Biomarkers in Pain and Pain Treatment

NCT03272893 | Completed

• 1 other identifier: pni-act-2016
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain; Inflammation

Keywords

psychoneuroimmunology

Outcome Measures

Primary Outcomes (1)

• Treatment success

  The Pain Disability Index

  At last psychological session (3 months post baseline)

Secondary Outcomes (2)

• Comorbid psychological problems

  At first psychological session (baseline)

• Blood biomarkers as an effect of treatment

  At last psychological session (3 months post baseline)

Other Outcomes (1)

• Blood biomarkers as predictor for treatment success

  At first psychological session (baseline)

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Also known as: ACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Referred to a specialist clinic within pain management
• Equal to or older than 18 years
• Chronic pain (\> 6 months)
• The pain is refractory
• The pain results in significant functional limitations
• Stable medication in the last 2 months and no planned changes in medication (except possibly discontinuation or lowering of current dose)

You may not qualify if:

• Spontaneous improvement can be expected (without treatment)
• 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
• Significant risk of suicide
• Poor teamwork, defined as repeated missed appointments during the assessment / investigation phase
• Language difficulties (Swedish)

Sponsors & Collaborators

• Rikard Wicksell: lead
• AFA Insurance: collaborator
• The Swedish Society of Medicine: collaborator

Related 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.

  PMID: 27469518 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma, whole blood

MeSH Terms

Conditions

Chronic Pain; Inflammation

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rikard Wicksell, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Functional Area Medical Psychology, Karolinska Univ Hospital and head of research group Behavior Medicine, KI

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: September 6, 2017
• Study Start: December 6, 2016
• Primary Completion: December 12, 2018
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share