Percutaneous Microelectrolysis on Myofascial Trigger Points Pain.

NCT03636386 | Completed Results DMC

• 1 other identifier: 60312069
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the design is to investigate the value of percutaneous microelectrolysis (MEP) as an analgesic technique in myofascial trigger points. This research seeks to evaluate influence of cathode polar effects on the reduction of painful pressure (PPT) threshold and pain intensity (PI) in the myofascial trigger points (MTrPs) of upper trapezius muscle. An assessment with algometry and visual analog scale (VAS) will be made before applying the intervention. The study will evaluate changes in PPT and PI in a group exposed to percutaneous microelectrolysis (MEP) aplication compared to control group. Both groups will be provided with a baseline treatment of therapeutic ultrasound. Treatment will include three evaluation sessions. Subsequently, researchers will proceed to compare PPT and PI obtained from algometry test and VAS in each groups, and between groups, before and after the intervention. Changes obtained between sessions will be compared.

Conditions

Myofascial Trigger Point Pain (MTrP)

Keywords

Electrotherapy; Electrolysis; Myofascial pain syndromes; Pain Threshold; Analogue visual scale

Outcome Measures

Primary Outcomes (1)

• Pain Pressure Threshold (PPT)

  Pain Intensity expressed in kilograms per square centimeter(kg/cm2) reported by participants when performing algometry test at sensitive point of upper trapezius muscle. PPT was valued in four occasions: PPT1 pre (baseline), PPT1 post, PPT 2 (at day 3) and PPT 3 (at day 7). PPT will be evaluated through the BASELINE® pressure algometer.

  PPTpre1 (baseline), PPTpost1 (post baseline), PPT2 (Day 3), PPT3 (Day 7), assessed an average of 30 minutes at each session

Secondary Outcomes (1)

• Pain Intensity (PI)

  PIpre1 (baseline), PIpost1 (post baseline), PI2 (Day 3), PI3 (Day 7), assessed an average of 3 minutes at each session

Study Arms (2)

Percutaneous microelectrolysis group (MEP)

EXPERIMENTAL

Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.

Device: Percutaneous microelectrolysis; Device: Ultrasound therapy

Ultrasound therapy

ACTIVE COMPARATOR

Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.

Device: Ultrasound therapy

Interventions

Percutaneous microelectrolysis DEVICE

284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.

Also known as: Electrolysis through the polar effect of the cathode

Percutaneous microelectrolysis group (MEP)

Ultrasound therapy DEVICE

Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.

Also known as: Treatment with conventional ultrasound

Percutaneous microelectrolysis group (MEP); Ultrasound therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Students of Sciences Rehabilitation Faculty.
• Participants over 18 years old.
• Participants presenting Hypersensitive Pain Points (Trigger Points) at level of upper trapezius muscle. The positive trigger point (+) will be the presence of pain at a pressure of less than 3kg/cm2 at muscle point.

You may not qualify if:

• Musculoskeletal problems or pathologies of the neck or shoulders in the last 6 months (fractures, sprains, tendinopathies, dislocations, muscle tears, etc.).
• Participants who present cervical pain.
• Presence of osteosynthesis materials near shoulders, neck or surrounding areas
• Alterations of sensitivity such as hypesthesia, anesthesia or hyperesthesia in the neck, shoulders and / or arms
• Presence of wounds or skin alterations in the shoulder region (psoriasis, scars, keloids).
• Apprehension or fear of electrotherapy aplication.
• Ingestion of medications or analgesic pharmacological treatment at time of recruitment (Non-steroidal anti-inflammatory or steroidal).
• Elimination Criteria
• Non-tolerance of electrotherapy intervention that requires suspension of treatment.
• Non-completion of evaluation protocol (attendance at all scheduled sessions).

Sponsors & Collaborators

• Quiropraxia y Equilibrio: lead
• Universidad Nacional Andres Bello: collaborator

Study Sites (1)

Universidad Andrés Bello

Santiago, Comuna Las Condes, 7550000, Chile

Location

Related Publications (16)

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  PMID: 1508974 BACKGROUND

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  PMID: 28331357 BACKGROUND

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  PMID: 31313700 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Ultrasonic Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced

Limitations and Caveats

Sample size, determined for convenience. Current dose and number of intervention sessions. Discomfort thresholds were detected at different emission´s times in participants of MEP group.

Results Point of Contact

• Title: Professor Hernán Andrés de la Barra Ortiz
• Organization: Universidad Andrés Bello

quiropraxiayequilibrio@gmail.com

+56984706322

Study Officials

• Hernán A de la Barra Ortiz, Mg.

  Universidad Andrés Bello

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: May 23, 2018
• Primary Completion: December 14, 2018
• Study Completion: September 4, 2019
• Last Updated: April 18, 2023
• Results First Posted: April 15, 2020

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)