NCT05288933

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

March 11, 2022

Last Update Submit

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 COMPARATOR

20 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.

Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound

Group (B )IASTM and conventional physical therapy

EXPERIMENTAL

20 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

Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound

Group (C) HPPT US and conventional physical therapy

EXPERIMENTAL

20 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

Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound

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.

Also known as: Ultrasound
Group (A) conventional physical therapyGroup (B )IASTM and conventional physical therapyGroup (C) HPPT US and conventional physical therapy

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

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

Locations