Biomarkers in Pain and Pain Treatment

Completed

• Conditions: Chronic Pain; Inflammation

• Registration Number: NCT03272893
• Lead Sponsor: Rikard Wicksell

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-06
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-06
• Primary Completion: 2018-12-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success	At last psychological session (3 months post baseline)	The Pain Disability Index

Secondary Outcome Measures

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