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Pressure Release Versus Thoracic Manipulation in Rhomboids MPS

Primary Purpose

Myofascial Pain Syndrome, Trigger Point Pain, Myofascial

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conventional therapy
Experimental group 1 : pressure release technique
Experimental group 2: thoracic spine manipulation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial pain syndrome, pressure release, Thoracic manipulation, Active trigger point, Rhomboids trigger point

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control group

    Experimental group 1 :pressure release technique

    Experimental group 2: thoracic spine manipulation

    Arm Description

    Each participant include 22 participants will receive conventional physical therapy treatment including TENS, continuous ultrasound ,infra-red radiation and combined stretching and strengthening exercise

    Each participant include 22 participants will receive the conventional physical therapy treatment in addition to pressure release technique

    Each participant include 22 participants will receive the conventional physical therapy treatment in addition to thoracic spine manipulation

    Outcomes

    Primary Outcome Measures

    Pain Intensity level
    pain intensity level will be measured by visual analogue scale (VAS)
    Pressure Pain threshold level (PPT)
    pressure pain threshold level (PPT) will be measured by digital algometer

    Secondary Outcome Measures

    Rom of Motion
    rom will be measured by digital inclinometer
    Physical function
    physical function will be measured by Disability of Arm, Shoulder, and Hand questionnaire (DASH)

    Full Information

    First Posted
    January 9, 2023
    Last Updated
    January 9, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05688800
    Brief Title
    Pressure Release Versus Thoracic Manipulation in Rhomboids MPS
    Official Title
    Pressure Release Versus Thoracic Spine Manipulation in Rhomboids Myofascial Pain Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
    Keywords
    Myofascial pain syndrome, pressure release, Thoracic manipulation, Active trigger point, Rhomboids trigger point

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Each participant include 22 participants will receive conventional physical therapy treatment including TENS, continuous ultrasound ,infra-red radiation and combined stretching and strengthening exercise
    Arm Title
    Experimental group 1 :pressure release technique
    Arm Type
    Experimental
    Arm Description
    Each participant include 22 participants will receive the conventional physical therapy treatment in addition to pressure release technique
    Arm Title
    Experimental group 2: thoracic spine manipulation
    Arm Type
    Experimental
    Arm Description
    Each participant include 22 participants will receive the conventional physical therapy treatment in addition to thoracic spine manipulation
    Intervention Type
    Device
    Intervention Name(s)
    conventional therapy
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Experimental group 1 : pressure release technique
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Experimental group 2: thoracic spine manipulation
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Pain Intensity level
    Description
    pain intensity level will be measured by visual analogue scale (VAS)
    Time Frame
    up to three weeks
    Title
    Pressure Pain threshold level (PPT)
    Description
    pressure pain threshold level (PPT) will be measured by digital algometer
    Time Frame
    up to three weeks
    Secondary Outcome Measure Information:
    Title
    Rom of Motion
    Description
    rom will be measured by digital inclinometer
    Time Frame
    up to three weeks
    Title
    Physical function
    Description
    physical function will be measured by Disability of Arm, Shoulder, and Hand questionnaire (DASH)
    Time Frame
    up to three weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    marwa medhat fawzy, bachelor
    Phone
    01111666514
    Email
    dr.marwa24red@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Pressure Release Versus Thoracic Manipulation in Rhomboids MPS

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