Pain Modulatory Profiles in Stretching | NCT05891353

NCT05891353

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cold Water Immersion	Active Comparator	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.	Other: Cold Water Immersion
Pain Inducing Stretch	Experimental	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.	Other: Pain Inducing Stretch
Pain Free Stretch	Active Comparator	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.	Other: Pain Free Stretch

Name	Type	Description	Arm Group Labels	Other Names
Cold Water Immersion	Other	Cold Water Immersion task of hand	Cold Water Immersion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Pressure Pain Threshold	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

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Central Florida		Orlando	Florida	32765	United States

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Cold Water Immersion, Pain Inducing Stretch, Pain Free Stretch	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. For the 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. For the 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Cold Water Immersion, Pain Inducing Stretch, Pain Free Stretch	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: Cold Water Immersion task of hand 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. Pain Inducing Stretch: Moderately painful stretch of the neck 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: Pain free stretch of the neck

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Pressure Pain Threshold

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.

Posted

Mean

Standard Deviation

kilopascals

Change in PPT is applied between minutes 1 and 4

ID	Title	Description
OG000	Cold Water Immersion, Pain Inducing Stretch, Pain Free Stretch	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. For the 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. For the 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cold Water Immersion, Pain Inducing Stretch, Pain Free Stretch	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. For the 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. For the 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.