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Clinical Trials/NCT05743556
NCT05743556Enrolling By InvitationNot Applicable

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

Charles University, Czech Republic1 site in 1 country60 target enrollmentStarted: November 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
determine whether HILT causes a change in neck muscle tone after 6 applications

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

HILT group

Experimental

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

Intervention: HILT laserotherapy (Device)

TRT group

Active Comparator

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

Intervention: TRT therapy (Device)

Control group

No Intervention

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Charles University, Czech Republic
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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