The Nor-Hand Study

Active, not recruiting

• Conditions: Image, Body; Osteoarthritis; Pain; Inflammation
• Interventions: Diagnostic Test: Imaging; Diagnostic Test: Physical examinations; Diagnostic Test: Questionnnaires

• Registration Number: NCT03083548
• Lead Sponsor: Diakonhjemmet Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hand osteoarthritis	Physical examinations	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.
Hand osteoarthritis	Questionnnaires	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.
Hand osteoarthritis	Imaging	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.

Primary Outcome Measures

Name	Time	Method
Comorbidity questionnaires and medications	3 year follow-up	Self-reported comorbidities and medications
Hair sample	Baseline	Small hair sample is collected from the back of the patients´ head for quantification of cortisol
Foot Function Index	3 year follow-up	Self-reported pain in feet, disability, activity restrictions
Use of shoewear	3 year follow-up	The use of shoes with varying type of forefoot and heels
Pain Sensitivity Questionnaire	3 year follow-up	Pain in different daily-life situations, normally leading to no or little pain
40 m walking test	3 year follow-up	Time in sec for 40 m walking
Sleep disturbances	3 year follow-up	Self-reported sleep disturbances
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)	Baseline	Modified version to assess constant and intermittent pain in patients with hand OA (self-reported)
Heart rate	3 year follow-up	Examination heart rate after rest (performed by medical student)
Demographic factors	3 year follow-up	Self-reported relationship status, social network, education, employment
Michigan Hand Outcomes Questionnaire (MHOQ)	3 year follow-up	All subscales
Localization of joint pain (homonculus)	3 year follow-up	Self-reported pain during the last 24 hours and previous 6 weeks
Self-reported joint pain, hand pain, feet pain, fatigue, disease activity	3 year follow-up	Numeric Rating Scale (0-10)
Western Ontario and McMaster Universities Arthrtis Index (WOMAC)	3 year follow-up	Self-reported knee/hip pain, stiffness and physical function
Pain sensitization tests	3 year follow-up	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
Ultrasound examination	3 year follow-up	Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
MRI	3 year follow-up	MRI of dominant hand
Life style factors	3 year follow-up	Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
Pain catastrophizing scale	3 year follow-up	Self-reported magnification, rumination, helplessness
Global health assessment	3 year follow-up	The evaluation of the global health on Visual analogue scale (VAS)
Short form 12 Energy	3 year follow-up	One question from Short form 12 about poor energy
Brief Illness Perception Questionnaire	3 year follow-up	Illness perception related to their hand OA disease and symptoms
Grip strength	3 year follow-up	Bilateral measurement of grip strength using Jamar dynamometer
Clinical disease variables	3 year follow-up	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
PainDetect	3 year follow-up	Modified version to assess neuropathic hand pain (self-reported)
EuroQol 5 dimensions	3 year follow-up	Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
Australian/Canadian hand index (AUSCAN)	3 year follow-up	Self-reported hand pain, stiffness and physical function
McGill Questionnaire	Baseline	Modified version to assess hand OA pain characteristics (self-reported)
Self-efficacy scales	3 year follow-up	Self-reported ability influence pain and symptoms
Height	3 year follow-up	Examination of height in standing position (performed by medical student)
Joint assessment (examination by rheumatologist)	3 year follow-up	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
Fluorescence Optical Imaging	3 year follow-up	Examination of altered microcirculation in the hands
Conventional radiographs	3 year follow-up	Hands (frontal), feet (frontal, oblique and side images)
Brief Approach/Avoidance Coping Questionnaire (BACQ)	Baseline	Self-reported approach-oriented and avoidance oriented coping
Hormonal factors in women	3 year follow-up	Menarche, menopause, gynecological operations, hormone treatment, pregnancies, breastfeeding
Fibromyalgia symptoms	3 year follow-up	ACR criteria for fibromyalgia
Weight	3 year follow-up	Examination of weight in light-weighted clothes (performed by medical student)
Hip/waist circumference	3 year follow-up	Examination of hip and waist circumference (performed by medical student)
Blood pressure	3 year follow-up	Examination of blood pressure after rest (performed by medical student)
Moberg Pick-Up test	3 year follow-up	Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)
Chair Stand test	3 year follow-up	Number of chair stands during 30 sec
CT	Baseline	CT of dominant hand
Biobank	3 year follow-up	Collection of whole blood, serum, plasma and urine

Trial Locations

Locations (1)

Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway