Myofascial Pain Syndrome of NeckNCT06273514
Comparison the Effects of TECAR With Dry Needling in the Treatment of Myofascial Trigger Points
A study testing TECAR and Dry needling in people with Myofascial Pain Syndrome of Neck and Myofascial Trigger Point Syndrome, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men only
- Conditions the study is for
- Myofascial Pain Syndrome of Neck, Myofascial Trigger Point Syndrome, Myofascial Trigger Point Pain
- What is being tested?
- TECAR and Dry needling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2020to 31 Dec 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 25 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- sex male
- age 25-45
- manually confirmed active MTrP in the upper trapezius
Who cannot join
- MTrP therapy in the upper trapezius region during the last year
- history of neck trauma
- history of cervical spine surgeries
- history of humeral joint surgeries
- cervical radiculopathy
- chronic and acute diseases of the cardiovascular system
Show all 13Show fewer
- chronic and acute diseases of the respiratory system
- chronic and acute diseases of the nervous systems
- endocrine disturbances
- skin lesions in upper trapezius area
- acute inflammation
- cancer
- BMI > 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TECAR Therapy Might be an Alternative to Dry Needling in the Treatment of Active Myofascial Trigger Points in Upper Trapezius
The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy.
Research hypothesis:
Read more
Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.
It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.
Therefore, the objectives of the work were:
Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.
The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.
In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy.
- Conditions
- Myofascial Pain Syndrome of Neck, Myofascial Trigger Point Syndrome, Myofascial Trigger Point Pain
- Being tested
- TECAR, Dry needling
- Keywords
- myofascial trigger point, myofascial pain syndrome, TECAR therapy, dry needling, upper trapezius.
- Medical subject headings
- Fibromyalgia, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAROther
Also called capacitive and resistive transfer of energy
TECAR therapy performs using a WINBACK® 1s device (Daeyang Medical Co. Ltd, South Korea) with a maximum power of 100W. A 500 kHz frequency capacitive electrode is applied directly to the active MTrP in the UT. The closed electrode is placed distally on the arm. Lowpulse modulation use during treatment with half-second pauses. This enables the application of the current directly into the MTrP without enrolling the entire muscle. The single exposure last for 10 min. The current dose participant-dependent and ranged from 40 to 60% (100% = 100 Watts).
Each time, before and after treatment, and 30 days after the first therapy, the following features will be asses: pain intensity, muscle strength, and ROM.
Dry needlingOther
Also called DN
Dry needling performs using SOMA needles (25 mm x 0.3 mm). During the therapy, the participant is in a prone position. The affected UT region is disinfect before needling. The taut band localizes between the thumb and index finger of the researcher. The needle within the plastic guide tube is place over the MTrP at the UT. The needle directly inserts into the MTrP. A local twitch response confirms the accuracy of the puncture. Needling performs using Hong's "fast in, fast out" technique. The needle will be withdrawn if no twitching will observe.
| Study group | Role | What they receive |
|---|---|---|
| TECAR | Experimental | TECAR therapy is a non-invasive method for treating musculoskeletal system disorders based on the application of high-frequency current (300 kHz - 1 MHz) Receives: Other: TECAR |
| Dry needling | Experimental | Dry needling, a form of intramuscular stimulation, is a therapeutic intervention employed in physiotherapy and sports medicine. It entails the precise insertion of fine needles into specific myofascial trigger points, taut bands of skeletal muscle, or connective tissue without the administration of pharmacological agents. Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Pressure pain threshold (PPT)
Defined as the minimum force applied which induces pain, asses using an algometer BioFEET V3 (MusTec, Almere, Netherlands). The head of the algometer was placed on the MTrP in the upper trapezius (UT) and then pressed until the participant verbally expressed their PPT.
Measured: The measurements were performed three times with a 30-second break. The results are presented as the mean value of these measurements and are expressed in kg/m2.
Pain - numerical rating scale (NRS)
This pain screening tool uses a 0-10 scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Measured: Up to 3 minutes before and up to 3 minutes after each interventions
Secondary outcomes (2)
Muscle strength
Measures using a dynamometer (BioFEET V3; -MusTec, Muscle Dynamic Technology BV, Louis Chrispijnstraat1, Netherlands 1325 PC ALMERE). We assume that scapula elevation is the indicatory movement for the UT. During the assessment, the humeral joint remained in a natural position with proximal stabilization. The head of the dynamometer will be then placed on the acromion. The physiotherapist resisted active movements to provoke isometric contraction of the UT.
Measured: Measurements will be perform three times on both sides of the body up to 5 minutes before and up to 5 minutes after each interventions . The highest results obtained for statistical analysis and will be expressed as kG (kilogram force)
Cervical spine range of motion (ROM)
Cervical spine ROM was measured using a goniometer (BASEline). The following movements were assessed: flexion, extension, rotation, and side bending.
During the measurements the participants sit. While measuring cervical spine flexion and extension, the axis of the goniometer is place on the auricle opening. During the rotation, the axis of the goniometer is place at the top of the skull. Side bends measures with the goniometer axis placed on the spinal process of the axis (C2).
Measured: Each movement will be perform three times up to 10 minutes before and up to 10 minutes after each interventions. The results are present as the mean value of these measurements and are express in degrees (°)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Dec 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome of NeckStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Piętka, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273514
- Sponsor's protocol ID
- TECAR and DN intervention
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 22 Feb 2024
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TECAR Therapy Might be an Alternative to Dry Needling in the Treatment of Active Myofascial Trigger Points in Upper Trapezius
- ClinicalTrials.gov ID
- NCT06273514
- Acronym / sponsor ID
- TECAR and DN intervention
- Conditions
- Myofascial Pain Syndrome of Neck, Myofascial Trigger Point Syndrome, Myofascial Trigger Point Pain
- Keywords
- myofascial trigger point, myofascial pain syndrome, TECAR therapy, dry needling, upper trapezius.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Feb 2024 (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 aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy.
Research hypothesis:
Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.
It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.
Therefore, the objectives of the work were:
Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.
The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.
In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECAR | Experimental | Other: TECARTECAR therapy is a non-invasive method for treating musculoskeletal system disorders based on the application of high-frequency current (300 kHz - 1 MHz) |
| Dry needling | Experimental | Other: Dry needlingDry needling, a form of intramuscular stimulation, is a therapeutic intervention employed in physiotherapy and sports medicine. It entails the precise insertion of fine needles into specific myofascial trigger points, taut bands of skeletal muscle, or connective tissue without the administration of pharmacological agents. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- sex male
- age 25-45
- manually confirmed active MTrP in the upper trapezius
Key exclusion criteria (13 listed)
- MTrP therapy in the upper trapezius region during the last year
- history of neck trauma
- history of cervical spine surgeries
- history of humeral joint surgeries
- cervical radiculopathy
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 |
|---|---|---|
| TECARAlso: capacitive and resistive transfer of energyTECAR therapy performs using a WINBACK® 1s device (Daeyang Medical Co. Ltd, South Korea) with a maximum power of 100W. A 500 kHz frequency capacitive electrode is applied directly to the active MTrP in the UT. The closed electrode is placed distally on the arm. Lowpulse modulation use during treatment with half-second pauses. This enables the application of the current directly into the MTrP without enrolling the entire muscle. The single exposure last for 10 min. The current dose participant-dependent and ranged from 40 to 60% (100% = 100 Watts). Each time, before and after treatment, and 30 days after the first therapy, the following features will be asses: pain intensity, muscle strength, and ROM. | Other | TECAR |
| Dry needlingAlso: DNDry needling performs using SOMA needles (25 mm x 0.3 mm). During the therapy, the participant is in a prone position. The affected UT region is disinfect before needling. The taut band localizes between the thumb and index finger of the researcher. The needle within the plastic guide tube is place over the MTrP at the UT. The needle directly inserts into the MTrP. A local twitch response confirms the accuracy of the puncture. Needling performs using Hong's "fast in, fast out" technique. The needle will be withdrawn if no twitching will observe. | Other | Dry needling |
Primary outcome
Pain - Pressure pain threshold (PPT)
Time frame: The measurements were performed three times with a 30-second break. The results are presented as the mean value of these measurements and are expressed in kg/m2.
Defined as the minimum force applied which induces pain, asses using an algometer BioFEET V3 (MusTec, Almere, Netherlands). The head of the algometer was placed on the MTrP in the upper trapezius (UT) and then pressed until the participant verbally expressed their PPT.
Pain - numerical rating scale (NRS)
Time frame: Up to 3 minutes before and up to 3 minutes after each interventions
This pain screening tool uses a 0-10 scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
2 secondary outcomes
Muscle strength
Time frame: Measurements will be perform three times on both sides of the body up to 5 minutes before and up to 5 minutes after each interventions . The highest results obtained for statistical analysis and will be expressed as kG (kilogram force)
Cervical spine range of motion (ROM)
Time frame: Each movement will be perform three times up to 10 minutes before and up to 10 minutes after each interventions. The results are present as the mean value of these measurements and are express in degrees (°)
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 22 Feb 2024.
- 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.
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 TECAR and Dry needling in people with Myofascial Pain Syndrome of Neck and Myofascial Trigger Point Syndrome, run by Medical University of Silesia at 1 site in Poland.
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 3 inclusion and 13 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 22 Feb 2024. 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 Poland. 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?
Pain - Pressure pain threshold (PPT) (time frame: The measurements were performed three times with a 30-second break. The results are presented as the mean value of these measurements and are expressed in kg/m2.). The study lists 2 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 22 Feb 2024.