An Investigation of Ball Rolling Effects on Trigger Points

The current study aims to examine the potential effects of rolling a Myostorm ball on the trigger points in the upper back muscles.

Study Overview

• Status: Not yet recruiting
• Conditions: Trigger Point Pain, Myofascial
• Intervention / Treatment: Device: ball-rolling (Myostorm ball)

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saman H Anvar; Phone Number: 7092194733; Email: SHADJIZADEHA@MUN.CA
• Study Contact Backup: Name: David Behm; Email: DBEHM@MUN.CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• trigger points on the trapezius muscle

Exclusion Criteria:

• back injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ball rolling; The ball-rolling group will be asked to roll the ball on the trapezius muscle.	Device: ball-rolling (Myostorm ball); the intervention group
No Intervention: Control; The control group with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion before ball rolling	the range of motion in the shoulder joint	3 minutes before the intervention (Ball-rolling)
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.	3 minutes before the intervention (Ball-rolling)
Range of Motion after ball rolling	the range of motion in the shoulder joint	up to 3 minutes after the intervention (Ball-rolling)
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.	up to 3 minutes after the intervention (Ball-rolling)

Collaborators and Investigators

• Sponsor: Memorial University of Newfoundland
• Collaborators: Mitacs

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes
• Other Study ID Numbers: 20211162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No