Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT02209259
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness
Sponsor:
Organization:
Raw JSON
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The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is better than the average and a T score less than 50 is worse than the average.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard PCS', 'description': 'The first intervention group will be comprised of patients who will complete the standard PCS.'}, {'id': 'OG001', 'title': 'Positively-adjusted PCS', 'description': 'The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.'}, {'id': 'OG002', 'title': 'Control', 'description': 'The third group (the control arm) will not complete the PCS.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': '10 point pain scale, where 0 is no pain and 10 is the most pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Measurement Information System (PROMIS) Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard PCS', 'description': 'The first intervention group will be comprised of patients who will complete the standard PCS.'}, {'id': 'OG001', 'title': 'Positively-adjusted PCS', 'description': 'The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.'}, {'id': 'OG002', 'title': 'Control', 'description': 'The third group (the control arm) will not complete the PCS.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '48', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '48', 'spread': '8.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard PCS', 'description': 'The first intervention group will be comprised of patients who will complete the standard PCS.'}, {'id': 'FG001', 'title': 'Positively-adjusted PCS', 'description': 'The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.'}, {'id': 'FG002', 'title': 'Control', 'description': 'The third group (the control arm) will not complete the PCS.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard PCS', 'description': 'The first intervention group will be comprised of patients who will complete the standard PCS.'}, {'id': 'BG001', 'title': 'Positively-adjusted PCS', 'description': 'The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.'}, {'id': 'BG002', 'title': 'Control', 'description': 'The third group (the control arm) will not complete the PCS.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '16', 'groupId': 'BG000'}, {'value': '51', 'spread': '18', 'groupId': 'BG001'}, {'value': '56', 'spread': '15', 'groupId': 'BG002'}, {'value': '52', 'spread': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-11', 'studyFirstSubmitDate': '2014-07-29', 'resultsFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-11', 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity', 'timeFrame': '1day', 'description': 'A computerized assessment of upper extremity physical function measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is better than the average and a T score less than 50 is worse than the average.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '1 day', 'description': '10 point pain scale, where 0 is no pain and 10 is the most pain'}, {'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS) Depression', 'timeFrame': '1 day', 'description': 'A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arm Illness']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Sullivan M J L, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development andvalidation. Psychol Assess 1995, 7: 524-532.'}, {'type': 'BACKGROUND', 'citation': 'Zajonc, R.B. Mere exposure: A gateway to the subliminal. Current Directions in Psychological Science 2001, 10 (6): 224-228.'}, {'pmid': '23761176', 'type': 'BACKGROUND', 'citation': 'Bossen JK, Hageman MG, King JD, Ring DC. Does rewording MRI reports improve patient understanding and emotional response to a clinical report? Clin Orthop Relat Res. 2013 Nov;471(11):3637-44. doi: 10.1007/s11999-013-3100-x. Epub 2013 Jun 13.'}, {'pmid': '26683347', 'type': 'DERIVED', 'citation': 'Claessen FM, Mellema JJ, Stoop N, Lubberts B, Ring D, Poolman RW. Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial. Psychosomatics. 2016 Jan-Feb;57(1):47-56. doi: 10.1016/j.psym.2015.09.005. Epub 2015 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The investigators plan a prospective randomized study to see whether negative questions affect measures of mood, pain, or disability. A total of 175 patients will participate at Massachusetts General Hospital.', 'detailedDescription': 'Patient mood, pain intensity, and magnitude of disability can be measured using questionnaires. The Pain Catastrophizing Scale (PCS) was developed to measure the extent to which the ineffective coping strategy of catastrophic thinking impacts pain experience. It is currently one of the most widely used measures of catastrophic thinking related to pain. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced 13 thoughts or feelings when experiencing pain. The questions in the PCS are negatively phrased, e.g. "it\'s terrible and I think it\'s never going to get any better."\n\nThe effect by which exposure to a stimulus influences a response to a later response is called "priming." Priming is the process of activating particular representations or associations in memory just before carrying out an action or task. Priming affects all aspects of human behavior. For example, syntactic priming is the tendency to use syntactic structures that parallel the structures of sentences we have heard recently: a speaker who has just heard a sentence in passive voice is subsequently more likely to use a passive construction himself.\n\nPriming apparently also has affective dimensions. Zajonc performed an experiment where he showed a list of Chinese characters to his test subjects. He subsequently showed the subjects a list of Chinese words and asked them which words they "liked the best." The words containing characters presented in the first list were evaluated more positively. The negative questions in the PCS may prime patients to be more negative in subsequent questionnaires.\n\nOur group has performed multiple studies on the use of certain words, phrases, and concepts in hand and upper extremity surgery. Bossen et al showed that positive or negative wording of MRI reports influences patients\' emotional response, satisfaction, and understanding. We are interested in looking at the possibility that certain questionnaires can affect other questionnaires via a priming effect.\n\nWe propose a three-arm single blind, randomized (1:1:1) controlled trial to assess whether negative questions of the PCS affect measures of mood, pain, or disability.\n\nAim:\n\nThe aim of this study is to assess whether the negative questions in the PCS affect measures of mood, pain, or disability.\n\nPrimary null hypothesis:\n\nThere is no difference in Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Function between patients who complete the standard PCS, patients who complete the positively adjusted PCS, and patients who do not complete the PCS.\n\nSecondary null hypothesis:\n\nThere is no difference in pain intensity, PROMIS depression, and (Positive Affect Negative Affect Scale) PANAS scores between patients who complete the standard PCS, patients who complete the positively adjusted PCS, and patient who do not complete the PCS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All new and follow-up patients presenting to the Orthopaedic Hand and Upper Extremity Service\n* English fluency and literacy\n\nExclusion Criteria:\n\n* pregnant women\n* Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).'}, 'identificationModule': {'nctId': 'NCT02209259', 'briefTitle': 'The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness', 'orgStudyIdInfo': {'id': '2014P000666'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group 1', 'description': 'The first intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing the standard PCS.', 'interventionNames': ['Other: PROMIS Upper Extremity Function', 'Other: Pain intensity', 'Other: PROMIS depression', 'Other: Positive affect negative affect scale (PANAS)', 'Other: standard PCS']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group 2', 'description': 'The second intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing a positively-adjusted version of the PCS.', 'interventionNames': ['Other: PROMIS Upper Extremity Function', 'Other: Pain intensity', 'Other: PROMIS depression', 'Other: Positive affect negative affect scale (PANAS)', 'Other: positively-adjusted version of the PCS']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).', 'interventionNames': ['Other: PROMIS Upper Extremity Function', 'Other: Pain intensity', 'Other: PROMIS depression', 'Other: Positive affect negative affect scale (PANAS)']}], 'interventions': [{'name': 'PROMIS Upper Extremity Function', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Intervention Group 1', 'Intervention Group 2']}, {'name': 'Pain intensity', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Intervention Group 1', 'Intervention Group 2']}, {'name': 'PROMIS depression', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Intervention Group 1', 'Intervention Group 2']}, {'name': 'Positive affect negative affect scale (PANAS)', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Intervention Group 1', 'Intervention Group 2']}, {'name': 'standard PCS', 'type': 'OTHER', 'armGroupLabels': ['Intervention Group 1']}, {'name': 'positively-adjusted version of the PCS', 'type': 'OTHER', 'armGroupLabels': ['Intervention Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David Ring, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David C. Ring, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}