Musculoskeletal PainNCT05412316
Test-Retest Reliability of an Experimental Model of Shoulder Muscle Pain
A study testing Intervention: Short-wave diathermy in people with Musculoskeletal Pain, run by University of Gran Rosario at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Intervention: Short-wave diathermy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteArgentina
- Study dates
- 8 Jun 2022to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understanding of the content and scope of the experiment, and compliance with the experiment's instructions.
- To have signed the informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This Test-Retest Reliability study comprises a sample of 31 healthy volunteers. Volunteers will be invited to participate in the study through social networks and e-mail.
Experimental pain model assessment
The radiofrequency electromagnetic fields can be produced in the range of 3 kHz to 300 GHz, but frequencies around 27 MHz (short-wave) are preferred to heat deep tissues. Deep tissue heating by means of RF is a safe and extensively used technique in palliative treatment of pain and as a healing agent in soft tissues. This study assess the reliability of SWD to induce soreness. The study will be conducted in two experimental sessions on different days, at least 48 to 72 hours apart each other in order to avoid carryover effects. In each experimental session, several measures will be performed to assess different physiological parameters, including: pressure pain thresholds (PPT), specific self-report questionnaire, isometric muscle strength, pain distribution and myoelectric activity.
In the first session (Test), participants will be interviewed to collect anthropometric data and health history. Basic upper quadrant physical examination will be performed to check inclusion and exclusion criteria. Before and after the application of SWD, several assessments will be performed. Among the different assessment, myoelectric activity of infraspinatus and deltoid muscle will be recorded during isometric arm lifting task. The isometric task will consist in maintaining the arm in 90 degree elevation in the scapular plane (arm flexion) for 8 seconds. This task will be repeated 5 times with 15 seconds of rest between each trial. Finally, a fatiguing motor task will be performed, consisting of flexion and extension of the arm executed cyclically in a range of motion between 30 and 90 degree in the scapular plane. To ensure fatigue, volunteers will perform the task with an additional weight. The size of the weight will be calculated according to each volunteer body mass (1.25 kg in participants under 68 kg and 2.5 kg in participants over 68 kg). The arm flexion and extension speed will be guided using a 60 beats/s metronome. Same process will be repeated in the second session (Retest).
Sample size considerations:
All the reliability assessment methods used in this study are related to the within-subject standard deviation (SD_w). For a test-retest experiment, the SD_w can be calculated as〖 SD〗_w=(SD_diff)⁄√2, and the LoA can be reformulated as bias ± 1.96 〖SD〗_w √2. The precision to estimate SD_w depends on both the number of subjects, n, and the number of observations per subject. A sample size of 31 subjects is required considering a confidence interval of 25% at either side of the estimation of SD_w, and for m=2 observations per subject.
- Conditions
- Musculoskeletal Pain
- Being tested
- Intervention: Short-wave diathermy
- Keywords
- Short-wave diathermy, Experimental pain model, Muscle pain, Generalized hypersensitivity, Shoulder pain
- Medical subject headings
- Musculoskeletal Pain, Myalgia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Short-wave diathermyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy volunteers that fulfill the inclusion criteria. Intervention: Short-wave diathermy (Radiation) Receives: Other: Intervention: Short-wave diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 30 - 60 minutes after of SWD.
Secondary outcomes (5)
Pain distribution
Extension of the reported pain drawings. The results will be expressed as the percentage of the total body area.
Measured: At 30 - 60 minutes after the application of SWD.
Modified Likert scale
A modified self-report Likert scale was used to follow the temporal progression of muscle pain/soreness after SWD, with 0 defining a complete absence of soreness and 6 indicating severe soreness.
Measured: At 30 - 60 minutes after the application of SWD.
Myoelectrical activity (EMG)
Change in muscle activity will be assessed. Monopolar multichannel recording (6 channels) will be distributed spatially across the infraspinatus muscle, and monopolar channels will be recorded for the medial and posterior deltoid muscle. BIOAMP Biopotential amplifier will be used for recording the EMG signals, 8-channel (sample rate: 2 KHz) (UNER, Argentina) during execution of the motor tasks. EMG will be recorded before and 30 - 60 minutes after SWD application to assess redistribution of the muscle activity induced by the transient pain.
Measured: At 10 minutes before and 30 - 60 minutes after the application of SWD.
Isometric muscle strength
Change in the maximal isometric strength (kgf) for external rotation in dominant shoulder will be assessed using a Hand Held Dynamometer (Lafayette Manual Muscle Testing System, Model 01165, Lafayette, IN). The measures will be taken with the volunteers in the standing position, and the arm will be placed at the side of the body with the elbow flexed at 90º, and the forearm in neutral pronosupination. The examiner will be held the dynamometer at the dorsal aspect of the distal third of the forearm. Three 6-seconds measures will be taken with rest between them and the peak and mean value will be calculated.
Measured: At baseline and 30 - 60 minutes after the application of SWD.
Visual analog scale
A continuous visual analog scale ranging from 0 to 100, where 0 represents no perception, 30 represents pain threshold (defined as the time to reach a painful sensation at the predefined stimulation intensity) and 100 represents the tolerance threshold (defined as the sensation of pain when becomes intolerable)
Measured: During the application of SWD.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start8 Jun 2022
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Intelangelo, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412316
- Sponsor's protocol ID
- approval number 04/22
- Status last verified
- Sep 2022
- First submitted
- 31 May 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24950186
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-Retest Reliability of an Experimental Model of Shoulder Muscle Pain
- ClinicalTrials.gov ID
- NCT05412316
- Acronym / sponsor ID
- approval number 04/22
- Conditions
- Musculoskeletal Pain
- Keywords
- Short-wave diathermy, Experimental pain model, Muscle pain, Generalized hypersensitivity, Shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Test-Retest Reliability study comprises a sample of 31 healthy volunteers. Volunteers will be invited to participate in the study through social networks and e-mail.
Experimental pain model assessment
The radiofrequency electromagnetic fields can be produced in the range of 3 kHz to 300 GHz, but frequencies around 27 MHz (short-wave) are preferred to heat deep tissues. Deep tissue heating by means of RF is a safe and extensively used technique in palliative treatment of pain and as a healing agent in soft tissues. This study assess the reliability of SWD to induce soreness. The study will be conducted in two experimental sessions on different days, at least 48 to 72 hours apart each other in order to avoid carryover effects. In each experimental session, several measures will be performed to assess different physiological parameters, including: pressure pain thresholds (PPT), specific self-report questionnaire, isometric muscle strength, pain distribution and myoelectric activity.
In the first session (Test), participants will be interviewed to collect anthropometric data and health history. Basic upper quadrant physical examination will be performed to check inclusion and exclusion criteria. Before and after the application of SWD, several assessments will be performed. Among the different assessment, myoelectric activity of infraspinatus and deltoid muscle will be recorded during isometric arm lifting task. The isometric task will consist in maintaining the arm in 90 degree elevation in the scapular plane (arm flexion) for 8 seconds. This task will be repeated 5 times with 15 seconds of rest between each trial. Finally, a fatiguing motor task will be performed, consisting of flexion and extension of the arm executed cyclically in a range of motion between 30 and 90 degree in the scapular plane. To ensure fatigue, volunteers will perform the task with an additional weight. The size of the weight will be calculated according to each volunteer body mass (1.25 kg in participants under 68 kg and 2.5 kg in participants over 68 kg). The arm flexion and extension speed will be guided using a 60 beats/s metronome. Same process will be repeated in the second session (Retest).
Sample size considerations:
All the reliability assessment methods used in this study are related to the within-subject standard deviation (SD_w). For a test-retest experiment, the SD_w can be calculated as〖 SD〗_w=(SD_diff)⁄√2, and the LoA can be reformulated as bias ± 1.96 〖SD〗_w √2. The precision to estimate SD_w depends on both the number of subjects, n, and the number of observations per subject. A sample size of 31 subjects is required considering a confidence interval of 25% at either side of the estimation of SD_w, and for m=2 observations per subject.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Other: Intervention: Short-wave diathermyHealthy volunteers that fulfill the inclusion criteria. Intervention: Short-wave diathermy (Radiation) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Understanding of the content and scope of the experiment, and compliance with the experiment's instructions.
- To have signed the informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention: Short-wave diathermyThe 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. | Other | Healthy Volunteers |
Primary outcome
Pressure pain threshold (PPT)
Time frame: At baseline and 30 - 60 minutes after of SWD.
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.
5 secondary outcomes
Pain distribution
Time frame: At 30 - 60 minutes after the application of SWD.
Modified Likert scale
Time frame: At 30 - 60 minutes after the application of SWD.
Myoelectrical activity (EMG)
Time frame: At 10 minutes before and 30 - 60 minutes after the application of SWD.
Isometric muscle strength
Time frame: At baseline and 30 - 60 minutes after the application of SWD.
Visual analog scale
Time frame: During the application of SWD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 24950186Biurrun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Short-wave diathermy in people with Musculoskeletal Pain, run by University of Gran Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (PPT) (time frame: At baseline and 30 - 60 minutes after of SWD.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05412316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.