Exercise Dosing for Pain in Healthy Participants

Not Applicable

Completed

• Conditions: Pain
• Interventions: Behavioral: Walking Exercise; Behavioral: Control

• Registration Number: NCT03642938
• Lead Sponsor: Duquesne University

Brief Summary

In this study investigators will examine the effect of dose related to exercise therapy for pain in healthy adult humans. An acute pain model will be employed to study the effect of exercise dose on pain. Acute pain models are currently used to study pain (both acute and chronic) in human samples as there is currently no chronic pain model.

Detailed Description

This study is designed as a randomized controlled trial with repeated measures. The effect of exercise dose on pain: subjects will be randomly assigned to one of four exercise groups: 1.) no exercise (control); 2.) low dose exercise (3x/week); 3.) moderate dose exercise (5x/week). 4.) high dose exercise (10x/week).

Study Timeline

• Study Start: 2015-02-11
• Primary Completion: 2017-06-06
• Study Completion: 2017-06-06
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Results First Submitted: 2021-04-02
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Results First Posted: 2023-08-02
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Between age 18-40
2. Normal BMI (18.5-25.0)
3. Heart Rate (HR) 60-100 bmp
4. BP less than or equal to 140/90

Exclusion Criteria

1. Age <18 or >40 years
2. Cardiac, respiratory, neurological or musculoskeletal disease
3. Acute pain
4. Chronic pain condition
5. Diabetes
6. BMI ≥ 25.1 or ≤ 18.4
7. Regular participation in high intensity athletic/sporting activities
8. Sedentary
9. Anxiety or depression disorders
10. Tape allergy
11. Currently pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Exercise	Walking Exercise	The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
High Dose Exercise	Walking Exercise	The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Control	Control	The Control group will perform quiet rest, three times per week for one week.
Moderate Dose Exercise	Walking Exercise	The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.

Primary Outcome Measures

Name	Time	Method
Intervention Effects on Constant Heat Pain Unpleasantness	baseline and 24 hrs-post final intervention session	Subjects' constant heat pain unpleasantness rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Mechanical Sensitivity Threshold	baseline and 24 hrs-post final intervention session	Subjects' cutaneous mechanical sensitivity threshold will be examined using standard monofilaments that apply a force of 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g and 1.0g to the forearm and calf. Percent Baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline). A filament of different weight is applied to the skin to look at the threshold of response.
Intervention Effects on Constant Heat Pain Intensity	baseline and 24 hrs-post final intervention session	Subjects' constant heat pain intensity rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Radiant Heat Sensitivity	baseline and 24 hrs-post final intervention session	Subjects' radiant heat sensitivity will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 60 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "sensitivity threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Pressure Pain Threshold	baseline and 24 hrs-post final intervention session	Subjects' pressure pain threshold will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied at constant ramping pressure until participant defined cutoff in kg at "pain threshold"). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Constant Pressure Pain Intensity	baseline and 24 hrs-post final intervention session	Subjects' constant pressure pain intensity rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Radiant Heat Pain	baseline and 24 hrs-post final intervention session	Subjects' radiant heat pain threshold will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 20 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "pain threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Constant Pressure Pain Unpleasantness	baseline and 24 hrs-post final intervention session	Subjects' constant pressure pain unpleasantness rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score).This will be assessed on the forearm and calf. Percent change from baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).

Secondary Outcome Measures

Name	Time	Method
Borg Rate of Perceived Exertion (RPE)	days 1, 3, & 5 at start and end of each exercise session	Subjects will indicate rate of perceived exertion before and after each exercise session. Percent of pre-exercise RPE from start to end of exercise session will be calculated (100\* end of trial / start of trial).
Heart Rate	days 1, 3, & 5 at start and end of each exercise session	Heart rate will be measured before and after each exercise session. Percent pre-exercise session in heart rate (bpm) from start to end of exercise session will be calculated (100\*Value at end trial/Value at start of trial).

Trial Locations

Locations (1)

Duquesne University; 🇺🇸 Pittsburgh, Pennsylvania, United States