Clinical trial NCT02701192: Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
Official title: Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coccygodynia
Keywords: coccygodynia
coccygectomy
coccyx
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be seen and enrolled through an outpatient spine specialty clinic of Dr. Edward Hanley.

Brief 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.

Detailed 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.

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

  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

Primary outcomes:
measure: Pain Change From Baseline at 2 Years
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status- SF-36v2:Physical Functioning
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status- SF-36v2: Role Functioning-Physical
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status-SF-36v2: Role Functioning- Emotional
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status-SF-36v2: Energy/Fatigue
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status-SF-36v2: Emotional Well-being
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status-SF-36v2: Social Functioning
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status-SF-36v2: Pain
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status-SF-36v2: General Health
timeFrame: Baseline,1 year and 2 years
measure: Patient Health Status-SF-36v2: Health Change
timeFrame: Baseline,1 year and 2 years
measure: Lower Back Disability
timeFrame: Baseline,1 year and 2 years
Secondary outcomes:
measure: Complication Rates
timeFrame: Baseline,1 year and 2 years
measure: Treatment Success
timeFrame: Baseline,1 year and 2 years
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center, Department of Orthopaedic Surgery
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center, Department of Orthopaedic Surgery
name: Edward N Hanley, MD
role: PRINCIPAL_INVESTIGATOR
References: