Clinical trial NCT03272893: Biomarkers in Pain and Pain Treatment
Official title: The Effect of Inflammation on Psychological Comorbidity and Behavioral Treatment in Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Inflammation
Keywords: psychoneuroimmunology
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: AFA Insurance
name: The Swedish Society of Medicine
First posted: 2017-09-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Treatment success
timeFrame: At last psychological session (3 months post baseline)
Secondary outcomes:
measure: Comorbid psychological problems
timeFrame: At first psychological session (baseline)
measure: Blood biomarkers as an effect of treatment
timeFrame: At last psychological session (3 months post baseline)
Other outcomes:
measure: Blood biomarkers as predictor for treatment success
timeFrame: At first psychological session (baseline)
Locations:
Study officials:
affiliation: Karolinska Institutet
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 University Hospital
name: Jenny Åström, lic psych
role: STUDY_CHAIR
References:
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.