NCT05688800

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 9, 2023

Last Update Submit

January 9, 2023

Conditions

Keywords

Myofascial pain syndromepressure releaseThoracic manipulationActive trigger pointRhomboids trigger point

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity level

    pain intensity level will be measured by visual analogue scale (VAS)

    up to three weeks

  • Pressure Pain threshold level (PPT)

    pressure pain threshold level (PPT) will be measured by digital algometer

    up to three weeks

Secondary Outcomes (2)

  • Rom of Motion

    up to three weeks

  • Physical function

    up to three weeks

Study Arms (3)

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

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

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

Other: Experimental group 2: thoracic spine manipulation

Interventions

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

Control group

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 1 :pressure release technique

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

Experimental group 2: thoracic spine manipulation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Central Study Contacts

marwa medhat fawzy, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01