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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05288933
Other study ID # P.T.REC/012/003544
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2022
Est. completion date June 12, 2022

Study information

Verified date January 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the purpose of this trial is to compare the effectiveness of instrument-assisted soft tissue mobilization and high power pain threshold ultrasound on pain intensity, pressure pain threshold (PPT), neck range of motion, and neck function in participants with upper trapezius myofascial trigger points.


Description:

Myofascial trigger points (MTPs) are hyperirritable, palpable nodules that form along with taut bands of muscle fibers. The trapezius is the muscle that is most commonly affected. MTPs can have a considerable impact on a person's daily activities and ability to work. Stretching exercises, ultrasound, massage, kinesiology taping, trigger point release, dry needling, laser, ischemic compression treatment, and high-power pain threshold ultrasound can all be used in a physical therapy program for myofascial pain and trigger points. There were previous studies on the effect of instrument-assisted soft tissue mobilization (IASTM) on upper trapezius myofascial trigger points that have shown positive effects such as reduction in pain level, improved neck function, and range of motion, increased activity level, and increased pressure pain threshold. There have been previous studies on the effect of high-power pain threshold ultrasound on upper trapezius trigger points that have shown a reduction in pain level, increased activity level, and increased pressure pain threshold. However till now, there is no study comparing the therapeutic potential of HPPT US and IASTM on upper trapezius trigger points, This study is conducted to compare the effect of instrument-assisted soft tissue mobilization (IASTM) and high-power pain threshold ultrasound ( HPPT US ) on upper trapezius trigger points. : Sixty participants ranging in age from 25 to 40 years old, from both genders, were diagnosed with active MTPs in the upper fibers of the trapezius muscle bilaterally. Participants were randomly allocated to the following three groups using sealed envelopes. Group (A) 20 participants received conventional physical therapy. Group (B) 20 participants received IASTM and conventional physical therapy. Group (C) 20 participants received HPPT US and conventional physical therapy for two weeks, twice per week.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 12, 2022
Est. primary completion date June 12, 2022
Accepts healthy volunteers No
Gender All
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: Having at least 1 active trigger point in bilateral upper trapezius muscles We will use a recommended diagnostic criterion to find active MTrPs which is: The presence of a palpable taut band in the skeletal muscle, The presence of a hypersensitive spot in the taut band, Local twitch response provoked by snapping palpation Production of referred pain pattern in response to the compression of tender spots Spontaneous presence of typically referred pain pattern. - A duration of symptoms of 2-4 weeks. - Age between 25 and 40 years. - Having a normal neurological examination result. - Not having any evidence of infection or inflammation in laboratory tests. Exclusion Criteria:- Existence of cervical disc hernia, advanced cervical osteoarthritis, radiculopathy, or myelopathy. - Having trigger point injection or physical therapy in the last 6 months. - Having a rheumatologic disease, such as fibromyalgia, rheumatoid arthritis, and spondyloarthritis, or hormonal diseases, such as hypothyroidism, hyperthyroidism, or hyperparathyroidism. - Existence of kyphosis, scoliosis, forward head posture, or cervical-genic headache. - History of spine surgery. - Having a cardiovascular problem

Study Design


Intervention

Device:
Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound
Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment for the myofascial limitation that is based on James Cyriax's rationale. High-power pain threshold ultrasound is a noninvasive approach used in myofascial pain syndrome ( MPS) treatment, and it has no serious adverse effects.

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity Pain intensity will be measured by the Visual Analogue Scale (VAS). It consists of a horizontal or vertical line, usually 10 cm long. The extremes of the line are labeled as "no pain" and "worst pain"
3-Neck Range of motion : by Cervical ROM 3- Neck function: by Arabic version of the Neck Disability
four weeks
Primary Pressure pain threshold (PPT) Pressure pain threshold (PPT) will be measured by a Pressure Algometer. four weeks
Primary Neck Range of motion Neck Range of motion will be measured by Cervical ROM four weeks
Primary Neck function Neck function will be measured by the Arabic version of the Neck Disability Index (ANDI). A total score of 0-4 indicated no disability. A score of 5-14 indicated mild disability, a score of 15-24 indicated moderate disability, a score of 25-34 indicated severe disability, and a score of 35 or greater indicated complete disability four weeks
See also
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