The Effects of EXOPULSE Mollii Suit on Low Back Pain

NCT06702189 | Recruiting

• 1 other identifier: 2024-A00020-47
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

EXOPULSE Mollii Suit and Low back pain

Outcome Measures

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).

  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 (9)

• Assessment of pain-related disability reduction using the ODQ (Owestry Disability scale)

  This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)

• Analgesic effects based on the VAS (Visual Analogue Scale)

  This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)

• Analgesic effects based on the Brief Pain Inventory (BPI)

  This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)

• Analgesic effects based on the Pain Catastrophizing Scale (PCS)

  This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)

• Assessment of anti-fatigue effects according to VAS (visual analogue scale)

  This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)

Study Arms (2)

Experimental Condition

ACTIVE COMPARATOR

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.

Device: EXOPULSE MOLLII SUIT (active)

Control Condition

SHAM COMPARATOR

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).

Device: EXOPULSE MOLLII SUIT (sham)

Interventions

EXOPULSE MOLLII SUIT (active) 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.

Experimental Condition

EXOPULSE MOLLII SUIT (sham) 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).

Control Condition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut De La Colonne Vertebrale Et Des Neurosciences: lead

Study Sites (1)

Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France

Créteil, VAL DE Marne, 94000, France

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samar S Ayache, MD, PhD, HDR

  Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samar S AYACHE, MD, PhD

CONTACT

+33 149814662; samarayache@gmail.com

Moussa A CHALAH, MD, PhD

CONTACT

moussachalah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 22, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

FR (1)