Electrotherapy in the Management of Myofascial Syndrome

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Device: TENS (transcutaneous electrical nerve stimulation); Device: TENS (transcutaneous electrical nerve stimulation) ECOMODYN

• Registration Number: NCT04936451
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Study Start: 2022-01-05
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TENS / TENS ECOMODYN	TENS (transcutaneous electrical nerve stimulation) ECOMODYN	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
TENS ECOMODYN / TENS	TENS (transcutaneous electrical nerve stimulation)	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
TENS / TENS ECOMODYN	TENS (transcutaneous electrical nerve stimulation)	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
TENS ECOMODYN / TENS	TENS (transcutaneous electrical nerve stimulation) ECOMODYN	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

Primary Outcome Measures

Name	Time	Method
The main objective is to evaluate the effectiveness of TENS and TENS ECOMODYN® on the management of chronic breast pain after surgery.	16,5 months	Chronic pain is assessed using the Digital Pain Rating Scale (0 worse outcome to 10 better outcome) before and after using the method (TENS and TENS ECOMODYN®) at M0, M2, M2.5 and M4.5.

Secondary Outcome Measures

Name	Time	Method
Evaluate the changes made by the treatment felt by the patient	16.5 months	The intensity of The patient's feelings will be evaluated by the Patient Global Impression of Change questionnaire: at M2 and M4.5

Trial Locations

Locations (1)

Institut de Cancerologie de l'Ouest; 🇫🇷 Saint-Herblain, France