Isometric Exercise and Endogenous Pain Inhibition
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03778476|
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Isometric Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.|
|Masking Description:||The participant is masked to the hypotheses of the treatment.|
|Official Title:||Isometric Exercise and Endogenous Pain Modulation|
|Actual Study Start Date :||May 25, 2018|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: Isometric Exercise
Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.
Other: Isometric Exercise
Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
No Intervention: Quiet Rest
Participants will sit quietly for a period of time that mimics the exercise.
- Conditioned Pain Modulation [ Time Frame: baseline, immediately after exercise or quiet rest ]the change in pressure pain threshold (kPa) during or after the immersion of the foot in a cold water bath (approximately 6 degrees) compared with baseline (before foot submersion) constitutes the measure of conditioned pain modulation in this study.
- Vibration Perception Threshold [ Time Frame: baseline, immediately after exercise or quiet rest ]a biothesiometer will be used to measure sense of vibration (threshold) local and distal from the exercising muscle.
- Numerical Pain Rating Scale (NPRS) [ Time Frame: baseline, during exercise, and immediately after exercise or quiet rest ]in both sessions, pain intensity will be evaluated during ice water bath immersion (i.e. before and after exercise or quiet rest) and during exercise using an 11-point NPRS with 0 being no pain and 10 worst pain possible.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778476
|Contact: Marie Hoeger Bement, PT, PhDemail@example.com|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53233|
|Contact: Marie Hoeger Bement, PT, PhD 414-288-6738 firstname.lastname@example.org|
|Sub-Investigator: Ali Alsouhibani, PT, MS|
|Principal Investigator:||Marie Hoeger Bement, PT, PhD||Marquette University|
|Study Director:||Ali Alsouhibani, PT, MS||Marquette University|