Non-specific Low Back PainNSLBP-MFRNCT06773247
Effectiveness of Myofascial Release Versus Dry Cupping in Management of Non-Specific Low Back Pain
A study testing I. Myofascial Release Technique ,Cupping Technique and II. Conventional Physical Therapy in people with Non-specific Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Objective: The aim of this study was to compare the differences between the effect of myofascial release technique versus cupping technique on pain intensity level, spinal mobility and functional disabilities level in patients with NSLBP. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- I. Myofascial Release Technique ,Cupping Technique and II. Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2025to 3 Apr 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 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients age ranged from 45 to 55 years old and body mass index of 18.5-24.9 (kg/m2) with NSLBP of 3 or more month's duration.
- All patients reported pain score of 4-6 based on the visual analog scale (VAS). 3.Patient with limitation in range of motion of lumbar spine due to tightness of the muscles, hypersensitive tender points on palpation along with pain localized para spinally .
Who cannot join
- Patients presented with lumbar radiculopathy
- spinal pathology (fracture or tumors) or history of any spinal surgery
- lumbar canal stenosis, osteoporosis
- pregnancy related back pain, and spinal deformities like scoliosis or kyphosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rabab M Assistant Professor of Physical Therapy, PHD contact
Rabab M Assistant Professor of Physical Therapy, PHD contact
Egypt1 site
Faculty of Physical Therapy, Cairo University.
Cairo, Egypt, 12518
Rabab M shoala, PHD, 00201158382830 ext. +966542462187, r.shoala@qu.edu.sa
Rabab M Shoala, PHD
About this study
Official title: Effectiveness of Myofascial Release Technique Versus Dry Cupping Therapy in Management of Patients with Non-Specific Low Back Pain
Objective: The aim of this study was to compare the differences between the effect of myofascial release technique versus cupping technique on pain intensity level, spinal mobility and functional disabilities level in patients with NSLBP.
Methods: The study participants were 60 patients from both genders diagnosed as NSLBP. Their age ranged from 45 to 55 years old. They were assigned randomly into two groups: Group A (MFR): 20 patients received MFR and conventional physical therapy treatment. Group B: 20 patients received cupping technique and conventional physical therapy treatment. Group C: 20 patients received conventional physical therapy treatment only. All groups received treatment protocols three times a week for 4 consecutive weeks.
Read the detailed description
The study participants were assigned randomly into two groups; Group A: 20 patients received MFR and conventional physical therapy treatment (therapeutic exercises in the form of stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes. Group B: 20 patients received cupping technique and conventional physical therapy treatment (therapeutic exercises in form of stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes. Group C: 20 patients received conventional physical therapy treatment only (therapeutic exercises in form of stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes. All groups received treatment protocols three times a week for 4 consecutive weeks.
Intervention I. Myofascial Release Technique Vertical stroking technique was performed in lumbar region to quadratus lumborum. Activities like sustained repetitive movements, twisting, bending, sedentary posture for prolonged duration, muscle imbalance, etc. leads to trigger point formation making quadratus lumborum as a common source of low back pain. It was performed as follow; Quadratus lumborum is palpated in prone and side lying for trigger points. The technique is applied by the patient positioned in side lying with a pillow under waist to exaggerate stretch of the muscle. The therapist stands at level of patient's hip posterior and counter pressure was applied by one hand on the ribs in a cephalic direction and with the other hand vertical stroking was performed by the knuckles caudally through its course in direction of the barrier. When a barrier was reached, light pressure was maintained to stretch the barrier and wait for approximately 3-5 minutes. Prior to release, a therapeutic pulse was felt (e.g. heat). As the barrier releases, the hand felt the motion and softening of the tissue. Sessions were conducted three days / week every other day for four weeks Cupping Technique The cupping procedure was performed as follows: Massage oil was applied over the area first to improve contact and makes it easier to move the cup's position. double-walled glass cups (6 glasses with diameters from 75 to 100 mm) were held inverted, after which each glass was placed on an afflicted area overlying the low back muscle (acupoint: BL23. This point is located 1.5 cm lateral to the posterior midline, on the level of the lower border of the spinous process of the second lumbar vertebra) and has been used to treat conditions such as lower back pain. As the air inside the cups cooled, vacuums were created, drawing up the skin within each cup. The cups were separated by 1-2 centimeters. The glasses were removed after 10 to 20 minutes depending on the colour of the circular so-called cupping marks, which range from slightly rose to dark pink. During cupping, the patients were asked to remain as still as possible. If the suctioning became too painful to bear, the cups were removed before the full time had elapsed.
II. Conventional Physical Therapy Treatment It consists of stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes. Three sets of stretching exercises, each involving a 30-sec hold and 30 sec of rest repeated three times, were performed in three sessions per week over four weeks. One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, sessions were conducted three days a week, every other day, for four weeks.
The cupping procedure was performed as follows: Massage oil was applied over the area first to improve contact and makes it easier to move the cup's position. double-walled glass cups (6 glasses with diameters from 75 to 100 mm) were held inverted, after which each glass was placed on an afflicted area overlying the low back muscle (acupoint: BL23. This point is located 1.5 cm lateral to the posterior midline, on the level of the lower border of the spinous process of the second lumbar vertebra) and has been used to treat conditions such as lower back pain. As the air inside the cups cooled, vacuums were created, drawing up the skin within each cup. The cups were separated by 1-2 centimeters. The glasses were removed after 10 to 20 minutes depending on the colour of the circular so-called cupping marks, which range from slightly rose to dark pink. During cupping, the patients were asked to remain as still as possible. If the suctioning became too painful to bear, the cups were removed before the full time has elapsed. Cupping therapy was performed for 15-20 minutes three days / week every other day for four weeks
- Conditions
- Non-specific Low Back Pain
- Being tested
- I. Myofascial Release Technique ,Cupping Technique and II. Conventional Physical Therapy
- Keywords
- Myofascial Release, Cupping, NSLBP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I. Myofascial Release Technique ,Cupping Technique and II. Conventional Physical TherapyOther
The cupping procedure was performed as follows: Massage oil was applied over the area first to improve contact and makes it easier to move the cup's position. double-walled glass cups (6 glasses with diameters from 75 to 100 mm) were held inverted, after which each glass was placed on an afflicted area overlying the low back muscle (acupoint: BL23).
Myofascial Release Technique Vertical stroking technique was performed in lumbar region to quadratus lumborum. AIt was performed as follow; Quadratus lumborum is palpated in prone and side lying for trigger points. The technique is applied by the patient positioned in side lying with a pillow under waist to exaggerate stretch of the muscle. The therapist stands at level of patient's hip posterior and counter pre
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release Technique | Experimental | Vertical stroking technique was performed in lumbar region to quadratus lumborum. Activities like sustained repetitive movements, twisting, bending, sedentary posture for prolonged duration, muscle imbalance, etc. leads to trigger point formation making quadratus lumborum as a common source of low back pain. It was performed as follow; Quadratus lumborum is palpated in prone and side lying for trigger points. The technique is applied by the patient positioned in side lying with a pillow under waist to exaggerate stretch of the muscle. Receives: Other: I. Myofascial Release Technique ,Cupping Technique and II. Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain in low back area
Visual analog scale (VAS) was used to assess the intensity of perceived pain pre and post treatment in patients with NSLBP. The VAS is a reliable and valid tool for the quantification of perceived pain
Measured: 4 weeks
Secondary outcomes (1)
Functional Disability
Level of daily living activities was measured using Oswestry Disability Index (Ar-ODI).The questionnaire contains 10 items related to limitations in daily life activities (like personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and work).Each item includes six potential responses that are rating on a 0 to 5 points scale, with maximum scores of ''5'' or ''total disability'' and a minimum score of ''0'' or ''no disability.'' 39-41 The total score is calculated as follows: (patient' score/50) *100 to obtain the score expressed in percentage
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start3 Jan 2025 (estimated)
- Primary completion3 Mar 2025 (estimated)
- Study completion3 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back PainStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Ali Mohamed, Cairo University
- Investigators
- Rabab M Shoala, PHD, Principal investigator, Basic Science Department, Faculty of Physical Therapy, Cairo University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773247
- Sponsor's protocol ID
- (P.T. REC/012/005495)
- Acronym
- NSLBP-MFR
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Myofascial Release Technique Versus Dry Cupping Therapy in Management of Patients with Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06773247
- Acronym / sponsor ID
- NSLBP-MFR / (P.T. REC/012/005495)
- Conditions
- Non-specific Low Back Pain
- Keywords
- Myofascial Release, Cupping, NSLBP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2025 (estimated)
- Primary completion
- 3 Mar 2025 (estimated)
- Study completion
- 3 Apr 2025 (estimated)
- First posted
- 14 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.
Objective: The aim of this study was to compare the differences between the effect of myofascial release technique versus cupping technique on pain intensity level, spinal mobility and functional disabilities level in patients with NSLBP.
Methods: The study participants were 60 patients from both genders diagnosed as NSLBP. Their age ranged from 45 to 55 years old. They were assigned randomly into two groups: Group A (MFR): 20 patients received MFR and conventional physical therapy treatment. Group B: 20 patients received cupping technique and conventional physical therapy treatment. Group C: 20 patients received conventional physical therapy treatment only. All groups received treatment protocols three times a week for 4 consecutive weeks.
Detailed description
The study participants were assigned randomly into two groups; Group A: 20 patients received MFR and conventional physical therapy treatment (therapeutic exercises in the form of stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes. Group B: 20 patients received cupping technique and conventional physical therapy treatment (therapeutic exercises in form of stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes. Group C: 20 patients received conventional physical therapy treatment only (therapeutic exercises in form of stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes. All groups received treatment protocols three times a week for 4 consecutive weeks.
Intervention I. Myofascial Release Technique Vertical stroking technique was performed in lumbar region to quadratus lumborum. Activities like sustained repetitive movements, twisting, bending, sedentary posture for prolonged duration, muscle imbalance, etc. leads to trigger point formation making quadratus lumborum as a common source of low back pain. It was performed as follow; Quadratus lumborum is palpated in prone and side lying for trigger points. The technique is applied by the patient positioned in side lying with a pillow under waist to exaggerate stretch of the muscle. The therapist stands at level of patient's hip posterior and counter pressure was applied by one hand on the ribs in a cephalic direction and with the other hand vertical stroking was performed by the knuckles caudally through its course in direction of the barrier. When a barrier was reached, light pressure was maintained to stretch the barrier and wait for approximately 3-5 minutes. Prior to release, a therapeutic pulse was felt (e.g. heat). As the barrier releases, the hand felt the motion and softening of the tissue. Sessions were conducted three days / week every other day for four weeks Cupping Technique The cupping procedure was performed as follows: Massage oil was applied over the area first to improve contact and makes it easier to move the cup's position. double-walled glass cups (6 glasses with diameters from 75 to 100 mm) were held inverted, after which each glass was placed on an afflicted area overlying the low back muscle (acupoint: BL23. This point is located 1.5 cm lateral to the posterior midline, on the level of the lower border of the spinous process of the second lumbar vertebra) and has been used to treat conditions such as lower back pain. As the air inside the cups cooled, vacuums were created, drawing up the skin within each cup. The cups were separated by 1-2 centimeters. The glasses were removed after 10 to 20 minutes depending on the colour of the circular so-called cupping marks, which range from slightly rose to dark pink. During cupping, the patients were asked to remain as still as possible. If the suctioning became too painful to bear, the cups were removed before the full time had elapsed.
II. Conventional Physical Therapy Treatment It consists of stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes. Three sets of stretching exercises, each involving a 30-sec hold and 30 sec of rest repeated three times, were performed in three sessions per week over four weeks. One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, sessions were conducted three days a week, every other day, for four weeks.
The cupping procedure was performed as follows: Massage oil was applied over the area first to improve contact and makes it easier to move the cup's position. double-walled glass cups (6 glasses with diameters from 75 to 100 mm) were held inverted, after which each glass was placed on an afflicted area overlying the low back muscle (acupoint: BL23. This point is located 1.5 cm lateral to the posterior midline, on the level of the lower border of the spinous process of the second lumbar vertebra) and has been used to treat conditions such as lower back pain. As the air inside the cups cooled, vacuums were created, drawing up the skin within each cup. The cups were separated by 1-2 centimeters. The glasses were removed after 10 to 20 minutes depending on the colour of the circular so-called cupping marks, which range from slightly rose to dark pink. During cupping, the patients were asked to remain as still as possible. If the suctioning became too painful to bear, the cups were removed before the full time has elapsed. Cupping therapy was performed for 15-20 minutes three days / week every other day for four weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release Technique | Experimental | Other: I. Myofascial Release Technique ,Cupping Technique and II. Conventional Physical TherapyVertical stroking technique was performed in lumbar region to quadratus lumborum. Activities like sustained repetitive movements, twisting, bending, sedentary posture for prolonged duration, muscle imbalance, etc. leads to trigger point formation making quadratus lumborum as a common source of low back pain. It was performed as follow; Quadratus lumborum is palpated in prone and side lying for trigger points. The technique is applied by the patient positioned in side lying with a pillow under waist to exaggerate stretch of the muscle. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients age ranged from 45 to 55 years old and body mass index of 18.5-24.9 (kg/m2) with NSLBP of 3 or more month's duration.
- All patients reported pain score of 4-6 based on the visual analog scale (VAS). 3.Patient with limitation in range of motion of lumbar spine due to tightness of the muscles, hypersensitive tender points on palpation along with pain localized para spinally .
Key exclusion criteria (4 listed)
- Patients presented with lumbar radiculopathy
- spinal pathology (fracture or tumors) or history of any spinal surgery
- lumbar canal stenosis, osteoporosis
- pregnancy related back pain, and spinal deformities like scoliosis or kyphosis.
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 |
|---|---|---|
| I. Myofascial Release Technique ,Cupping Technique and II. Conventional Physical TherapyThe cupping procedure was performed as follows: Massage oil was applied over the area first to improve contact and makes it easier to move the cup's position. double-walled glass cups (6 glasses with diameters from 75 to 100 mm) were held inverted, after which each glass was placed on an afflicted area overlying the low back muscle (acupoint: BL23). Myofascial Release Technique Vertical stroking technique was performed in lumbar region to quadratus lumborum. AIt was performed as follow; Quadratus lumborum is palpated in prone and side lying for trigger points. The technique is applied by the patient positioned in side lying with a pillow under waist to exaggerate stretch of the muscle. The therapist stands at level of patient's hip posterior and counter pre | Other | Myofascial Release Technique |
Primary outcome
pain in low back area
Time frame: 4 weeks
Visual analog scale (VAS) was used to assess the intensity of perceived pain pre and post treatment in patients with NSLBP. The VAS is a reliable and valid tool for the quantification of perceived pain
1 secondary outcome
Functional Disability
Time frame: 4 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 14 Jan 2025.
Related trials for Non-specific Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
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.
Rabab M Assistant Professor of Physical Therapy, PHD contact
Rabab M Assistant Professor of Physical Therapy, PHD contact
Rabab M Shoala, PHD principal investigator
Basic Science Department, Faculty of Physical Therapy, Cairo University, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I. Myofascial Release Technique ,Cupping Technique and II. Conventional Physical Therapy in people with Non-specific Low Back Pain, 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 4 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 14 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 Rabab M Assistant Professor of Physical Therapy, PHD (r.shoala@qu.edu.sa ext. 00201158382830, drrabab0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain in low back area (time frame: 4 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 14 Jan 2025.