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Completed

NCT Number: NCT03083548

The Nor-Hand Study

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.

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Key information

Conditions

Osteoarthritis Arthritis Image, Body Inflammation Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diakonhjemmet Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

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

Physical examinations

Diagnostic Test

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

Questionnnaires

Diagnostic Test

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

Primary outcomes

  1. Demographic factors

    Time frame: Baseline

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

  2. Demographic factors

    Time frame: 3 year follow-up

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

  3. Life style factors

    Time frame: Baseline

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

  4. Life style factors

    Time frame: 3 year follow-up

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

  5. Clinical disease variables

    Time frame: Baseline

    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

  6. Clinical disease variables

    Time frame: 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

  7. EuroQol 5 dimensions

    Time frame: Baseline

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

  8. EuroQol 5 dimensions

    Time frame: 3 year follow-up

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

  9. Sleep disturbances

    Time frame: Baseline

    Self-reported sleep disturbances

  10. Sleep disturbances

    Time frame: 3 year follow-up

    Self-reported sleep disturbances

  11. Michigan Hand Outcomes Questionnaire (MHOQ)

    Time frame: Baseline

    Aesthetic damage subscale

  12. Michigan Hand Outcomes Questionnaire (MHOQ)

    Time frame: 3 year follow-up

    All subscales

  13. Localization of joint pain (homonculus)

    Time frame: Baseline

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

  14. Localization of joint pain (homonculus)

    Time frame: 3 year follow-up

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

  15. Self-reported joint pain, hand pain, feet pain, fatigue, disease activity

    Time frame: Baseline

    Numeric Rating Scale (0-10)

  16. Self-reported joint pain, hand pain, feet pain, fatigue, disease activity

    Time frame: 3 year follow-up

    Numeric Rating Scale (0-10)

  17. Australian/Canadian hand index (AUSCAN)

    Time frame: Baseline

    Self-reported hand pain, stiffness and physical function

  18. Australian/Canadian hand index (AUSCAN)

    Time frame: 3 year follow-up

    Self-reported hand pain, stiffness and physical function

  19. Western Ontario and McMaster Universities Arthrtis Index (WOMAC)

    Time frame: Baseline

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

  20. Western Ontario and McMaster Universities Arthrtis Index (WOMAC)

    Time frame: 3 year follow-up

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

  21. Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)

    Time frame: Baseline

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

  22. McGill Questionnaire

    Time frame: Baseline

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

  23. PainDetect

    Time frame: Baseline

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

  24. PainDetect

    Time frame: 3 year follow-up

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

  25. Brief Approach/Avoidance Coping Questionnaire (BACQ)

    Time frame: Baseline

    Self-reported approach-oriented and avoidance oriented coping

  26. Pain catastrophizing scale

    Time frame: Baseline

    Self-reported magnification, rumination, helplessness

  27. Pain catastrophizing scale

    Time frame: 3 year follow-up

    Self-reported magnification, rumination, helplessness

  28. Self-efficacy scales

    Time frame: Baseline

    Self-reported ability influence pain and symptoms

  29. Self-efficacy scales

    Time frame: 3 year follow-up

    Self-reported ability influence pain and symptoms

  30. Foot Function Index

    Time frame: Baseline

    Self-reported pain in feet, disability, activity restrictions

  31. Foot Function Index

    Time frame: 3 year follow-up

    Self-reported pain in feet, disability, activity restrictions

  32. Hormonal factors in women

    Time frame: Baseline

    Menopause

  33. Hormonal factors in women

    Time frame: 3 year follow-up

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

  34. Use of shoewear

    Time frame: 3 year follow-up

    The use of shoes with varying type of forefoot and heels

  35. Global health assessment

    Time frame: 3 year follow-up

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

  36. Pain Sensitivity Questionnaire

    Time frame: 3 year follow-up

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

  37. Fibromyalgia symptoms

    Time frame: 3 year follow-up

    ACR criteria for fibromyalgia

  38. Short form 12 Energy

    Time frame: 3 year follow-up

    One question from Short form 12 about poor energy

  39. Brief Illness Perception Questionnaire

    Time frame: 3 year follow-up

    Illness perception related to their hand OA disease and symptoms

  40. Height

    Time frame: Baseline

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

  41. Height

    Time frame: 3 year follow-up

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

  42. Weight

    Time frame: Baseline

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

  43. Weight

    Time frame: 3 year follow-up

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

  44. Hip/waist circumference

    Time frame: Baseline

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

  45. Hip/waist circumference

    Time frame: 3 year follow-up

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

  46. Blood pressure

    Time frame: Baseline

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

  47. Blood pressure

    Time frame: 3 year follow-up

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

  48. Heart rate

    Time frame: Baseline

    Examination heart rate after rest (performed by medical student)

  49. Heart rate

    Time frame: 3 year follow-up

    Examination heart rate after rest (performed by medical student)

  50. Comorbidity questionnaires and medications

    Time frame: Baseline

    Self-reported comorbidities and medications

  51. Comorbidity questionnaires and medications

    Time frame: 3 year follow-up

    Self-reported comorbidities and medications

  52. Hair sample

    Time frame: Baseline

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

  53. Joint assessment (examination by rheumatologist)

    Time frame: Baseline

    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

  54. Joint assessment (examination by rheumatologist)

    Time frame: 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

  55. Grip strength

    Time frame: Baseline, follow-up

    Bilateral measurement of grip strength using Jamar dynamometer

  56. Grip strength

    Time frame: 3 year follow-up

    Bilateral measurement of grip strength using Jamar dynamometer

  57. Moberg Pick-Up test

    Time frame: Baseline

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

  58. Moberg Pick-Up test

    Time frame: 3 year follow-up

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

  59. Chair Stand test

    Time frame: 3 year follow-up

    Number of chair stands during 30 sec

  60. 40 m walking test

    Time frame: 3 year follow-up

    Time in sec for 40 m walking

  61. Pain sensitization tests

    Time frame: Baseline

    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

  62. Pain sensitization tests

    Time frame: 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

  63. Ultrasound examination

    Time frame: Baseline

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

  64. Ultrasound examination

    Time frame: 3 year follow-up

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

  65. Fluorescence Optical Imaging

    Time frame: Baseline

    Examination of altered microcirculation in the hands

  66. Fluorescence Optical Imaging

    Time frame: 3 year follow-up

    Examination of altered microcirculation in the hands

  67. Conventional radiographs

    Time frame: Baseline

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

  68. Conventional radiographs

    Time frame: 3 year follow-up

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

  69. MRI

    Time frame: Baseline

    MRI of dominant hand

  70. MRI

    Time frame: 3 year follow-up

    MRI of dominant hand

  71. CT

    Time frame: Baseline

    CT of dominant hand

  72. Biobank

    Time frame: Baseline

    Collection of whole blood, serum, plasma and urine

  73. Biobank

    Time frame: 3 year follow-up

    Collection of whole blood, serum, plasma and urine

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2017
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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