Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05541718
Status:
COMPLETED
Last Update Posted:
2025-11-13
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Options for Treating Knee Osteoarthritis Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019124', 'term': 'Therapeutic Touch'}, {'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-12', 'size': 96439, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-10T12:58', 'hasProtocol': False}, {'date': '2022-04-27', 'size': 317117, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-01T16:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-12', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in State Self-Transcendence', 'timeFrame': 'Immediately before to after the first and last treatment session, which comprises a 20 minute span', 'description': 'Change in self-transcendent state will be measured with the Nondual Awareness Dimensional Assessment - State Version. Scores range from 0 to 10, with higher scores reflecting greater self-transcendence.'}, {'measure': 'Change in State Decentering', 'timeFrame': 'Immediately before to after the first and last treatment session, which comprises a 20 minute span', 'description': 'Change in state decentering will be measured with the Metacognitive Processes of Decentering Scale - State Version. Scores range from 0 to 10, with higher scores reflecting greater state decentering.'}, {'measure': 'Change in Trait Self-Transcendence', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'Change in trait self-transcendence will be assessed with the Nondual Awareness Dimensional Assessment - Trait Version. Scores range from 0 to 10, with higher scores reflecting greater trait self-transcendence.'}, {'measure': 'Change in Trait Decentering', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'Change in trait decentering will be assessed with the Metacognitive Processes of Decentering Scale - Trait Version. Scores range from 0 to 10, with higher scores reflecting greater trait decentering.'}, {'measure': 'Change in Prescription Pain Medication Misuse', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'The PROMIS Prescription Pain Medication Misuse v1.0 - Short Form 7a will measure prescription pain medicine misuse. Scores range from 0 to 35, with higher scores reflecting greater misuse.'}, {'measure': 'Pleasant Sensation Ratio', 'timeFrame': 'Immediately before to after the first and last treatment session, which comprises a 20 minute span', 'description': 'Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations.'}, {'measure': 'Quantitative sensory testing', 'timeFrame': 'Immediately before the first treatment session and immediately after the last treatment session, which comprises a 4 week span', 'description': 'Pain threshold and tolerance, temporal summation, and conditioned pain modulation'}], 'primaryOutcomes': [{'measure': 'Change in Osteoarthritis symptoms', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'The Western Ontario and McMaster Universities Arthritis Index will be used to measure change in osteoarthritis symptoms. Scores range from 0 to 96, with higher scores reflect worse pain, stiffness and physical function'}], 'secondaryOutcomes': [{'measure': 'Change in Depression', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'The Patient Health Questionnaire-2 will be used to measure depression. Scores range from 0 to 6, with higher scores reflect worse depression'}, {'measure': 'Change in Anxiety', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'The Generalized Anxiety Disorder 2-item will be used to measure anxiety. Scores range from 0 to 6, with higher scores reflect worse anxiety.'}, {'measure': 'Change in Pain Catastrophizing', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'The Pain Catastrophizing Scale will be used to measure pain catastrophizing. Scores range from 0 to 52, with higher scores reflect worse pain catastrophizing'}, {'measure': 'Change in Sleep', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'The PROMIS Sleep Disturbance - Short Form 6a will measure changes in sleep. Scores range from 0 to 30, with higher scores reflect greater sleep disturbance'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'One week before treatment to one week after treatment, which comprises a 6 week span', 'description': 'The WHOQOL-BREF will measure quality of life. Scores range from 0 to 100, with higher scores reflect better quality of life'}, {'measure': 'Change in Acute Pain Intensity', 'timeFrame': 'Immediately before to after the first and last treatment session, which comprises a 20 minute span', 'description': 'Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study will be a single-site, four-arm, randomized, placebo-controlled clinical trial. Knee osteoarthritis patients (N=164) will be randomized to Reiki, Sham Reiki (placebo control), mindfulness meditation (active control), or a waitlist control condition. The three active interventions will be applied for 20 minutes, once a week, for four consecutive weeks in a university laboratory setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis in at least one knee\n* Report a WOMAC pain score average \\>/= 2\n* Not using any kind of energy therapy different from the proposed study\n* Ability to read, understand and speak English\n\nExclusion Criteria:\n\n* Knee arthroplasty in the previous year\n* Have cognitive impairment as determined by clinical interview'}, 'identificationModule': {'nctId': 'NCT05541718', 'briefTitle': 'New Options for Treating Knee Osteoarthritis Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'New Options for Treating Knee Osteoarthritis Pain', 'orgStudyIdInfo': {'id': 'IRB_00153103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reiki', 'interventionNames': ['Behavioral: Reiki']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Reiki', 'interventionNames': ['Behavioral: Sham Reiki']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness Meditation', 'interventionNames': ['Behavioral: Mindfulness Meditation']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control'}], 'interventions': [{'name': 'Reiki', 'type': 'BEHAVIORAL', 'description': "Reiki will be provided by a trained Reiki master with the aim of balancing the flow of energy in the patient's body.", 'armGroupLabels': ['Reiki']}, {'name': 'Sham Reiki', 'type': 'BEHAVIORAL', 'description': "Sham Reiki will be delivered by an individual trained to simulate the Reiki interventionist's movements, but they will not visualize patient healing", 'armGroupLabels': ['Sham Reiki']}, {'name': 'Mindfulness Meditation', 'type': 'BEHAVIORAL', 'description': 'The mindfulness meditation intervention will be adapted from a standardized mindfulness induction script validated in prior research. The mindfulness practice will guide patients to focus attention on breath and body sensations while monitoring and accepting discursive thoughts, negative emotions, and pain. The MM interventionist will be a trained mindfulness provider and have experience using MM in medical settings.', 'armGroupLabels': ['Mindfulness Meditation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Assistant Professor', 'investigatorFullName': 'Adam Hanley', 'investigatorAffiliation': 'University of Utah'}}}}