NCT06273514

Brief Summary

The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy. Research hypothesis: Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points. It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points. Therefore, the objectives of the work were: Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle. The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy. In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

February 7, 2024

Last Update Submit

February 15, 2024

Conditions

Keywords

myofascial trigger pointmyofascial pain syndromeTECAR therapydry needlingupper trapezius.

Outcome Measures

Primary Outcomes (2)

  • Pain - Pressure pain threshold (PPT)

    Defined as the minimum force applied which induces pain, asses using an algometer BioFEET V3 (MusTec, Almere, Netherlands). The head of the algometer was placed on the MTrP in the upper trapezius (UT) and then pressed until the participant verbally expressed their PPT.

    The measurements were performed three times with a 30-second break. The results are presented as the mean value of these measurements and are expressed in kg/m2.

  • Pain - numerical rating scale (NRS)

    This pain screening tool uses a 0-10 scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Up to 3 minutes before and up to 3 minutes after each interventions

Secondary Outcomes (2)

  • Muscle strength

    Measurements will be perform three times on both sides of the body up to 5 minutes before and up to 5 minutes after each interventions . The highest results obtained for statistical analysis and will be expressed as kG (kilogram force)

  • Cervical spine range of motion (ROM)

    Each movement will be perform three times up to 10 minutes before and up to 10 minutes after each interventions. The results are present as the mean value of these measurements and are express in degrees (°)

Study Arms (2)

TECAR

EXPERIMENTAL

TECAR therapy is a non-invasive method for treating musculoskeletal system disorders based on the application of high-frequency current (300 kHz - 1 MHz)

Other: TECAR

Dry needling

EXPERIMENTAL

Dry needling, a form of intramuscular stimulation, is a therapeutic intervention employed in physiotherapy and sports medicine. It entails the precise insertion of fine needles into specific myofascial trigger points, taut bands of skeletal muscle, or connective tissue without the administration of pharmacological agents.

Other: Dry needling

Interventions

TECAROTHER

TECAR therapy performs using a WINBACK® 1s device (Daeyang Medical Co. Ltd, South Korea) with a maximum power of 100W. A 500 kHz frequency capacitive electrode is applied directly to the active MTrP in the UT. The closed electrode is placed distally on the arm. Lowpulse modulation use during treatment with half-second pauses. This enables the application of the current directly into the MTrP without enrolling the entire muscle. The single exposure last for 10 min. The current dose participant-dependent and ranged from 40 to 60% (100% = 100 Watts). Each time, before and after treatment, and 30 days after the first therapy, the following features will be asses: pain intensity, muscle strength, and ROM.

Also known as: capacitive and resistive transfer of energy
TECAR

Dry needling performs using SOMA needles (25 mm x 0.3 mm). During the therapy, the participant is in a prone position. The affected UT region is disinfect before needling. The taut band localizes between the thumb and index finger of the researcher. The needle within the plastic guide tube is place over the MTrP at the UT. The needle directly inserts into the MTrP. A local twitch response confirms the accuracy of the puncture. Needling performs using Hong's "fast in, fast out" technique. The needle will be withdrawn if no twitching will observe.

Also known as: DN
Dry needling

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sex male
  • age 25-45
  • manually confirmed active MTrP in the upper trapezius

You may not qualify if:

  • MTrP therapy in the upper trapezius region during the last year
  • history of neck trauma
  • history of cervical spine surgeries
  • history of humeral joint surgeries
  • cervical radiculopathy
  • chronic and acute diseases of the cardiovascular system
  • chronic and acute diseases of the respiratory system
  • chronic and acute diseases of the nervous systems
  • endocrine disturbances
  • skin lesions in upper trapezius area
  • acute inflammation
  • cancer
  • BMI \> 30 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical fit

Ruda Śląska, Silesian Voivodeship, 41-717, Poland

Location

MeSH Terms

Conditions

FibromyalgiaMyofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Health Sciences in Katowice, Department of Physical Medicine, Chair of Physiotherapy, Medical University of Silesia in Katowice, Poland

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 22, 2024

Study Start

December 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations