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Electrotherapy in the Management of Myofascial Syndrome

NCT04936451 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-08-01

No results posted yet for this study

Summary

Myofascial syndrome is defined as "musculoskeletal pain characterized by local and referred pain perceived to be deep and constant, and by the presence of myofascial trigger points in any part of the body" Post-breast surgery myofascial syndrome affects up to 44.7% of operated women, mainly on the muscles of the greater shoulder girdle. The repercussions are significant, functional, somatic, psychological and socio-professional affecting the quality of life. The treatments offered may or may not be medicinal. Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.

Conditions

Interventions

DEVICE

TENS (transcutaneous electrical nerve stimulation)

Patients will benefit from screening for refractory pain, neuropathic or not, with myofascial syndrome, between 3 and 12 months after surgery. The healthcare professional will determine 4 trigger points. TENS is applied twice 45 min every day for 2 months. Pain treatment will be done by using the P6 program in alternative mode: 2hz / 100Hz. The time between 2 electrostimulations will be a minimum of 4 hours and a maximum of 15 hours.

DEVICE

TENS (transcutaneous electrical nerve stimulation) ECOMODYN

TENS ECOMODYN® is applied to 4 treatment points, 5 minutes per point 2 times a day for 2 months. A minimum rest period of 4 hours between 2 sessions on the same point must be respected Stimulation is performed directly with the bipolar probe of the TENS ECOMODYN® device on the painful area by fixed stimulation of 4 active pain points in 77Hz mode.

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • EVA KERROUAULT, MD · Institut de Cancérologie de l'Ouest

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2023-04-14
Completion
2023-04-14

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936451 on ClinicalTrials.gov