- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925855
Effect of Phonophoresis on Trigger Points
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
participants will be divided into 3 groups, 2 study groups and 1 control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jeddah, Saudi Arabia
- Batterjee Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- upper trapezius trigger point
Exclusion Criteria:
- cervical disc
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study Fastum
participant in this group will receive US with fastum gel |
apply fastum on trigger point with US |
|
Experimental: study Reparil
participant in this group will receive US with reparil gel |
apply reparil on trigger point with US |
|
Active Comparator: Control plain gel
participant in this group will receive US with gel |
apply gel on trigger point with US |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: Two weeks and 3 months follow up
|
change of pain intensity by using VAS from 0 to 10 |
Two weeks and 3 months follow up
|
|
pain threshold
Time Frame: two weeks and 3 months follow up
|
change of pain threshold by using PPA |
two weeks and 3 months follow up
|
|
ROM
Time Frame: two weeks and 3 months follow up
|
change of ROM by using CROM |
two weeks and 3 months follow up
|
|
neck function
Time Frame: Two weeks and 3 months follow up
|
change of neck function by using Neck Disability Index (NDI) questionnaire |
Two weeks and 3 months follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Osama R Abdelraouf, PhD, Batterjee Medical College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Phonophoresis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
all data are secured with principle investigator.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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