Using the EXOPULSE Mollii Suit to treat low back pain
The Effects of EXOPULSE Mollii Suit on Low Back Pain (EXOBACK)" / EXOPULSE Mollii Suit and Low Back Pain (EXOBACK)
This study is testing if wearing the EXOPULSE Mollii Suit can help people with chronic low back pain feel better compared to a fake version of the suit.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institut De La Colonne Vertebrale Et Des Neurosciences Academic / other |
| Locations | 1 site (Créteil, VAL DE Marne) |
| Trial ID | NCT06702189 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are French-speaking adults aged 18 to 75 with chronic low back pain lasting more than three months.
Not a fit: Patients with a visual analog scale (VAS) score of less than 4 or those with surgical indications for their low back pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-invasive and effective treatment option for patients suffering from chronic low back pain.
How similar studies have performed: Previous studies have shown the efficacy of transcutaneous electrical nerve stimulation (TENS) in managing low back pain, suggesting that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Créteil, VAL DE Marne
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.