Exercise-induced Hypoaglesia After Comparative Forms of Exercise

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01883895
First received: June 12, 2013
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

The study involves recording response to discomfort following different forms of exercise. We think that there will be a increased pain tolerance following exercise but are unsure if there will be a difference between exercises.


Condition Intervention
Pain
Device: Forgioni-Barber pressure-pain stimulator
Other: Concentric Exercise
Other: isometric exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise-induced Hypoaglesia After Comparative Forms of Anaerobic Training in Healthy Adults

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Pain intensity ratings [ Time Frame: Ratings will be recorded at 20 second intervals following each administration of the pressure stimulator. ] [ Designated as safety issue: No ]
    Subjects will rate pain intensity using a 0 (no pain) to 100 (most intense pain imaginable) pain rating scale before and after application of a validated pressure stimulator immediately prior to, and after exercise.


Secondary Outcome Measures:
  • Pain Threshold [ Time Frame: We will monitor the subject's reported pain thresholds during the two minute interval that the pressure stimulus is applied. Expected average is less than one minute. ] [ Designated as safety issue: No ]
    Subjects will press a button attached to a timer out of view of the subject when the pressure stimulus first becomes painful. This will utilize a protocol recognized as a validated measurement of pain threshold.


Estimated Enrollment: 32
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concentric exercise
Concentric exercise will utilize a dumbbell with elbow flexion exercise.
Device: Forgioni-Barber pressure-pain stimulator
Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study.
Other: Concentric Exercise
Concentric testing will utilize a dumbbell with elbow flexion exercise. Subjects will perform 5 sets of 20 reps at 30% MVC. Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator immediately before and after the exercise.
Experimental: isometric exercise
Subjects will perform 5 sets of sustained muscle contraction.
Device: Forgioni-Barber pressure-pain stimulator
Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study.
Other: isometric exercise
When undergoing isometric exercise, subjects will perform 5 sets of sustained muscle contraction for 65 seconds using a hand-grip dynamometer. Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator immediately before and after the exercise.
Active Comparator: Control
Subjects will undergo a control arm where they will rest for approximately 10 minutes.
Device: Forgioni-Barber pressure-pain stimulator
Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normotensive
  • age range 18 to 40 years

Exclusion Criteria:

  • currently taking prescription medications
  • current use of tobacco or recreational drugs including opiates and/or marijuana
  • any chronic illness such as diabetes, cancer, fibromyalgia, or hypertension
  • upper limb musculoskeletal pain, injury, or surgery that will limit ability to exercise
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883895

Contacts
Contact: ben rawson, DO 2168498685 rawson.rehab@gmail.com
Contact: nalini sehgal, MD 6082630102 sehgal@rehab.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Hospitals and Clinics Recruiting
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Nalini Sehgal, MD University of Wisconsin Dept Ortho/Rehab
Study Director: ben rawson, DO University of Wisconsin Dept Ortho/Rehab
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01883895     History of Changes
Other Study ID Numbers: 2012-0805
Study First Received: June 12, 2013
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Pain
exercise-induced hypoalgesia

ClinicalTrials.gov processed this record on August 28, 2014