Management of Coccydynia: A Prospective, Observational Study of Coccygectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Management of Coccydynia: A Prospective, Observational Study of Coccygectomy

Conditions
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Coccygodynia

Intervention / Treatment
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* Other: Coccygectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Coexisting low back pain Total previous coccyx surgery or previous lumbar fashion Under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coccygectomy Treatment<br>Patients undergoing coccygectomy surgical procedure. | Other: Coccygectomy<br>* Patient receiving coccygectomy surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Change From Baseline at 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. | Baseline,1 year and 2 years | 
| Patient Health Status- SF-36v2:Physical Functioning | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Patient Health Status- SF-36v2: Role Functioning-Physical | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Patient Health Status-SF-36v2: Role Functioning- Emotional | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Patient Health Status-SF-36v2: Energy/Fatigue | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Patient Health Status-SF-36v2: Emotional Well-being | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Patient Health Status-SF-36v2: Social Functioning | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Patient Health Status-SF-36v2: Pain | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Patient Health Status-SF-36v2: General Health | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Patient Health Status-SF-36v2: Health Change | The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state. | Baseline,1 year and 2 years | 
| Lower Back Disability | 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 | Baseline,1 year and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rates | Complication rates after coccygectomy surgery | Baseline,1 year and 2 years | 
| Treatment Success | Threshold for treatment success was based on a minimum clinically importance difference (MCID) of 20 points on the oswestry disability index at 2 year follow-up and an overall oswestry disability index score of <22 points. | Baseline,1 year and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coccygodynia, coccygectomy, coccyx