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临床试验/NCT07356362
NCT07356362招募中不适用

The Effectiveness of High-power Laser Therapy in the Treatment of Notalgia Paresthetica: A Randomised Controlled Study.

Uşak University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年7月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Pain screening with PainDETECT

研究概览

简要总结

A non-invasive modality for the management of neuromusculoskeletal pain conditions that has emerged as a compelling option is high-power laser therapy (HPLT). The pathophysiology of notalgia paresthetica (NP) is treated uniquely by HPLT, which targets both the presumed muscular component of nerve entrapment and the resultant neuropathic symptoms. The main goal of this study, which is randomised, controlled and blinded by assessors, is to find out how well High-Power Laser Therapy (HPLT) works as an extra treatment to standard care in reducing itching, pain and improving quality of life for patients with long-term nerve pain.

详细描述

Notalgia Paresthetica (NP) is a sensory mononeuropathy characterized by a well-circumscribed area of pruritus, paresthesia, burning pain, and hyperpigmentation on the medial aspect of the scapular and infrascapular regions. The condition results from the entrapment or compression of the posterior rami of the thoracic spinal nerves T2 through T6 as they traverse through the multifidus spinae muscle, making a sharp turn to penetrate the fascia of the back muscles. This anatomical vulnerability creates a predisposition to nerve irritation, leading to the characteristic symptoms. NP is often chronic and recalcitrant to treatment, with significant negative impacts on sleep, daily activities, and quality of life.

The current management of NP is challenging and often unsatisfactory. First-line treatments typically include topical agents such as capsaicin cream, topical anesthetics, or corticosteroids to alleviate localized symptoms. For more persistent cases, systemic medications like gabapentinoids or tricyclic antidepressants may be employed, though their efficacy is variable and side effects can be limiting. Interventional procedures, including trigger point injections with anesthetics and corticosteroids, or botulinum toxin A injections, have shown promise by targeting the underlying muscular entrapment. However, the evidence base for these interventions remains limited, consisting largely of case reports and small series, highlighting a significant gap in the availability of effective, non-invasive, and well-tolerated therapeutic options.

High-Power Laser Therapy (HPLT) has emerged as a compelling non-invasive modality for the management of neuromusculoskeletal pain conditions. Operating at power outputs typically between 1 and 15 Watts, HPLT utilizes wavelengths (e.g., 980 nm, 1064 nm) that provide deep tissue penetration, reaching the affected neurovascular structures beneath the thick paraspinal musculature. The therapeutic mechanisms of HPLT are multifactorial, combining significant photothermal effects with photobiomodulation. These include deep tissue analgesia, reduction of inflammation and edema, relaxation of hypertonic muscles, enhanced microcirculation, and stimulation of nerve repair processes. By targeting both the presumed muscular component of nerve entrapment and the resultant neuropathic symptoms, HPLT presents a uniquely suited, non-pharmacological intervention for the pathophysiology of NP.

Despite the growing body of evidence supporting HPLT for various entrapment neuropathies, such as meralgia paresthetica, its application specifically for Notalgia Paresthetica remains largely unexplored. A rigorous, controlled investigation is necessary to determine its clinical value and establish it as a viable treatment option.

Aim of the Study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessors will be blinded. The clinician conducting the outcome assessments will be unaware of group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-75 years
  • Clinical diagnosis of unilateral Notalgia Paresthetica for at least 3 months
  • Presence of characteristic symptoms (pruritus, paresthesia, and/or burning pain) in the typical T2-T6 dermatomal distribution
  • A minimum score of 4 on the Numeric Rating Scale (NRS) for pruritus intensity
  • Presence of hyperpigmentation in the affected area

排除标准

  • - Secondary causes of symptoms (e.g., spinal pathology, herpes zoster, renal failure)
  • Previous spinal surgery in the thoracic region
  • Coagulopathy or use of anticoagulant medication
  • Skin diseases or infections in the treatment area
  • Pregnancy or lactation
  • Cognitive impairment affecting ability to complete questionnaires
  • Previous treatment with botulinum toxin in the affected area within 6 months

研究组 & 干预措施

Experimental Group: High-Power Laser Therapy group

Experimental

Methodology for application, method for scanning, the laser probe will be shifted gradually and without interruption over the whole length of the LFCN (from just the medial and inferior aspects of the ASIS, distally along the thigh).

干预措施: High-power laser (Device)

Sham Laser Group

Sham Comparator

The procedure is the same as Group 1, but without the therapeutic energy emitted by the sham laser applicator. The device will make a beeping sound and show a display as if it is functioning.

干预措施: Sham Laser (Other)

结局指标

主要结局

Pain screening with PainDETECT

时间窗: Baseline, 3rd week, 3rd months

PainDETECT screening questionnaire: PainDETECT is a simple, easy to use screening questionnaire. The questionnaire consists of 9 items and is completed by the patient (no clinical examination is required). There are 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics. A total score of 19 or more is indicative of likely neuropathic pain.

次要结局

  • Pruritus Intensity(Baseline, 3rd week, 3rd months)

研究者

发起方
Uşak University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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