Clinical trial NCT03083548: The Nor-Hand Study
Official title: The Nor-Hand Study: An Observational Cohort of Hand Osteoarthritis Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Pain
Inflammation
Image, Body
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of men and women between the ages of 40-70 years. Their diagnosis of hand OA has been proven either by ultrasound and/or clinical examination performed by a rheumatologist at the Rheumatology Outpatient clinic at Diakonhjemmet Hospital. In addition, all patients must be able to sign and understand an informed consent form.

Brief summary: The Nor-Hand study is a hospital-based observational study including 300 patients with evidence of hand OA by ultrasound and/or clinical examination. The baseline examination (2016-17) consists of functional tests and joint assessment of the hands, medical assessment, pain sensitization tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet), computer tomography (CT) and Magnetic Resonance Imaging (MRI) of the dominant hand, conventional radiographs of the hands and feet, fluorescence optical imaging of the hands, collection of blood and urine samples as well as self-reported demographic factors and OA-related questionnaires. Two follow-up examinations are planned after 3 (2019-20) and 8 years (2024-25), respectively. Cross-sectional analyses will be used to investigate agreements and associations between different relevant measures at the baseline examination, whereas the longitudinal data will be used for evaluation of predictors for clinical outcomes and disease progression.


Eligibility criteria: Inclusion Criteria:

* Age between 40-70 years at screening
* Proven hand OA by clinical examination and/or ultrasound

  1. Clinical examination criteria: Heberden/Bouchards nodes and/or bony enlargement, squaring and/or deformity of the thumb base and no clinical signs of inflammatory arthritis (e.g. soft tissue swelling of two or less metacarpophalangeal (MCP) joints, and no soft tissue swelling of the wrist).
  2. Ultrasound criteria: Osteophytes in the interphalangeal joints and/or the thumb base, and no signs of inflammatory arthritis (e.g. synovitis with power Doppler activity in two or less MCP joints and no synovitis with power Doppler activity in the wrist).
* Capable of understanding and signing an informed consent form
* Provided a written informed consent to participate in the study

Exclusion Criteria:

* Diagnosis of inflammatory arthritic disease, e.g. seropositive or seronegative rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthritis or arthritis related to connective tissue disorders
* Diagnosis of psoriasis
* Erythrocyte sedimentation rate (ESR) \> 40 mm/hour and/or C-reactive protein (CRP) \>20 mg/L, without a known ongoing infection
* Anti Cyclic Citrullinated Protein (anti-CCP) and/or rheumatoid factor positivity
* Ferritin \>200 microgram/L for women and \>300 microgram/L for men and s-iron/s-total iron binding capacity (TIBC) above 50%
* Major co-morbidities (e.g. severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease or severe respiratory disease)
* Mental or psychiatric disorders, alcohol or drug abuse, language difficulties or other factors that make compliance to the study protocol difficult.

Primary outcomes:
measure: Demographic factors
timeFrame: Baseline
measure: Demographic factors
timeFrame: 3 year follow-up
measure: Life style factors
timeFrame: Baseline
measure: Life style factors
timeFrame: 3 year follow-up
measure: Clinical disease variables
timeFrame: Baseline
measure: Clinical disease variables
timeFrame: 3 year follow-up
measure: EuroQol 5 dimensions
timeFrame: Baseline
measure: EuroQol 5 dimensions
timeFrame: 3 year follow-up
measure: Sleep disturbances
timeFrame: Baseline
measure: Sleep disturbances
timeFrame: 3 year follow-up
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: Baseline
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: 3 year follow-up
measure: Localization of joint pain (homonculus)
timeFrame: Baseline
measure: Localization of joint pain (homonculus)
timeFrame: 3 year follow-up
measure: Self-reported joint pain, hand pain, feet pain, fatigue, disease activity
timeFrame: Baseline
measure: Self-reported joint pain, hand pain, feet pain, fatigue, disease activity
timeFrame: 3 year follow-up
measure: Australian/Canadian hand index (AUSCAN)
timeFrame: Baseline
measure: Australian/Canadian hand index (AUSCAN)
timeFrame: 3 year follow-up
measure: Western Ontario and McMaster Universities Arthrtis Index (WOMAC)
timeFrame: Baseline
measure: Western Ontario and McMaster Universities Arthrtis Index (WOMAC)
timeFrame: 3 year follow-up
measure: Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
timeFrame: Baseline
measure: McGill Questionnaire
timeFrame: Baseline
measure: PainDetect
timeFrame: Baseline
measure: PainDetect
timeFrame: 3 year follow-up
measure: Brief Approach/Avoidance Coping Questionnaire (BACQ)
timeFrame: Baseline
measure: Pain catastrophizing scale
timeFrame: Baseline
measure: Pain catastrophizing scale
timeFrame: 3 year follow-up
measure: Self-efficacy scales
timeFrame: Baseline
measure: Self-efficacy scales
timeFrame: 3 year follow-up
measure: Foot Function Index
timeFrame: Baseline
measure: Foot Function Index
timeFrame: 3 year follow-up
measure: Hormonal factors in women
timeFrame: Baseline
measure: Hormonal factors in women
timeFrame: 3 year follow-up
measure: Use of shoewear
timeFrame: 3 year follow-up
measure: Global health assessment
timeFrame: 3 year follow-up
measure: Pain Sensitivity Questionnaire
timeFrame: 3 year follow-up
measure: Fibromyalgia symptoms
timeFrame: 3 year follow-up
measure: Short form 12 Energy
timeFrame: 3 year follow-up
measure: Brief Illness Perception Questionnaire
timeFrame: 3 year follow-up
measure: Height
timeFrame: Baseline
measure: Height
timeFrame: 3 year follow-up
measure: Weight
timeFrame: Baseline
measure: Weight
timeFrame: 3 year follow-up
measure: Hip/waist circumference
timeFrame: Baseline
measure: Hip/waist circumference
timeFrame: 3 year follow-up
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: 3 year follow-up
measure: Heart rate
timeFrame: Baseline
measure: Heart rate
timeFrame: 3 year follow-up
measure: Comorbidity questionnaires and medications
timeFrame: Baseline
measure: Comorbidity questionnaires and medications
timeFrame: 3 year follow-up
measure: Hair sample
timeFrame: Baseline
measure: Joint assessment (examination by rheumatologist)
timeFrame: Baseline
measure: Joint assessment (examination by rheumatologist)
timeFrame: 3 year follow-up
measure: Grip strength
timeFrame: Baseline, follow-up
measure: Grip strength
timeFrame: 3 year follow-up
measure: Moberg Pick-Up test
timeFrame: Baseline
measure: Moberg Pick-Up test
timeFrame: 3 year follow-up
measure: Chair Stand test
timeFrame: 3 year follow-up
measure: 40 m walking test
timeFrame: 3 year follow-up
measure: Pain sensitization tests
timeFrame: Baseline
measure: Pain sensitization tests
timeFrame: 3 year follow-up
measure: Ultrasound examination
timeFrame: Baseline
measure: Ultrasound examination
timeFrame: 3 year follow-up
measure: Fluorescence Optical Imaging
timeFrame: Baseline
measure: Fluorescence Optical Imaging
timeFrame: 3 year follow-up
measure: Conventional radiographs
timeFrame: Baseline
measure: Conventional radiographs
timeFrame: 3 year follow-up
measure: MRI
timeFrame: Baseline
measure: MRI
timeFrame: 3 year follow-up
measure: CT
timeFrame: Baseline
measure: Biobank
timeFrame: Baseline
measure: Biobank
timeFrame: 3 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Ida K Haugen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fjellstad CM, Mathiessen A, Slatkowsky-Christensen B, Kvien TK, Hammer HB, Haugen IK. Associations Between Ultrasound-Detected Synovitis, Pain, and Function in Interphalangeal and Thumb Base Osteoarthritis: Data From the Nor-Hand Cohort. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1530-1535. doi: 10.1002/acr.24047.
citation: Gloersen M, Steen Pettersen P, Kvien TK, Haugen IK. Validation of the Intermittent and Constant Osteoarthritis Pain Questionnaire in Patients with Hand Osteoarthritis: Results from the Nor-Hand Study. J Rheumatol. 2019 Jun;46(6):645-651. doi: 10.3899/jrheum.180835. Epub 2019 Mar 15.
citation: Steen Pettersen P, Neogi T, Magnusson K, Berner Hammer H, Uhlig T, Kvien TK, Haugen IK. Peripheral and Central Sensitization of Pain in Individuals With Hand Osteoarthritis and Associations With Self-Reported Pain Severity. Arthritis Rheumatol. 2019 Jul;71(7):1070-1077. doi: 10.1002/art.40850. Epub 2019 May 14.
citation: Gloersen M, Mulrooney E, Mathiessen A, Hammer HB, Slatkowsky-Christensen B, Faraj K, Isaksen T, Neogi T, Kvien TK, Magnusson K, Haugen IK. A hospital-based observational cohort study exploring pain and biomarkers in patients with hand osteoarthritis in Norway: The Nor-Hand protocol. BMJ Open. 2017 Sep 24;7(9):e016938. doi: 10.1136/bmjopen-2017-016938.