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The Nor-Hand Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083548
Recruitment Status : Active, not recruiting
First Posted : March 20, 2017
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ida Kristin Haugen, 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.

Condition or disease Intervention/treatment
Osteoarthritis Pain Inflammation Image, Body Diagnostic Test: Imaging Diagnostic Test: Physical examinations Diagnostic Test: Questionnnaires

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Nor-Hand Study: An Observational Cohort of Hand Osteoarthritis Patients
Actual Study Start Date : April 2016
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Serum, urine, plasma and whole-blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083548


Locations
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Norway
Diakonhjemmet Hospital
Oslo, Norway
Sponsors and Collaborators
Diakonhjemmet Hospital
Investigators
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Principal Investigator: Ida K Haugen, MD, PhD Diakonhjemmet Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ida Kristin Haugen, MD, PhD, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT03083548    
Other Study ID Numbers: DIA2017-1
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Inflammation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes