Electrotherapy in the Management of Myofascial Syndrome

NCT04936451 | Terminated

• 1 other identifier: ICO-A-2020-10
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Surgery; Myofascial syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the changes made by the treatment felt by the patient

  16.5 months

Study Arms (2)

TENS / TENS ECOMODYN

OTHER

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

TENS ECOMODYN / TENS

OTHER

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

Interventions

TENS (transcutaneous electrical nerve stimulation) DEVICE

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 / TENS ECOMODYN; TENS ECOMODYN / TENS

TENS (transcutaneous electrical nerve stimulation) ECOMODYN DEVICE

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.

TENS / TENS ECOMODYN; TENS ECOMODYN / TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de l'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• EVA KERROUAULT, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, randomized in cross over in two arms, open

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: January 5, 2022
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)