An interventional study of TENS (transcutaneous electrical nerve stimulation) and TENS (transcutaneous electrical nerve stimulation) ECOMODYN in Breast Cancer, sponsored by Institut Cancerologie de l'Ouest. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Institut Cancerologie de l'Ouest · Not applicable, Interventional, and Supportive care
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.
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Exclusion Criteria:
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
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
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 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.
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.
Time frame: 16,5 months
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
Time frame: 16.5 months
Plan to share: No
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This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Institut Cancerologie de l'Ouest