Clinical trial NCT06702189: The Effects of EXOPULSE Mollii Suit on Low Back Pain
Official title: The Effects of EXOPULSE Mollii Suit on Low Back Pain (EXOBACK)" / EXOPULSE Mollii Suit and Low Back Pain (EXOBACK)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: EXOPULSE Mollii Suit and Low back pain
Lead sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We designed a randomized, sham-controlled, double-blind trial to demonstrate the improvement of pain, pain-related disability, quality of life, fatigue and mood in adult patients with chronic low back pain following a 2-week intervention of "active" versus "sham" EXOPULSE Mollii suit. A 2-week washout period should be enough to prevent a potential carry-over effect. After this phase (phase 1), a second open-label phase (phase 2) will be proposed for patients to understand the effects of the EXOPULSE Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.

Summary:

* Phase 1: randomized sham-controlled crossover study (active versus sham condition)
* Phase 2: Open-label study (active condition)
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Pain-related disability reduction will be assessed using the QBPDS (Quebec Back Pain Disability Scale) before and after active and sham stimulation
timeFrame: This will be assessed through study completion, an average of 3 months at Visit 1(Day 0) , Visit 2 (Day 15), Visit 3 (Day 30), Visit 4 (Day45), Visit 5 (Day 60) and Visit 6 (Day 90)
Secondary outcomes:
measure: Assessment of pain-related disability reduction using the ODQ (Owestry Disability scale)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Analgesic effects based on the VAS (Visual Analogue Scale)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Analgesic effects based on the Brief Pain Inventory (BPI)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Analgesic effects based on the Pain Catastrophizing Scale (PCS)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Assessment of anti-fatigue effects according to VAS (visual analogue scale)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Mood symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Improvement of the quality of life using the Short Form 36 Health Survey (SF-36)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Evaluation of overall improvement using the CGI (Clinical Global Impression)
timeFrame: This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions
measure: Evaluation of patient's blinding to the type of stimulation in the crossover trial
timeFrame: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) of Phase 1.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France
state: Val de Marne
Study officials:
affiliation: Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France
name: Samar S Ayache, MD, PhD, HDR
role: PRINCIPAL_INVESTIGATOR
References: