Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT03588793
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2018-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability and Validity of Outcome Measures for Phantom Limb Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Statistical analysis of change in Visual Analogue Scale (VAS) for pain scores', 'timeFrame': 'Administered on 2 separate occasions, 7-14 days apart', 'description': 'Intra-rater reliability analysis'}], 'secondaryOutcomes': [{'measure': 'Statistical analysis of change in EQ-5D-L scores', 'timeFrame': 'Administered on 2 separate occasions, 7-14 days apart', 'description': 'Health related Quality of Life questionnaire. Intra-rater reliability analysis'}, {'measure': 'Statistical analysis of change in Short Form McGill Pain Questionnaire 2 (SF-MPQ-2) scores', 'timeFrame': 'Administered on 2 separate occasions, 7-14 days apart', 'description': 'Intra-rater reliability analysis'}, {'measure': 'Statistical analysis of change in Trinity Amputation and Prosthetic Evaluation Score - Revised (TAPES-R) - Amended version to include phantom limb pain and demographics questions', 'timeFrame': 'Administered on 2 separate occasions, 7-14 days apart', 'description': 'Intra-rater reliability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Phantom Limb Pain']}, 'descriptionModule': {'briefSummary': 'Phantom limb pain (PLP) is experienced by 60-80% of all people who have had an amputation. This persistent pain condition can impact on independence, activities of daily living and overall quality of life.\n\nWhile there is some research into PLP there is no consensus on appropriate outcome measures and there is (to our knowledge) neither guideline nor literature evidence on the reliability and validity of outcomes measures for this patient group. Such measures are vital to the robust evaluation of any interventions and/or monitoring progression.\n\nThe aim of the proposed study is to assess the reliability and validity of four self-report questionnaires (Visual Analog Scale (VAS) for pain, Short Form McGill Pain Questionnaire 2 (SFMPQ-2), Trinity Amputation and Prosthetic Evaluation Scale (TAPES), a health-related quality of life measure (EQ-5D-L), a pain diary, a left/right limb judgement task (Implicit Motor Imagery Testing - IMIT) and the two-point discrimination (TPD)test.\n\nThe data will be collated and statistically analysed to assess how stable each of the measures are over time (intra session reliability) and how each measure co-relates with the others (validity).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Amputees', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥ 18 years At least six months post amputation (date of surgery) The amputation must be above wrist/ankle. Are currently experiencing PLP which has persisted for at least 3 months or more They rate their PLP as ≥3 on a 0-10 scale on at least 2 days in the preceding week Concomitant medications;\n\nExclusion Criteria:\n\n* Participating in any research trial of any intervention hypothesised to affect PLP.\n\nCurrently under-going active prosthetic rehabilitation e.g. walking training sessions or upper limb rehabilitation sessions.\n\nAny current non-prescribed substance dependency An inability to understand and follow basic instructions - both the two-point discrimination test and left/right limb judgement task requires the participant to follow basic/simple instructions.\n\nAny person, otherwise eligible, who commences any treatment for PLP (physical or pharmacological, prescribed or non-prescribed) will be withdrawn from the study.'}, 'identificationModule': {'nctId': 'NCT03588793', 'briefTitle': 'Reliability and Validity of Outcome Measures for Phantom Limb Pain', 'organization': {'class': 'OTHER', 'fullName': 'Teesside University'}, 'officialTitle': 'The Reliability and Validity of Outcome Measures for People Who Have Phantom Limb Pain', 'orgStudyIdInfo': {'id': 'TU243418'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Two Point Discrimination', 'type': 'OTHER', 'otherNames': ['Implicit Motor Imagery Testing'], 'description': 'Validity of mechanism in phantom limb pain i.e. cortical reorganisation to be tested using comparison of data from interventions above'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'Teesside University School of Health & Social Care', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teesside University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD candidate', 'investigatorFullName': 'Andrew Graham', 'investigatorAffiliation': 'Teesside University'}}}}