Biomarkers in Pain and Pain Treatment

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272893
• Other study ID #: pni-act-2016
• Status: Completed
• Start date: December 6, 2016

Study information

• Verified date: February 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Inflammation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rikard Wicksell	AFA Insurance, The Swedish Society of Medicine

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood biomarkers as predictor for treatment success	Pro-inflammatory cytokines	At first psychological session (baseline)
Primary	Treatment success	The Pain Disability Index	At last psychological session (3 months post baseline)
Secondary	Comorbid psychological problems	PHQ-9	At first psychological session (baseline)
Secondary	Blood biomarkers as an effect of treatment	Pro-inflammatory cytokines	At last psychological session (3 months post baseline)