Nociceptive Processing in Acute Cutaneous Nerve Entrapment Syndrome: a Quantitative Sensory Testing Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pressure pain threshold
研究概览
简要总结
Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of penetration out of the ventral rectus sheet should be considered. This neurectomy however is effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory ACNES patients suffer from underlying pathologic pain disorders is subject to investigation, by using quantitative sensory testing (QST).
Objective: To investigate nociceptive processing and possible underlying pathological pain processing mechanisms in ACNES patients.
Study design: An observational case-control study.
Study population: Patients treated for ACNES (n = 50) compared to healthy controls from an existing database.
Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment of ACNES for both successfully treated and refractory patients in comparison to healthy controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures. Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires.
Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST. Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been diagnosed with abdominal complaints, matching ACNES:
- •Patient had a constant site of tenderness that is superficially located with a small (<2cm2) area of maximal tenderness.
- •The most intense pain could be localized with the tip of one finger.
- •Tenderness increased by abdominal muscle tensing (Carnett's test).
- •has been treated (successfully and unsuccessfully) for ACNES.
- •Patient is at least 18 years old on the day the informed consent form will be signed.
- •Patient is willing and able to comply with the trial protocol.
- •Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
排除标准
- •Abdominal complaints were due to a condition other than ACNES (e.g. pain related to scar tissue).
- •Patient has (a history of) another (chronic) pain syndrome that interferes with the interpretation of QST results.
- •Patient has (a history of) Raynaud syndrome or fenomenon, or a medical disorder that interferes with the study measurements or may pose a risk for the patient.
- •Patient does not feel a pinprick test to the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
- •Female patient is pregnant during the course of the study.
结局指标
主要结局
pressure pain threshold
时间窗: > 6 weeks after treatment
The pressure pain threshold (pPT) will be determined by pressing an electronic pressure algometer, which has a surface area of 1 cm2, on a distinct muscles. The patient will be asked to say 'now' when the sensation is rated as unpleasant. The pressure will be increased at a rate of 50 kPa/sec until the pPT is reached.
次要结局
- Electrical Sensation Threshold (eST)(> 6 weeks after treatment)
- Electrical Pain Threshold (ePT)(> 6 weeks after treatment)
- Electrical Pain Tolerance Threshold (ePTT)(>6 weeks after treatment)
- Electric Wind-Up Response (e-WUR)(> 6 weeks after treatment)
- Visual Analogue Scale(> 6 weeks after treatment)