The Nor-Hand Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03083548
• Other study ID #: DIA2017-1
• Status: Active, not recruiting
• Start date: April 2016
• Est. completion date: May 2025

Study information

• Verified date: April 2023
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Image, Body
• Inflammation
• Osteoarthritis
• Pain

Intervention

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
• Physical examinations
Joint assessment of hands and feet, pain sensitization test and functional tests
• Questionnnaires
Self-reported demographic factors, clinical variables and OA history and symptoms

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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