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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coccygectomy Treatment | Patients undergoing coccygectomy surgical procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coccygectomy | Other | Patient receiving coccygectomy surgery. |
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| 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 |
| 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. |
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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
Failure of conservative treatment methods: 4 weeks of NSAIDS, seat cushion, and rest
Partial coccygectomy
Exclusion Criteria:
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All patients will be seen and enrolled through an outpatient spine specialty clinic of Dr. Edward Hanley.
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| Name | Affiliation | Role |
|---|---|---|
| Edward N Hanley, MD | Carolinas Medical Center, Department of Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center, Department of Orthopaedic Surgery | Charlotte | North Carolina | 28204 | United States |
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From 2007-2011, 98 patients underwent coccygectomy for chronic coccydynia. Included patients were over 18 years, had coccygeal pain and abnormality on physical and radiographic evaluation and had failed conservative management. Outcome measures were the Oswestry Disability Index (ODI), Visual Analog Scale (VAS) and the Short Form 36 (SF-36).
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| ID | Title | Description |
|---|---|---|
| FG000 | Coccygectomy Treatment | Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The study then evolved into a prospective observational case series of surgical treatment with total coccygectomy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Coccygectomy Treatment | Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | Baseline,1 year and 2 years |
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Two years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coccygectomy Treatment | Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Seymour, PhD | Carolinas Healthcare System | 704-355-2000 | Rachel.Seymour@carolinas.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2011 | Jan 23, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2011 | Jan 24, 2018 | ICF_001.pdf |
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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 |
| Baseline,1 year and 2 years |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Etiology for Symptoms | Count of Participants | Participants |
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| Co-morbidities | Count of Participants | Participants |
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| Coccydynia Pain Management | Count of Participants | Participants |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline,1 year and 2 years |
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| Primary | 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" | Posted | Mean | Full Range | units on a scale | Baseline,1 year and 2 years |
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| Secondary | Complication Rates | Complication rates after coccygectomy surgery | Posted | Count of Participants | Participants | Baseline,1 year and 2 years |
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| Secondary | 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. | Posted | Count of Participants | Participants | Baseline,1 year and 2 years |
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| 0 |
| 98 |
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| 98 |
| 0 |
| 98 |
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