Trial Outcomes & Findings for Exercise-induced Hypoalgesia After Comparative Forms of Exercise (NCT NCT01883895)

Last Updated: 2017-07-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Average pain rating over 120 seconds

Results posted on

2017-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise Treatment Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,. 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. .
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Exercise Treatment Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,. 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. .
Overall Study Lost to Follow-up	2

Baseline Characteristics

one subject did not complete and not included in analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Treatment n=33 Participants Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,. 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. .
Age, Categorical <=18 years	0 Participants n=32 Participants • one subject did not complete and not included in analysis
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants • one subject did not complete and not included in analysis
Age, Categorical >=65 years	0 Participants n=32 Participants • one subject did not complete and not included in analysis
Age, Continuous	25.4 years STANDARD_DEVIATION 4.2 • n=33 Participants
Sex: Female, Male Female	16 Participants n=32 Participants • one subject did not complete and not included in analysis
Sex: Female, Male Male	16 Participants n=32 Participants • one subject did not complete and not included in analysis
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=32 Participants • one subject did not complete and not included in analysis
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=32 Participants • one subject did not complete and not included in analysis
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants • one subject did not complete and not included in analysis
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=32 Participants • one subject did not complete and not included in analysis
Race (NIH/OMB) Asian	4 Participants n=32 Participants • one subject did not complete and not included in analysis
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=32 Participants • one subject did not complete and not included in analysis
Race (NIH/OMB) Black or African American	1 Participants n=32 Participants • one subject did not complete and not included in analysis
Race (NIH/OMB) White	24 Participants n=32 Participants • one subject did not complete and not included in analysis
Race (NIH/OMB) More than one race	0 Participants n=32 Participants • one subject did not complete and not included in analysis
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants • one subject did not complete and not included in analysis

PRIMARY outcome

Timeframe: Average pain rating over 120 seconds

Population: Participants completing both exercise sessions and control session

Outcome measures

Outcome measures
Measure	Exercise Treatment n=32 Participants 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 Forgionei-Barber pressure pain stimulator
Change in Pain Intensity Ratings (0-100 Pain Scale) isometric	40.2 scores on a scale Interval 31.0 to 60.9
Change in Pain Intensity Ratings (0-100 Pain Scale) control	33.5 scores on a scale Interval 22.7 to 44.5
Change in Pain Intensity Ratings (0-100 Pain Scale) concentric	46.2 scores on a scale Interval 31.3 to 61.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Exercise Treatment n=32 Participants 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 Forgionei-Barber pressure pain stimulator
Pain Threshold isometric	24.5 seconds Interval -4.5 to 53.5
Pain Threshold control	34.6 seconds Interval 16.4 to 52.7
Pain Threshold concentric	23.6 seconds Interval -3.9 to 54.2

Adverse Events

Exercise Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nalini Sehgal

UW Madison

Phone: 608-263-8639

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place