Clinical Trials Directory

Trials / Terminated

TerminatedNCT04936451

Electrotherapy in the Management of Myofascial Syndrome

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Institut Cancerologie de l'Ouest · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICETENS (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.
DEVICETENS (transcutaneous electrical nerve stimulation) ECOMODYNTENS 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.

Timeline

Start date
2022-01-05
Primary completion
2023-04-14
Completion
2023-04-14
First posted
2021-06-23
Last updated
2023-08-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04936451. Inclusion in this directory is not an endorsement.