Management of Coccydynia: A Prospective, Observational Study of Coccygectomy (Coccyx)

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.

Study Overview

• Status: Completed
• Conditions: Coccygodynia
• Intervention / Treatment: Other: Coccygectomy

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center, Department of Orthopaedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients will be seen and enrolled through an outpatient spine specialty clinic of Dr. Edward Hanley.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coccygectomy Treatment; Patients undergoing coccygectomy surgical procedure.	Other: Coccygectomy; Patient receiving coccygectomy surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Edward N Hanley, MD, Carolinas Medical Center, Department of Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: coccygodynia; coccygectomy; coccyx
• Other Study ID Numbers: 04-07-08B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided