- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05688800
Pressure Release Versus Thoracic Manipulation in Rhomboids MPS
Pressure Release Versus Thoracic Spine Manipulation in Rhomboids Myofascial Pain Syndrome
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: marwa medhat fawzy, bachelor
- Phone Number: 01111666514
- Email: dr.marwa24red@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
Each participant include 22 participants will receive conventional physical therapy treatment including TENS, continuous ultrasound ,infra-red radiation and combined stretching and strengthening exercise
|
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: Experimental group 1 :pressure release technique
Each participant include 22 participants will receive the conventional physical therapy treatment in addition to pressure release technique
|
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: Experimental group 2: thoracic spine manipulation
Each participant include 22 participants will receive the conventional physical therapy treatment in addition to thoracic spine manipulation
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity level
Time Frame: up to three weeks
|
pain intensity level will be measured by visual analogue scale (VAS)
|
up to three weeks
|
Pressure Pain threshold level (PPT)
Time Frame: up to three weeks
|
pressure pain threshold level (PPT) will be measured by digital algometer
|
up to three weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rom of Motion
Time Frame: up to three weeks
|
rom will be measured by digital inclinometer
|
up to three weeks
|
Physical function
Time Frame: up to three weeks
|
physical function will be measured by Disability of Arm, Shoulder, and Hand questionnaire (DASH)
|
up to three weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- p.t.REC/012/004127
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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