Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient Health Status- SF-36v2: Role Functioning-Physical
研究概览
简要总结
The purpose of the study is to analyze the outcomes of patients with coccygodynia (pain in and around the coccyx region) treated with coccygectomy (a procedure during which the coccyx is removed) and to report on the rate of complications of the procedure. The study will also aim to find pre-operative clinical predictors of good outcomes after coccygectomy. The investigators hypothesize that coccygectomy will not improve scores on the Short Form-36 (SF-36), Oswestry Disability Scale (ODI), tolerable sitting time, or Visual Analog Pain Scale (VAS). Also, the investigators hypothesize that there are no independent variables associated with improved outcomes.
详细描述
Coccygodynia can be a functionally limiting and painful disease with conservative treatment providing mixed results. When proper surgical indications are met, results seem to be promising. However, there is a lack of data in the literature to support surgical treatment. The case series reports currently in the literature are small and retrospective with ill-defined selection criteria. To date there has been no study prospectively following patients undergoing coccygectomy. This type of study could accurately obtain data prospectively. This information will help better guide the clinician through treatment of this disease.
All patients will be seen and enrolled through an outpatient spine specialty clinic of the senior author. Patients that meet the inclusion criteria will be offered enrollment in the study by a third party (clinical research assistant). Patients enrolled will then complete pre-treatment SF-36, Oswestry Disability Scale and a pain visual analog scale. Patients will be followed at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years after treatment. Patients will complete the questionnaire containing the VAS and tolerable sitting time at all visits with SF-36 and Oswestry disability scale completed at one year post treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Pain in the region of the coccyx
- •Pain for greater than 2 months
- •Tenderness to palpation over coccyx
- •Radiographic abnormalities of the coccyx
- •Hypermobility of greater than 25 degrees, posterior subluxation of a mobile segment, or a coccygeal spicule on sitting radiographs
- •post-traumatic coccygodynia
- •Failure of conservative treatment methods: 4 weeks of NSAIDS, seat cushion, and rest
- •Partial coccygectomy
排除标准
- •Coexisting low back pain
- •Total previous coccyx surgery or previous lumbar fashion
- •Under 18 years of age
结局指标
主要结局
Patient Health Status- SF-36v2: Role Functioning-Physical
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Social Functioning
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status- SF-36v2:Physical Functioning
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Pain Change From Baseline at 2 Years
时间窗: Baseline,1 year and 2 years
Patients will complete the100mm Visual Analog Scale (VAS) at Baseline and 2 years after procedure. Patient will be instructed to indicate pain intensity by marking a 100mm line where one end, 0 indicates no pain and 100 indicates extreme pain on the other end.
Patient Health Status-SF-36v2: Energy/Fatigue
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Emotional Well-being
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Role Functioning- Emotional
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Pain
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Health Change
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Lower Back Disability
时间窗: Baseline,1 year and 2 years
Oswestry Disability Index used to measure a patient's permanent functional disability. Scores range from 0 to 100. scores between 0 and 20 described as "minimal disability", scores between 21and 40 described as "moderate disability",scores between 41and 60 described as "severe disability",scores between 61 and 80 described as "crippled" and scores between 81 and 100 described as " bed bounded"
Patient Health Status-SF-36v2: General Health
时间窗: Baseline,1 year and 2 years
The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
次要结局
- Complication Rates(Baseline,1 year and 2 years)
- Treatment Success(Baseline,1 year and 2 years)