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Exercise Dosing for Pain in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03642938
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Benedict Kolber, 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.

Condition or disease Intervention/treatment Phase
Pain Behavioral: Walking Exercise Behavioral: Control Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Managing Pain: Testing the Dosing and Social Aspects of Exercise Therapy Using a Multi-school Collaborative Approach With Human Participants
Actual Study Start Date : February 11, 2015
Actual Primary Completion Date : June 6, 2017
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose Exercise
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Behavioral: Walking Exercise
Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.

Experimental: Moderate Dose Exercise
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Behavioral: Walking Exercise
Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.

Experimental: High Dose Exercise
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Behavioral: Walking Exercise
Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.

Sham Comparator: Control
The Control group will perform quiet rest, three times per week for one week.
Behavioral: Control
The Control group will perform 30 minutes of quiet rest.




Primary Outcome Measures :
  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 change from baseline to 24 hrs post-intervention will then be calculated.

  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 change from baseline to 24 hrs post-intervention will then be calculated.

  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 change from baseline to 24 hrs post-intervention will then be calculated.

  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 change from baseline to 24 hrs post-intervention will then be calculated.

  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 change from baseline to 24 hrs post-intervention will then be calculated.

  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 change from baseline to 24 hrs post-intervention will then be calculated.

  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 change from baseline to 24 hrs post-intervention will then be calculated.

  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.


Secondary Outcome Measures :
  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 change in heart rate (bpm) from start to end of exercise session will be calculated.

  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 change in RPE from start to end of exercise session will be calculated.

  3. Acute effects of exercise on Constant Heat Pain Intensity [ Time Frame: 5 minutes- and 30 minutes-post exercise session on days 1, 3, and 5 ]
    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 change from baseline across days 1, 3 & 5 at 5 minutes and 30 minutes-post session will then be calculated.

  4. Acute effects of exercise on Constant Heat Pain Unpleasantness [ Time Frame: 5 minutes- and 30 minutes-post exercise session on days 1, 3, and 5 ]
    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 change from baseline across days 1, 3 & 5 at 5 minutes and 30 minutes-post session will then be calculated.

  5. Acute effects of exercise on Radiant Heat Sensitivity [ Time Frame: 5 minutes- and 30 minutes-post exercise session on days 1, 3, and 5 ]
    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 change from baseline across days 1, 3 & 5 at 5 minutes and 30 minutes-post session will then be calculated.

  6. Acute effects of exercise on Radiant Heat Pain [ Time Frame: 5 minutes- and 30 minutes-post exercise session on days 1, 3, and 5 ]
    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 change from baseline across days 1, 3 & 5 at 5 minutes and 30 minutes-post session will then be calculated.

  7. Acute effects of exercise on Pressure Pain Threshold [ Time Frame: 5 minutes- and 30 minutes-post exercise session on days 1, 3, and 5 ]
    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 change from baseline across days 1, 3 & 5 at 5 minutes and 30 minutes-post session will then be calculated.

  8. Acute effects of exercise on Constant Pressure Pain Intensity [ Time Frame: 5 minutes- and 30 minutes-post exercise session on days 1, 3, and 5 ]
    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 change from baseline across days 1, 3 & 5 at 5 minutes and 30 minutes-post session will then be calculated.

  9. Acute effects of exercise on Constant Pressure Pain Unpleasantness [ Time Frame: 5 minutes- and 30 minutes-post exercise session on days 1, 3, and 5 ]
    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 across days 1, 3 & 5 at 5 minutes and 30 minutes-post session will then be calculated.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Between age 18-40
  2. Normal BMI (18.5-25.0)
  3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642938


Locations
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United States, Pennsylvania
Duquesne University
Pittsburgh, Pennsylvania, United States, 15282
Sponsors and Collaborators
Duquesne University
Investigators
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Principal Investigator: Kimberly A Szucs, PhD Duquesne University
Principal Investigator: Amy L Phelps, PhD Duquesne University
Principal Investigator: Matthew C Kostek, PhD Duquesne University
  Study Documents (Full-Text)

Documents provided by Benedict Kolber, Duquesne University:
Study Protocol  [PDF] June 2, 2016
Statistical Analysis Plan  [PDF] February 2, 2018


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Responsible Party: Benedict Kolber, Associate Professor, Duquesne University
ClinicalTrials.gov Identifier: NCT03642938    
Other Study ID Numbers: 2014-04-22
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benedict Kolber, Duquesne University:
Exercise
Dose
Analgesia