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

Primary Purpose

Muscle Tone Abnormalities, Muscle Spasm

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
HILT laserotherapy
TRT therapy
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Muscle Tone Abnormalities focused on measuring muscle tone, HILT, TRT, scalene muscle, levator scapulae, trapezius muscle

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Charles University, Faculty of physical education and sport

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

HILT group

TRT group

Control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2023
Last Updated
March 1, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT05743556
Brief Title
The Comparison of Effectivity Therapy by HILT and TRT in Muscle Hypertonus
Official Title
Comparison of the Effect of HILT and TRT on Muscle Tone in Cervicobrachial Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tone Abnormalities, Muscle Spasm
Keywords
muscle tone, HILT, TRT, scalene muscle, levator scapulae, trapezius muscle

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HILT group
Arm Type
Experimental
Arm Description
Therapy of muscle hypertonus by Hight intensive laser applied on cervical muscles.
Arm Title
TRT group
Arm Type
Active Comparator
Arm Description
Muscle hypertonus of the cervical area treated by Target radio frequency current.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Group of patients with muscle cervical hyper tone without any therapy.
Intervention Type
Device
Intervention Name(s)
HILT laserotherapy
Intervention Description
application of high intensive laser therapy on cervical muscles
Intervention Type
Device
Intervention Name(s)
TRT therapy
Intervention Description
application of radiofrekvention therapy on cervical muscles
Primary Outcome Measure Information:
Title
determine whether HILT causes a change in neck muscle tone after 6 applications
Description
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.
Time Frame
15 minutes
Title
determine whether TRT causes a change in neck muscle tone after 6 applications
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jitka Malá, PhDr.
Organizational Affiliation
Charles University Prague
Official's Role
Study Director
Facility Information:
Facility Name
Charles University, Faculty of physical education and sport
City
Praha
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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