NCT05891353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

May 22, 2023

Results QC Date

August 26, 2024

Last Update Submit

October 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Interventions

Cold Water Immersion task of hand

Cold Water Immersion

Moderately painful stretch of the neck

Pain Inducing Stretch

Pain free stretch of the neck

Pain Free Stretch

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pain Free

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32765, United States

Location

Results Point of Contact

Title
Abigail Anderson
Organization
University of Central Florida

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 6, 2023

Study Start

June 20, 2023

Primary Completion

September 27, 2023

Study Completion

September 27, 2023

Last Updated

December 16, 2024

Results First Posted

December 16, 2024

Record last verified: 2024-10

Locations