The Nor-Hand Study

NCT03083548 | Completed

• 1 other identifier: DIA2017-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Pain; Inflammation; Image, Body

Outcome Measures

Primary Outcomes (73)

• Demographic factors

  Self-reported relationship status, education, employment, hand tasks in work/previous work, birth place

  Baseline

• Demographic factors

  Self-reported relationship status, social network, education, employment

  3 year follow-up

• Life style factors

  Self-reported physical activity, smoking, use of alcohol (AUDIT-C)

  Baseline

• Life style factors

  Self-reported physical activity, smoking, use of alcohol (AUDIT-C)

  3 year follow-up

• Clinical disease variables

  Self-reported year diagnosed with OA, number of years with OA symptoms, OA in family, previous injuries of hand/foot, use of medications, previous steroid injections, use of hand orthoses, use of customized tools, previous surgeries, use of alternative therapies, use of supplements, use of nature cures, use of self-help techniques

  Baseline

• Clinical disease variables

  Previous injuries of hand/foot, use of medications, previous steroid injections, use of hand orthoses, use of customized tools, previous surgeries, use of alternative therapies, use of supplements, use of nature cures, use of self-help techniques

  3 year follow-up

• EuroQol 5 dimensions

  Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression

  Baseline

• EuroQol 5 dimensions

  Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression

  3 year follow-up

• Sleep disturbances

  Self-reported sleep disturbances

  Baseline

• Sleep disturbances

  Self-reported sleep disturbances

  3 year follow-up

• Michigan Hand Outcomes Questionnaire (MHOQ)

  Aesthetic damage subscale

  Baseline

• Michigan Hand Outcomes Questionnaire (MHOQ)

  All subscales

  3 year follow-up

• Localization of joint pain (homonculus)

  Self-reported pain during the last 24 hours and previous 6 weeks

  Baseline

• Localization of joint pain (homonculus)

  Self-reported pain during the last 24 hours and previous 6 weeks

  3 year follow-up

• Self-reported joint pain, hand pain, feet pain, fatigue, disease activity

  Numeric Rating Scale (0-10)

  Baseline

• Self-reported joint pain, hand pain, feet pain, fatigue, disease activity

  Numeric Rating Scale (0-10)

  3 year follow-up

• Australian/Canadian hand index (AUSCAN)

  Self-reported hand pain, stiffness and physical function

  Baseline

• Australian/Canadian hand index (AUSCAN)

  Self-reported hand pain, stiffness and physical function

  3 year follow-up

• Western Ontario and McMaster Universities Arthrtis Index (WOMAC)

  Self-reported knee/hip pain, stiffness and physical function

  Baseline

• Western Ontario and McMaster Universities Arthrtis Index (WOMAC)

  Self-reported knee/hip pain, stiffness and physical function

  3 year follow-up

• Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)

  Modified version to assess constant and intermittent pain in patients with hand OA (self-reported)

  Baseline

• McGill Questionnaire

  Modified version to assess hand OA pain characteristics (self-reported)

  Baseline

• PainDetect

  Modified version to assess neuropathic hand pain (self-reported)

  Baseline

• PainDetect

  Modified version to assess neuropathic hand pain (self-reported)

  3 year follow-up

• Brief Approach/Avoidance Coping Questionnaire (BACQ)

  Self-reported approach-oriented and avoidance oriented coping

  Baseline

• Pain catastrophizing scale

  Self-reported magnification, rumination, helplessness

  Baseline

• Pain catastrophizing scale

  Self-reported magnification, rumination, helplessness

  3 year follow-up

• Self-efficacy scales

  Self-reported ability influence pain and symptoms

  Baseline

• Self-efficacy scales

  Self-reported ability influence pain and symptoms

  3 year follow-up

• Foot Function Index

  Self-reported pain in feet, disability, activity restrictions

  Baseline

• Foot Function Index

  Self-reported pain in feet, disability, activity restrictions

  3 year follow-up

• Hormonal factors in women

  Menopause

  Baseline

• Hormonal factors in women

  Menarche, menopause, gynecological operations, hormone treatment, pregnancies, breastfeeding

  3 year follow-up

• Use of shoewear

  The use of shoes with varying type of forefoot and heels

  3 year follow-up

• Global health assessment

  The evaluation of the global health on Visual analogue scale (VAS)

  3 year follow-up

• Pain Sensitivity Questionnaire

  Pain in different daily-life situations, normally leading to no or little pain

  3 year follow-up

• Fibromyalgia symptoms

  ACR criteria for fibromyalgia

  3 year follow-up

• Short form 12 Energy

  One question from Short form 12 about poor energy

  3 year follow-up

• Brief Illness Perception Questionnaire

  Illness perception related to their hand OA disease and symptoms

  3 year follow-up

• Height

  Examination of height in standing position (performed by medical student)

  Baseline

• Height

  Examination of height in standing position (performed by medical student)

  3 year follow-up

• Weight

  Examination of weight in light-weighted clothes (performed by medical student)

  Baseline

• Weight

  Examination of weight in light-weighted clothes (performed by medical student)

  3 year follow-up

• Hip/waist circumference

  Examination of hip and waist circumference (performed by medical student)

  Baseline

• Hip/waist circumference

  Examination of hip and waist circumference (performed by medical student)

  3 year follow-up

• Blood pressure

  Examination of blood pressure after rest (performed by medical student)

  Baseline

• Blood pressure

  Examination of blood pressure after rest (performed by medical student)

  3 year follow-up

• Heart rate

  Examination heart rate after rest (performed by medical student)

  Baseline

• Heart rate

  Examination heart rate after rest (performed by medical student)

  3 year follow-up

• Comorbidity questionnaires and medications

  Self-reported comorbidities and medications

  Baseline

• Comorbidity questionnaires and medications

  Self-reported comorbidities and medications

  3 year follow-up

• Hair sample

  Small hair sample is collected from the back of the patients´ head for quantification of cortisol

  Baseline

• Joint assessment (examination by rheumatologist)

  Bony enlargement, tenderness (Doyle index in hand) and soft tissue swelling in hands and feet, and assessment of the ACR criteria of hand, knee and hip

  Baseline

• Joint assessment (examination by rheumatologist)

  Bony enlargement, tenderness (Doyle index in hand) and soft tissue swelling in hands and feet, and assessment of the ACR criteria of hand, knee and hip

  3 year follow-up

• Grip strength

  Bilateral measurement of grip strength using Jamar dynamometer

  Baseline, follow-up

• Grip strength

  Bilateral measurement of grip strength using Jamar dynamometer

  3 year follow-up

• Moberg Pick-Up test

  Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)

  Baseline

• Moberg Pick-Up test

  Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)

  3 year follow-up

• Chair Stand test

  Number of chair stands during 30 sec

  3 year follow-up

• 40 m walking test

  Time in sec for 40 m walking

  3 year follow-up

• Pain sensitization tests

  Temporal summation, pressure pain threshold (painful finger joint, non-painful finger joint, trapezius muscle, left distal radioulnar joint and tibialis anterior muscle), conditioned pain modulation, light touch

  Baseline

• Pain sensitization tests

  Temporal summation, pressure pain threshold (painful finger joint, non-painful finger joint, trapezius muscle, left distal radioulnar joint and tibialis anterior muscle), conditioned pain modulation, light touch

  3 year follow-up

• Ultrasound examination

  Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet

  Baseline

• Ultrasound examination

  Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet

  3 year follow-up

• Fluorescence Optical Imaging

  Examination of altered microcirculation in the hands

  Baseline

• Fluorescence Optical Imaging

  Examination of altered microcirculation in the hands

  3 year follow-up

• Conventional radiographs

  Hands (frontal), feet (frontal, oblique and side images)

  Baseline

• Conventional radiographs

  Hands (frontal), feet (frontal, oblique and side images)

  3 year follow-up

• MRI

  MRI of dominant hand

  Baseline

• MRI

  MRI of dominant hand

  3 year follow-up

• CT

  CT of dominant hand

  Baseline

• Biobank

  Collection of whole blood, serum, plasma and urine

  Baseline

• Biobank

  Collection of whole blood, serum, plasma and urine

  3 year follow-up

Study Arms (1)

Hand osteoarthritis

Men and women (40-70 years) with a diagnosis of hand OA based on clinical or ultrasound examination are included. Patients with systemic inflammatory joint diseases, psoriasis and hemochromatosis are excluded.

Diagnostic Test: Imaging; Diagnostic Test: Physical examinations; Diagnostic Test: Questionnnaires

Interventions

Imaging DIAGNOSTIC_TEST

Conventional radiographs (hands/feet), CT of dominant hand, MRI of dominant hand, ultrasound (hands/shoulder/feet/hips/knees), fluorescence optical imaging of hands

Hand osteoarthritis

Physical examinations DIAGNOSTIC_TEST

Joint assessment of hands and feet, pain sensitization test and functional tests

Hand osteoarthritis

Questionnnaires DIAGNOSTIC_TEST

Self-reported demographic factors, clinical variables and OA history and symptoms

Hand osteoarthritis

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Norway

Location

Related Publications (4)

• 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.

  PMID: 31421023 DERIVED

• 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.

  PMID: 30877221 DERIVED

• 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.

  PMID: 30741501 DERIVED

• 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.

  PMID: 28947452 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, urine, plasma and whole-blood

MeSH Terms

Conditions

Osteoarthritis; Pain; Inflammation

Interventions

Diagnostic Imaging; Physical Examination

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ida K Haugen, MD, PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 20, 2017
• Study Start: April 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)