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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
Sponsor:
Information provided by (Responsible Party):
José Biurrun Manresa, National Council of Scientific and Technical Research, Argentina

Brief Summary:
This study evaluates the use of short-wave diathermy (SWD) as an novel experimental model to induce transient and intensity-controlled muscle pain by heating muscle tissue.

Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Musculoskeletal Injury Radiation: Short-wave diathermy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Assessment of changes in pain time course in direct relation to the experimental model [ Time Frame: 0 to 1 hour ]
    Duration of pain (seconds)

  3. 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).

  4. Assessment of changes in Pinprick sensitivity [ Time Frame: 0 to 1 hour ]
    Pinprick sensitivity (PS) (0 to 100 score).

  5. Assessment of changes in Dynamic tactile sensitivity [ Time Frame: 0 to 1 hour ]
    Dynamic tactile sensitivity (DTS) (0 to 100 score).

  6. Assessment of changes in Electrical pain threshold [ Time Frame: 0 to 1 hour ]
    Electrical pain threshold (EPT) (mA).

  7. 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)

  8. Assessment of changes in Movement-related cortical potentials [ Time Frame: 0 to 1 hour ]
    Change in Movement-related cortical potentials (MRCP), assessed through EEG.

  9. Assessment of changes in motor responses for upper limb [ Time Frame: 0 to 1 hour ]
    Change in precision during motor execution (percentage)

  10. Assessment of changes in motor responses for lower limb [ Time Frame: 0 to 1 hour ]
    Change in balance (Centre of pressure)

  11. Assessment of changes in weight loading [ Time Frame: 0 to 1 hour ]
    Measured in Kg



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Understanding of the content and scope of the experiment, and compliance with the experiment's instructions.
  • To have signed the informed consent.

Exclusion Criteria:

  • Pregnancy.
  • Previous history of neurological or musculoskeletal disorders or chronic pain.
  • Previous history of addictive behavior, defined as abuse of alcohol, cannabis, opioids or other drugs.
  • Previous history of thermosensitivity disorders.
  • Previous history of mental illness.
  • Presence of fever, tuberculosis, tumors, infectious processes, or acute inflammatory processes.
  • Implantation of peacemaker or metallic prosthesis.
  • Use of analgesics within 24 h prior to the experiment.

Information from the National Library of Medicine

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


Locations
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Argentina
Facultad de Ingeniería - Universidad Nacional de Entre Ríos (Argentina)
Oro Verde, Entre Ríos, Argentina, 3100
Sponsors and Collaborators
National Council of Scientific and Technical Research, Argentina
Investigators
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Principal Investigator: José Biurrun Manresa, PhD National Scientific and Technical Research Council - Argentina
Publications:
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Responsible Party: José Biurrun Manresa, Principal Investigator, National Council of Scientific and Technical Research, Argentina
ClinicalTrials.gov Identifier: NCT03573219    
Other Study ID Numbers: IS001890
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: From first date of publication of journal article.
Access Criteria: IPD will be provided upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Biurrun Manresa, National Council of Scientific and Technical Research, Argentina:
Short-Wave Diathermy
Transient muscle pain
Non-invasive pain model
Additional relevant MeSH terms:
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Musculoskeletal Pain
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Neuromuscular Diseases
Nervous System Diseases