Exercise Dosing for Pain in Healthy Participants

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642938
• Other study ID #: 2014-04-22
• Secondary ID: UL1TR001857
• Status: Completed
• Phase: N/A
• Start date: February 11, 2015
• Est. completion date: June 6, 2017

Study information

• Verified date: July 2023
• Source: Duquesne University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 6, 2017
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• Control
The Control group will perform 30 minutes of quiet rest.

Locations

Country	Name	City	State
United States	Duquesne University	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duquesne University	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Polaski AM, Phelps AL, Szucs KA, Ramsey AM, Kostek MC, Kolber BJ. The dosing of aerobic exercise therapy on experimentally-induced pain in healthy female participants. Sci Rep. 2019 Oct 16;9(1):14842. doi: 10.1038/s41598-019-51247-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Effects on Mechanical Sensitivity Threshold	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.	baseline and 24 hrs-post final intervention session
Primary	Intervention Effects on Constant Heat Pain Intensity	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).	baseline and 24 hrs-post final intervention session
Primary	Intervention Effects on Constant Heat Pain Unpleasantness	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).	baseline and 24 hrs-post final intervention session
Primary	Intervention Effects on Radiant Heat Sensitivity	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).	baseline and 24 hrs-post final intervention session
Primary	Intervention Effects on Radiant Heat Pain	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).	baseline and 24 hrs-post final intervention session
Primary	Intervention Effects on Pressure Pain Threshold	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).	baseline and 24 hrs-post final intervention session
Primary	Intervention Effects on Constant Pressure Pain Intensity	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).	baseline and 24 hrs-post final intervention session
Primary	Intervention Effects on Constant Pressure Pain Unpleasantness	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).	baseline and 24 hrs-post final intervention session
Secondary	Heart Rate	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).	days 1, 3, & 5 at start and end of each exercise session
Secondary	Borg Rate of Perceived Exertion (RPE)	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).	days 1, 3, & 5 at start and end of each exercise session