Test-Retest Reliability of an Experimental Model of Shoulder Muscle Pain

NCT05412316 | Completed DMC

• 1 other identifier: approval number 04/22
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

High frequency oscillations of non-ionizing electromagnetic fields range can heat deep tissues in a well-localized region. Recently, a new SWD-based model showed to be a promising tool for investigating muscle pain in humans. The main advantages of the model are its noninvasiveness, the ability to control stimulation parameters, and the convenience of the time frame in which pain and hyperalgesia are developed. This study assess the reliability of SWD pain model to induced transient and intensity-controlled muscle soreness on shoulder in healthy volunteers.

Conditions

Musculoskeletal Pain

Keywords

Short-wave diathermy; Experimental pain model; Muscle pain; Generalized hypersensitivity; Shoulder pain

Outcome Measures

Primary Outcomes (1)

• Pressure pain threshold (PPT)

  Change in the PPT (kPa) will be assessed bilaterally over the medial portion of the infraspinatus muscle using a digital algometer (Somedic SenseLab AB, Sweden) with a 1-cm2 round tip. Pressure will be gradually increased from 0 kPa at a rate of approximately 50 kPa/s (maximal achievable pressure: 2,000 kPa). The volunteers will be asked to press the button when they perceive that the pressure changes to pain, stopping the estimation at this point. The assessment will be repeated 3 times for each sides, alternating sides between measurements. Each measure will be performed at 30-second intervals.

  At baseline and 30 - 60 minutes after of SWD.

Secondary Outcomes (5)

• Pain distribution

  At 30 - 60 minutes after the application of SWD.

• Modified Likert scale

  At 30 - 60 minutes after the application of SWD.

• Myoelectrical activity (EMG)

  At 10 minutes before and 30 - 60 minutes after the application of SWD.

• Isometric muscle strength

  At baseline and 30 - 60 minutes after the application of SWD.

• Visual analog scale

  During the application of SWD.

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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

Other: Intervention: Short-wave diathermy

Interventions

Intervention: Short-wave diathermy OTHER

The SWD will be applied using a CEC M-8 shortwave thermotherapy unit (CEC Electrónica S.R.L., Argentina) that emits RF at a frequency of 27.12 MHz. The device has two rectangular capacitive applicators (18 × 12 cm), which will be placed below and above the dominant shoulder. The coplanar application will be done using the continuous wave mode. The intensity of SWD will be gradually increased until the volunteer perceives a sensation of heat, and once familiar 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 SWD application, and three repetitions will be performed. Healthy volunteers will be in a lateral supine position, and a cotton towel will be used to absorb perspiration and avoid unwanted heat effects.

Healthy Volunteers

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

• University of Gran Rosario: lead

Study Sites (1)

University of Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Related Publications (1)

• Biurrun Manresa JA, Fritsche R, Vuilleumier PH, Oehler C, Morch CD, Arendt-Nielsen L, Andersen OK, Curatolo M. Is the conditioned pain modulation paradigm reliable? A test-retest assessment using the nociceptive withdrawal reflex. PLoS One. 2014 Jun 20;9(6):e100241. doi: 10.1371/journal.pone.0100241. eCollection 2014.

  PMID: 24950186 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain; Myalgia; Shoulder Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases; Arthralgia; Joint Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the University Center for Assistance, Teaching and Research

Model Details: The SWD will be applied using a CEC M-8 shortwave thermotherapy unit (CEC Electrónica S.R.L., Argentina) that emits RF at a frequency of 27.12 MHz. The device has two rectangular capacitive applicators (18 × 12 cm), which will be placed below and above the dominant shoulder. The coplanar application will be done using the continuous wave mode. The intensity of SWD will be gradually increased until the volunteer perceives a sensation of heat, and once familiar 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 SWD application. Once the first application is completed, the volunteer will be allowed to rest for a period of 2-3 minutes and three repetitions will be performed. Healthy volunteers will be in a lateral supine position, and a cotton towel will be used to absorb perspiration and avoid unwanted heat effects.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 9, 2022
• Study Start: June 8, 2022
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

AR (1)