The Comparison of Effectivity Therapy by HILT and TRT in Muscle Hypertonus

NCT ID: NCT05743556

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-03-30

Brief Summary

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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

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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

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Muscle Tone Abnormalities Muscle Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HILT group

Therapy of muscle hypertonus by Hight intensive laser applied on cervical muscles.

Group Type EXPERIMENTAL

HILT laserotherapy

Intervention Type DEVICE

application of high intensive laser therapy on cervical muscles

TRT group

Muscle hypertonus of the cervical area treated by Target radio frequency current.

Group Type ACTIVE_COMPARATOR

TRT therapy

Intervention Type DEVICE

application of radiofrekvention therapy on cervical muscles

Control group

Group of patients with muscle cervical hyper tone without any therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HILT laserotherapy

application of high intensive laser therapy on cervical muscles

Intervention Type DEVICE

TRT therapy

application of radiofrekvention therapy on cervical muscles

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jitka Malá, PhDr.

Role: STUDY_DIRECTOR

Charles University Prague

Locations

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Charles University, Faculty of physical education and sport

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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Cemusova, HILT, TRT

Identifier Type: -

Identifier Source: org_study_id

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