Management of Coccydynia: A Prospective, Observational Study of Coccygectomy

NCT02701192 | Completed Results

• 1 other identifier: 04-07-08B
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coccygodynia

Keywords

coccygodynia; coccygectomy; coccyx

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• Complication Rates

  Baseline,1 year and 2 years

• Treatment Success

  Baseline,1 year and 2 years

Study Arms (1)

Coccygectomy Treatment

Patients undergoing coccygectomy surgical procedure.

Other: Coccygectomy

Interventions

Coccygectomy OTHER

Patient receiving coccygectomy surgery.

Coccygectomy Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Coexisting low back pain
• Total previous coccyx surgery or previous lumbar fashion
• Under 18 years of age

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center, Department of Orthopaedic Surgery

Charlotte, North Carolina, 28204, United States

Location

Results Point of Contact

• Title: Rachel Seymour, PhD
• Organization: Carolinas Healthcare System

Rachel.Seymour@carolinas.org

704-355-2000

Study Officials

• Edward N Hanley, MD

  Carolinas Medical Center, Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: March 8, 2016
• Study Start: September 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2016
• Last Updated: April 22, 2022
• Results First Posted: June 14, 2021

Record last verified: 2021-06

Locations

US (1)