HealthyNCT05891353
Pain Modulatory Profiles in Stretching
A study testing Cold Water Immersion, Pain Inducing Stretch and Pain Free Stretch in people with Healthy, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cold Water Immersion, Pain Inducing Stretch and Pain Free Stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pain Free
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32765
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Cold Water Immersion, Pain Inducing Stretch, Pain Free Stretch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Water ImmersionOther
Cold Water Immersion task of hand
Pain Inducing StretchOther
Moderately painful stretch of the neck
Pain Free StretchOther
Pain free stretch of the neck
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Pain Free Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in PPT is applied between minutes 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start20 Jun 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Wilson, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891353
- Sponsor's protocol ID
- 4
- Status last verified
- Oct 2024
- First submitted
- 22 May 2023
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Modulatory Profiles in Stretching in Healthy Participants
- ClinicalTrials.gov ID
- NCT05891353
- Acronym / sponsor ID
- 4
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 6 Jun 2023 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cold Water Immersion | Active comparator | Other: Cold Water ImmersionParticipants 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. |
| Pain Inducing Stretch | Experimental | Other: Pain Inducing StretchParticipants 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 Free Stretch | Active comparator | Other: Pain Free StretchParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pain Free
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Water ImmersionCold Water Immersion task of hand | Other | Cold Water Immersion |
| Pain Inducing StretchModerately painful stretch of the neck | Other | Pain Inducing Stretch |
| Pain Free StretchPain free stretch of the neck | Other | Pain Free Stretch |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Water Immersion, Pain Inducing Stretch and Pain Free Stretch in people with Healthy, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pressure Pain Threshold (time frame: Change in PPT is applied between minutes 1 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.