Myofascial Pain SyndromesNCT02924259
Does Self-myofascial Release With a Foam Roll Change Pressure Pain Thresholds in Lower Extremity Muscles
A study testing The GRID foam roll in people with Myofascial Pain Syndromes, run by California State University, Dominguez Hills at 1 site in United States.
Trial summary
The purpose of this study was to examine the effects of a foam rolling intervention on pressure pain thresholds (PPT) of the ipsilateral antagonist and contralateral muscle groups. Through this research we sought to gather data to further develop the methodology for future studies of this intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- The GRID foam roll
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Nov 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- Musculoskeletal, systemic, or metabolic disease that would affect lower extremity joint ROM or tolerance to pressure pain threshold testing and the inability to avoid medications that may affect testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cal State University Dominguez Hills
Carson, California, 90747
About this study
Official title: Does Self-myofascial Release With a Foam Roll Change Pressure Pain Threshold of the Ipsilateral Lower Extremity Agonist, Antagonist, and Contralateral Muscle Groups? an Exploratory Study
The purpose of this study was to examine the effects of a foam rolling intervention on pressure pain thresholds (PPT) of the ipsilateral antagonist and contralateral muscle groups. Through this research we sought to gather data to further develop the methodology for future studies of this intervention.
Read the detailed description
To date, no studies have examined how foam rolling effects the PPT of the ipsilateral antagonist and contralateral muscle. There is a gap in the literature regarding our knowledge of the effects of foam rolling on these muscles. This will be the first study to examine the acute effects of a foam rolling intervention on ipsilateral antagonist and contralateral muscle group PPT.
Forty-five (N=45) healthy adults (18-65 years) from California State University Dominguez Hills (CSUDH) will be recruited for this study via convenience sampling. Data collection will take place in the CSUDH sports medicine laboratory. Prior to testing, participants will fill out a screening questionnaire with questions that represent the exclusion criteria which will be used to determine ineligibility for this study.
Prior to participant recruitment and enrollment, a pilot study will be done on 10 participants to establish rater reliability using the methods mentioned below. After acceptable reliability is achieved, recruitment and enrollment will continue.
Participants who meet the inclusion criteria and consent to participate will be enrolled in the study. Participants will read and sign a CSUDH approved consent form prior to beginning data collection. Following consent, participants will also fill out a questionnaire to provide demographic information which includes age, height, and weight.
Following completion of the paperwork, all participants will undergo testing which will be conducted between the hours of 10am and 2pm. Each data collection session will last for approximately 10 minutes. Pressure pain threshold (PPT) will be measured using a digital algometer on the ipsilateral left quadriceps, left hamstring, and right quadriceps muscle group. All subjects will follow a 2-minute video-guided foam roll intervention on the left quadriceps using a rigid foam roll with outer foam covering. The data collection process is as follows:
- Pretest measures (subject standing): PPT of the ipsilateral left quadriceps, left hamstring and right quadriceps group (subject is standing during testing)
- Intervention: 2-minute video-guided foam roll intervention using a rigid foam roller.
- Posttest measures (subject standing): PPT of the ipsilateral left quadriceps, left hamstring, and right quadriceps group.
Collected data will be transferred to SPSS v.22 (IBM SPSS, Chicago, IL). Means,standard deviations, 95% confidence intervals (95% CI), and ranges for participant descriptive data will be calculated. Pressure pain threshold pretest and posttest differences will be calculated using the paired t-test The p-value will be considered significant at the .05 level using a two-tailed test (α2 =.05)
- Conditions
- Myofascial Pain Syndromes
- Being tested
- The GRID foam roll
- Keywords
- muscle soreness, pain, myofascial release
- Medical subject headings
- Myofascial Pain Syndromes, Myalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The GRID foam rollDevice
Commercial rigid foam roll with an outer foam covering
| Study group | Role | What they receive |
|---|---|---|
| Foam Roll Group | Experimental | Subjects will undergo a 2-minute video-guided foam roll intervention on the left quadriceps muscle using the GRID foam roll. Receives: Device: The GRID foam roll |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pressure pain threshold to immediate post intervention.
Pressure pain threshold will be tested immediately before the intervention and immediately after the intervention on the left hamstring and right quadriceps muscle groups.
Measured: baseline and immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Dominguez Hills
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Cheatham, California State University, Dominguez Hills
- Investigators
- Scott W Cheatham, PhD, DPT, Principal investigator, CSUDH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924259
- Sponsor's protocol ID
- No.17-039
- Status last verified
- Nov 2016
- First submitted
- 30 Sep 2016
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Self-myofascial Release With a Foam Roll Change Pressure Pain Threshold of the Ipsilateral Lower Extremity Agonist, Antagonist, and Contralateral Muscle Groups? an Exploratory Study
- ClinicalTrials.gov ID
- NCT02924259
- Acronym / sponsor ID
- No.17-039
- Conditions
- Myofascial Pain Syndromes
- Keywords
- muscle soreness, pain, myofascial release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- California State University, Dominguez HillsUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Oct 2016 (estimated)
- 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 purpose of this study was to examine the effects of a foam rolling intervention on pressure pain thresholds (PPT) of the ipsilateral antagonist and contralateral muscle groups. Through this research we sought to gather data to further develop the methodology for future studies of this intervention.
Detailed description
To date, no studies have examined how foam rolling effects the PPT of the ipsilateral antagonist and contralateral muscle. There is a gap in the literature regarding our knowledge of the effects of foam rolling on these muscles. This will be the first study to examine the acute effects of a foam rolling intervention on ipsilateral antagonist and contralateral muscle group PPT.
Forty-five (N=45) healthy adults (18-65 years) from California State University Dominguez Hills (CSUDH) will be recruited for this study via convenience sampling. Data collection will take place in the CSUDH sports medicine laboratory. Prior to testing, participants will fill out a screening questionnaire with questions that represent the exclusion criteria which will be used to determine ineligibility for this study.
Prior to participant recruitment and enrollment, a pilot study will be done on 10 participants to establish rater reliability using the methods mentioned below. After acceptable reliability is achieved, recruitment and enrollment will continue.
Participants who meet the inclusion criteria and consent to participate will be enrolled in the study. Participants will read and sign a CSUDH approved consent form prior to beginning data collection. Following consent, participants will also fill out a questionnaire to provide demographic information which includes age, height, and weight.
Following completion of the paperwork, all participants will undergo testing which will be conducted between the hours of 10am and 2pm. Each data collection session will last for approximately 10 minutes. Pressure pain threshold (PPT) will be measured using a digital algometer on the ipsilateral left quadriceps, left hamstring, and right quadriceps muscle group. All subjects will follow a 2-minute video-guided foam roll intervention on the left quadriceps using a rigid foam roll with outer foam covering. The data collection process is as follows:
- Pretest measures (subject standing): PPT of the ipsilateral left quadriceps, left hamstring and right quadriceps group (subject is standing during testing)
- Intervention: 2-minute video-guided foam roll intervention using a rigid foam roller.
- Posttest measures (subject standing): PPT of the ipsilateral left quadriceps, left hamstring, and right quadriceps group.
Collected data will be transferred to SPSS v.22 (IBM SPSS, Chicago, IL). Means,standard deviations, 95% confidence intervals (95% CI), and ranges for participant descriptive data will be calculated. Pressure pain threshold pretest and posttest differences will be calculated using the paired t-test The p-value will be considered significant at the .05 level using a two-tailed test (α2 =.05)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foam Roll Group | Experimental | Device: The GRID foam rollSubjects will undergo a 2-minute video-guided foam roll intervention on the left quadriceps muscle using the GRID foam roll. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (1 listed)
- Musculoskeletal, systemic, or metabolic disease that would affect lower extremity joint ROM or tolerance to pressure pain threshold testing and the inability to avoid medications that may affect testing.
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 |
|---|---|---|
| The GRID foam rollCommercial rigid foam roll with an outer foam covering | Device | Foam Roll Group |
Primary outcome
Change from baseline pressure pain threshold to immediate post intervention.
Time frame: baseline and immediately post intervention
Pressure pain threshold will be tested immediately before the intervention and immediately after the intervention on the left hamstring and right quadriceps muscle groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Scott W Cheatham, PhD, DPT principal investigator
CSUDH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The GRID foam roll in people with Myofascial Pain Syndromes, run by California State University, Dominguez Hills at 1 site in United States.
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: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pressure pain threshold to immediate post intervention. (time frame: baseline and immediately post intervention). 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 1 Dec 2016.