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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02701192
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 109
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coccygodynia	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 Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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"

Secondary Outcome Measures

1. Complication Rates [Baseline,1 year and 2 years]

   Complication rates after coccygectomy surgery

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolinas Medical Center, Department of Orthopaedic Surgery	Charlotte	North Carolina	United States	28204

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Edward N Hanley, MD, Carolinas Medical Center, Department of Orthopaedic Surgery

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 17, 2011
• Informed Consent Form - May 10, 2011

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02701192
• Other Study ID Numbers: 04-07-08B
• First Posted: Mar 8, 2016
• Last Update Posted: Apr 22, 2022
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Wake Forest University Health Sciences: coccygodynia; coccygectomy; coccyx

Study Results

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).

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Period Title: Overall Study
STARTED	100
COMPLETED	94
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Overall Participants	98
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47.2 (13)
Sex: Female, Male (Count of Participants)
Female	87 88.8%
Male	11 11.2%
Etiology for Symptoms (Count of Participants)
Idiopathic	47 48%
Trauma	35 35.7%
Significant weight loss	8 8.2%
Post-partum	7 7.1%
Post floor surgery	1 1%
Co-morbidities (Count of Participants)
Pre-existing Spinal disorder	17 17.3%
Non-spine related musculoskletal pathology	37 37.8%
Psychiatric illness	45 45.9%
Chronic pain	28 28.6%
Genitourinary pain disorder	3 3.1%
Other pain syndrome	2 2%
Coccydynia Pain Management (Count of Participants)
Prior Steroid Injection Therapy	70 71.4%
Prior Opioid Use	45 45.9%

Outcome Measures

1. Primary Outcome

Title	Pain Change From Baseline at 2 Years
Description	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.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Pre-operative Baseline	59.08
One year	19.35
Two Years	20.28

2. Primary Outcome

Title	Patient Health Status- SF-36v2:Physical Functioning
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	55.23
One Year	80.68
Two Years	79.24

3. Primary Outcome

Title	Patient Health Status- SF-36v2: Role Functioning-Physical
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	30.21
One Year	69.41
Two Years	70.12

4. Primary Outcome

Title	Patient Health Status-SF-36v2: Role Functioning- Emotional
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	54.17
One Year	86.99
Two Years	73.4

5. Primary Outcome

Title	Patient Health Status-SF-36v2: Energy/Fatigue
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	43.07
One Year	62.05
Two Years	60.78

6. Primary Outcome

Title	Patient Health Status-SF-36v2: Emotional Well-being
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	66.28
One Year	79.73
Two Years	77.44

7. Primary Outcome

Title	Patient Health Status-SF-36v2: Social Functioning
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	47.18
One Year	55.45
Two Years	55.81

8. Primary Outcome

Title	Patient Health Status-SF-36v2: Pain
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	39.95
One Year	70.34
Two Years	71.75

9. Primary Outcome

Title	Patient Health Status-SF-36v2: General Health
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	68.39
One Year	73.41
Two Years	69.31

10. Primary Outcome

Title	Patient Health Status-SF-36v2: Health Change
Description	The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Baseline	45.31
One Year	81.4
Two Years	74.47

11. Primary Outcome

Title	Lower Back Disability
Description	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"
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Pre-operative Baseline	39.07
One Year	15.39
Two Years	16.26

12. Secondary Outcome

Title	Complication Rates
Description	Complication rates after coccygectomy surgery
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	94
Count of Participants [Participants]	20 20.4%

13. Secondary Outcome

Title	Treatment Success
Description	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.
Time Frame	Baseline,1 year and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
Measure Participants	98
Treatment Success	69 70.4%
Treatment Failure	29 29.6%

Adverse Events

Time Frame	Two years
Arm/Group Title	Coccygectomy Treatment
Arm/Group Description	Patients undergoing coccygectomy surgical procedure. Coccygectomy: Patient receiving coccygectomy surgery.
All Cause Mortality
	Coccygectomy Treatment
	Affected / at Risk (%)	# Events
Total	0/98 (0%)
Serious Adverse Events
	Coccygectomy Treatment
	Affected / at Risk (%)	# Events
Total	0/98 (0%)
Other (Not Including Serious) Adverse Events
	Coccygectomy Treatment
	Affected / at Risk (%)	# Events
Total	0/98 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.