Trial Outcomes & Findings for Pain Modulatory Profiles in Stretching (NCT NCT05891353)

Last Updated: 2024-12-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Change in PPT is applied between minutes 1 and 4

Results posted on

2024-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study Completed Cold Water Immersion	30
Overall Study Completed Pain Inducing Stretch	29
Overall Study Completed Pain Free Stretch	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain Modulatory Profiles in Stretching

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cold Water Immersion, Pain Inducing Stretch, Pain Free Stretch n=30 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	22.88 years STANDARD_DEVIATION 4.76 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Change in PPT is applied between minutes 1 and 4

Outcome measures

Outcome measures
Measure	Cold Water Immersion, Pain Inducing Stretch, Pain Free Stretch n=30 Participants 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.
Change in Pressure Pain Threshold Pain Inducing Stretch	286.73 kilopascals Standard Deviation 154.48
Change in Pressure Pain Threshold Pain Free Stretch	304.69 kilopascals Standard Deviation 145.05
Change in Pressure Pain Threshold Cold Water Immersion	317.27 kilopascals Standard Deviation 137.27

Adverse Events

Cold Water Immersion, Pain Inducing Stretch, Pain Free Stretch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Abigail Anderson

University of Central Florida

Phone: 4078231026

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place