Pain in Inflammatory Joint Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDiakonhjemmet Hospital

About this trial

Our primary objective is to better understand the etiology and consequences of chronic paint by using an explorative approach to identify phenotypes and endotypes of patients with inflammatory joint diseases, with a special focus on central sensitization and cognitive functioning as a key element in chronic pain. We will also examine the risk factors and clinical impact of these factors on pain, disease activity and treatment effects in a longitudinal study of patients with inflammatory joint disesases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients who initiate or switch biological or targeted synthetic DMARDs

Disqualifiers

None

Trial population

The study population consists of men and women (\>18 years of age at screening) who are enrolled in the Nor-DMARD register and give their consent to also participate in this sub-study. We will not have other inclusion and exclusion criteria than those that are already part of the Nor-DMARD register. This means that all patients who are being enrolled in the Nor-DMARD register will be asked to be part of this sub-study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biological or targeted synthetic DMARD

    Drug

    All biological or targeted synthetic DMARDs that are available for treatment of patients with inflammatory joint diseases

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Patients who initiate or switch biological or targeted synthetic DMARD1 intervention

Trial outcomes

Primary outcomes

1

PROMIS Pain Interference - Short Form 8a

PROMIS Pain Interference - Short Form 8a assesses to which extend pain affect various aspects in daily life. This includes 8 items covering social, emotional, physical, and recreational activities \[74\], such as "How much did pain interfere with your day-to-day activities?" and "How much did pain interfere with your enjoyment of life?". The items have a 7-day time frame. Participants are asked to rate their responses on a three different 5-point Likert response scales. Scores are converted to a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD). Higher scores represent more pain interference.

Time frame
Baseline, 3 months

Secondary outcomes

1

Social network

Questions about how many close friends the participants have, and whether they have a feeling of loneliness

Time frame
Baseline
2

Gender role perception

One question is included regarding which gender the participants identify with, where the participant reports whether they identify with their biological gender, identify as non-binary or gender diverse, or wishes not to answer.

Time frame
Baseline
3

Arthritis Self-Efficacy Scale (ASES)

We have included the pain subscale only. The pain subscale consists of five questions about how certain the respondent is that he/she can do the following tasks regarding their rheumatic pain. The response categories are 10-100 with 10 points increment between each response categories, with "moderately certain" is placed midway between "very uncertain" and "very certain". TA sum score is created based on the average of the five questions (10-100 scale) with higher score representing higher self-efficacy.

Time frame
Baseline
4

Pain Catastrophizing Scale (PSC)

The PCS is a thirteen-item self-report scale to measure pain catastrophizing. The PCS consists of thirteen questions, and the respondents are instructed to reflect on past painful experiences and to indicate whether they have experienced each of the thirteen thoughts or feelings during their past experience of pain. Each question is rated from 0 ("not at all") to 4 ("all the time"). A total score and three subscale scores regarding helplessness (item 1-5 and 12), magnification (item 6-7 and 13) and rumination (item 8-11) can be calculated.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diakonhjemmet Hospital

Lead sponsor

University of Oslo

Collaborator