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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05688800
Other study ID # p.t.REC/012/004127
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2023
Est. completion date September 2023

Study information

Verified date January 2023
Source Cairo University
Contact marwa medhat fawzy, bachelor
Phone 01111666514
Email dr.marwa24red@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date September 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Intervention

Device:
conventional therapy
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
Other:
Experimental group 1 : 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 group 2: 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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity level pain intensity level will be measured by visual analogue scale (VAS) up to three weeks
Primary Pressure Pain threshold level (PPT) pressure pain threshold level (PPT) will be measured by digital algometer up to three weeks
Secondary Rom of Motion rom will be measured by digital inclinometer up to three weeks
Secondary Physical function physical function will be measured by Disability of Arm, Shoulder, and Hand questionnaire (DASH) up to three weeks
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