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Completed

NCT Number: NCT03642938

Exercise Dosing for Pain in Healthy Participants

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age <18 or >40 years
  • Cardiac, respiratory, neurological or musculoskeletal disease
  • Acute pain
  • Chronic pain condition
  • Diabetes
  • BMI ≥ 25.1 or ≤ 18.4
  • Regular participation in high intensity athletic/sporting activities
  • Sedentary
  • Anxiety or depression disorders
  • Tape allergy
  • Currently pregnant

Treatment and study plan

Walking exercise

Behavioral

Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.

Control

Behavioral

The Control group will perform 30 minutes of quiet rest.

Primary outcomes

  1. Intervention Effects on Mechanical Sensitivity Threshold

    Time frame: 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.

  2. Intervention Effects on Constant Heat Pain Intensity

    Time frame: 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).

  3. Intervention Effects on Constant Heat Pain Unpleasantness

    Time frame: 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).

  4. Intervention Effects on Radiant Heat Sensitivity

    Time frame: 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).

  5. Intervention Effects on Radiant Heat Pain

    Time frame: 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).

  6. Intervention Effects on Pressure Pain Threshold

    Time frame: 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).

  7. Intervention Effects on Constant Pressure Pain Intensity

    Time frame: 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).

  8. Intervention Effects on Constant Pressure Pain Unpleasantness

    Time frame: 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 outcomes

  1. Heart Rate

    Time frame: 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).

  2. Borg Rate of Perceived Exertion (RPE)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

The Dosing of Aerobic Exercise Therapy on Experimentally-induced Pain in Healthy Female Participants.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2018
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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