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

Muscle Tone Abnormalities Clinical Trial

Official title:

Comparison of the Effect of HILT and TRT on Muscle Tone in Cervicobrachial Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05743556
• Other study ID #: Cemusova, HILT, TRT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: January 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This is an intervention experiment applied to a group of 60 probands.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: March 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasm
• Muscle Tone Abnormalities
• Spasm

Intervention

Device:
• HILT laserotherapy
application of high intensive laser therapy on cervical muscles
• TRT therapy
application of radiofrekvention therapy on cervical muscles

Locations

Country	Name	City	State
Czechia	Charles University, Faculty of physical education and sport	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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