N/A
N=100
Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
Coccygodynia
Bottom Line
View on ClinicalTrials.gov: NCT02701192 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Pain Change From Baseline at 2 Years — 59.08; 19.35; 20.28 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Coccygectomy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Change From Baseline at 2 Years |
59.08; 19.35; 20.28 | — |
| PRIMARY Patient Health Status- SF-36v2:Physical Functioning |
55.23; 80.68; 79.24 | — |
| PRIMARY Patient Health Status- SF-36v2: Role Functioning-Physical |
30.21; 69.41; 70.12 | — |
| PRIMARY Patient Health Status-SF-36v2: Role Functioning- Emotional |
54.17; 86.99; 73.4 | — |
| PRIMARY Patient Health Status-SF-36v2: Energy/Fatigue |
43.07; 62.05; 60.78 | — |
| PRIMARY Patient Health Status-SF-36v2: Emotional Well-being |
66.28; 79.73; 77.44 | — |
| PRIMARY Patient Health Status-SF-36v2: Social Functioning |
47.18; 55.45; 55.81 | — |
| PRIMARY Patient Health Status-SF-36v2: Pain |
39.95; 70.34; 71.75 | — |
| PRIMARY Patient Health Status-SF-36v2: General Health |
68.39; 73.41; 69.31 | — |
| PRIMARY Patient Health Status-SF-36v2: Health Change |
45.31; 81.4; 74.47 | — |
| PRIMARY Lower Back Disability |
39.07; 15.39; 16.26 | — |
| SECONDARY Complication Rates |
20 | — |
| SECONDARY Treatment Success |
69; 29 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02701192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.