Electrotherapy in the Management of Myofascial Syndrome

Breast Cancer Clinical Trial

— MODYMYO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04936451
• Other study ID #: ICO-A-2020-10
• Status: Terminated
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: July 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Institut de Cancerologie de l'Ouest	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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