Trial Outcomes & Findings for Management of Coccydynia: A Prospective, Observational Study of Coccygectomy (NCT NCT02701192)

NCT ID: NCT02701192

Last Updated: 2022-04-22

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline,1 year and 2 years
• Results posted on: 2022-04-22

Participant Flow

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).

Participant milestones

Measure	Coccygectomy Treatment Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Overall Study STARTED	100
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Coccygectomy Treatment Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Overall Study Protocol Violation	2
Overall Study Lost to Follow-up	4

Baseline Characteristics

Management of Coccydynia: A Prospective, Observational Study of Coccygectomy

Baseline characteristics by cohort

Measure	Coccygectomy Treatment n=98 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Age, Continuous	47.2 Years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Etiology for Symptoms Idiopathic	47 Participants n=5 Participants
Etiology for Symptoms Trauma	35 Participants n=5 Participants
Etiology for Symptoms Significant weight loss	8 Participants n=5 Participants
Etiology for Symptoms Post-partum	7 Participants n=5 Participants
Etiology for Symptoms Post floor surgery	1 Participants n=5 Participants
Co-morbidities Pre-existing Spinal disorder	17 Participants n=5 Participants
Co-morbidities Non-spine related musculoskletal pathology	37 Participants n=5 Participants
Co-morbidities Psychiatric illness	45 Participants n=5 Participants
Co-morbidities Chronic pain	28 Participants n=5 Participants
Co-morbidities Genitourinary pain disorder	3 Participants n=5 Participants
Co-morbidities Other pain syndrome	2 Participants n=5 Participants
Coccydynia Pain Management Prior Steroid Injection Therapy	70 Participants n=5 Participants
Coccydynia Pain Management Prior Opioid Use	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Pain Change From Baseline at 2 Years Pre-operative Baseline	59.08 units on a scale Interval 54.06 to 64.1
Pain Change From Baseline at 2 Years One year	19.35 units on a scale Interval 13.97 to 24.73
Pain Change From Baseline at 2 Years Two Years	20.28 units on a scale Interval 14.64 to 25.92

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status- SF-36v2:Physical Functioning Baseline	55.23 units on a scale Interval 48.65 to 61.81
Patient Health Status- SF-36v2:Physical Functioning One Year	80.68 units on a scale Interval 74.67 to 86.99
Patient Health Status- SF-36v2:Physical Functioning Two Years	79.24 units on a scale Interval 73.82 to 84.66

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status- SF-36v2: Role Functioning-Physical Baseline	30.21 units on a scale Interval 22.07 to 38.35
Patient Health Status- SF-36v2: Role Functioning-Physical Two Years	70.12 units on a scale Interval 61.13 to 79.11
Patient Health Status- SF-36v2: Role Functioning-Physical One Year	69.41 units on a scale Interval 59.98 to 78.84

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status-SF-36v2: Role Functioning- Emotional Baseline	54.17 units on a scale Interval 45.08 to 63.26
Patient Health Status-SF-36v2: Role Functioning- Emotional One Year	86.99 units on a scale Interval 80.02 to 93.96
Patient Health Status-SF-36v2: Role Functioning- Emotional Two Years	73.4 units on a scale Interval 64.67 to 82.13

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status-SF-36v2: Energy/Fatigue Baseline	43.07 units on a scale Interval 38.21 to 47.93
Patient Health Status-SF-36v2: Energy/Fatigue One Year	62.05 units on a scale Interval 56.86 to 67.24
Patient Health Status-SF-36v2: Energy/Fatigue Two Years	60.78 units on a scale Interval 56.0 to 65.56

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status-SF-36v2: Emotional Well-being Baseline	66.28 units on a scale Interval 62.02 to 70.54
Patient Health Status-SF-36v2: Emotional Well-being One Year	79.73 units on a scale Interval 75.81 to 83.65
Patient Health Status-SF-36v2: Emotional Well-being Two Years	77.44 units on a scale Interval 73.36 to 81.52

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status-SF-36v2: Social Functioning Baseline	47.18 units on a scale Interval 42.11 to 52.25
Patient Health Status-SF-36v2: Social Functioning One Year	55.45 units on a scale Interval 51.26 to 59.64
Patient Health Status-SF-36v2: Social Functioning Two Years	55.81 units on a scale Interval 51.89 to 59.73

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status-SF-36v2: Pain Baseline	39.95 units on a scale Interval 35.4 to 44.5
Patient Health Status-SF-36v2: Pain One Year	70.34 units on a scale Interval 63.96 to 76.72
Patient Health Status-SF-36v2: Pain Two Years	71.75 units on a scale Interval 66.06 to 77.44

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status-SF-36v2: General Health Baseline	68.39 units on a scale Interval 64.4 to 72.38
Patient Health Status-SF-36v2: General Health One Year	73.41 units on a scale Interval 68.61 to 78.21
Patient Health Status-SF-36v2: General Health Two Years	69.31 units on a scale Interval 64.46 to 74.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Patient Health Status-SF-36v2: Health Change Baseline	45.31 units on a scale Interval 39.82 to 50.8
Patient Health Status-SF-36v2: Health Change One Year	81.4 units on a scale Interval 76.03 to 86.77
Patient Health Status-SF-36v2: Health Change Two Years	74.47 units on a scale Interval 68.98 to 79.96

PRIMARY outcome

Timeframe: 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"

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Lower Back Disability Pre-operative Baseline	39.07 units on a scale Interval 35.22 to 49.92
Lower Back Disability One Year	15.39 units on a scale Interval 11.26 to 42.92
Lower Back Disability Two Years	16.26 units on a scale Interval 12.59 to 19.93

SECONDARY outcome

Timeframe: Baseline,1 year and 2 years

Complication rates after coccygectomy surgery

Outcome measures

Measure	Coccygectomy Treatment n=94 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Complication Rates	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Coccygectomy Treatment n=98 Participants Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Treatment Success Treatment Success	69 Participants
Treatment Success Treatment Failure	29 Participants

Adverse Events

Coccygectomy Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Seymour, PhD

Carolinas Healthcare System

Phone: 704-355-2000

Email: Rachel.Seymour@carolinas.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place