NCT07002593

Brief Summary

This study aimed to compare the efficacy of MFR plus HPPT-US versus stretching plus HPPT-US on pain intensity, cervical range of motion (ROM), muscle length (ML), and neck disability in athletes with active upper trapezius MTrPs. Methods: A randomized clinical trial was conducted on 60 male athletes diagnosed with active upper trapezius MTrPs. Participants were randomly assigned to Group A (MFR + HPPT-US) or Group B (stretching + HPPT-US). Interventions were administered over two weeks. Outcome measures including Visual Analog Scale (VAS), ROM, ML, and Neck Disability Index (NDI) were recorded at baseline, week 1, week 2, and one-week follow-up. Between-group comparisons were analyzed using independent t-tests, and effect sizes were calculated using Cohen's d. For all statistical analyses, the level of significance alpha was set at 95% (p \< .05).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

May 25, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Myofascial Pain SyndromesUltrasonic TherapyAthletesTrigger PointsRange of Motion

Outcome Measures

Primary Outcomes (4)

  • Pain intensity

    Pain intensity was assessed using the visual analog scale (VAS), an imaginary line with either end marked with 0 or 10, indicating no pain or extremely unbearable pain, respectively.

    Once a week for 3 weeks (baseline, week 1 and 2 post-intervention, and follow up at week 3 after one-week completion of intervention.

  • Cervical range of motion

    Cervical range of motion (ROM) was assessed with a universal goniometer for flexion, extension, right and left lateral flexion, and rotation.

    Once a week for 3 weeks (baseline, week 1 and 2 post-intervention, and follow up at week 3 after one-week completion of intervention.

  • Functional disability

    Neck disability was quantified using the Neck Disability Index (NDI), a 10-item questionnaire with established reliability. The minimum and maximum scores are 0 and 50, indicating no disability to severe disability, respectively.

    Once a week for 3 weeks (baseline, week 1 and 2 post-intervention, and follow up at week 3 after one-week completion of intervention.

  • Upper trapezius muscle length

    Upper trapezius muscle length was measured using a vernier calliper with the participants seated in a standardized position. The distance between the mastoid process (posterior to the ear) and the acromioclavicular joint (distal end of the clavicle) was considered.

    Once a week for 3 weeks (baseline, week 1 and 2 post-intervention, and follow-up at week 3 after one-week completion of intervention).

Study Arms (2)

MFR Group

EXPERIMENTAL

MFR Group received a 10-minute manual myofascial release (MFR) technique followed by a 5-minute session of high-powered pulsed therapeutic ultrasound (HPPT-US). It was performed three times per week for two weeks.

Other: Myofascial release (MFR)Other: High-powered pulsed therapeutic ultrasound (HPPT-US)

Stretching Group

ACTIVE COMPARATOR

Stretching Group received three 30-second static stretches for the upper trapezius, involving neck side flexion with contralateral rotation, followed by a 5-minute session of HPPT ultrasound. It was performed three times per week for two weeks.

Other: Muscle StretchingOther: High-powered pulsed therapeutic ultrasound (HPPT-US)

Interventions

A 10-minute manual myofascial release (MFR) technique targeting active upper trapezius trigger points (MTrPs), applying sustained pressure until tissue release was achieved.

MFR Group

Three 30-second static muscle stretches were performed for the upper trapezius by placing neck side flexion with contralateral rotation.

Stretching Group

A 5-minute high-powered pulsed therapeutic ultrasound (HPPT) was delivered subcutaneously with specific parameters of 1.5 W/cm², 1 MHz, and pulsed mode.

MFR GroupStretching Group

Eligibility Criteria

Age20 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male athletes
  • Aged between 20-40 years
  • Active MTrPs in the upper trapezius, confirmed via Travell and Simons' (1999) criteria (palpable taut band, spot tenderness, referred pain, and local twitch response);
  • Chronic pain lasting 2-3 months; and
  • Willingness to provide informed consent.

You may not qualify if:

  • Fibromyalgia (per American College of Rheumatology criteria; Wolfe et al., 1990);
  • Recent MTrP injections or physical therapy (within 1 year);
  • Acute trauma or systemic conditions (e.g., inflammatory diseases); and
  • Neurological deficits.
  • Non-willingness to participation or showed non-cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University Hospital

Riyadh, 10219, Saudi Arabia

Location

Related Publications (1)

  • Khan N, Ghai T, Kashyap R, Bhat P, Ahmad F, Iqbal A, Alghadir T, Alghadir F, Anwer S, Alghadir AH. Comparative efficacy of myofascial release versus stretching combined with high-powered pulsed therapeutic ultrasound in amateur overhead athletes with active trapezius trigger point pain: a randomized clinical trial. BMC Sports Sci Med Rehabil. 2025 Dec 17. doi: 10.1186/s13102-025-01474-y. Online ahead of print.

Related Links

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Myofascial Release TherapyMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

May 25, 2025

First Posted

June 3, 2025

Study Start

August 7, 2022

Primary Completion

January 17, 2023

Study Completion

April 27, 2023

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations