Electrotherapy in the Management of Myofascial Syndrome

NCT ID: NCT04936451

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2023-04-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

TENS (transcutaneous electrical nerve stimulation)

Intervention Type: 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 (transcutaneous electrical nerve stimulation) ECOMODYN

Intervention Type: 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 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

Group Type: OTHER

TENS (transcutaneous electrical nerve stimulation)

Intervention Type: 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 (transcutaneous electrical nerve stimulation) ECOMODYN

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EVA KERROUAULT, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

Institut de Cancerologie de l'Ouest

Saint-Herblain, , France

Countries

France

Other Identifiers

ICO-A-2020-10

Identifier Type: -

Identifier Source: org_study_id