Comparison the Effects of TECAR With Dry Needling in the Treatment of Myofascial Trigger Points

Myofascial Trigger Point Pain Clinical Trial

Official title:

TECAR Therapy Might be an Alternative to Dry Needling in the Treatment of Active Myofascial Trigger Points in Upper Trapezius

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06273514
• Other study ID #: TECAR and DN intervention
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• sex male

• age 25-45

• manually confirmed active MTrP in the upper trapezius

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome of Neck
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain
• Syndrome

Intervention

Other:
• TECAR
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.
• Dry needling
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.

Locations

Country	Name	City	State
Poland	Medical fit	Ruda Slaska	Slask

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Muscle strength	Measures using a dynamometer (BioFEET V3; -MusTec, Muscle Dynamic Technology BV, Louis Chrispijnstraat1, Netherlands 1325 PC ALMERE). We assume that scapula elevation is the indicatory movement for the UT. During the assessment, the humeral joint remained in a natural position with proximal stabilization. The head of the dynamometer will be then placed on the acromion. The physiotherapist resisted active movements to provoke isometric contraction of the UT.	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)
Secondary	Cervical spine range of motion (ROM)	Cervical spine ROM was measured using a goniometer (BASEline). The following movements were assessed: flexion, extension, rotation, and side bending.; During the measurements the participants sit. While measuring cervical spine flexion and extension, the axis of the goniometer is place on the auricle opening. During the rotation, the axis of the goniometer is place at the top of the skull. Side bends measures with the goniometer axis placed on the spinal process of the axis (C2).	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 (°)