Muscle Tone AbnormalitiesNCT05743556
The Comparison of Effectivity Therapy by HILT and TRT in Muscle Hypertonus
A study testing HILT laserotherapy and TRT therapy in people with Muscle Tone Abnormalities and Muscle Spasm, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Comparing the effect of high-intensity laser therapy (HILT) and targeted radiofrequency therapy (TRT) on muscle tone in the cervical and thoracic regions. The research aims to determine the effectiveness of the effect of novel physical therapy on the change of muscle tone in the cervical and thoracic region. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Abnormalities, Muscle Spasm
- What is being tested?
- HILT laserotherapy and TRT therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2022to 30 Mar 2023
- 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
- the presence of hypertonus in the mm.scalene, m.levator scapulae and m.trapezius pars descendens bilaterally
- tension demonstrated by palpation and subjective assessment of the patient on an analogue pain scale
Who cannot join
- Individuals with acute or infectious disease
- probands psychiatric diagnoses
- patients with cancers
- problems with skin integrity disorders
- other contraindications to the use of HILT and TRT
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Charles University, Faculty of physical education and sport
Prague
About this study
Official title: Comparison of the Effect of HILT and TRT on Muscle Tone in Cervicobrachial Syndrome
Comparing the effect of high-intensity laser therapy (HILT) and targeted radiofrequency therapy (TRT) on muscle tone in the cervical and thoracic regions. The research aims to determine the effectiveness of the effect of novel physical therapy on the change of muscle tone in the cervical and thoracic region. This is an intervention experiment applied to a group of 60 probands.
Read the detailed description
Approximately 60 probands, aged 18-60 years, with no gender preference, will be recruited from patients of an unnamed healthcare facility based on their voluntary participation while receiving a current indication for physiotherapy with a diagnosis of CB syndrome.
Subjects will be randomized into three groups. The first probands (n'20) will have HILT applied bilaterally to the mm. scalene, m.levator scapulae and m.trapezius pars descendens. The second group (n'20) will have TRT applied bilaterally to mm. scalene, m.levator scapulae and m.trapezius pars descendens. No physical therapy or physiotherapy will be used for the third group (n'20) for the duration of the study. Subjects will be examined and treated three times a week for a total of 6 times. The effect of each type of therapy will be demonstrated palpationally and subjectively using an analogue pain scale and an algometer. The obtained results will be further statistically processed.
- Conditions
- Muscle Tone Abnormalities, Muscle Spasm
- Being tested
- HILT laserotherapy, TRT therapy
- Keywords
- muscle tone, HILT, TRT, scalene muscle, levator scapulae, trapezius muscle
- Medical subject headings
- Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HILT laserotherapyDevice
application of high intensive laser therapy on cervical muscles
TRT therapyDevice
application of radiofrekvention therapy on cervical muscles
| Study group | Role | What they receive |
|---|---|---|
| HILT group | Experimental | Therapy of muscle hypertonus by Hight intensive laser applied on cervical muscles. Receives: Device: HILT laserotherapy |
| TRT group | Active comparator | Muscle hypertonus of the cervical area treated by Target radio frequency current. Receives: Device: TRT therapy |
| Control group | No intervention | Group of patients with muscle cervical hyper tone without any therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine whether HILT causes a change in neck muscle tone after 6 applications
High- intensive laser therapy will be applied to m. scaleni, m. levator scapulae and m. trapezius. Before and after application, the degree of tenderness of the muscle will be determined using an algometer. This will be recorded in an Excel MS spreadsheet.
Measured: 15 minutes
determine whether TRT causes a change in neck muscle tone after 6 applications
Radiofrekvention therapy will be applied to m. scaleni, m. levator scapulae and m. trapezius. Before and after application, the degree of tenderness of the muscle will be determined using an algometer. This will be recorded in an Excel MS spreadsheet.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Nov 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Tone AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jitka Malá, PhDr., Study director, Charles University Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743556
- Sponsor's protocol ID
- Cemusova, HILT, TRT
- Status last verified
- Jan 2023
- First submitted
- 15 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of HILT and TRT on Muscle Tone in Cervicobrachial Syndrome
- ClinicalTrials.gov ID
- NCT05743556
- Acronym / sponsor ID
- Cemusova, HILT, TRT
- Conditions
- Muscle Tone Abnormalities, Muscle Spasm
- Keywords
- muscle tone, HILT, TRT, scalene muscle, levator scapulae, trapezius muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 24 Feb 2023 (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.
Comparing the effect of high-intensity laser therapy (HILT) and targeted radiofrequency therapy (TRT) on muscle tone in the cervical and thoracic regions. The research aims to determine the effectiveness of the effect of novel physical therapy on the change of muscle tone in the cervical and thoracic region. This is an intervention experiment applied to a group of 60 probands.
Detailed description
Approximately 60 probands, aged 18-60 years, with no gender preference, will be recruited from patients of an unnamed healthcare facility based on their voluntary participation while receiving a current indication for physiotherapy with a diagnosis of CB syndrome.
Subjects will be randomized into three groups. The first probands (n'20) will have HILT applied bilaterally to the mm. scalene, m.levator scapulae and m.trapezius pars descendens. The second group (n'20) will have TRT applied bilaterally to mm. scalene, m.levator scapulae and m.trapezius pars descendens. No physical therapy or physiotherapy will be used for the third group (n'20) for the duration of the study. Subjects will be examined and treated three times a week for a total of 6 times. The effect of each type of therapy will be demonstrated palpationally and subjectively using an analogue pain scale and an algometer. The obtained results will be further statistically processed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HILT group | Experimental | Device: HILT laserotherapyTherapy of muscle hypertonus by Hight intensive laser applied on cervical muscles. |
| TRT group | Active comparator | Device: TRT therapyMuscle hypertonus of the cervical area treated by Target radio frequency current. |
| Control group | No intervention | –Group of patients with muscle cervical hyper tone without any therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- the presence of hypertonus in the mm.scalene, m.levator scapulae and m.trapezius pars descendens bilaterally
- tension demonstrated by palpation and subjective assessment of the patient on an analogue pain scale
Key exclusion criteria (5 listed)
- Individuals with acute or infectious disease
- probands psychiatric diagnoses
- patients with cancers
- problems with skin integrity disorders
- other contraindications to the use of HILT and TRT
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 |
|---|---|---|
| HILT laserotherapyapplication of high intensive laser therapy on cervical muscles | Device | HILT group |
| TRT therapyapplication of radiofrekvention therapy on cervical muscles | Device | TRT group |
Primary outcome
determine whether HILT causes a change in neck muscle tone after 6 applications
Time frame: 15 minutes
High- intensive laser therapy will be applied to m. scaleni, m. levator scapulae and m. trapezius. Before and after application, the degree of tenderness of the muscle will be determined using an algometer. This will be recorded in an Excel MS spreadsheet.
determine whether TRT causes a change in neck muscle tone after 6 applications
Time frame: 15 minutes
Radiofrekvention therapy will be applied to m. scaleni, m. levator scapulae and m. trapezius. Before and after application, the degree of tenderness of the muscle will be determined using an algometer. This will be recorded in an Excel MS spreadsheet.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- 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.
Jitka Malá, PhDr. study director
Charles University Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HILT laserotherapy and TRT therapy in people with Muscle Tone Abnormalities and Muscle Spasm, run by Charles University, Czech Republic at 1 site in Czechia.
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 5 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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 Czechia. 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?
Results are not available in the source record.
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?
determine whether HILT causes a change in neck muscle tone after 6 applications (time frame: 15 minutes). 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 2 Mar 2023.