Myofascial Pain SyndromeNCT05688800
Pressure Release Versus Thoracic Manipulation in Rhomboids MPS
A study testing conventional therapy, Experimental group 1 : pressure release technique and Experimental group 2: thoracic spine manipulation in people with Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, run by Cairo University.
Trial summary
The purpose of the stud will be to compare the effect of pressure release with thoracic spine manipulation on pain intensity level and pain pressure threshold, thoracic spine ROM and physical function onactive rhomboids muscle trigger point in myofascial pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
- What is being tested?
- conventional therapy, Experimental group 1 : pressure release technique and Experimental group 2: thoracic spine manipulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants ages will be from 18 to 30 years Participants will be from both genders. Participants that have Myofascial pain syndrome due to at least one active trigger points in rhomboid muscle (Haleema and Riaz, 2021). Participants have myofascial pain syndrome since more than three months. Presence of a palpable taut band in a skeletal muscle
Who cannot join
- Malignancy. Fractures of the Thoracic spine. Cervical radiculopathy or myelopathy. Vascular syndromes such as vertebrobasilar insufficiency. Rheumatoid arthritis. Neck or upper back surgery. Taking anticoagulants. Local infection. Whiplash injury. Open wounds. Pregnancy. Receiving radiation or chemotherapy. Scapular pain due to any degeneration disease. Osteoporosis. Cardiac pacemaker. Any contraindication for thoracic manipulation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pressure Release Versus Thoracic Spine Manipulation in Rhomboids Myofascial Pain Syndrome
The purpose of the stud will be to compare the effect of pressure release with thoracic spine manipulation on pain intensity level and pain pressure threshold, thoracic spine ROM and physical function onactive rhomboids muscle trigger point in myofascial pain syndrome.
Read the detailed description
Myofascial pain syndrome (MPS) is one of the most common chronic disorders causing persistent musculoskeletal pain which is characterized by myofascial trigger points (MTrPs) in palpable taut bands of skeletal muscle. In recent years, due to our modern lifestyle people is exposed to postural stresses, inefficient biomechanics, repetitive postural dysfunction, which are some of the causes of myofascial pain syndrome .Active Rhomboid muscle trigger point are one of the main causes of inter- scapular pain, as the referral pattern of this muscle is on the medial border of the scapula. The aim of the study is to find if there any significant difference between the effect of pressure release and thoracic spine manipulation on pain intensity level, pain pressure threshold ,thoracic spine ROM and physical function and symptoms in people with musculoskeletal disorders of the upper limb on active rhomboids muscle trigger point in myofascial pain syndrome. 66 participants will be allocated randomly to three groups ; The Participants will be assigned randomly into three groups by simple methods of randomization. Control group: will receive conventional physical therapy treatment, Experimental group 1: will receive conventional physical therapy treatment in addition to pressure release Experimental group 2: will receive conventional physical therapy treatment in addition to thoracic spine manipulation.
- Being tested
- conventional therapy, Experimental group 1 : pressure release technique, Experimental group 2: thoracic spine manipulation
- Keywords
- Myofascial pain syndrome, pressure release, Thoracic manipulation, Active trigger point, Rhomboids trigger point
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapyDevice
Participants in control group will receive conventional physical therapy treatment including Conventional TENS high frequency (90-130hz) low intensity according to the patient sensation for 30-45 min(Gozani, 2019) , continuous ultrasound with frequency 1 MHz and intensity 0.8 W/cm 2 will be applied by slow circular perpendicular movements with slightly deep pressure. Application time was 5 minutes at each side of the level of C7_T4 along the medial borders of the scapulae width, infra-red radiation will be four 15 minutes and directed perpendicular to the inter-scapular area, centered at the level of C7_T4 long and between the 2 medial borders of the scapulae width . Also combined stretching and strengthening exercise will be added due to its greater pain-relieving effect
Experimental group 1 : pressure release techniqueOther
Participants who are assigned to this group will receive conventionalphysical therapy treatment in addition to pressure release technique. the participant will be positioned either sitting or prone position according to his preferred position, the researcher will apply the pressure release procedure by a pressure below the PPT dependent onsoft tissue release. When the researcher detected a reduction in soft tissue resistance, the amount of compression will be increased. The pressure should -33- be nonpainful, applied at slow rate, and will maintained until release of tissue barrier. Further pressure was increased to reach a new barrier. The pressure will last 60 seconds. With the thumb or the second and third fingers, the non-painful manual therapy approach was applied to the active MTrPs of therhomboid muscle
Experimental group 2: thoracic spine manipulationOther
Thoracic spine manipulation will be performed as screw thrust manipulation technique; the vertebral transverse processes will beforced from posterior to anterior direction. The direction of the manipulation should be identified by applying springing test to the adjacent spinous process to determine the painful and stiff segment. Patient will be prone and researcher hand placement will be positioned as the following one pisiform on the right facet of the above, and the other pisiform on the left facet of the below vertebrae.A slack will be taken up. The thrust applied directly toward the patient once
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Each participant include 22 participants will receive conventional physical therapy treatment including TENS, continuous ultrasound ,infra-red radiation and combined stretching and strengthening exercise Receives: Device: conventional therapy |
| Experimental group 1 :pressure release technique | Experimental | Each participant include 22 participants will receive the conventional physical therapy treatment in addition to pressure release technique Receives: Other: Experimental group 1 : pressure release technique |
| Experimental group 2: thoracic spine manipulation | Experimental | Each participant include 22 participants will receive the conventional physical therapy treatment in addition to thoracic spine manipulation Receives: Other: Experimental group 2: thoracic spine manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity level
pain intensity level will be measured by visual analogue scale (VAS)
Measured: up to three weeks
Pressure Pain threshold level (PPT)
pressure pain threshold level (PPT) will be measured by digital algometer
Measured: up to three weeks
Secondary outcomes (2)
Rom of Motion
rom will be measured by digital inclinometer
Measured: up to three weeks
Physical function
physical function will be measured by Disability of Arm, Shoulder, and Hand questionnaire (DASH)
Measured: up to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study startMar 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- Model description
- Control group: will receive conventional physical therapy treatment Experimental group 1: will receive conventional physical therapy treatment in addition to pressure release Experimental group 2: will receive conventional physical therapy treatment in addition to thoracic spine manipulation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Medhat Fawzy Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688800
- Sponsor's protocol ID
- p.t.REC/012/004127
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Release Versus Thoracic Spine Manipulation in Rhomboids Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05688800
- Acronym / sponsor ID
- p.t.REC/012/004127
- Keywords
- Myofascial pain syndrome, pressure release, Thoracic manipulation, Active trigger point, Rhomboids trigger point
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 18 Jan 2023 (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.
The purpose of the stud will be to compare the effect of pressure release with thoracic spine manipulation on pain intensity level and pain pressure threshold, thoracic spine ROM and physical function onactive rhomboids muscle trigger point in myofascial pain syndrome.
Detailed description
Myofascial pain syndrome (MPS) is one of the most common chronic disorders causing persistent musculoskeletal pain which is characterized by myofascial trigger points (MTrPs) in palpable taut bands of skeletal muscle. In recent years, due to our modern lifestyle people is exposed to postural stresses, inefficient biomechanics, repetitive postural dysfunction, which are some of the causes of myofascial pain syndrome .Active Rhomboid muscle trigger point are one of the main causes of inter- scapular pain, as the referral pattern of this muscle is on the medial border of the scapula. The aim of the study is to find if there any significant difference between the effect of pressure release and thoracic spine manipulation on pain intensity level, pain pressure threshold ,thoracic spine ROM and physical function and symptoms in people with musculoskeletal disorders of the upper limb on active rhomboids muscle trigger point in myofascial pain syndrome. 66 participants will be allocated randomly to three groups ; The Participants will be assigned randomly into three groups by simple methods of randomization. Control group: will receive conventional physical therapy treatment, Experimental group 1: will receive conventional physical therapy treatment in addition to pressure release Experimental group 2: will receive conventional physical therapy treatment in addition to thoracic spine manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Control group: will receive conventional physical therapy treatment Experimental group 1: will receive conventional physical therapy treatment in addition to pressure release Experimental group 2: will receive conventional physical therapy treatment in addition to thoracic spine manipulation
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: conventional therapyEach participant include 22 participants will receive conventional physical therapy treatment including TENS, continuous ultrasound ,infra-red radiation and combined stretching and strengthening exercise |
| Experimental group 1 :pressure release technique | Experimental | Other: Experimental group 1 : pressure release techniqueEach participant include 22 participants will receive the conventional physical therapy treatment in addition to pressure release technique |
| Experimental group 2: thoracic spine manipulation | Experimental | Other: Experimental group 2: thoracic spine manipulationEach participant include 22 participants will receive the conventional physical therapy treatment in addition to thoracic spine manipulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants ages will be from 18 to 30 years Participants will be from both genders. Participants that have Myofascial pain syndrome due to at least one active trigger points in rhomboid muscle (Haleema and Riaz, 2021). Participants have myofascial pain syndrome since more than three months. Presence of a palpable taut band in a skeletal muscle
Key exclusion criteria (1 listed)
- Malignancy. Fractures of the Thoracic spine. Cervical radiculopathy or myelopathy. Vascular syndromes such as vertebrobasilar insufficiency. Rheumatoid arthritis. Neck or upper back surgery. Taking anticoagulants. Local infection. Whiplash injury. Open wounds. Pregnancy. Receiving radiation or chemotherapy. Scapular pain due to any degeneration disease. Osteoporosis. Cardiac pacemaker. Any contraindication for thoracic manipulation
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 |
|---|---|---|
| conventional therapyParticipants in control group will receive conventional physical therapy treatment including Conventional TENS high frequency (90-130hz) low intensity according to the patient sensation for 30-45 min(Gozani, 2019) , continuous ultrasound with frequency 1 MHz and intensity 0.8 W/cm 2 will be applied by slow circular perpendicular movements with slightly deep pressure. Application time was 5 minutes at each side of the level of C7_T4 along the medial borders of the scapulae width, infra-red radiation will be four 15 minutes and directed perpendicular to the inter-scapular area, centered at the level of C7_T4 long and between the 2 medial borders of the scapulae width . Also combined stretching and strengthening exercise will be added due to its greater pain-relieving effect | Device | Control group |
| Experimental group 1 : pressure release techniqueParticipants who are assigned to this group will receive conventionalphysical therapy treatment in addition to pressure release technique. the participant will be positioned either sitting or prone position according to his preferred position, the researcher will apply the pressure release procedure by a pressure below the PPT dependent onsoft tissue release. When the researcher detected a reduction in soft tissue resistance, the amount of compression will be increased. The pressure should -33- be nonpainful, applied at slow rate, and will maintained until release of tissue barrier. Further pressure was increased to reach a new barrier. The pressure will last 60 seconds. With the thumb or the second and third fingers, the non-painful manual therapy approach was applied to the active MTrPs of therhomboid muscle | Other | Experimental group 1 :pressure release technique |
| Experimental group 2: thoracic spine manipulationThoracic spine manipulation will be performed as screw thrust manipulation technique; the vertebral transverse processes will beforced from posterior to anterior direction. The direction of the manipulation should be identified by applying springing test to the adjacent spinous process to determine the painful and stiff segment. Patient will be prone and researcher hand placement will be positioned as the following one pisiform on the right facet of the above, and the other pisiform on the left facet of the below vertebrae.A slack will be taken up. The thrust applied directly toward the patient once | Other | Experimental group 2: thoracic spine manipulation |
Primary outcome
Pain Intensity level
Time frame: up to three weeks
pain intensity level will be measured by visual analogue scale (VAS)
Pressure Pain threshold level (PPT)
Time frame: up to three weeks
pressure pain threshold level (PPT) will be measured by digital algometer
2 secondary outcomes
Rom of Motion
Time frame: up to three weeks
Physical function
Time frame: up to three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
Related trials for Myofascial Pain Syndrome
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing conventional therapy, Experimental group 1 : pressure release technique and Experimental group 2: thoracic spine manipulation in people with Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, run by Cairo University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jan 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marwa medhat fawzy, bachelor (01111666514, dr.marwa24red@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity level (time frame: up to three weeks). The study lists 2 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 18 Jan 2023.