- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924259
Does Self-myofascial Release With a Foam Roll Change Pressure Pain Thresholds in Lower Extremity Muscles
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Carson, California, United States, 90747
- Cal State University Dominguez Hills
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Foam Roll Group
Subjects will undergo a 2-minute video-guided foam roll intervention on the left quadriceps muscle using the GRID foam roll.
|
Commercial rigid foam roll with an outer foam covering
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline and immediately post intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Scott W Cheatham, PhD, DPT, CSUDH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No.17-039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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