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Effect of Phonophoresis on Trigger Points

Primary Purpose

Trigger Point Pain, Myofascial

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
US with fastum
US with reparil
US with plain gel
Sponsored by
Batterjee Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: upper trapezius trigger point Exclusion Criteria: cervical disc

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    study Fastum

    study Reparil

    Control plain gel

    Arm Description

    participant in this group will receive US with fastum gel

    participant in this group will receive US with reparil gel

    participant in this group will receive US with gel

    Outcomes

    Primary Outcome Measures

    pain intensity
    change of pain intensity by using VAS from 0 to 10
    pain threshold
    change of pain threshold by using PPA
    ROM
    change of ROM by using CROM

    Secondary Outcome Measures

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    July 18, 2023
    Sponsor
    Batterjee Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05925855
    Brief Title
    Effect of Phonophoresis on Trigger Points
    Official Title
    Effect of Phonophoresis on Trigger Points
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Batterjee Medical College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.
    Detailed Description
    participants will be divided into 3 groups, 2 study groups and 1 control group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trigger Point Pain, Myofascial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study Fastum
    Arm Type
    Experimental
    Arm Description
    participant in this group will receive US with fastum gel
    Arm Title
    study Reparil
    Arm Type
    Experimental
    Arm Description
    participant in this group will receive US with reparil gel
    Arm Title
    Control plain gel
    Arm Type
    Active Comparator
    Arm Description
    participant in this group will receive US with gel
    Intervention Type
    Other
    Intervention Name(s)
    US with fastum
    Intervention Description
    apply fastum on trigger point with US
    Intervention Type
    Other
    Intervention Name(s)
    US with reparil
    Intervention Description
    apply reparil on trigger point with US
    Intervention Type
    Other
    Intervention Name(s)
    US with plain gel
    Intervention Description
    apply gel on trigger point with US
    Primary Outcome Measure Information:
    Title
    pain intensity
    Description
    change of pain intensity by using VAS from 0 to 10
    Time Frame
    Two weeks
    Title
    pain threshold
    Description
    change of pain threshold by using PPA
    Time Frame
    two weeks
    Title
    ROM
    Description
    change of ROM by using CROM
    Time Frame
    two weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: upper trapezius trigger point Exclusion Criteria: cervical disc
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reem S Dawood, PhD
    Phone
    +966126562415
    Ext
    1257
    Email
    pt9.jed@bmc.edu.sa
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Osama R Abdelraouf, PhD
    Organizational Affiliation
    Batterjee Medical College
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    all data are secured with principle investigator.

    Learn more about this trial

    Effect of Phonophoresis on Trigger Points

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