Myofascial ReleaseNCT06796881
Instrument Assisted Soft Tissue Mobilization Versus Myofascial Release in Patients With Chronic Non¬Specific Low Back Pain
A study testing Instrument assisted soft tissue mobilization, Myofascial release and The conventional exercise program in people with Myofascial Release and Instrument Assisted Soft Tissue Mobilization, run by Cairo University at 1 site in Egypt.
Trial summary
This study was done to compare the effect of instrumental-assisted soft tissue mobilization versus the effect of myofascial release on pain intensity, pressure pain threshold, back function, and back range of motion in patients with chronic nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Myofascial Release, Instrument Assisted Soft Tissue Mobilization, Chronic Low-back Pain
- What is being tested?
- Instrument assisted soft tissue mobilization, Myofascial release and The conventional exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2025to 24 Jun 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with chronic non-specific low back pain for more than 3 months.
- Age between 25-45 years.
Who cannot join
- Patients who have serious spinal pathologies, such as fractures, tumors or inflammatory diseases (such as ankylosing spondylitis)
- Patients who have nerve root compromise, disk herniation, spondylolisthesis with neurological involvement, or narrowing of spinal canal
- Pregnant women
- Cancer patients .
- Lower limb injuries.
- Body mass index (BMI) greater than 25.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
the Outpatient Clinic of the Police Authority Hospital
Cairo
Dalia Salah Ahmed Elshatoury, physical therapist, +201550677823, safsafahmed53@gmail.com
About this study
This study was done to compare the effect of instrumental-assisted soft tissue mobilization versus the effect of myofascial release on pain intensity, pressure pain threshold, back function, and back range of motion in patients with chronic nonspecific low back pain.
Read the detailed description
Low back pain affects 20% of the workforce annually, leading to increased work absenteeism. Chronic non specific low back pain restricts functional and occupational activities, impacting society and the economy. Treatment is often unsatisfactory, and there is no consensus on the optimal approach. Further scientific research is needed to understand the effects of facial tissue manipulation on Chronic non specific low back pain patients. The literature has not addressed the distinctions between myofascial force transmission instrumental assisted soft tissue mobilization and myofascial release on Chronic non specific low back pain patients, which could help physical therapists find effective treatments. This study is the first to include pain, Pressure pain threshold, back function, and range of motion as outcome measures and compare instrumental assisted soft tissue mobilization and myofascial release in Chronic non specific low back pain patients.
- Being tested
- Instrument assisted soft tissue mobilization, Myofascial release, The conventional exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument assisted soft tissue mobilizationOther
The group will undergo Instrument assisted soft tissue mobilization using M2Tblade, applying it for 40-120 seconds until hyperemia occurs. After treatment, ice packs will be applied for 5 minutes to reduce hyperemia. The therapist will ensure comfort through continuous communication and reporting any discomfort.
Myofascial releaseOther
The therapist will use a cross-hand release technique to release the lumbar spine, ensuring the patient is prone and suitable. They will lean into the patient to the tissue depth barrier, wait, and follow each release, avoiding force or slipping. The technique will be applied for 5 minutes on each side.
The conventional exercise programOther
Patients will undergo a 12-session exercise program for 6 weeks, consisting of straight leg raising, bridging exercise, prone hip extension exercise, and abdominal curl exercise. The exercises will be done 3 sets, 10 repetitions each, with 1 minute rest between each set. The abdominal curl exercises involve supine or hook-lying positions with the lumbar spine neutral, with the patient performing a drawing in maneuver to stabilize the abdominal muscles. The progression involves lifting the shoulders, changing arm positions, and holding a weight or medicine ball. The patient's position is hook-lying, maintaining a neutral spinal position.
| Study group | Role | What they receive |
|---|---|---|
| Instrument assisted soft tissue mobilization group | Experimental | treatment group A involved 22 patients who will receive instrumental-assisted soft tissue mobilization and exercises Receives: Other: Instrument assisted soft tissue mobilization; Other: The conventional exercise program |
| Myofascial Release group | Active comparator | treatment group B involved 22 patients who will receive myofascial release and exercises Receives: Other: Myofascial release; Other: The conventional exercise program |
| Exercise only group | Active comparator | control group (C) involved 22 patients who will receive exercises only. Receives: Other: The conventional exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change of pain intensity using visual analogue scale
The visual analogue scale is a reliable tool for assessing chronic musculoskeletal pain, including chronic low back pain, with high correlations with verbal descriptive and numeric rating scales. It is a 10-cm line marked with no pain and severe pain, with higher scores indicating greater pain intensity.
Measured: at baseline and after 6 weeks
Secondary outcomes (6)
Assessing the change of pressure pain threshold using the pressure algometer
A 1-cm diameter disk with a calibrated dial gauge is used to measure soft tissue tenderness on myofascial trigger points. The force applied to the point gradually increases, and patients are instructed to stop the algometry when experiencing a painful sensation. The force in Pascal is then read from the display.
Measured: at baseline and after 6 weeks
Assessing the change of flexion range of motion of the lumbar spine using the back range of motion device
The back range of motion II uses two Universal Inclinometers to measure range of motion to the spine, eliminating errors associated with stand-alone inclinometers. The investigator uses these inclinometers for flexion measurements, with the patient in an upright position. The therapist palpates and marks S1 and T12 on bare skin, centers the inclinometers, zeros them, and records the readings after the patient flexes forward.
Measured: at baseline and after 6 weeks
Assessing the change of extension range of motion of the lumbar spine using the back range of motion device
The back range of motion II uses two Universal Inclinometers to measure range of motion to the spine, eliminating errors associated with stand-alone inclinometers. The investigator uses these inclinometers for extension measurements, with the patient in an upright position. The therapist will repeat flexion protocol for extension having the patient extends back for full extension and will record the value
Measured: at baseline and after 6 weeks
Assessing the change of lateral flexion range of motion of the lumbar spine using the back range of motion device
The therapist will position the patient against a wall to prevent bending during lateral flexion measurements. The back range of motion unit will be adjusted until the inclinometer reads zero. For right lateral flexion, the patient will slide their hand down their leg while keeping their legs straight.
Measured: at baseline and after 6 weeks
Assessing the change of rotation range of motion of the lumbar spine using the back range of motion device
The therapist will place the back range of motion unit, so the unit's feet are in line with T12. The therapist will hold the center of the unit firmly against the patient's back and zero the compass. The therapist will have the patient slowly turn the shoulders to either side, making sure they go to full range and record the reading
Measured: at baseline and after 6 weeks
Assessing the change of back function using the 5) The Arabic version of Oswestry Disability Index
The Oswestry Disability Index is a self-reported questionnaire with 10 questions assessing daily living activities in patients with low back pain. The questions range from pain intensity to personal care and are scored on a 6-item Likert scale. The Arabic version of the oswestry disability index has good intra-observer reliability and good construct validity, with strong correlations with the visual analogue scale pain scale, Roland-Morris Low Back Pain Disability, and Quebec Back Pain Disability Scale.
Measured: at baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start23 Jan 2025
- Primary completion23 May 2025 (estimated)
- Study completion24 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial ReleaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Salah Ahmed elshatoury, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796881
- Sponsor's protocol ID
- Dalia-003373
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrument Assisted Soft Tissue Mobilization Versus Myofascial Release in Patients With Chronic Non¬Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06796881
- Acronym / sponsor ID
- Dalia-003373
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 23 May 2025 (estimated)
- Study completion
- 24 Jun 2025 (estimated)
- First posted
- 28 Jan 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 study was done to compare the effect of instrumental-assisted soft tissue mobilization versus the effect of myofascial release on pain intensity, pressure pain threshold, back function, and back range of motion in patients with chronic nonspecific low back pain.
Detailed description
Low back pain affects 20% of the workforce annually, leading to increased work absenteeism. Chronic non specific low back pain restricts functional and occupational activities, impacting society and the economy. Treatment is often unsatisfactory, and there is no consensus on the optimal approach. Further scientific research is needed to understand the effects of facial tissue manipulation on Chronic non specific low back pain patients. The literature has not addressed the distinctions between myofascial force transmission instrumental assisted soft tissue mobilization and myofascial release on Chronic non specific low back pain patients, which could help physical therapists find effective treatments. This study is the first to include pain, Pressure pain threshold, back function, and range of motion as outcome measures and compare instrumental assisted soft tissue mobilization and myofascial release in Chronic non specific low back pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Instrument assisted soft tissue mobilization group | Experimental | Other: Instrument assisted soft tissue mobilization, Other: The conventional exercise programtreatment group A involved 22 patients who will receive instrumental-assisted soft tissue mobilization and exercises |
| Myofascial Release group | Active comparator | Other: Myofascial release, Other: The conventional exercise programtreatment group B involved 22 patients who will receive myofascial release and exercises |
| Exercise only group | Active comparator | Other: The conventional exercise programcontrol group (C) involved 22 patients who will receive exercises only. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with chronic non-specific low back pain for more than 3 months.
- Age between 25-45 years.
Key exclusion criteria (6 listed)
- Patients who have serious spinal pathologies, such as fractures, tumors or inflammatory diseases (such as ankylosing spondylitis)
- Patients who have nerve root compromise, disk herniation, spondylolisthesis with neurological involvement, or narrowing of spinal canal
- Pregnant women
- Cancer patients .
- Lower limb injuries.
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 |
|---|---|---|
| Instrument assisted soft tissue mobilizationThe group will undergo Instrument assisted soft tissue mobilization using M2Tblade, applying it for 40-120 seconds until hyperemia occurs. After treatment, ice packs will be applied for 5 minutes to reduce hyperemia. The therapist will ensure comfort through continuous communication and reporting any discomfort. | Other | Instrument assisted soft tissue mobilization group |
| Myofascial releaseThe therapist will use a cross-hand release technique to release the lumbar spine, ensuring the patient is prone and suitable. They will lean into the patient to the tissue depth barrier, wait, and follow each release, avoiding force or slipping. The technique will be applied for 5 minutes on each side. | Other | Myofascial Release group |
| The conventional exercise programPatients will undergo a 12-session exercise program for 6 weeks, consisting of straight leg raising, bridging exercise, prone hip extension exercise, and abdominal curl exercise. The exercises will be done 3 sets, 10 repetitions each, with 1 minute rest between each set. The abdominal curl exercises involve supine or hook-lying positions with the lumbar spine neutral, with the patient performing a drawing in maneuver to stabilize the abdominal muscles. The progression involves lifting the shoulders, changing arm positions, and holding a weight or medicine ball. The patient's position is hook-lying, maintaining a neutral spinal position. | Other | Exercise only group, Instrument assisted soft tissue mobilization group, Myofascial Release group |
Primary outcome
Assessing the change of pain intensity using visual analogue scale
Time frame: at baseline and after 6 weeks
The visual analogue scale is a reliable tool for assessing chronic musculoskeletal pain, including chronic low back pain, with high correlations with verbal descriptive and numeric rating scales. It is a 10-cm line marked with no pain and severe pain, with higher scores indicating greater pain intensity.
6 secondary outcomes
Assessing the change of pressure pain threshold using the pressure algometer
Time frame: at baseline and after 6 weeks
Assessing the change of flexion range of motion of the lumbar spine using the back range of motion device
Time frame: at baseline and after 6 weeks
Assessing the change of extension range of motion of the lumbar spine using the back range of motion device
Time frame: at baseline and after 6 weeks
Assessing the change of lateral flexion range of motion of the lumbar spine using the back range of motion device
Time frame: at baseline and after 6 weeks
Assessing the change of rotation range of motion of the lumbar spine using the back range of motion device
Time frame: at baseline and after 6 weeks
Assessing the change of back function using the 5) The Arabic version of Oswestry Disability Index
Time frame: at baseline and after 6 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 28 Jan 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 Instrument assisted soft tissue mobilization, Myofascial release and The conventional exercise program in people with Myofascial Release and Instrument Assisted Soft Tissue Mobilization, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Jan 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 Egypt. 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 Dalia salah Ahmed Elshatoury, physical therapist (+201550677823, safsafahmed53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change of pain intensity using visual analogue scale (time frame: at baseline and after 6 weeks). 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 28 Jan 2025.