The Effects of EXOPULSE Mollii Suit on Low Back Pain (EXOBACK)" / EXOPULSE Mollii Suit and Low Back Pain (EXOBACK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain-related disability reduction will be assessed using the QBPDS (Quebec Back Pain Disability Scale) before and after active and sham stimulation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: EXOPULSE MOLLII SUIT (active) (Device)
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).
干预措施: EXOPULSE MOLLII SUIT (sham) (Device)
结局指标
主要结局
Pain-related disability reduction will be assessed using the QBPDS (Quebec Back Pain Disability Scale) before and after active and sham stimulation
时间窗: 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)
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).
次要结局
- 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))
- Mood symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS)(This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6))
- Improvement of the quality of life using the Short Form 36 Health Survey (SF-36)(This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6))
- Evaluation of overall improvement using the CGI (Clinical Global Impression)(This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions)
- Evaluation of patient's blinding to the type of stimulation in the crossover trial(This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) of Phase 1.)