- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05891353
Pain Modulatory Profiles in Stretching
October 31, 2024 updated by: Abigail Wilson, University of Central Florida
Pain Modulatory Profiles in Stretching in Healthy Participants
The purpose of this study is to characterize immediate changes in pain sensitivity during stretching to the point of pain, stretching in a pain free range, and a cold water immersion task.
Participants will attend three sessions during which they will undergo pain sensitivity assessment and complete the assigned intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32765
- University of Central Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pain Free
Exclusion Criteria:
- Non-English speaking
- Regular use of prescription pain medications
- Current or history of chronic pain condition
- Currently taking blood-thinning medication
- Any blood clotting disorder, such as hemophilia
- Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
- Any contraindication to the application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
- Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
- Surgery, injury, or fracture to the neck or upper extremity within the past 6 months
- Unable to perform the stretch
- Unable to attend all three sessions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cold Water Immersion
Participants will complete a cold water immersion task to the hand for one minute, four times.
Change in Pressure Pain Threshold will be measured between each one-minute interval on the web space of the foot between the first and second toes.
|
Cold Water Immersion task of hand
|
|
Experimental: Pain Inducing Stretch
Participants will be seated in a chair and asked to complete an upper trapezius stretch.
They will feel a gentle stretch in the area between the top of their shoulder and the base of their neck.
Participants will be asked to stretch until the point of pain.
They will hold this stretch for 1 minute, 4 times.
Change in Pressure Pain Threshold will be examined on the web space of their foot between each one minute interval of the stretch.
Participants will be notified that they may stop the stretch at any point if needed.
|
Moderately painful stretch of the neck
|
|
Active Comparator: Pain Free Stretch
Participants will be seated in a chair and asked to complete an upper trapezius stretch.
They will feel a gentle stretch in the area between the top of their shoulder and the base of their neck.
Participants will be asked to stretch in a pain free range.
They will hold this stretch for 1 minute, 4 times.
Change in Pressure Pain Threshold will be examined on the web space of their foot between each one minute interval of the stretch.
Participants will be notified that they may stop the stretch at any point if needed.
|
Pain free stretch of the neck
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pressure Pain Threshold
Time Frame: Change in PPT is applied between minutes 1 and 4
|
A pressure algometer will be applied between the first and second toe until the pressure sensation first becomes painful.
Pressure pain threshold is applied between each one minute interval of the intervention.
|
Change in PPT is applied between minutes 1 and 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2023
Primary Completion (Actual)
September 27, 2023
Study Completion (Actual)
September 27, 2023
Study Registration Dates
First Submitted
May 22, 2023
First Submitted That Met QC Criteria
June 5, 2023
First Posted (Actual)
June 6, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
October 31, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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