Exercise Dosing for Pain in Healthy Participants

NCT03642938 | Completed Results

• 2 other identifiers: 2014-04-22UL1TR001857
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Exercise; Dose; Analgesia

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Heart Rate

  days 1, 3, & 5 at start and end of each exercise session

• Borg Rate of Perceived Exertion (RPE)

  days 1, 3, & 5 at start and end of each exercise session

Study Arms (4)

Low Dose Exercise

EXPERIMENTAL

The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.

Behavioral: Walking Exercise

Moderate Dose Exercise

EXPERIMENTAL

The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.

Behavioral: Walking Exercise

High Dose Exercise

EXPERIMENTAL

The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.

Behavioral: Walking Exercise

Control

SHAM COMPARATOR

The Control group will perform quiet rest, three times per week for one week.

Behavioral: Control

Interventions

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.

High Dose Exercise; Low Dose Exercise; Moderate Dose Exercise

Control BEHAVIORAL

The Control group will perform 30 minutes of quiet rest.

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duquesne University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

Related 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.

  PMID: 31619738 RESULT

MeSH Terms

Conditions

Pain; Motor Activity; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Benedict Kolber
• Organization: Duquesne University (now at University of Texas at Dallas)

Benedict.kolber@utdallas.edu

972-883-7225

Study Officials

• Kimberly A Szucs, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

• Amy L Phelps, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

• Matthew C Kostek, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pseudo-randomized controlled trial

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 22, 2018
• Study Start: February 11, 2015
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)