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Biomarkers in Pain and Pain Treatment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03272893
Enrollment
90
Registered
2017-09-06
Start date
2016-12-06
Completion date
Unknown
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Inflammation

Keywords

psychoneuroimmunology

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.

Interventions

BEHAVIORALAcceptance 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.

Sponsors

AFA Insurance
CollaboratorINDUSTRY
The Swedish Society of Medicine
CollaboratorOTHER
Rikard Wicksell
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Treatment successAt last psychological session (3 months post baseline)The Pain Disability Index

Secondary

MeasureTime frameDescription
Comorbid psychological problemsAt first psychological session (baseline)PHQ-9
Blood biomarkers as an effect of treatmentAt last psychological session (3 months post baseline)Pro-inflammatory cytokines

Other

MeasureTime frameDescription
Blood biomarkers as predictor for treatment successAt first psychological session (baseline)Pro-inflammatory cytokines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026