NCT05743556

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

March 2, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

February 15, 2023

Last Update Submit

March 1, 2023

Conditions

Keywords

muscle toneHILTTRTscalene musclelevator scapulaetrapezius muscle

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

HILT group

EXPERIMENTAL

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

Device: HILT laserotherapy

TRT group

ACTIVE COMPARATOR

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

Device: TRT therapy

Control group

NO INTERVENTION

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

Interventions

application of high intensive laser therapy on cervical muscles

HILT group

application of radiofrekvention therapy on cervical muscles

TRT group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University, Faculty of physical education and sport

Prague, Czechia

Location

MeSH Terms

Conditions

Spasm

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jitka Malá, PhDr.

    Charles University Prague

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 24, 2023

Study Start

November 1, 2022

Primary Completion

February 28, 2023

Study Completion

March 30, 2023

Last Updated

March 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations