Determination of the Effectiveness of Desensitisation and Pain Neuroscience Training in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain Phenotype
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
- Pressure Paın Threshold Measurement
研究概览
简要总结
The aim of our study was to determine the effectiveness of desensitisation and pain neuroscience education in a group of patients with mixed phenotype pain (neuropathic and nosiplastic).
详细描述
People between the ages of 18-65, diagnosed with Carpal Tunnel Sedrome, who are suitable for the Nosiplastic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain will be applied to patients with CTS. After determining the predominant pain phenotype in patients with CTS, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. One group (Group 1) will receive desensitisation and the other group (Group 2) will receive desensitisation and pain neuroscience education. Numerical rating scale (NRS) will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale will be used for symptom severity assessment and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used for functional status assessment. Pressure pain threshold will be measured with an algometer to evaluate hypersensitivity. The Pain Catastrophising Scale and the Tampa Kinesiophobia Scale will be administered to the patients. Normality of the data distribution will be assessed using the Shapiro-Wilk test. Fischer's exact test and chi-square test will be used to verify the relationship between categorical variables. A mixed model ANOVA will be performed on 2 (group 1 and group 2) x 3 (time: baseline, post-intervention, 3 months post-intervention) different outcome measures (pain intensity, symptom severity, functional status, pain catastrophising and kinesiophobia) to detect between-group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Being diagnosed with CTS
- •Being suitable for the nosiplastic pain phenotype
- •Being between the ages of 18-65
- •Volunteering to participate in the study
排除标准
- •Having systemic inflammatory disease
- •Having a disease that may cause polyneuropathy such as diabetes mellitus
- •Having a pacemaker
- •Having a disease affecting the central nervous system
- •Having cervical radiculopathy
- •History of previous operation or local steroid injection due to CTS
- •Hypersensitivity to heat and cold
研究组 & 干预措施
Group 1 (desensitisation)
Group 1 will receive desensitisation.
干预措施: Desensitisation (Other)
Group 2 (desensitisation and pain neuroscience education)
Group 2 will receive desensitisation and pain neuroscience education.
干预措施: Desensitisation (Other)
Group 2 (desensitisation and pain neuroscience education)
Group 2 will receive desensitisation and pain neuroscience education.
干预措施: Pain neuroscience education (Other)
结局指标
主要结局
Pressure Paın Threshold Measurement
时间窗: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
The pressure pain threshold (PPT), the minimum amount of pressure at which the pressure sensation changes to pain, is measured with an electronic algometer (median nerve, ulnar nerve and radial nerve, C5-C6 zygapophyseal joint level (proximal), and tibialis anterior). Participants are asked to report when the sensation changes from pressure to pain. The mean of the three trials is calculated (with a 30 s rest interval in between).
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale
时间窗: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale is an 11-item questionnaire used to assess symptom severity in individuals with CTS. Each item is scored from 1 to 5. Scores range from 1 (no symptoms) to 5 (worst symptoms). The patient's symptom severity score is the average score of 11 items.
Boston Carpal Tunnel Questionnaire - Functional Status Scale
时间窗: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
Boston Carpal Tunnel Questionnaire - Functional Status Scale is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.
Pain Catastrophising Scale
时间窗: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
The Catastrophising Pain Scale (PCS) is used to measure catastrophising in response to pain through 13 statements with four possible options from 1 "never" to 4 "always". Higher scores indicate greater catastrophised pain.
Tampa Kinesiophobia Scale
时间窗: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
It is a 17-question scale. The scale has a 4-point Likert scale (1= Strongly disagree, 4= Strongly agree). After reversing items 4, 8, 12 and 16, a total score is calculated. The person receives a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Numerical Rating Scale
时间窗: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
次要结局
- Cold Pain Threshold(2 minutes)
- Hot Pain Threshold(2 minutes)
- Pressure Pain Threshold(3 minutes)
- Mechanical Pain Threshold(3 minutes)
- Dynamic Mechanical Allodynia(3 minutes)
研究者
Emrah Afsar
Phd
Kutahya Health Sciences University