Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-05 @ 3:21 AM
Study NCT ID:
NCT02701192
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2016-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
Sponsor:
Organization:
Raw JSON
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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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Health Status- SF-36v2:Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '55.23', 'groupId': 'OG000', 'lowerLimit': '48.65', 'upperLimit': '61.81'}]}]}, {'title': 'One Year', 'categories': [{'measurements': [{'value': '80.68', 'groupId': 'OG000', 'lowerLimit': '74.67', 'upperLimit': '86.99'}]}]}, {'title': 'Two Years', 'categories': [{'measurements': [{'value': 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'Baseline', 'categories': [{'measurements': [{'value': '43.07', 'groupId': 'OG000', 'lowerLimit': '38.21', 'upperLimit': '47.93'}]}]}, {'title': 'One Year', 'categories': [{'measurements': [{'value': '62.05', 'groupId': 'OG000', 'lowerLimit': '56.86', 'upperLimit': '67.24'}]}]}, {'title': 'Two Years', 'categories': [{'measurements': [{'value': '60.78', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '65.56'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Health Status-SF-36v2: Emotional Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy 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Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.95', 'groupId': 'OG000', 'lowerLimit': '35.4', 'upperLimit': '44.5'}]}]}, {'title': 'One Year', 'categories': [{'measurements': [{'value': '70.34', 'groupId': 'OG000', 'lowerLimit': '63.96', 'upperLimit': '76.72'}]}]}, {'title': 'Two Years', 'categories': [{'measurements': [{'value': '71.75', 'groupId': 'OG000', 'lowerLimit': '66.06', 'upperLimit': '77.44'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Health Status-SF-36v2: General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '68.39', 'groupId': 'OG000', 'lowerLimit': '64.4', 'upperLimit': '72.38'}]}]}, {'title': 'One Year', 'categories': [{'measurements': [{'value': '73.41', 'groupId': 'OG000', 'lowerLimit': '68.61', 'upperLimit': '78.21'}]}]}, {'title': 'Two Years', 'categories': [{'measurements': [{'value': '69.31', 'groupId': 'OG000', 'lowerLimit': '64.46', 'upperLimit': '74.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Health Status-SF-36v2: Health Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '45.31', 'groupId': 'OG000', 'lowerLimit': '39.82', 'upperLimit': '50.8'}]}]}, {'title': 'One Year', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '76.03', 'upperLimit': '86.77'}]}]}, {'title': 'Two Years', 'categories': [{'measurements': [{'value': '74.47', 'groupId': 'OG000', 'lowerLimit': '68.98', 'upperLimit': '79.96'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lower Back Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'classes': [{'title': 'Pre-operative Baseline', 'categories': [{'measurements': [{'value': '39.07', 'groupId': 'OG000', 'lowerLimit': '35.22', 'upperLimit': '49.92'}]}]}, {'title': 'One Year', 'categories': [{'measurements': [{'value': '15.39', 'groupId': 'OG000', 'lowerLimit': '11.26', 'upperLimit': '42.92'}]}]}, {'title': 'Two Years', 'categories': [{'measurements': [{'value': '16.26', 'groupId': 'OG000', 'lowerLimit': '12.59', 'upperLimit': '19.93'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,1 year and 2 years', '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"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complication Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'Complication rates after coccygectomy surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'classes': [{'categories': [{'title': 'Treatment Success', 'measurements': [{'value': '69', 'groupId': 'OG000'}]}, {'title': 'Treatment Failure', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline,1 year and 2 years', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.\n\nCoccygectomy: Patient receiving coccygectomy surgery.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Etiology for Symptoms', 'classes': [{'categories': [{'title': 'Idiopathic', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Trauma', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Significant weight loss', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Post-partum', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Post floor surgery', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Co-morbidities', 'classes': [{'title': 'Pre-existing Spinal disorder', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Non-spine related musculoskletal pathology', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Psychiatric illness', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Chronic pain', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Genitourinary pain disorder', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other pain syndrome', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coccydynia Pain Management', 'classes': [{'title': 'Prior Steroid Injection Therapy', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}, {'title': 'Prior Opioid Use', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The study then evolved into a prospective observational case series of surgical treatment with total coccygectomy.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-05-17', 'size': 395772, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-01-23T16:01', 'hasProtocol': True}, {'date': '2011-05-10', 'size': 142259, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-01-24T08:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2016-02-11', 'resultsFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-10', 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Change From Baseline at 2 Years', 'timeFrame': 'Baseline,1 year and 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.'}, {'measure': 'Patient Health Status- SF-36v2:Physical Functioning', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Patient Health Status- SF-36v2: Role Functioning-Physical', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Patient Health Status-SF-36v2: Role Functioning- Emotional', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Patient Health Status-SF-36v2: Energy/Fatigue', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Patient Health Status-SF-36v2: Emotional Well-being', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Patient Health Status-SF-36v2: Social Functioning', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Patient Health Status-SF-36v2: Pain', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Patient Health Status-SF-36v2: General Health', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Patient Health Status-SF-36v2: Health Change', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'The SF-36 is on a 0-100 scale, with higher scores indicating a more favorable/better health state.'}, {'measure': 'Lower Back Disability', 'timeFrame': 'Baseline,1 year and 2 years', '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"'}], 'secondaryOutcomes': [{'measure': 'Complication Rates', 'timeFrame': 'Baseline,1 year and 2 years', 'description': 'Complication rates after coccygectomy surgery'}, {'measure': 'Treatment Success', 'timeFrame': 'Baseline,1 year and 2 years', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coccygodynia', 'coccygectomy', 'coccyx'], 'conditions': ['Coccygodynia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients will be seen and enrolled through an outpatient spine specialty clinic of Dr. Edward Hanley.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain in the region of the coccyx\n* Pain for greater than 2 months\n* Tenderness to palpation over coccyx\n* Radiographic abnormalities of the coccyx\n\n 1. Hypermobility of greater than 25 degrees, posterior subluxation of a mobile segment, or a coccygeal spicule on sitting radiographs\n 2. post-traumatic coccygodynia\n* Failure of conservative treatment methods: 4 weeks of NSAIDS, seat cushion, and rest\n* Partial coccygectomy\n\nExclusion Criteria:\n\n* Coexisting low back pain\n* Total previous coccyx surgery or previous lumbar fashion\n* Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT02701192', 'acronym': 'Coccyx', 'briefTitle': 'Management of Coccydynia: A Prospective, Observational Study of Coccygectomy', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Management of Coccydynia: A Prospective, Observational Study of Coccygectomy', 'orgStudyIdInfo': {'id': '04-07-08B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coccygectomy Treatment', 'description': 'Patients undergoing coccygectomy surgical procedure.', 'interventionNames': ['Other: Coccygectomy']}], 'interventions': [{'name': 'Coccygectomy', 'type': 'OTHER', 'description': 'Patient receiving coccygectomy surgery.', 'armGroupLabels': ['Coccygectomy Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center, Department of Orthopaedic Surgery', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Edward N Hanley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolinas Medical Center, Department of Orthopaedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}