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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

r.shoala@qu.edu.sa ext. 00201158382830

drrabab0@gmail.com

Rabab M Assistant Professor of Physical Therapy, PHD contact

00201158382830 ext. +966542462187

r.shoala@qu.edu.sa

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

Other trials in Egypt

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

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 groups in NCT06773247
Study groupRoleWhat they receive
Myofascial Release TechniqueExperimentalVertical 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.

  1. 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)
  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.

  1. First posted14 Jan 2025
  2. Study start3 Jan 2025 (estimated)
  3. Primary completion3 Mar 2025 (estimated)
  4. Study completion3 Apr 2025 (estimated)

Resources

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)
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

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.

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