Biomarkers in Pain and Pain Treatment

NCT ID: NCT03272893

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Acceptance and Commitment Therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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ACT

Eligibility Criteria

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Inclusion Criteria

1. Referred to a specialist clinic within pain management
2. Equal to or older than 18 years
3. Chronic pain (\> 6 months)
4. The pain is refractory
5. The pain results in significant functional limitations
6. Stable medication in the last 2 months and no planned changes in medication (except possibly discontinuation or lowering of current dose)

Exclusion Criteria

1. Spontaneous improvement can be expected (without treatment)
2. 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
3. Significant risk of suicide
4. Poor teamwork, defined as repeated missed appointments during the assessment / investigation phase
5. Language difficulties (Swedish)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AFA Insurance

INDUSTRY

Sponsor Role collaborator

The Swedish Society of Medicine

OTHER

Sponsor Role collaborator

Rikard Wicksell

OTHER

Sponsor Role lead

Responsible Party

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Rikard Wicksell

Director of Functional Area Medical Psychology, Karolinska Univ Hospital and head of research group Behavior Medicine, KI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rikard Wicksell, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Bianka Karshikoff, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Linda Holmström, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Mats Lekander, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Jenny Åström, lic psych

Role: STUDY_CHAIR

Karolinska University Hospital

References

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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.

Reference Type BACKGROUND
PMID: 27469518 (View on PubMed)

Other Identifiers

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pni-act-2016

Identifier Type: -

Identifier Source: org_study_id

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