The Effects of EXOPULSE Mollii Suit on Low Back Pain
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitut De La Colonne Vertebrale Et Des Neurosciences
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
EXOPULSE MOLLII SUIT (active)
DeviceExopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company. Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate several groups of muscles. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more. EXOPULSE Mollii suit consists of transcutaneous stimulation of several muscles by means of a feeble electric current (i.e., low frequency \~20 Hz, low-intensity 2mA), aiming to reduce pain. This treatment method theoretical background primarily refers to the theory of gate control. Based on this theory, the stimulation of large proprioceptive fibers would inhibit the nociceptive information transmitted by small fibers.
EXOPULSE MOLLII SUIT (sham)
DeviceIt consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 175 µs) but for a shorter duration of time (1 minute).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Experimental ConditionActive comparator 1 intervention
Group B: Control ConditionSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain-related disability reduction will be assessed using the QBPDS (Quebec Back Pain Disability Scale) before and after active and sham stimulation
The QBPDS (Quebec Back Pain Disability Scale) is a 20-item scale that is widely used in back pain research. Items evaluate the ability to perform the mentioned activity and are rated using 5 possibilities ranging from "not difficult at all" to "unable to do". Lower scores reflect lower disability. The French version has good psychometric properties (internal consistency, content validity, and acceptability).
Time frame
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
1
Assessment of pain-related disability reduction using the ODQ (Owestry Disability scale)
The ODQ (Owestry Disability scale) consists of 10 items questionnaire (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, driving/riding a car, changing degree of pain) rated using 6 possibilities as well as a visual item assessing pain quality from absence to extreme. ). Lower scores reflect lower disability.
Time frame
This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)2
Analgesic effects based on the VAS (Visual Analogue Scale)
The visual analogue scale of pain (VASpain) consists of rating the symptom on a 10 cm horizontal line going from "no pain" to "worst pain imaginable" .
Time frame
This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)3
Analgesic effects based on the Brief Pain Inventory (BPI)
The validated French version of the Brief Pain Inventory (BPI) will be used to assess pain severity (4 items) and pain interference (7 items). BPI items are rated on a 10-point scale running from 0 (no pain/does not interfere) to 10 (pain as bad as you can feel/interferes completely). A total pain severity score can be found by averaging these items. Higher scores indicate greater severity and more interference.
Time frame
This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)4
Analgesic effects based on the Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a valid and reliable scale that includes 13 items assessing the presence and severity of feelings or thoughts that emerge when experiencing pain. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing. A total score of \>30 represents a clinically significant level of pain catastrophization.
Time frame
This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)Sponsors and contacts
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Source ClinicalTrials.gov