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An Investigation of Ball Rolling Effects on Trigger Points

Primary Purpose

Trigger Point Pain, Myofascial

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ball-rolling (Myostorm ball)
Sponsored by
Memorial University of Newfoundland
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 - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: trigger points on the trapezius muscle Exclusion Criteria: back injury

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Ball rolling

    Control

    Arm Description

    The ball-rolling group will be asked to roll the ball on the trapezius muscle.

    The control group with no intervention

    Outcomes

    Primary Outcome Measures

    Range of Motion before ball rolling
    the range of motion in the shoulder joint
    Pain pressure threshold before ball rolling
    the measurement of the pain pressure threshold on the trapezius muscle using Lafayette Muscle Tester; A hand-held algometer will be applied on the participant's skin and an incremental pressure will be applied until the participant notify the experimenter to stop. The pain pressure threshold will be reported in kilogram/cm2.
    Range of Motion after ball rolling
    the range of motion in the shoulder joint
    Pain pressure threshold after ball rolling
    the measurement of the pain pressure threshold on the trapezius muscle using Lafayette Muscle Tester; A hand-held algometer will be applied on the participant's skin and an incremental pressure will be applied until the participant notify the experimenter to stop. The pain pressure threshold will be reported in kilogram/cm2.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2023
    Last Updated
    June 29, 2023
    Sponsor
    Memorial University of Newfoundland
    Collaborators
    Mitacs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05826834
    Brief Title
    An Investigation of Ball Rolling Effects on Trigger Points
    Official Title
    An Investigation of Ball Rolling Effects on Trigger Points
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Memorial University of Newfoundland
    Collaborators
    Mitacs

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The current study aims to examine the potential effects of rolling a Myostorm ball on the trigger points in the upper back muscles.
    Detailed Description
    The investigators will ask the participants to attend the laboratory in two sessions. They will seek the tender spots on the trapezius muscle. Then the participants will be asked to roll a Myostorm ball ( a small hard ball made of plastic with a layer of soft material cover) on their affected muscles. They will be tested for pain-pressure threshold (PPT), shoulder range of motion, electromyography (EMG), and force before and after the manipulation.

    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
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ball rolling
    Arm Type
    Experimental
    Arm Description
    The ball-rolling group will be asked to roll the ball on the trapezius muscle.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group with no intervention
    Intervention Type
    Device
    Intervention Name(s)
    ball-rolling (Myostorm ball)
    Intervention Description
    the intervention group
    Primary Outcome Measure Information:
    Title
    Range of Motion before ball rolling
    Description
    the range of motion in the shoulder joint
    Time Frame
    3 minutes before the intervention (Ball-rolling)
    Title
    Pain pressure threshold before ball rolling
    Description
    the measurement of the pain pressure threshold on the trapezius muscle using Lafayette Muscle Tester; A hand-held algometer will be applied on the participant's skin and an incremental pressure will be applied until the participant notify the experimenter to stop. The pain pressure threshold will be reported in kilogram/cm2.
    Time Frame
    3 minutes before the intervention (Ball-rolling)
    Title
    Range of Motion after ball rolling
    Description
    the range of motion in the shoulder joint
    Time Frame
    up to 3 minutes after the intervention (Ball-rolling)
    Title
    Pain pressure threshold after ball rolling
    Description
    the measurement of the pain pressure threshold on the trapezius muscle using Lafayette Muscle Tester; A hand-held algometer will be applied on the participant's skin and an incremental pressure will be applied until the participant notify the experimenter to stop. The pain pressure threshold will be reported in kilogram/cm2.
    Time Frame
    up to 3 minutes after the intervention (Ball-rolling)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: trigger points on the trapezius muscle Exclusion Criteria: back injury
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Saman H Anvar
    Phone
    7092194733
    Email
    SHADJIZADEHA@MUN.CA
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Behm
    Email
    DBEHM@MUN.CA

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The data will be kept confidential, and the participant codes will be used to link individual data across the experiment sessions. Data will be stored physically and digitally in Dr. Behm's office. Every reasonable effort will be made to ensure the participants' anonymity. They will not be identified in publications without their explicit permission. All data will be collected independently and kept confidential. All data will be stored in hardcopy and password-protected digital copy in Dr. David Behm's office at the Memorial University of Newfoundland. Consent forms will be stored separately from participant data in a locked cabinet in Dr. David Behm's office. Data access will be limited only to our research team members. Data potentially may be published in an online journal article. Published data will contain no personally identifying information.
    IPD Sharing Time Frame
    Data will be kept for at least five years, as Memorial University's policy on Integrity in Scholarly Research requires.

    Learn more about this trial

    An Investigation of Ball Rolling Effects on Trigger Points

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