Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05658224 |
| Other study ID # |
USouthDakota |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
May 1, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of South Dakota |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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). 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.
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.
