Biomarkers in Pain and Pain Treatment

The Effect of Inflammation on Psychological Comorbidity and Behavioral Treatment in Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Chronic Pain
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

• Study Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success	The Pain Disability Index	At last psychological session (3 months post baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbid psychological problems	PHQ-9	At first psychological session (baseline)
Blood biomarkers as an effect of treatment	Pro-inflammatory cytokines	At last psychological session (3 months post baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood biomarkers as predictor for treatment success	Pro-inflammatory cytokines	At first psychological session (baseline)

Collaborators and Investigators

• Sponsor: Rikard Wicksell
• Collaborators: AFA Insurance; The Swedish Society of Medicine
• Investigators: Principal Investigator: Rikard Wicksell, PhD, Karolinska Institutet; Study Chair: Bianka Karshikoff, PhD, Karolinska Institutet; Study Chair: Linda Holmström, PhD, Karolinska Institutet; Study Chair: Mats Lekander, PhD, Karolinska Institutet; Study Chair: Jenny Åström, lic psych, Karolinska University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2016
• Primary Completion (Actual): December 12, 2018

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: psychoneuroimmunology
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Inflammation; Chronic Pain
• Other Study ID Numbers: pni-act-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No