be delivered under physiotherapist supervision in the physiotherapy and rehabilitation laboratories. The exercise program will include progressive core stabilization exercises performed twice per week for eight weeks, each session lasting approximately 50 minutes (10 minutes warm-up, 30 minutes core stabilization, 10 minutes cool-down). The experimental group will additionally receive 20 minutes of connective tissue massage twice per week during the same 8-week intervention period.
Outcome measures will include:
Pain: Visual Analog Scale (VAS).
Functionality: Oswestry Disability Index.
Endurance: Static and dynamic curl-up, static back endurance, and horizontal side bridge tests.
Lumbar mobility: Finger-to-floor distance.
Muscle strength: Manual muscle testing.
Quality of life: Short Form-36 (SF-36).
Instrumental activities of daily living: Lawton \& Brody Instrumental ADL Scale.
Assessments will be performed at baseline and after the 8-week intervention period. The study will hypothesize that connective tissue massage combined with core stabilization exercises will provide greater improvements in pain relief, functional status, muscular endurance, and quality of life compared to core stabilization exercises alone.
The results will contribute evidence on whether connective tissue massage will offer an additional therapeutic benefit when integrated into a rehabilitation program for patients with mechanical low back pain.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Core Stabilization Exercises, Connective tissue massage
- Keywords
- mechanical low back pain, connective tissue massage, core stabilization exercise
- 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.
Core Stabilization ExercisesOther
Participants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed.
Connective tissue massageOther
each supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization+connective tissue massage | Experimental | Participants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed. In addition, each supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort. Interventions will be delivered under physiotherapist supervision in the university physiotherapy laboratories. Receives: Other: Core Stabilization Exercises; Other: Connective tissue massage |
| Core Stabilization Exercises Only | Active comparator | Participants will receive the same supervised core stabilization program as the experimental arm (twice weekly for 8 weeks, ≈50 min per session with progressive exercises from activation to advanced tasks) and the same daily 60-min home exercise prescription. No connective tissue massage will be provided. Sessions will be delivered under physiotherapist supervision in the same laboratory setting to ensure consistency across arms. Receives: Other: Core Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Functional status will be assessed with the ODI, a 10-item questionnaire scored from 0 to 5 per item, covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and changing pain intensity. Scores will be converted into percentages, with higher scores indicating greater disability. The total score will be calculated as a percentage, where 0% indicates no disability and 100% represents the highest level of disability.
Measured: From enrollment to the end of treatment at 8 weeks
Visual Analog Scale (VAS)
Pain intensity will be measured using the Visual Analog Scale, a 10-cm horizontal line ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Higher scores will indicate greater pain severity.
Measured: From enrollment to the end of treatment at 8 weeks
Curl-Up Test (Static and Dynamic)
Abdominal endurance will be measured by static and dynamic curl-up tests. For the static test, participants will maintain a standardized trunk-flexion position until fatigue. For the dynamic test, participants will perform as many curl-ups as possible within 1 minute. Longer holding times or higher repetitions will indicate greater endurance. Measured in seconds/repetitions, with higher values indicating greater endurance.
Measured: From enrollment to the end of treatment at 8 weeks
Biering-Sørensen Test
Back extensor endurance will be evaluated by maintaining the upper body in a horizontal position over the edge of a table while the pelvis and legs are stabilized. Time will be recorded in seconds, with longer duration indicating greater endurance. Higher scores will indicate greater endurance.
Measured: From enrollment to the end of treatment at 8 weeks.
Side Bridge Test
Spinal stabilizer endurance will be measured in a side-lying position with support on the elbow and feet. Participants will elevate the pelvis to align the body horizontally and maintain this position as long as possible. Longer holding times will indicate higher endurance capacity. The test will be terminated when the participant can no longer maintain the straight body position or after 240 seconds. Higher scores will indicate greater endurance.
Measured: From enrollment to the end of treatment at 8 weeks.
Secondary outcomes (4)
Finger-to-Floor Distance Test
Lumbar spine flexibility will be assessed by asking participants to bend forward with knees extended and attempt to touch the floor. The distance in centimeters between the fingertips and the floor will be measured. Smaller distances will indicate better mobility.
Measured: From enrollment to the end of treatment at 8 weeks
Manual Muscle Testing (MMT, Lovett Scale)
Flexibility of hip flexors, hamstrings, and lumbar extensors will be assessed through standardized muscle length tests. Presence of limited range will indicate muscle tightness.
Measured: From enrollment to the end of treatment at 8 weeks
Short Form-36 Health Survey (SF-36)
Health-related quality of life will be evaluated using the SF-36, consisting of 8 subscales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health). Each domain is scored from 0 to 100, with higher scores reflecting better health status.
Measured: From enrollment to the end of treatment at 8 weeks
Lawton & Brody Instrumental Activities of Daily Living (IADL) Scale
Functional independence in daily living will be assessed with the IADL scale, which includes activities such as using the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and handling finances. Scores range from 0 to 24, with higher scores indicating greater independence.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu AKKURT, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193251
- Sponsor's protocol ID
- 1234
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Connective Tissue Massage Combined With Core Stabilization Exercises on Pain, Functionality, and Endurance in Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT07193251
- Acronym / sponsor ID
- 1234
- Conditions
- Mechanical Low Back Pain
- Keywords
- mechanical low back pain, connective tissue massage, core stabilization exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Sep 2025 (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.
This randomized controlled study will investigate the effects of connective tissue massage combined with core stabilization exercises in patients with mechanical low back pain. Participants will be assigned to two groups: one will receive core stabilization exercises with connective tissue massage, while the other will receive only core stabilization exercises. Pain will be evaluated using the Visual Analog Scale, functionality will be assessed with the Oswestry Disability Index, and endurance will be measured with static and dynamic curl-up, static back endurance, and side bridge tests. Quality of life will be assessed with the SF-36, and instrumental daily living activities will be evaluated with the Lawton \& Brody Scale. The results will demonstrate whether adding connective tissue massage to core stabilization exercises will provide additional benefits in pain reduction, functional improvement, endurance, and quality of life compared to exercises alone.
Detailed description
This randomized controlled clinical trial will evaluate the effects of connective tissue massage (CTM) combined with core stabilization exercises (CSEs) on pain, functionality, endurance, and quality of life in patients with mechanical low back pain. A total of 29-30 participants aged 20 to 55 years who will be diagnosed with mechanical low back pain will be recruited. Participants will be randomized into two groups:
Experimental group: will receive core stabilization exercises plus connective tissue massage.
Control group: will receive only core stabilization exercises.
All interventions will be delivered under physiotherapist supervision in the physiotherapy and rehabilitation laboratories. The exercise program will include progressive core stabilization exercises performed twice per week for eight weeks, each session lasting approximately 50 minutes (10 minutes warm-up, 30 minutes core stabilization, 10 minutes cool-down). The experimental group will additionally receive 20 minutes of connective tissue massage twice per week during the same 8-week intervention period.
Outcome measures will include:
Pain: Visual Analog Scale (VAS).
Functionality: Oswestry Disability Index.
Endurance: Static and dynamic curl-up, static back endurance, and horizontal side bridge tests.
Lumbar mobility: Finger-to-floor distance.
Muscle strength: Manual muscle testing.
Quality of life: Short Form-36 (SF-36).
Instrumental activities of daily living: Lawton \& Brody Instrumental ADL Scale.
Assessments will be performed at baseline and after the 8-week intervention period. The study will hypothesize that connective tissue massage combined with core stabilization exercises will provide greater improvements in pain relief, functional status, muscular endurance, and quality of life compared to core stabilization exercises alone.
The results will contribute evidence on whether connective tissue massage will offer an additional therapeutic benefit when integrated into a rehabilitation program for patients with mechanical low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stabilization+connective tissue massage | Experimental | Other: Core Stabilization Exercises, Other: Connective tissue massageParticipants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed. In addition, each supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort. Interventions will be delivered under physiotherapist supervision in the university physiotherapy laboratories. |
| Core Stabilization Exercises Only | Active comparator | Other: Core Stabilization ExercisesParticipants will receive the same supervised core stabilization program as the experimental arm (twice weekly for 8 weeks, ≈50 min per session with progressive exercises from activation to advanced tasks) and the same daily 60-min home exercise prescription. No connective tissue massage will be provided. Sessions will be delivered under physiotherapist supervision in the same laboratory setting to ensure consistency across arms. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants will be 20-55 years of age.
- Participants will have a clinician-confirmed diagnosis of mechanical low back pain and will be referred by specialists in Physical Medicine and Rehabilitation.
- Participants will have adequate cognitive ability to follow assessments and the treatment protocol and will agree to attend supervised sessions (2×/week for 8 weeks) and to perform daily home exercises.
- Participants will provide informed consent prior to any study procedures
Key exclusion criteria (5 listed)
- Participants will be excluded if they have a history of lumbar spine surgery.
- Participants will be excluded for conditions affecting the lumbar region, including inflammatory arthritis, tumor, or infectious diseases.
- Participants will be excluded if they present congenital anomalies of the lumbosacral region or secondary orthopedic problems that could interfere with the study.
- Participants will be excluded if they have neurological disorders (e.g.,Parkinson's disease, Alzheimer's disease, multiple sclerosis) or systemic diseases such as diabetes mellitus.
- Any medical condition judged by the investigators to preclude safe participation or adherence to the protocol will lead to exclusion.
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 |
|---|---|---|
| Core Stabilization ExercisesParticipants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed. | Other | Core Stabilization Exercises Only, Core stabilization+connective tissue massage |
| Connective tissue massageeach supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort | Other | Core stabilization+connective tissue massage |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: From enrollment to the end of treatment at 8 weeks
Functional status will be assessed with the ODI, a 10-item questionnaire scored from 0 to 5 per item, covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and changing pain intensity. Scores will be converted into percentages, with higher scores indicating greater disability. The total score will be calculated as a percentage, where 0% indicates no disability and 100% represents the highest level of disability.
Visual Analog Scale (VAS)
Time frame: From enrollment to the end of treatment at 8 weeks
Pain intensity will be measured using the Visual Analog Scale, a 10-cm horizontal line ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Higher scores will indicate greater pain severity.
Curl-Up Test (Static and Dynamic)
Time frame: From enrollment to the end of treatment at 8 weeks
Abdominal endurance will be measured by static and dynamic curl-up tests. For the static test, participants will maintain a standardized trunk-flexion position until fatigue. For the dynamic test, participants will perform as many curl-ups as possible within 1 minute. Longer holding times or higher repetitions will indicate greater endurance. Measured in seconds/repetitions, with higher values indicating greater endurance.
Biering-Sørensen Test
Time frame: From enrollment to the end of treatment at 8 weeks.
Back extensor endurance will be evaluated by maintaining the upper body in a horizontal position over the edge of a table while the pelvis and legs are stabilized. Time will be recorded in seconds, with longer duration indicating greater endurance. Higher scores will indicate greater endurance.
Side Bridge Test
Time frame: From enrollment to the end of treatment at 8 weeks.
Spinal stabilizer endurance will be measured in a side-lying position with support on the elbow and feet. Participants will elevate the pelvis to align the body horizontally and maintain this position as long as possible. Longer holding times will indicate higher endurance capacity. The test will be terminated when the participant can no longer maintain the straight body position or after 240 seconds. Higher scores will indicate greater endurance.
4 secondary outcomes
Finger-to-Floor Distance Test
Time frame: From enrollment to the end of treatment at 8 weeks
Manual Muscle Testing (MMT, Lovett Scale)
Time frame: From enrollment to the end of treatment at 8 weeks
Short Form-36 Health Survey (SF-36)
Time frame: From enrollment to the end of treatment at 8 weeks
Lawton & Brody Instrumental Activities of Daily Living (IADL) Scale
Time frame: From enrollment to the end of treatment at 8 weeks
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 25 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization Exercises and Connective tissue massage in people with Mechanical Low Back Pain, run by Fenerbahce 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 5 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 25 Sep 2025. 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?
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?
Contact Burcu AKKURT, PhD (+905536046713, burcu.akkurt@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: From enrollment to the end of treatment at 8 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 25 Sep 2025.