CoccygodyniaCoccyxNCT02701192
Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
An observational study of Coccygodynia, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coccygodynia
- What is being tested?
- Coccygectomy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients will be seen and enrolled through an outpatient spine specialty clinic of Dr. Edward Hanley.
Who may be able to join
- 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
Who cannot join
- Coexisting low back pain
- Total previous coccyx surgery or previous lumbar fashion
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center, Department of Orthopaedic Surgery
Charlotte, North Carolina, 28204
About this study
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.
Read the 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.
- Conditions
- Coccygodynia
- Being tested
- Coccygectomy
- Keywords
- coccygodynia, coccygectomy, coccyx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoccygectomyOther
Patient receiving coccygectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| Coccygectomy Treatment | Patients undergoing coccygectomy surgical procedure. Receives: Other: Coccygectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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"
Measured: Baseline,1 year and 2 years
Secondary outcomes (2)
Complication Rates
Complication rates after coccygectomy surgery
Measured: Baseline,1 year and 2 years
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.
Measured: Baseline,1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startSep 2007
- Primary completionDec 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CoccygodyniaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward N Hanley, MD, Principal investigator, Carolinas Medical Center, Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701192
- Sponsor's protocol ID
- 04-07-08B
- Acronym
- Coccyx
- Status last verified
- Jun 2021
- First submitted
- 11 Feb 2016
- Last updated
- 22 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
- ClinicalTrials.gov ID
- NCT02701192
- Acronym / sponsor ID
- Coccyx / 04-07-08B
- Conditions
- Coccygodynia
- Keywords
- coccygodynia, coccygectomy, coccyx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coccygectomy Treatment | – | Other: CoccygectomyPatients undergoing coccygectomy surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be seen and enrolled through an outpatient spine specialty clinic of Dr. Edward Hanley.
Key inclusion criteria (8 listed)
- Pain in the region of the coccyx
- Pain for greater than 2 months
- Tenderness to palpation over coccyx
- Radiographic abnormalities of the coccyx
- Failure of conservative treatment methods: 4 weeks of NSAIDS, seat cushion, and rest
Key exclusion criteria (3 listed)
- Coexisting low back pain
- Total previous coccyx surgery or previous lumbar fashion
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoccygectomyPatient receiving coccygectomy surgery. | Other | Coccygectomy Treatment |
Primary outcome
Pain Change From Baseline at 2 Years
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: General Health
Time frame: 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
Time frame: 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.
Lower Back Disability
Time frame: 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"
2 secondary outcomes
Complication Rates
Time frame: Baseline,1 year and 2 years
Treatment Success
Time frame: Baseline,1 year and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward N Hanley, MD principal investigator
Carolinas Medical Center, Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coccygodynia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Change From Baseline at 2 Years (time frame: Baseline,1 year and 2 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.