Electrotherapy in the Management of Myofascial Syndrome (MODYMYO)

Institut Cancerologie de l'Ouest

Status: Terminated

Conditions: Breast Cancer

Treatments: Device: TENS (transcutaneous electrical nerve stimulation) ECOMODYN; Device: TENS (transcutaneous electrical nerve stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT04936451

ICO-A-2020-10

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female who had first breast cancer surgery, regardless of the type of surgery
• Age ≥ 18 years
• Patients with refractory pain with myofascial syndrome, with a numerical scale ≥ 4
• Topical treatment for refractory pain completed more than 30 days ago
• Healthy, non-irritated skin on painful areas to treat
• Patient with a third party who can attend visits M0 and M2.5
• Obtaining the signed written consent of the patient
• Major patient affiliated to a social security scheme

Exclusion criteria

• Patient who has used TENS before on the muscles affected by the myofascial syndrome
• Post-surgery management of the affected area by a physiotherapist
• Person with venous thrombosis
• Contraindications specific to the treatments studied

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

TENS / TENS ECOMODYN

Other group

Description:

Patients who have signed their consent receive, after randomization, the trial treatments assigned to them. Arm TENS / TENS ECOMODYN Patients first start with TENS during 2 months puis change with TENS ECOMODYN during 2 months with a wash-out period of 15 days

Treatment:

Device: TENS (transcutaneous electrical nerve stimulation) ECOMODYN

Device: TENS (transcutaneous electrical nerve stimulation)

TENS ECOMODYN / TENS

Other group

Description:

Patients who have signed their consent receive, after randomization, the trial treatments assigned to them. Arm TENS ECOMODYN / TENS Patients first start with TENS ECOMODYN during 2 months puis change with TENS during 2 months with a wash-out period of 15 days

Treatment:

Device: TENS (transcutaneous electrical nerve stimulation) ECOMODYN

Device: TENS (transcutaneous electrical nerve stimulation)