A New Experimental Model of Transient and Short-lasting Muscle Pain in Humans Based on Diathermy
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|ClinicalTrials.gov Identifier: NCT03573219|
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Pain Musculoskeletal Injury||Radiation: Short-wave diathermy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The SWD applicators will be placed in the desired position, around the forearm for the upper limb experiments, or below the knee for the lower limb experiments. The distance between applicators will be adjusted until the desired pain sensation is obtained according to the subjective criterion of the volunteer. This sensation should be mild or moderate pain, but tolerable for the duration of the application. Once the first application is completed, the volunteer will be allowed to rest for a period of 10 minutes, and the assessment will be repeated to test for possible after effects. After it is verified that the muscles recovered their normal temperature and the pain sensation has completely disappeared, the variables related to changes in motor responses under rest conditions will be recorded. Then SWD will be applied a second time using the same parameters as in the first application. Once the registration is complete, the experiment will be finished.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A New Experimental Model of Acute Muscle Pain in Humans Based on Short-wave Diathermy|
|Actual Study Start Date :||February 19, 2018|
|Actual Primary Completion Date :||August 29, 2018|
|Actual Study Completion Date :||August 29, 2018|
Experimental: Healthy participant
Healthy volunteers that fulfill the inclusion criteria. Intervention: Short-wave diathermy (Radiation)
Radiation: Short-wave diathermy
The application of SWD will be carried out by a CEC M-8 short-wave thermotherapy unit. The device has capacitive applicators, that will be situated around the muscle to be irradiated on top of a cotton towel, in order to absorb perspiration and avoid undesired heating effects. Afterwards the emission mode (continuous or pulsed) will be selected, and application of SWD will start. The intensity of SWD will be gradually increased until the volunteer perceives a warm sensation, and once familiarized with this perception, the intensity will be increased until a sensation of constant but tolerable pain is evoked. This sensation will be maintained throughout the duration of the SWD application, estimated in approximately 10 minutes.
- Pressure pain threshold (PPT) [ Time Frame: 0 to 1 hour ]Change in the pressure pain threshold (kPa) recorded after the induced of muscle pain using SWD on the established time point records.
- Assessment of changes in pain intensity in direct relation to the experimental model [ Time Frame: 0 to 1 hour ]Maximum and average pain ratings (0 to 100 score).
- Assessment of changes in pain time course in direct relation to the experimental model [ Time Frame: 0 to 1 hour ]Duration of pain (seconds)
- Assessment of changes in functional connectivity in direct relation to the experimental model [ Time Frame: 0 to 1 hour ]Changes in functional connectivity (FC), assessed through surface electroencephalography (EEG).
- Assessment of changes in Pinprick sensitivity [ Time Frame: 0 to 1 hour ]Pinprick sensitivity (PS) (0 to 100 score).
- Assessment of changes in Dynamic tactile sensitivity [ Time Frame: 0 to 1 hour ]Dynamic tactile sensitivity (DTS) (0 to 100 score).
- Assessment of changes in Electrical pain threshold [ Time Frame: 0 to 1 hour ]Electrical pain threshold (EPT) (mA).
- Assessment of changes in Somatosensory evoked potentials [ Time Frame: 0 to 1 hour ]Somatosensory evoked potentials in response to electrical stimuli (SEP), assessed through EEG. (mV)
- Assessment of changes in Movement-related cortical potentials [ Time Frame: 0 to 1 hour ]Change in Movement-related cortical potentials (MRCP), assessed through EEG.
- Assessment of changes in motor responses for upper limb [ Time Frame: 0 to 1 hour ]Change in precision during motor execution (percentage)
- Assessment of changes in motor responses for lower limb [ Time Frame: 0 to 1 hour ]Change in balance (Centre of pressure)
- Assessment of changes in weight loading [ Time Frame: 0 to 1 hour ]Measured in Kg
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): NCT03573219
|Facultad de Ingeniería - Universidad Nacional de Entre Ríos (Argentina)|
|Oro Verde, Entre Ríos, Argentina, 3100|
|Principal Investigator:||José Biurrun Manresa, PhD||National Scientific and Technical Research Council - Argentina|