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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Muscle Tone Abnormalities; Muscle Spasm
• Intervention / Treatment: Device: HILT laserotherapy; Device: TRT therapy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia
    • Charles University, Faculty of physical education and sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HILT group; Therapy of muscle hypertonus by Hight intensive laser applied on cervical muscles.	Device: HILT laserotherapy; application of high intensive laser therapy on cervical muscles
Active Comparator: TRT group; Muscle hypertonus of the cervical area treated by Target radio frequency current.	Device: TRT therapy; application of radiofrekvention therapy on cervical muscles
No Intervention: Control group; Group of patients with muscle cervical hyper tone without any therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	15 minutes

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Study Director: Jitka Malá, PhDr., Charles University Prague

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: muscle tone; TRT; trapezius muscle; HILT; scalene muscle; levator scapulae
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Spasm
• Other Study ID Numbers: Cemusova, HILT, TRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No