Actively Recruiting
The Effects of EXOPULSE Mollii Suit on Low Back Pain
Led by Institut De La Colonne Vertebrale Et Des Neurosciences · Updated on 2026-02-18
30
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Low back pain is a common musculoskeletal problem. It is the main cause of activity limitation and work absence and carries a huge medical burden and economic cost. Low back pain is considered "chronic" when it persists for more than 3 months. Chronic low back pain affects daily activities and constitutes a psychological burden, which could lead to anxiety and/or depression. Prevention of low back pain is recognized as a pivotal challenge in high-risk populations to help tackle high healthcare costs related to therapy and rehabilitation. Current pharmacological drugs, namely anti-inflammatory and narcotics medications, have limited efficacy and numerous side effects. In addition, most available treatment options only address single, targeted causes; however, given the complexity of low back pain, a multi-modal interdisciplinary approach is highly needed. Transcutaneous electrical nerve stimulation (TENS) is a safe alternative to current treatments. Many studies have shown its efficacy and benefit in reducing pain. However, it only targets a limited number of muscles. For this reason, transcutaneous stimulation using the EXOPULSE Mollii suit might help reduce pain and related outcomes in this context since it simultaneously targets several muscle groups.
CONDITIONS
Official Title
The Effects of EXOPULSE Mollii Suit on Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 75 years with a definite diagnosis of low back pain lasting at least 3 months and no surgical indication
- Stable pharmacological treatment over the last three months
- Residual back pain after spinal surgery with no new surgical indication
- Ability to understand French verbal instructions and affiliation with national health insurance
You will not qualify if you...
- Pain level less than 4 on the Visual Analog Scale
- Presence of any surgical indication such as isthmic spondylolisthesis, herniated disc, spinal canal stenosis, vertebral fracture, degenerative spondylolisthesis, or scoliosis
- Failed Back Surgery Syndrome
- Spinal infection
- Obstetrical or gynecological causes of low back pain
- Retroperitoneal or spinal tumors
- Participation in another research protocol during the study
- Inability to undergo medical monitoring due to geographic or social reasons
- Having a cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump, or contraindications to EXOPULSE Mollii suit
- Pregnancy
- Changes in pharmacological therapy in the last three months
- Other somatic or neuropsychiatric diagnoses like arrhythmias or uncontrolled epilepsy
- Body mass index above 35 Kg/m2
- Introduction of a medical device other than EXOPULSE Mollii suit during the study
- Under juridical protection measures
- Prisoners
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France
Créteil, VAL DE Marne, France, 94000
Actively Recruiting
Research Team
S
Samar S AYACHE, MD, PhD
CONTACT
M
Moussa A CHALAH, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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