The Effects of EXOPULSE Mollii Suit on Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Condition

Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted.

Group Type ACTIVE_COMPARATOR

EXOPULSE MOLLII SUIT (active)

Intervention Type DEVICE

Exopulse 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.

Control Condition

The control arm will be a sham intervention. The patients will receive a sham stimulation, for which the same EXOPULSE Mollii suit will be used but the suit control unit will be programmed to start stimulating for 1 minute then it will shut off which could enable cutaneous sensations that mimic the active condition, aiming to achieve an effective blinding integrity. There is no risk related to the sham intervention since it 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).

Group Type SHAM_COMPARATOR

EXOPULSE MOLLII SUIT (sham)

Intervention Type DEVICE

It 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).

Interventions

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EXOPULSE MOLLII SUIT (active)

Exopulse 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.

Intervention Type DEVICE

EXOPULSE MOLLII SUIT (sham)

It 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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No