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OpenTrials
Completed

NCT Number: NCT03272893

Biomarkers in Pain and Pain Treatment

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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Key information

Conditions

Chronic Pain Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: ACT

Primary outcomes

  1. Treatment success

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

    The Pain Disability Index

Secondary outcomes

  1. Comorbid psychological problems

    Time frame: At first psychological session (baseline)

    PHQ-9

  2. Blood biomarkers as an effect of treatment

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

    Pro-inflammatory cytokines

Other outcomes

  1. Blood biomarkers as predictor for treatment success

    Time frame: At first psychological session (baseline)

    Pro-inflammatory cytokines

Sponsors and collaborators

Lead sponsor

Rikard Wicksell

Other

Collaborators

  • AFA Insurance
  • The Swedish Society of Medicine

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
First posted
Sep 6, 2017
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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