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Low Back PainEXOBACKNCT06702189

The Effects of EXOPULSE Mollii Suit on Low Back Pain

A study testing EXOPULSE MOLLII SUIT (active) in people with Low Back Pain, run by Institut De La Colonne Vertebrale Et Des Neurosciences at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Low Back Pain
What is being tested?
EXOPULSE MOLLII SUIT (active)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteFrance
Study dates
7 May 2024to 1 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Samar S AYACHE, MD, PhD contact

+33 149814662

samarayache@gmail.com

Moussa A CHALAH, MD, PhD contact

moussachalah@gmail.com

France1 site, 1 recruiting
  • Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France

    Créteil, VAL DE Marne, 94000

    Samar S AYACHE, MD,PhD, +33 149814662, samarayache@gmail.com

    Samar S AYACHE, MD, PhD

    Recruiting

Other trials in France

About this study

Official title: The Effects of EXOPULSE Mollii Suit on Low Back Pain (EXOBACK)" / EXOPULSE Mollii Suit and Low Back Pain (EXOBACK)

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
Being tested
EXOPULSE MOLLII SUIT (active), EXOPULSE MOLLII SUIT (sham)
Keywords
EXOPULSE Mollii Suit and Low back pain
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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).

Study groups in NCT06702189
Study groupRoleWhat they receive
Experimental ConditionActive comparatorActive 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.
Receives: Device: EXOPULSE MOLLII SUIT (active)
Control ConditionSham comparatorThe 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).
Receives: Device: EXOPULSE MOLLII SUIT (sham)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)
  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.

    Measured: 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" .

    Measured: 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.

    Measured: 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.

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

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

    The visual analogue fatigue scale (EVA fatigue) is a 10 mm straight hozontal line, with one end corresponding to no fatigue and the other to extreme fatigue.

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

  6. Mood symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS)

    It is a 14-item generic scale with good psychometric properties. It consists of seven items assessing anxiety and seven others assessing depression. Scores can range from 0 to 21 on each subscale, with higher scores indicating worse symptomatology .

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

  7. Improvement of the quality of life using the Short Form 36 Health Survey (SF-36)

    It is a generic survey that contains 36 items that assess the quality of life and yield eight dimensions: physical functioning, physical role, emotional role, bodily pain, general health, vitality, social functioning, and mental health. The score of each dimension ranges from 0 to 100, with higher scales implying better health status. The French version has excellent convergent and discriminant validity (100% and 97.9%, respectively) and good internal consistency.

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

  8. Evaluation of overall improvement using the CGI (Clinical Global Impression)

    It consists of 7-point scale ranging from "very much improved since the initiation of treatment" to "very much worse since the initiation of treatment" (from 1 to 7)

    Measured: This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions

  9. Evaluation of patient's blinding to the type of stimulation in the crossover trial

    This blind evaluation will be done in phase 1 using a dedicated questionnaire (only for each condition since all patients will receive the same active treatment in the open-label phase 2).

    Measured: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) of Phase 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2024
  2. Study start7 May 2024
  3. Primary completion20 Sep 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06702189
Sponsor's protocol ID
2024-A00020-47
Acronym
EXOBACK
Status last verified
Feb 2026
First submitted
2 Nov 2024
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing EXOPULSE MOLLII SUIT (active) in people with Low Back Pain, run by Institut De La Colonne Vertebrale Et Des Neurosciences at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Samar S AYACHE, MD, PhD (+33 149814662, samarayache@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain-related disability reduction will be assessed using the QBPDS (Quebec Back Pain Disability Scale) before and after active and sham stimulation (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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