Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Intraepidermal Nerve Fibre density (IENFD)
研究概览
简要总结
ACNES is a neuropathic pain condition of the abdominal wall. It is a clinical diagnosis based on patient's history and physical examination. No diagnostic test is available to confirm the diagnosis.
This pilot study will determine if skin biopsies can be used as diagnostic test. Two 3mm biopsies will be taken and used to count the small nerve fibres in the skin. The number of small nerve fibres of the painful skin will be compared to non-painful skin. Skin biopsy and small fibre nerve count is already used as diagnostic test in patients with small-fibre neuropathy.
The investigators hypothesize that patients with ACNES will have a reduced number of small nerve fibres in the affected skin, compared to the non-affected skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The pathologists who will measure the nerve fibre density are blinded; they will not know if the biopsy is from the affected or non-affected side.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of pain >3 months
- •Newly diagnosed unilateral ACNES
- •Fully completed intake questionnaire
- •Obtained written informed consent
排除标准
- •Inability to understand Dutch language
- •Bilateral ACNES
- •Previously administered injections with corticosteroids at trigger point (injection with a local anaesthetic is allowed)
- •Previous Pulsed Radiofrequency (PRF)-treatment at trigger point
- •History of open abdominal surgery
- •History of neurectomy
- •Known neuromuscular or neurodegenerative disease
- •Antiplatelet or anticoagulants use or known coagulation disorders
- •Disorder known to cause a reduced IENFD;
- •Hypothyroidism
- •Renal failure
- •Vitamin B12 deficiency
- •Monoclonal gammopathy
- •Alcohol abuse (>5 IU a day)
- •Malignancies
- •Medication that cause neuropathy (for example chemotherapy)
结局指标
主要结局
Intraepidermal Nerve Fibre density (IENFD)
时间窗: Both biopsies will be taken at the same time, as their difference will be studied. The biopsies will be taken at the second outpatient visit, 2 or 3 weeks after the first visit, just after the second triggger point injection (standard of care).
Difference in IENFD (measured in IENF/mm) from both affected and non-affected side of the abdominal wall.
次要结局
- Treatment response(Treatment response will be assessed 2 to 6 weeks after each treatment (trigger point injections, PRF and neurectomy), as standard of care.)
- Pain score(Assessed at first outpatient visit, used as baseline data.)
- Duration of pain(Assessed at first outpatient visit, used as baseline data.)
研究者
dr. RMH Roumen, surgeon
Head of surgery, Principal Investigator
Maxima Medical Center