Electrotherapy in the Management of Myofascial Syndrome (MODYMYO)

Contribution of an Electrotherapy Technique Such as TENS ECOMODYN® vs Electrotherapy Only Type TENS in the Management of Myofascial Syndrome After Breast Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Device: TENS (transcutaneous electrical nerve stimulation); Device: TENS (transcutaneous electrical nerve stimulation) ECOMODYN

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: EVA KERROUAULT, MD; Phone Number: +33 0240679900; Email: eva.kerrouault@ico.unicancer.fr
• Study Contact Backup: Name: MARINE TIGREAT; Phone Number: +33 0240679878; Email: marine.tigreat@ico.unicancer.fr

Study Locations

• France
  • Saint-Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TENS / TENS 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	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.
Other: TENS ECOMODYN / TENS; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main objective is to evaluate the effectiveness of TENS and TENS ECOMODYN® on the management of chronic breast pain after surgery.	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.	16,5 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: EVA KERROUAULT, MD, Institut de Cancérologie de l'Ouest

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Breast cancer; Myofascial syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: ICO-A-2020-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No