NCT01883895

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 24, 2017

Completed
Last Updated

July 24, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 12, 2013

Results QC Date

May 15, 2017

Last Update Submit

June 23, 2017

Conditions

Keywords

Painexercise-induced hypoalgesia

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity Ratings (0-100 Pain Scale)

    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. Ratings will be recorded at 20 second intervals following each administration of the pressure stimulator for a total of 120 seconds. The ratings will then be averaged over all the time points.

    Average pain rating over 120 seconds

Secondary Outcomes (1)

  • Pain Threshold

    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.

Study Arms (1)

exercise treatment

OTHER

Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise. Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction. Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes. Pain testing conducted by Forgionei-Barber pressure pain-stimulator for both the control and exercise treatments.

Device: Forgionei-Barber pressure-pain stimulatorOther: Concentric ExerciseOther: isometric exercise

Interventions

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. This will be used for both exercise sessions and the control session. Forgionei-Barber pressure-pain stimulator will be used.

exercise treatment

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 Forgionei-Barber pressure-pain stimulator immediately before and after the exercise.

exercise treatment

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 Forgionei-Barber pressure-pain stimulator immediately before and after the exercise.

exercise treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normotensive
  • age range 18 to 40 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Nalini Sehgal
Organization
UW Madison

Study Officials

  • Nalini Sehgal, MD

    University of Wisconsin Dept Ortho/Rehab

    PRINCIPAL INVESTIGATOR
  • ben rawson, DO

    University of Wisconsin Dept Ortho/Rehab

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: three treatment design, all participants will perform two exercise sessions (isometric exercise, concentric exercise), as well as a control session in a randomized manner. (This is not a cross-over design as each participant will have their own randomized order of sessions of exercise \& control sessions.)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 24, 2017

Results First Posted

July 24, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

There is no plan to share the IPD with any other researchers.

Locations