Trigger Point Pain, MyofascialNCT05826834
An Investigation of Ball Rolling Effects on Trigger Points
A study testing ball-rolling (Myostorm ball) in people with Trigger Point Pain, Myofascial, run by Memorial University of Newfoundland.
Trial summary
The current study aims to examine the potential effects of rolling a Myostorm ball on the trigger points in the upper back muscles. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- ball-rolling (Myostorm ball)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- trigger points on the trapezius muscle
Who cannot join
- back injury
Trial locations and contacts
No sites are listed yet.
David Behm contact
About this study
The current study aims to examine the potential effects of rolling a Myostorm ball on the trigger points in the upper back muscles.
Read the 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.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- ball-rolling (Myostorm ball)
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ball-rolling (Myostorm ball)Device
the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Ball rolling | Experimental | The ball-rolling group will be asked to roll the ball on the trapezius muscle. Receives: Device: ball-rolling (Myostorm ball) |
| Control | No intervention | The control group with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion before ball rolling
the range of motion in the shoulder joint
Measured: 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.
Measured: 3 minutes before the intervention (Ball-rolling)
Range of Motion after ball rolling
the range of motion in the shoulder joint
Measured: 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.
Measured: up to 3 minutes after the intervention (Ball-rolling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Principal investigator, Saman Anvar, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826834
- Sponsor's protocol ID
- 20211162
- Status last verified
- Jun 2023
- First submitted
- 23 Mar 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Ball Rolling Effects on Trigger Points
- ClinicalTrials.gov ID
- NCT05826834
- Acronym / sponsor ID
- 20211162
- Conditions
- Trigger Point Pain, Myofascial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ball rolling | Experimental | Device: ball-rolling (Myostorm ball)The ball-rolling group will be asked to roll the ball on the trapezius muscle. |
| Control | No intervention | –The control group with no intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- trigger points on the trapezius muscle
Key exclusion criteria (1 listed)
- back injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ball-rolling (Myostorm ball)the intervention group | Device | Ball rolling |
Primary outcome
Range of Motion before ball rolling
Time frame: 3 minutes before the intervention (Ball-rolling)
the range of motion in the shoulder joint
Pain pressure threshold before ball rolling
Time frame: 3 minutes before the intervention (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
Time frame: up to 3 minutes after the intervention (Ball-rolling)
the range of motion in the shoulder joint
Pain pressure threshold after ball rolling
Time frame: up to 3 minutes after the intervention (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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Behm contact
Questions about this trial
What is this clinical trial studying?
A study testing ball-rolling (Myostorm ball) in people with Trigger Point Pain, Myofascial, run by Memorial University of Newfoundland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saman H Anvar (7092194733, SHADJIZADEHA@MUN.CA), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion before ball rolling (time frame: 3 minutes before the intervention (Ball-rolling)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.