Chronic PainNCT03272893

Biomarkers in Pain and Pain Treatment

An observational study of Chronic Pain and Inflammation, run by Rikard Wicksell.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain, Inflammation
What is being tested?: Acceptance and Commitment Therapy
Type of treatment: Lifestyle or therapy programme
How many people: 90 participants
Where: No sites listed yet
Study dates: 6 Dec 2016to 12 Dec 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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)

Who cannot join

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)

About this study

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

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
Being tested: Acceptance and Commitment Therapy
Keywords: psychoneuroimmunology
Medical subject headings: Chronic Pain, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acceptance and Commitment TherapyBehavioural
Also called ACT
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment success
The Pain Disability Index
Measured: At last psychological session (3 months post baseline)

Secondary outcomes (2)

Comorbid psychological problems
PHQ-9
Measured: At first psychological session (baseline)
Blood biomarkers as an effect of treatment
Pro-inflammatory cytokines
Measured: At last psychological session (3 months post baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 201612 Dec 2018

First posted6 Sep 2017
Study start6 Dec 2016
Primary completion12 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03272893
Sponsor's protocol ID: pni-act-2016
Status last verified: Feb 2020
First submitted: 15 Aug 2017
Last updated: 26 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Inflammation on Psychological Comorbidity and Behavioral Treatment in Chronic Pain
ClinicalTrials.gov ID: NCT03272893
Acronym / sponsor ID: pni-act-2016
Conditions: Chronic Pain, Inflammation
Keywords: psychoneuroimmunology
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Rikard WicksellUniversity, hospital or other
Collaborators: AFA Insurance, The Swedish Society of Medicine
Study start: 6 Dec 2016 (actual)
Primary completion: 12 Dec 2018 (actual)
First posted: 6 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acceptance and Commitment TherapyAlso: ACTThe 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.	Behavioural	–

Primary outcome

Treatment success
Time frame: At last psychological session (3 months post baseline)
The Pain Disability Index

2 secondary outcomes

Comorbid psychological problems
Time frame: At first psychological session (baseline)
Blood biomarkers as an effect of treatment
Time frame: At last psychological session (3 months post baseline)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
Background: PubMed 27469518Lasselin 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.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

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Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rikard Wicksell, PhD principal investigator

Karolinska Institutet

Bianka Karshikoff, PhD study chair

Karolinska Institutet

Linda Holmström, PhD study chair

Karolinska Institutet

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain and Inflammation, run by Rikard Wicksell.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment success (time frame: At last psychological session (3 months post baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03272893, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.