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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02924259
Other study ID # No.17-039
Secondary ID
Status Completed
Phase N/A
First received September 30, 2016
Last updated November 30, 2016
Start date September 2016
Est. completion date November 2016

Study information

Verified date November 2016
Source California State University, Dominguez Hills
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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:

1. Pretest measures (subject standing): PPT of the ipsilateral left quadriceps, left hamstring and right quadriceps group (subject is standing during testing)

2. Intervention: 2-minute video-guided foam roll intervention using a rigid foam roller.

3. 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)


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
The GRID foam roll
Commercial rigid foam roll with an outer foam covering

Locations

Country Name City State
United States Cal State University Dominguez Hills Carson California

Sponsors (1)

Lead Sponsor Collaborator
California State University, Dominguez Hills

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline and immediately post intervention No
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