Instrument-Assisted Soft Tissue Mobilization Versus High Power Pain Threshold Ultrasound For Trapezius Myofascial Trigger Points
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
March 9, 2022
CompletedFirst Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2022
CompletedJanuary 18, 2023
January 1, 2023
3 months
March 11, 2022
January 16, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
Pressure pain threshold (PPT)
Pressure pain threshold (PPT) will be measured by a Pressure Algometer.
four weeks
Neck Range of motion
Neck Range of motion will be measured by Cervical ROM
four weeks
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
Study Arms (3)
Group (A) conventional physical therapy
ACTIVE COMPARATOR20 participants will receive conventional physical therapy.TENS, the frequency of the current is 100 Hz and the duty cycle is 250 microseconds, three times per week for 4 weeks. Ultrasound waves, frequency 1 MHz with intensity 1 W/cm2, a pulsed mode for 5 minutes, three times per week for 4 weeks, passive stretching, and isometric exercises three times per week for 4 weeks.
Group (B )IASTM and conventional physical therapy
EXPERIMENTAL20 participants will receive Instrument-Assisted Soft Tissue Mobilization (IASTM) and conventional physical therapy, the M2T blade will be used to find the exact areas of restriction in the upper trapezius. Then the M2T blade will be used, at an angle of 45 and using treatment planes 1, 2, and 3, to apply slow strokes along with the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 3 min. This procedure will be repeated twice a week for four weeks
Group (C) HPPT US and conventional physical therapy
EXPERIMENTAL20 participants will receive High Power Pain Threshold Ultrasound (HPPT US) and conventional physical therapy. For the HPPT US, ultrasound waves will be applied to trigger points of the upper trapezius in continuous mode, and the power of ultrasound will first increase to the threshold pain level at intensity (1.5-2 W/cm) according to the patient for 4-5 seconds with the probe placed directly on the trigger point and held motionlessly and then reduced to one-half of that intensity for15 seconds with the probe placed directly on the trigger point and move in a circular motion and repeat this three times. This procedure will be repeated twice a week for two weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, 12613, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 21, 2022
Study Start
March 9, 2022
Primary Completion
June 12, 2022
Study Completion
June 12, 2022
Last Updated
January 18, 2023
Record last verified: 2023-01