Education Time Influence on Exercise-Induced Hypoalgesia

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.

Study Overview

• Status: Completed
• Conditions: Exercise
• Intervention / Treatment: Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Vermillion, South Dakota, United States, 57069
      • University of South Dakota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Short education; Individuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia	Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise; Educational session with participants
Active Comparator: Long education; Individuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia	Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise; Educational session with participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain pressure threshold	algometry measurement	3 minutes post exercise

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge and Beliefs about Exercise and pain questionnaire	paper questionnaire	3 minutes post exercise

Collaborators and Investigators

• Sponsor: University of South Dakota
• Investigators: Principal Investigator: Kory Zimney, DPT, PT, University of South Dakota

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Education; Exercise induced hypoalgesia
• Other Study ID Numbers: USouthDakota

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: upon request
• IPD Sharing Time Frame: Upon completion of study for 3 years after closing study.
• IPD Sharing Access Criteria: email PI at kory.zimney@usd.edu for data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No