Using the EXOPULSE Mollii Suit to treat low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of the EXOPULSE Mollii Suit on patients suffering from chronic low back pain, which is a prevalent condition that significantly impacts daily activities and mental health. The study employs a randomized approach, comparing the active suit to a sham version to assess its efficacy in alleviating pain. Participants must have a confirmed diagnosis of low back pain for at least three months and meet specific eligibility criteria, including stable pharmacological treatment. The trial aims to explore a multi-modal approach to pain management, potentially offering a safer alternative to traditional pharmacological treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged between 18 and 75 years, with a definite diagnosis of Low Back Pain for at least 3 months, with absence of any surgical indication.
* Stable pharmacological treatment over the last three months
* Residual back pain post-spinal surgery with no new surgical indication
* Patients should be French speakers, able to understand verbal instructions, and affiliated to the national health insurance NHI.

Exclusion Criteria:

* Patient with VAS \< 4
* Presence of any surgical indication (i.e,. isthmic spondylolisthesis, herniated disc, Spinal canal stenosis, Vertebral fracture, Degenerative Spondylolisthesis, scoliosis)
* Failed Back Surgery Syndrome (FBSS)
* Presence of spinal infection
* Presence of obstetrical or gynecological cause of the low back pain (ovarian torsion, ovarian cyst, endometriosis, menses)
* Retroperitoneal tumors - Spinal tumors - Being included in another research protocol during the study period
* Inability to undergo medical monitoring for the study purposes due to geographical or social reasons
* Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump, or other contraindications to using EXOPULSE Mollii suit
* Being pregnant
* Having a change in their pharmacological therapy in the last three months.
* Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain)
* Having a body mass index above 35 Kg/m2
* In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period
* Patients under juridical protection (" mesure de protection judiciaire : tutelle, curatelle, sauvegarde de justice ")
* Prisoners

Where it's running

• Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France
  Créteil, VAL DE Marne, France Recruiting

Study contacts

• Principal investigator: Samar S Ayache, MD, PhD, HDR — Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France
• Study coordinator: Samar S AYACHE, MD, PhD
• Email: samarayache@gmail.com
• Phone: +33 149814662

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.