Muscle TonusNCT03154632
Effectiveness of Digital Capacitive Diathermy Versus Ultrasound on Myofascial Trigger Points
A study testing Ultrasound Therapy and Digital Capacitive Diathermy Therapy in people with Muscle Tonus, run by Universidad San Jorge at 1 site in Spain.
Trial summary
The main objective: To compare the effect on muscle tone between the application of digital capacitive diathermy and the application of ultrasound on the myofascial trigger points (MTP) of the upper trapezius muscle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tonus
- What is being tested?
- Ultrasound Therapy and Digital Capacitive Diathermy Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2017to 15 Oct 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Presence of an active or latent MTrP 1 in the upper trapezius:
- Presence of taut band in a skeletal muscle.
- Presence of a hypersensitive point in the taut band.
- Local twitch response caused by palpation of the taut band.
- Reproduction of the typical referred pain pattern of MTrPs in response to compression.
- Spontaneous presence of the typical pain pattern and/or patient's recognition of that pain as familiar (criteria only applicable to the active MTrPs).
Who cannot join
- History of neurological disorders (radiculopathy).
- Cervical surgery.
- Chronic pain in any part of the body as a result of a traumatic incident.
- Chronic rheumatic disease.
- Medical diagnosis of fibromyalgia.
- Systemic diseases.
Show all 14Show fewer
- Actual pregnancy.
- Clinical depression.
- Body mass index ≥30.
- To receive treatment of myofascial syndrome in the muscles of the cervico-dorsal area (physical therapy, invasive techniques ...) during the month prior to the beginning of the study.
- Ingestion of medication (analgesics, muscle relaxants, psychotropic or anti-inflammatory agents) in the three days prior to the start of the study.
- Exit criteria:
- Patient´s petition.
- Appearance of any lesion that might contraindicate the use of electrotherapy techniques.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective:
To compare the effect on muscle tone between the application of digital capacitive diathermy and the application of ultrasound on the myofascial trigger points (MTP) of the upper trapezius muscle.
Hypothesis:
The application of digital capacitive diathermy on myofascial trigger points of the trapezius muscle compared to the application of ultrasound produces objective changes in muscle tone, and this change is superior to the changes generated by the US.
Read the detailed description
It is a simple-blinded randomized crossover clinical trial where volunteer subjects, older than 18 years, have a latent or active proximal MTP1 (intermediate part of the anterior margin of the upper part of the muscle near the vertical fibers of the muscle attached to clavicle) in the upper trapezius.
It will assess if there are changes in the muscle tone of the trapezius muscle after applying digital capacitive diathermy (DCD) or ultrasound (US) in the latent or active MTP1 of the trapezius muscle in healthy adults.
Each patient will receive a single session of each treatment in the affected trapezius. The order in which treatments are received - US followed by digital capacitive diathermy, or vice versa - is determined at random.
To remove any carryover of effects, there will be a week of washing period between the two interventions.
Intervention:
- DCD: The patient is positioned in prone position on stretcher. Firstly, it will apply almonds oil on the MTP1 of the upper trapezius affected. Then, it will put the "musculotendinous injury FAST" program which lasts 6 minutes; and, it will move the ultrasound applicator in contact with the skin with a velocity approximately between 2.5 and 4 centimeters per second.
- US: The patient is positioned in prone position on the stretcher. Firstly, it will select parameters (frequency: 1MHz, intensity: 1.0 W/cm2, mode: continuous). Then it will apply a slow technique of circular movements with a speed of approximately between 2.5 and 4 centimeters per second over the area of the MTP1 of the upper trapezius affected during 6 minutes.
Assessment:
To assess the effectiveness of these techniques, several tests will be performed on the subjects:
- Myotonometric measurements using a myotonometer to obtain frequency, decrement (elasticity) and stiffness of the evaluated points and MTPs.
- Algometry results will bring information of the PPT of evaluated MTPs.
- The 0-10 Numeric Pain Rating Scale results will bring information of the subjective dolor perception of the subjects.
- Inclinometer results will bring information of the ROM of cervical spine lateral inclination.
- The Neck Disability Index results will provide information on how much neck pain interferes in the daily activities of patients.
- Conditions
- Muscle Tonus
- Being tested
- Ultrasound Therapy, Digital Capacitive Diathermy Therapy
- Keywords
- Myofascial trigger point, Trapezius Muscle, Diathermy, Ultrasound
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound TherapyDevice
Ultrasound equipment will be used, choosing a continuous mode, with a frequency of 1MHz and an intensity of 1.0 W/cm2. The technique will be applied during 6 minutes with circular movements and a speed of approximately between 2.5 and 4 centimeters per second.
Digital Capacitive Diathermy TherapyDevice
The DCD equipment will be used choosing the "musculotendinous injury FAST" program which lasts 6 minutes. The applicator will move with a velocity approximately between 2.5 and 4 centimeters per second.
| Study group | Role | What they receive |
|---|---|---|
| US Group | Active comparator | Ultrasound Therapy Receives: Device: Ultrasound Therapy |
| DCD Group | Active comparator | Digital Capacitive Diathermy Therapy Receives: Device: Digital Capacitive Diathermy Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stiffness
The muscle stiffness reflects muscle resistance to the force that changes its shape (Nm). This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Change in Decrement (elasticity)
Logarithmic decrement of the dampening of muscle oscillations is an indicator of the elasticity. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Change in Frequency
Frequency of muscle oscillations (Hz) is an indicator of the tone. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle. The assessment is realized in these points:
- MTrP 1 of the affected superior trapezius.
- MTrP 3 of the affected superior trapezius.
- MTrP 1 of the NO affected superior trapezius.
- Point in the middle of the muscle belly of the affected superior trapezius. 10 mechanical stimuli of 0.4 N of force and 0.15 ms of duration will be applied. The MyotonPro® must remain perpendicular to the surface to be measured (the subject will be lying in a prone position for the MTrP 3, and sit down for the three other points). Each assessment will consist of 10 multiple measurements, spaced for 1 second. To be considerate as valid, the variation coefficient of the measure should not exceed 3%.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Secondary outcomes (4)
Change in the Pressure Pain Threshold (PPT)
The PPT is measured using a pressure algometer in these points:
- MTrP 1 of the affected superior trapezius.
- MTrP 3 of the affected superior trapezius.
- MTrP 1 of the NO affected superior trapezius.
- MTrP 2 of the lateral gastrocnemius of the affected side. The subject will be lying in a prone position for more stability and with a pillow under his feet. The algometer must remain perpendicular to the surface to be measured. It will be measured three consecutive times, with an interval of 30 seconds between each measurement.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Change in the Range Of Motion (ROM) of cervical spine lateral inclination
It will be used a portable inclinometer to assess the ROM of the contralateral active cervical spine inclination. The subject will be in a relaxed and comfortable sitting position, leaning on the backrest, arms resting on his knees and fixing a point with his eyes. It will be measured three consecutive times, with an interval of 30 seconds between each measurement.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Change in Pain Perception
Change in pain perception using Numeric Pain Rating Scale (NPRS). The NPRS is a scale from 0-10 ("0" = no pain; "10" = the most intense pain imaginable).
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Change in Neck Disability Index (NDI)
The NDI consists of ten questions in the following domains: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation.
Measured: Pre-intervention; Follow up (1 week after the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Feb 2017
- Primary completion1 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TonusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Jiménez-Sánchez, MSc, Principal investigator, Universidad San JorgeMaria Ortiz-Lucas, PhD, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154632
- Sponsor's protocol ID
- 01/2017
- Status last verified
- May 2017
- First submitted
- 2 May 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Capacitive Diathermy Versus Ultrasound on Myofascial Trigger Points
- ClinicalTrials.gov ID
- NCT03154632
- Acronym / sponsor ID
- 01/2017
- Conditions
- Muscle Tonus
- Keywords
- Myofascial trigger point, Trapezius Muscle, Diathermy, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 16 May 2017 (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.
The main objective:
To compare the effect on muscle tone between the application of digital capacitive diathermy and the application of ultrasound on the myofascial trigger points (MTP) of the upper trapezius muscle.
Hypothesis:
The application of digital capacitive diathermy on myofascial trigger points of the trapezius muscle compared to the application of ultrasound produces objective changes in muscle tone, and this change is superior to the changes generated by the US.
Detailed description
It is a simple-blinded randomized crossover clinical trial where volunteer subjects, older than 18 years, have a latent or active proximal MTP1 (intermediate part of the anterior margin of the upper part of the muscle near the vertical fibers of the muscle attached to clavicle) in the upper trapezius.
It will assess if there are changes in the muscle tone of the trapezius muscle after applying digital capacitive diathermy (DCD) or ultrasound (US) in the latent or active MTP1 of the trapezius muscle in healthy adults.
Each patient will receive a single session of each treatment in the affected trapezius. The order in which treatments are received - US followed by digital capacitive diathermy, or vice versa - is determined at random.
To remove any carryover of effects, there will be a week of washing period between the two interventions.
Intervention:
- DCD: The patient is positioned in prone position on stretcher. Firstly, it will apply almonds oil on the MTP1 of the upper trapezius affected. Then, it will put the "musculotendinous injury FAST" program which lasts 6 minutes; and, it will move the ultrasound applicator in contact with the skin with a velocity approximately between 2.5 and 4 centimeters per second.
- US: The patient is positioned in prone position on the stretcher. Firstly, it will select parameters (frequency: 1MHz, intensity: 1.0 W/cm2, mode: continuous). Then it will apply a slow technique of circular movements with a speed of approximately between 2.5 and 4 centimeters per second over the area of the MTP1 of the upper trapezius affected during 6 minutes.
Assessment:
To assess the effectiveness of these techniques, several tests will be performed on the subjects:
- Myotonometric measurements using a myotonometer to obtain frequency, decrement (elasticity) and stiffness of the evaluated points and MTPs.
- Algometry results will bring information of the PPT of evaluated MTPs.
- The 0-10 Numeric Pain Rating Scale results will bring information of the subjective dolor perception of the subjects.
- Inclinometer results will bring information of the ROM of cervical spine lateral inclination.
- The Neck Disability Index results will provide information on how much neck pain interferes in the daily activities of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US Group | Active comparator | Device: Ultrasound TherapyUltrasound Therapy |
| DCD Group | Active comparator | Device: Digital Capacitive Diathermy TherapyDigital Capacitive Diathermy Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than 18 years
- Presence of an active or latent MTrP 1 in the upper trapezius:
Key exclusion criteria (14 listed)
- History of neurological disorders (radiculopathy).
- Cervical surgery.
- Chronic pain in any part of the body as a result of a traumatic incident.
- Chronic rheumatic disease.
- Medical diagnosis of fibromyalgia.
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 |
|---|---|---|
| Ultrasound TherapyUltrasound equipment will be used, choosing a continuous mode, with a frequency of 1MHz and an intensity of 1.0 W/cm2. The technique will be applied during 6 minutes with circular movements and a speed of approximately between 2.5 and 4 centimeters per second. | Device | US Group |
| Digital Capacitive Diathermy TherapyThe DCD equipment will be used choosing the "musculotendinous injury FAST" program which lasts 6 minutes. The applicator will move with a velocity approximately between 2.5 and 4 centimeters per second. | Device | DCD Group |
Primary outcome
Change in Stiffness
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
The muscle stiffness reflects muscle resistance to the force that changes its shape (Nm). This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.
Change in Decrement (elasticity)
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Logarithmic decrement of the dampening of muscle oscillations is an indicator of the elasticity. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.
Change in Frequency
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Frequency of muscle oscillations (Hz) is an indicator of the tone. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle. The assessment is realized in these points: * MTrP 1 of the affected superior trapezius. * MTrP 3 of the affected superior trapezius. * MTrP 1 of the NO affected superior trapezius. * Point in the middle of the muscle belly of the affected superior trapezius. 10 mechanical stimuli of 0.4 N of force and 0.15 ms of duration will be applied. The MyotonPro® must remain perpendicular to the surface to be measured (the subject will be lying in a prone position for the MTrP 3, and sit down for the three other points). Each assessment will consist of 10 multiple measurements, spaced for 1 second. To be considerate as valid, the variation coefficient of the measure should not exceed 3%.
4 secondary outcomes
Change in the Pressure Pain Threshold (PPT)
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Change in the Range Of Motion (ROM) of cervical spine lateral inclination
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Change in Pain Perception
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Change in Neck Disability Index (NDI)
Time frame: Pre-intervention; Follow up (1 week after the intervention).
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 3 May 2018.
- Individual participant dataSharing planned: No
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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.
Carolina Jiménez-Sánchez, MSc principal investigator
Universidad San Jorge
Maria Ortiz-Lucas, PhD principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Therapy and Digital Capacitive Diathermy Therapy in people with Muscle Tonus, run by Universidad San Jorge at 1 site in Spain.
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 7 inclusion and 14 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 3 May 2018. 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 Spain. 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?
Change in Stiffness (time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.