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CompletedNCT03272893Updated Feb 26, 2020

Biomarkers in Pain and Pain Treatment

An observational study in Chronic Pain and Inflammation, sponsored by Rikard Wicksell. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Rikard Wicksell · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Chronic Pain
  • Inflammation

Keywords

  • psychoneuroimmunology
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

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.

    Also known as: ACT

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What researchers measure

Primary outcomes

  1. Treatment success

    The Pain Disability Index

    Time frame: At last psychological session (3 months post baseline)

Secondary outcomes

  1. Comorbid psychological problems

    PHQ-9

    Time frame: At first psychological session (baseline)

  2. Blood biomarkers as an effect of treatment

    Pro-inflammatory cytokines

    Time frame: At last psychological session (3 months post baseline)

Other outcomes

  1. Blood biomarkers as predictor for treatment success

    Pro-inflammatory cytokines

    Time frame: At first psychological session (baseline)

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 27469518 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03272893
Lead sponsor
Rikard Wicksell
Collaborators
AFA Insurance, The Swedish Society of Medicine
Responsible party
Rikard Wicksell (Director of Functional Area Medical Psychology, Karolinska Univ Hospital and head of research group Behavior Medicine, KI, Karolinska Institutet) — Sponsor-investigator
First posted
Sep 6, 2017
Start date
Dec 6, 2016
Primary completion
Dec 12, 2018
Last update
Feb 26, 2020

Study contacts

Rikard Wicksell, PhD
principal investigator · Karolinska Institutet
Bianka Karshikoff, PhD
study chair · Karolinska Institutet
Linda Holmström, PhD
study chair · Karolinska Institutet
Mats Lekander, PhD
study chair · Karolinska Institutet
Jenny Åström, lic psych
study chair · Karolinska University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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