Management of Coccydynia: A Prospective, Observational Study of Coccygectomy

Coccygodynia Clinical Trial

— Coccyx  

Official title:

Management of Coccydynia: A Prospective, Observational Study of Coccygectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701192
• Other study ID #: 04-07-08B
• Status: Completed
• Start date: September 2007
• Est. completion date: October 2016

Study information

• Verified date: June 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coccygodynia

Intervention

Other:
• Coccygectomy
Patient receiving coccygectomy surgery.

Locations

Country	Name	City	State
United States	Carolinas Medical Center, Department of Orthopaedic Surgery	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Complication Rates	Complication rates after coccygectomy surgery	Baseline,1 year and 2 years
Secondary	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