The Nor-Hand Study

The Nor-Hand Study: An Observational Cohort of Hand Osteoarthritis Patients

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.

Study Overview

• Status: Completed
• Conditions: Pain; Inflammation; Osteoarthritis; Image, Body
• Intervention / Treatment: Diagnostic test: Imaging; Diagnostic test: Physical examinations; Diagnostic test: Questionnnaires

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Diakonhjemmet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; Conventional radiographs (hands/feet), CT of dominant hand, MRI of dominant hand, ultrasound (hands/shoulder/feet/hips/knees), fluorescence optical imaging of hands; Diagnostic test: Physical examinations; Joint assessment of hands and feet, pain sensitization test and functional tests; Diagnostic test: Questionnnaires; Self-reported demographic factors, clinical variables and OA history and symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Investigators: Principal Investigator: Ida K Haugen, MD, PhD, Diakonhjemmet Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Osteoarthritis; Inflammation; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination; Diagnostic Imaging
• Other Study ID Numbers: DIA2017-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No