Management of Coccydynia: A Prospective, Observational Study of Coccygectomy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02701192

Acronym

Coccyx

Enrollment

100

Registered

2016-03-08

Start date

2007-09-30

Completion date

2016-10-31

Last updated

2022-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coccygodynia

Keywords

coccygodynia, coccygectomy, coccyx

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.

Interventions

OTHERCoccygectomy

Patient receiving coccygectomy surgery.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Lower Back Disability	Baseline,1 year and 2 years	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
Patient Health Status-SF-36v2: General Health	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Health Change	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Pain Change From Baseline at 2 Years	Baseline,1 year and 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.
Patient Health Status- SF-36v2:Physical Functioning	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status- SF-36v2: Role Functioning-Physical	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Role Functioning- Emotional	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Energy/Fatigue	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Emotional Well-being	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Social Functioning	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Patient Health Status-SF-36v2: Pain	Baseline,1 year and 2 years	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.

Secondary

Measure	Time frame	Description
Treatment Success	Baseline,1 year and 2 years	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.
Complication Rates	Baseline,1 year and 2 years	Complication rates after coccygectomy surgery

Countries

United States

Participant flow

Recruitment details

From 2007-2011, 98 patients underwent coccygectomy for chronic coccydynia. Included patients were over 18 years, had coccygeal pain and abnormality on physical and radiographic evaluation and had failed conservative management. Outcome measures were the Oswestry Disability Index (ODI), Visual Analog Scale (VAS) and the Short Form 36 (SF-36).

Participants by arm

Arm	Count
Coccygectomy Treatment Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.	98
Total	98

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	4
Overall Study	Protocol Violation	2

Baseline characteristics

Characteristic	Coccygectomy Treatment
Age, Continuous	47.2 Years STANDARD_DEVIATION 13
Coccydynia Pain Management Prior Opioid Use	45 Participants
Coccydynia Pain Management Prior Steroid Injection Therapy	70 Participants
Co-morbidities Chronic pain	28 Participants
Co-morbidities Genitourinary pain disorder	3 Participants
Co-morbidities Non-spine related musculoskletal pathology	37 Participants
Co-morbidities Other pain syndrome	2 Participants
Co-morbidities Pre-existing Spinal disorder	17 Participants
Co-morbidities Psychiatric illness	45 Participants
Etiology for Symptoms Idiopathic	47 Participants
Etiology for Symptoms Post floor surgery	1 Participants
Etiology for Symptoms Post-partum	7 Participants
Etiology for Symptoms Significant weight loss	8 Participants
Etiology for Symptoms Trauma	35 Participants
Sex: Female, Male Female	87 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 98
other Total, other adverse events	0 / 98
serious Total, serious adverse events	0 / 98

Outcome results

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