Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT03272893
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2017-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Pain and Pain Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2017-09-01', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood biomarkers as predictor for treatment success', 'timeFrame': 'At first psychological session (baseline)', 'description': 'Pro-inflammatory cytokines'}], 'primaryOutcomes': [{'measure': 'Treatment success', 'timeFrame': 'At last psychological session (3 months post baseline)', 'description': 'The Pain Disability Index'}], 'secondaryOutcomes': [{'measure': 'Comorbid psychological problems', 'timeFrame': 'At first psychological session (baseline)', 'description': 'PHQ-9'}, {'measure': 'Blood biomarkers as an effect of treatment', 'timeFrame': 'At last psychological session (3 months post baseline)', 'description': 'Pro-inflammatory cytokines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychoneuroimmunology'], 'conditions': ['Chronic Pain', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '27469518', 'type': 'BACKGROUND', 'citation': 'Lasselin J, Kemani MK, Kanstrup M, Olsson GL, Axelsson J, Andreasson A, Lekander M, Wicksell RK. Low-grade inflammation may moderate the effect of behavioral treatment for chronic pain in adults. J Behav Med. 2016 Oct;39(5):916-24. doi: 10.1007/s10865-016-9769-z. Epub 2016 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research project is to explore if levels of inflammation predict levels of comorbid mood disorders and treatment success in chronic pain patients. More knowledge in this respect will advance our understanding of chronic pain and comorbid syndromes, and facilitate subgroupings of patients based on the presence and/or level of low-grade inflammation. This research is an important step towards finding an explanation to why treatment effects following behavioral interventions differ across individuals, and generate new hypothesis regarding novel treatment approaches. The specific aims are: 1) to explore if baseline levels of inflammatory biomarkers predict the effects of behavioral intervention and 2) to investigate if baseline levels of inflammatory biomarkers are associated with psychological co-morbidity (e.g. depression, anxiety and fatigue) in patients with chronic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients at the Karolinska Pain Center, suffering from chronic pain that does not respond to any other pain treatments and affects daily functioning severely.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Referred to a specialist clinic within pain management\n2. Equal to or older than 18 years\n3. Chronic pain (\\> 6 months)\n4. The pain is refractory\n5. The pain results in significant functional limitations\n6. Stable medication in the last 2 months and no planned changes in medication (except possibly discontinuation or lowering of current dose)\n\nExclusion Criteria:\n\n1. Spontaneous improvement can be expected (without treatment)\n2. Psychiatric comorbidity a) is deemed to be the main reason for the restrictions, or b) should be promptly evaluated and possibly treated, or c) may adversely affect the treatment given in the context of the study\n3. Significant risk of suicide\n4. Poor teamwork, defined as repeated missed appointments during the assessment / investigation phase\n5. Language difficulties (Swedish)'}, 'identificationModule': {'nctId': 'NCT03272893', 'briefTitle': 'Biomarkers in Pain and Pain Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'The Effect of Inflammation on Psychological Comorbidity and Behavioral Treatment in Chronic Pain', 'orgStudyIdInfo': {'id': 'pni-act-2016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Acceptance and Commitment Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['ACT'], 'description': 'The main component in the treatment is exposure to symptoms and feared situations. The iACT program is adapted from the evidence based face-to-face treatment at the Behavioral Medicine unit at Karolinska University Hospital. The iACT program has a different structure but is equal in content to face-to-face treatment, and is to be completed within ten weeks. Participants receive texts, audio files, movies and exercises and have online contact with their psychologist via an internet platform or a smart phone application. The treatment aims to encourage valued behaviors in the presence of inner discomfort.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rikard Wicksell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Bianka Karshikoff, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Linda Holmström, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Mats Lekander, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Jenny Åström, lic psych', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rikard Wicksell', 'class': 'OTHER'}, 'collaborators': [{'name': 'AFA Insurance', 'class': 'INDUSTRY'}, {'name': 'The Swedish Society of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Functional Area Medical Psychology, Karolinska Univ Hospital and head of research group Behavior Medicine, KI', 'investigatorFullName': 'Rikard Wicksell', 'investigatorAffiliation': 'Karolinska Institutet'}}}}