Breast Cancer
Conditions
Keywords
Breast cancer, Surgery, Myofascial syndrome
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.
Interventions
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.
DEVICETENS (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.
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Monocentric, randomized in cross over in two arms, open
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed