Percutaneous Electrical Nerve Stimulation As Alternative To Nerve Blocks In Anesthesia, Pain Medicine And Rehabilitation Of Nonspecific Chronic Pain
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
Chronic musculoskeletal pain of non-specific origin affects approximately 30% of the global population. Beyond its prevalence, it represents a serious health and socioeconomic problem. It is considered the leading cause of years lived with disability and is characterized by persistent functional limitation, deterioration of quality of life, and poorer mental health, with a high comorbidity of depression, anxiety, and sleep disorders, as well as a greater risk of suicidal ideation and behavior.
From a socioeconomic perspective, chronic pain entails an impact of up to USD 635 billion annually just in United States (USA). In fact, spinal pain alone represents the condition with the highest direct costs (around USD 134.5 billion in USA) and additional indirect costs due to absenteeism and presenteeism, which impair productivity and work performance. These figures are expected to be substantially higher when considered at a global scale.
One of the main aggravating factors of this condition is that in up to 90% of patients experiencing pain there is no identifiable anatomopathological substrate that reliably explains the symptoms (non-specific pain). Radiological findings are extremely common in asymptomatic populations, and making diagnostic or therapeutic decisions based on such findings, promotes overdiagnosis and low-value clinical cascades. It is estimated that up to 50% of imaging requests and 60% of spinal surgeries6 are unnecessary or unjustified. For this reason, Clinical Practice Guidelines recommend prioritizing interventional diagnostic techniques based on functional criteria over the interpretation of radiological findings, as they allow for more sensitive and specific identification of nociceptive sources (with a recommendation grade I-II).
In this context, the motivation of the project is to study PENS as a non-pharmacological, safe, and transferable alternative to nerve blocks, reducing the risk of complications associated with the use of local anesthetics/corticosteroids and large-gauge needles. According to recent systematic reviews and meta-analyses confirming immediate analgesic responses, PENS could be a feasible alternative that maintains functional diagnostic and therapeutic value with a generally mild adverse-event profile and lower cost.
详细描述
Within the broad spectrum of chronic pain conditions, low back pain (LBP) is the leading cause of years lived with disability worldwide and one of the largest contributors to the global disease burden. According to the latest Global Burden of Disease analysis, approximately 620 million people suffered from LBP in 2020. Projections for the coming decades are not encouraging since, by 2050, the number of affected individuals is expected to rise to 843 million, a 36.4% increase compared to 2020. This growth will be mainly driven by population increase and aging, with the sharpest rises expected in Asia and Africa.
Beyond its direct health consequences, LBP imposes a considerable economic burden on both individuals and societies, as its highest incidence occurs during the most productive working years (approximately 45-55 years old). In the USA alone, direct costs related to spinal disorders reached USD 315 billion between 2012 and 2014, in addition to productivity losses estimated in hundreds of millions of workdays each year. Considering its growing prevalence and socioeconomic implications, LBP is regarded as a global health priority.
LBP may originate from a wide variety of musculoskeletal, neurological, or visceral conditions, and its clinical expression may combine nociceptive mechanisms (related to tissue injury or stimulation of lumbar structures), neuropathic mechanisms (involving lesions or disease of the somatosensory system), and nociplastic mechanisms (involving altered nociceptive processing without structural lesions, often with central sensitization and descending inhibitory dysfunction).
Current clinical frameworks establish that in up to 90% of patients, it is not possible to identify a clear anatomopathological pain source (thus defined as non-specific LBP). The main challenge lies in identifying which structures (i.e., intervertebral discs, facet /zygapophyseal joints, sacroiliac joints, ligaments, or myofascial tissues) are the nociceptive sources. The absence of a defined structural correlate (as most structural abnormalities are also frequent in asymptomatic individuals) largely explains the high recurrence and chronicity rates, as well as the frequency of ineffective treatments, unjustified surgeries, and the economic impact of healthcare utilization without a clearly established etiology. Consequently, diagnosis in these patients is essentially clinical and based on exclusion criteria, with a therapeutic focus on symptom modulation and functional recovery rather than on identifying and correcting a single structural lesion.
Although scientific evidence consistently supports the high percentage of non-specific LBP cases and discourage routine imaging in such patients, this practice remains common in hospital care. It is estimated that 30% to 55% of imaging studies requested for LBP are unnecessary or not clinically indicated. The indiscriminate use of imaging not only generates unnecessary costs and delays, but also exposes patients to unjustified radiation and overdiagnosis risk. For example, the prevalence of disc protrusions in asymptomatic individuals increases from 30% at age 20 to 84% at age 80, which may lead to misinterpreting benign degenerative changes as pathological, fueling overtreatment and patient anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor would be a different investigator blinded to the interventions
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with chronic LBP lasting at least three months and clinical suspicion of facet joint pain.
- •A balanced sex distribution and a wide range of body mass index (BMI) will be promoted to allow subgroup analyses and to explore potential associations between obesity and procedural complications, thus strengthening the external validity of the study. This demographic selection is justified by prevalence patterns reported in the literature and by the need to capture clinically relevant effect modifiers in real clinical environments.
- •The suspicion of facet joint pain will be based on a compatible axial clinical pattern and the absence of objective neurological deficit, considering that neither physical examination nor imaging tests provide sufficient specificity. Therefore, diagnostic confirmation will be performed functionally through ultrasound-guided medial branch diagnostic blocks, which are the most reliable tool for attributing pain to the facet joint. The dual innervation of each lumbar facet joint will be considered; thus, two adjacent levels will be blocked per joint (the medial branch at the affected level and the one immediately above).
- •Eligible patients will be those with a positive functional screening in two independent medial branch diagnostic blocks performed with anesthetics of different duration, in separate sessions, to reduce false positives.
- •The diagnosis will be confirmed in cases reporting clinically relevant pain relief within the expected pharmacological window.
排除标准
- •Exclusion criteria will include red flags or specific etiologies such as infection, neoplasm, fracture, or cauda equina syndrome, as well as patients with progressive motor radiculopathy or another demonstrated neuropathic pain source other than facet origin.
- •Individuals who have undergone prior procedures that could compromise response interpretation such as recent radiofrequency denervation, cryoneurolysis or intra-articular corticosteroid injections within a period that could extend analgesic effects.
研究组 & 干预措施
PENS
A single ultrasound-guided session will be applied using fine solid needles (0.32 mm diameter), accounting for dual innervation. Electrical parameters will be fixed within recommended ranges (10 Hz, 250 µs, current intensity sufficient to produce a strong but tolerable sensation below the motor threshold using a standardized ramp, and session duration of 20 minutes).
干预措施: Percutaneous electrical nerve stimulation (Device)
Nerve block
Two adjacent levels per joint will be blocked in a single session. After minimal intradermal infiltration for local anesthesia, a sterile 25G-22G needle will be inserted in-plane toward the target under continuous visualization. Before administering the drug in opaque syringes, negative aspiration and fractional injection will be performed, confirming the absence of abnormal resistance or radiating pain. The diagnostic injectate will be a local anesthetic without corticosteroid (1% lidocaine) with low volumes of 0.5 ml per branch to limit diffusion.
干预措施: Nerve block with Lidocain (Drug)
PENS + nerve block
Both procedures will be performed in a single visit (first PENS, followed by the nerve block) following the same procedures described above
干预措施: Nerve block with Lidocain (Drug)
PENS + nerve block
Both procedures will be performed in a single visit (first PENS, followed by the nerve block) following the same procedures described above
干预措施: Percutaneous electrical nerve stimulation (Device)
PENS + placebo block
In the same visit, PENS will be applied following the same described protocol, and the full ritual of the nerve block will be reproduced. However, in this group, no active drug will be administered (a minimal volume of inert solution will be injected into the subcutaneous/superperiosteal plane to mimic the injection sensation without depositing perineural anesthetic).
干预措施: Percutaneous electrical nerve stimulation (Device)
PENS + placebo block
In the same visit, PENS will be applied following the same described protocol, and the full ritual of the nerve block will be reproduced. However, in this group, no active drug will be administered (a minimal volume of inert solution will be injected into the subcutaneous/superperiosteal plane to mimic the injection sensation without depositing perineural anesthetic).
干预措施: Sham Block (Other)
结局指标
主要结局
Pain intensity
时间窗: From baseline within the pre-specified time window for each intervention (two post-intervention assessments will be performed in all groups at 15 and 45 minutes) and maintained at 7 days
The primary variable will be immediate analgesic response, defined as a ≥50% reduction in the Numerical Pain Rating Scale (NPRS, 0-10). Lower scores indicate less pain intensity.
次要结局
- Participants' satisfaction(After 7 days)
- Pain during specific movements(Baseline, 45 minutes, and 7 days)
- Analgesic drug consumption(From 3 months before the study until 7 days after the intervention.)
- Pressure pain threshold(Baseline, 45 minutes, and 7 days)
研究者
JUAN ANTONIO VALERA CALERO
Doctor in Health Sciences
Universidad Complutense de Madrid
