NCT05925855

Brief Summary

purpose of this study was to investigate the effects of phonophoresis with fastum gel versus reparil gel on pain intensity, pain threshold, and cervical ROM of participant with trigger point of upper trapezius.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

First Submitted

Initial submission to the registry

June 13, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 24, 2026

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

June 13, 2023

Last Update Submit

February 23, 2026

Conditions

Trigger Point Pain, Myofascial

Outcome Measures

Primary Outcomes (4)

  • pain intensity

    change of pain intensity by using VAS from 0 to 10

    Two weeks and 3 months follow up

  • pain threshold

    change of pain threshold by using PPA

    two weeks and 3 months follow up

  • ROM

    change of ROM by using CROM

    two weeks and 3 months follow up

  • neck function

    change of neck function by using Neck Disability Index (NDI) questionnaire

    Two weeks and 3 months follow up

Study Arms (3)

study Fastum

EXPERIMENTAL

participant in this group will receive US with fastum gel

Other: US with fastum

study Reparil

EXPERIMENTAL

participant in this group will receive US with reparil gel

Other: US with reparil

Control plain gel

ACTIVE COMPARATOR

participant in this group will receive US with gel

Other: US with plain gel

Interventions

US with fastumOTHER

apply fastum on trigger point with US

study Fastum
US with reparilOTHER

apply reparil on trigger point with US

study Reparil
US with plain gelOTHER

apply gel on trigger point with US

Control plain gel

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • upper trapezius trigger point

You may not qualify if:

  • cervical disc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batterjee Medical College

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

ketoprofen topical gelEscin

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pentacyclic TriterpenesTriterpenesTerpenesHydrocarbonsOrganic ChemicalsSaponinsGlycosidesCarbohydrates

Study Officials

  • Osama R Abdelraouf, PhD

    Batterjee Medical College

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 29, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2023

Study Completion

December 30, 2023

Last Updated

February 24, 2026

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

all data are secured with principle investigator.

Locations

SA(1)