NCT05826834

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

March 23, 2023

Last Update Submit

June 29, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (2)

Ball rolling

EXPERIMENTAL

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

Device: ball-rolling (Myostorm ball)

Control

NO INTERVENTION

The control group with no intervention

Interventions

the intervention group

Ball rolling

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • trigger points on the trapezius muscle

You may not qualify if:

  • back injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Central Study Contacts

Saman H Anvar

CONTACT

David Behm

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 24, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR
Time Frame
Data will be kept for at least five years, as Memorial University's policy on Integrity in Scholarly Research requires.