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ExerciseNCT05658224

Education Time Influence on Exercise-Induced Hypoalgesia

A study testing Education on effects of Exercise-induced hypoalgesia from exercise in people with Exercise, run by University of South Dakota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We will investigate the effects of the length of education on exercise-induced hypoalgesia (EIH). Two previous studies have shown that positive education about the effects of exercise and the phenomena of EIH produce enhancements to EIH response (having decreased reports of pain with exercise). Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Exercise
What is being tested?
Education on effects of Exercise-induced hypoalgesia from exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Nov 2022to 1 May 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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to read and understand English,
  • Refrained from alcohol, pain medication, and vigorous exercise for the past 24 hours,
  • No history of chronic pain (pain > 3 months), or current pain/injury that would prevent the ability to do exercise.

Who cannot join

  • unable to meet screening questions for PAR-Q+ for safe exercise

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of South Dakota

    Vermillion, South Dakota, 57069

Other trials in United States

About this study

We will investigate the effects of the length of education on exercise-induced hypoalgesia (EIH). Two previous studies have shown that positive education about the effects of exercise and the phenomena of EIH produce enhancements to EIH response (having decreased reports of pain with exercise). These previous studies used different amounts of education time, this study will compare directly if the length of education time varies the effects on EIH.

Read the detailed description

The use of fliers will be posted on USD campus explaining study and the need for volunteers. Potential volunteers will contact study personal listed on the flier to set up potential time for study enrollment. When the prospective participant arrives, they will be provided a hard copy of informed consent and study personnel will be available to answer questions. If the participant consents and signs, they will then be screened to ensure inclusion/exclusion by answering screening questions.

Once they have consented and met study inclusion/exclusion the participants will then be randomized into 1 of 2 groups by picking a number out of an envelope. Group 1 will receive a more extensive education session (10-15 min) on the benefits of exercise and EIH. Group 2 will receive a brief education session (1 minute) on the benefits of exercise and EIH. Next participants will complete basic demographic information: age, gender, history of injuries, athletic participation history, and Knowledge and Beliefs about Exercise and Pain Questionnaire (questions 1 -4).

Then they will be introduced and tested for pain pressure threshold (PPT). This standard measurement assesses the threshold when a pressure applied to the body passes from pressure to pain. A PPT algometer with a 1 cm tip is used to apply pressure to a body part slowly. When the participant first feels the sensation of pain, the pressure being applied is stopped and the amount of force is recorded as the individual's PPT. The participant will initially be introduced to the testing at the web space of the thumb and index finger on their dominant hand, this is done 3 times with minimum 15 seconds between each measurement and the average of the 3 measurements is used.

Participants then will receive the education about EIH depending on their group allocation last 1 minute or 10-15 minutes. After the education, the participants will be asked question #5 on the Knowledge and Beliefs about exercise and pain questionnaire. Both groups will be shown a picture of the exercise (wall squat) that they will perform and provided instruction on the exercise before they begin. The wall squat exercise will consist of standing upright with their back against the wall with feet 45 cm from the wall, feet parallel and shoulder width apart, and hands at their side. They will slide down the wall bending at the hips and knees, keeping their back against the wall and feet in place until their knee joint angle reaches 100 degrees of flexion measured by the study personnel. All participants are asked to maintain the position for 3 minutes or until fatigued and need to stop.

Prior to beginning the wall squat exercise, participants are asked to rate the intensity of pain in their legs using the Numeric Rating Scale (NRS=0-10, 0=no pain, 10=worst imaginable pain). Pain Pressure Threshold will be measured on the dominant quadriceps muscle and the non-dominate upper trapezius muscle. During the exercise, the NRS and category-ration scale of Rating of Perceived Exertion (CR 10, 0=nothing at all, 10=extremely strong) will be measured while performing the exercise at 1 minute, 2 minutes, and 3 minutes. Immediately post-exercise, Pain Pressure Threshold will be measured again on the dominant quadriceps muscle and the non-dominate upper trapezius muscle. The participants will also be asked to assess exercise expectations on EIH immediately post-exercise.

Conditions
Exercise
Being tested
Education on effects of Exercise-induced hypoalgesia from exercise
Keywords
Exercise induced hypoalgesia, Education
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education on effects of Exercise-induced hypoalgesia from exerciseBehavioural

    Educational session with participants

Study groups in NCT05658224
Study groupRoleWhat they receive
Short educationActive comparatorIndividuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia
Receives: Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise
Long educationActive comparatorIndividuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia
Receives: Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Pressure Threshold

    Measurement in kg/cm2, higher score is better outcome

    Measured: 3 minutes post exercise on Day following educational session and exercise

Secondary outcomes (1)
  1. Knowledge and Beliefs About Exercise and Pain Questionnaire

    paper questionnaire on Likert scale 1 strongly disagree, 5 strongly agree. higher number indicates more knowledge.

    Measured: 3 minutes post exercise on Day following educational session and exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start1 Nov 2022
  3. Primary completion15 Feb 2023
  4. Study completion1 May 2023

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658224
Sponsor's protocol ID
USouthDakota
Status last verified
Nov 2024
First submitted
30 Nov 2022
Last updated
9 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: upon request

Questions about this trial

What is this clinical trial studying?

A study testing Education on effects of Exercise-induced hypoalgesia from exercise in people with Exercise, run by University of South Dakota 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 3 inclusion and 1 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 9 Jan 2025. 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 9 Jan 2025). 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?

Pain Pressure Threshold (time frame: 3 minutes post exercise on Day following educational session and exercise). 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 9 Jan 2025.

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