This trial is active, not recruiting.

Condition coccygodynia
Treatment coccygectomy
Sponsor Carolinas Healthcare System
Start date September 2007
End date December 2015
Trial size 77 participants
Trial identifier NCT02701192, 04-07-08B


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients undergoing coccygectomy surgical procedure.
Patient receiving coccygectomy surgery.

Primary Outcomes

Pain level
time frame: 2 years
Patient Health Status
time frame: 1 year
Lower Back Disability
time frame: 1 year

Secondary Outcomes

Complication rates
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 1. Hypermobility of greater than 25 degrees, posterior subluxation of a mobile segment, or a coccygeal spicule on sitting radiographs 2. 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

Additional Information

Official title Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
Principal investigator Edward N Hanley, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Carolinas Healthcare System.