A New Experimental Model of Transient and Short-lasting Muscle Pain in Humans Based on Diathermy

NCT03573219 | Completed DMC

• 1 other identifier: IS001890
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Musculoskeletal Injury

Keywords

Short-Wave Diathermy; Transient muscle pain; Non-invasive pain model

Outcome Measures

Primary Outcomes (1)

• Pressure pain threshold (PPT)

  Change in the pressure pain threshold (kPa) recorded after the induced of muscle pain using SWD on the established time point records.

  0 to 1 hour

Secondary Outcomes (11)

• Assessment of changes in pain intensity in direct relation to the experimental model

  0 to 1 hour

• Assessment of changes in pain time course in direct relation to the experimental model

  0 to 1 hour

• Assessment of changes in functional connectivity in direct relation to the experimental model

  0 to 1 hour

• Assessment of changes in Pinprick sensitivity

  0 to 1 hour

• Assessment of changes in Dynamic tactile sensitivity

  0 to 1 hour

Study Arms (1)

Healthy participant

EXPERIMENTAL

Healthy volunteers that fulfill the inclusion criteria. Intervention: Short-wave diathermy (Radiation)

Radiation: Short-wave diathermy

Interventions

Short-wave diathermy RADIATION

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.

Healthy participant

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina: lead

Study Sites (1)

Facultad de Ingeniería - Universidad Nacional de Entre Ríos (Argentina)

Oro Verde, Entre Ríos Province, 3100, Argentina

Location

Related Publications (4)

• Goats GC. Continuous short-wave (radio-frequency) diathermy. Br J Sports Med. 1989 Jun;23(2):123-7. doi: 10.1136/bjsm.23.2.123.

  PMID: 2691003 BACKGROUND

• Graven-Nielsen T. Fundamentals of muscle pain, referred pain, and deep tissue hyperalgesia. Scand J Rheumatol Suppl. 2006;122:1-43. doi: 10.1080/03009740600865980. No abstract available.

  PMID: 16997767 BACKGROUND

• Neziri AY, Scaramozzino P, Andersen OK, Dickenson AH, Arendt-Nielsen L, Curatolo M. Reference values of mechanical and thermal pain tests in a pain-free population. Eur J Pain. 2011 Apr;15(4):376-83. doi: 10.1016/j.ejpain.2010.08.011. Epub 2010 Oct 6.

  PMID: 20932788 BACKGROUND

• Vuilleumier PH, Biurrun Manresa JA, Ghamri Y, Mlekusch S, Siegenthaler A, Arendt-Nielsen L, Curatolo M. Reliability of Quantitative Sensory Tests in a Low Back Pain Population. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):665-73. doi: 10.1097/AAP.0000000000000289.

  PMID: 26222349 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• José Biurrun Manresa, PhD

  National Scientific and Technical Research Council - Argentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 29, 2018
• Study Start: February 19, 2018
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From first date of publication of journal article.
• Access Criteria: IPD will be provided upon request.

Locations

AR (1)