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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

Tracking Information
First Submitted Date March 8, 2017
First Posted Date March 20, 2017
Last Update Posted Date November 29, 2019
Actual Study Start Date April 2016
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2019)
  • Demographic factors [ Time Frame: Baseline ]
    Self-reported relationship status, education, employment, hand tasks in work/previous work, birth place
  • Demographic factors [ Time Frame: 3 year follow-up ]
    Self-reported relationship status, social network, education, employment
  • Life style factors [ Time Frame: Baseline ]
    Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
  • Life style factors [ Time Frame: 3 year follow-up ]
    Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
  • 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
  • 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
  • EuroQol 5 dimensions [ Time Frame: Baseline ]
    Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
  • EuroQol 5 dimensions [ Time Frame: 3 year follow-up ]
    Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
  • Sleep disturbances [ Time Frame: Baseline ]
    Self-reported sleep disturbances
  • Sleep disturbances [ Time Frame: 3 year follow-up ]
    Self-reported sleep disturbances
  • Michigan Hand Outcomes Questionnaire (MHOQ) [ Time Frame: Baseline ]
    Aesthetic damage subscale
  • Michigan Hand Outcomes Questionnaire (MHOQ) [ Time Frame: 3 year follow-up ]
    All subscales
  • Localization of joint pain (homonculus) [ Time Frame: Baseline ]
    Self-reported pain during the last 24 hours and previous 6 weeks
  • Localization of joint pain (homonculus) [ Time Frame: 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 [ Time Frame: Baseline ]
    Numeric Rating Scale (0-10)
  • Self-reported joint pain, hand pain, feet pain, fatigue, disease activity [ Time Frame: 3 year follow-up ]
    Numeric Rating Scale (0-10)
  • Australian/Canadian hand index (AUSCAN) [ Time Frame: Baseline ]
    Self-reported hand pain, stiffness and physical function
  • Australian/Canadian hand index (AUSCAN) [ Time Frame: 3 year follow-up ]
    Self-reported hand pain, stiffness and physical function
  • Western Ontario and McMaster Universities Arthrtis Index (WOMAC) [ Time Frame: Baseline ]
    Self-reported knee/hip pain, stiffness and physical function
  • Western Ontario and McMaster Universities Arthrtis Index (WOMAC) [ Time Frame: 3 year follow-up ]
    Self-reported knee/hip pain, stiffness and physical function
  • 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)
  • McGill Questionnaire [ Time Frame: Baseline ]
    Modified version to assess hand OA pain characteristics (self-reported)
  • PainDetect [ Time Frame: Baseline ]
    Modified version to assess neuropathic hand pain (self-reported)
  • PainDetect [ Time Frame: 3 year follow-up ]
    Modified version to assess neuropathic hand pain (self-reported)
  • Brief Approach/Avoidance Coping Questionnaire (BACQ) [ Time Frame: Baseline ]
    Self-reported approach-oriented and avoidance oriented coping
  • Pain catastrophizing scale [ Time Frame: Baseline ]
    Self-reported magnification, rumination, helplessness
  • Pain catastrophizing scale [ Time Frame: 3 year follow-up ]
    Self-reported magnification, rumination, helplessness
  • Self-efficacy scales [ Time Frame: Baseline ]
    Self-reported ability influence pain and symptoms
  • Self-efficacy scales [ Time Frame: 3 year follow-up ]
    Self-reported ability influence pain and symptoms
  • Foot Function Index [ Time Frame: Baseline ]
    Self-reported pain in feet, disability, activity restrictions
  • Foot Function Index [ Time Frame: 3 year follow-up ]
    Self-reported pain in feet, disability, activity restrictions
  • Hormonal factors in women [ Time Frame: Baseline ]
    Menopause
  • Hormonal factors in women [ Time Frame: 3 year follow-up ]
    Menarche, menopause, gynecological operations, hormone treatment, pregnancies, breastfeeding
  • Use of shoewear [ Time Frame: 3 year follow-up ]
    The use of shoes with varying type of forefoot and heels
  • Global health assessment [ Time Frame: 3 year follow-up ]
    The evaluation of the global health on Visual analogue scale (VAS)
  • Pain Sensitivity Questionnaire [ Time Frame: 3 year follow-up ]
    Pain in different daily-life situations, normally leading to no or little pain
  • Fibromyalgia symptoms [ Time Frame: 3 year follow-up ]
    ACR criteria for fibromyalgia
  • Short form 12 Energy [ Time Frame: 3 year follow-up ]
    One question from Short form 12 about poor energy
  • Brief Illness Perception Questionnaire [ Time Frame: 3 year follow-up ]
    Illness perception related to their hand OA disease and symptoms
  • Height [ Time Frame: Baseline ]
    Examination of height in standing position (performed by medical student)
  • Height [ Time Frame: 3 year follow-up ]
    Examination of height in standing position (performed by medical student)
  • Weight [ Time Frame: Baseline ]
    Examination of weight in light-weighted clothes (performed by medical student)
  • Weight [ Time Frame: 3 year follow-up ]
    Examination of weight in light-weighted clothes (performed by medical student)
  • Hip/waist circumference [ Time Frame: Baseline ]
    Examination of hip and waist circumference (performed by medical student)
  • Hip/waist circumference [ Time Frame: 3 year follow-up ]
    Examination of hip and waist circumference (performed by medical student)
  • Blood pressure [ Time Frame: Baseline ]
    Examination of blood pressure after rest (performed by medical student)
  • Blood pressure [ Time Frame: 3 year follow-up ]
    Examination of blood pressure after rest (performed by medical student)
  • Heart rate [ Time Frame: Baseline ]
    Examination heart rate after rest (performed by medical student)
  • Heart rate [ Time Frame: 3 year follow-up ]
    Examination heart rate after rest (performed by medical student)
  • Comorbidity questionnaires and medications [ Time Frame: Baseline ]
    Self-reported comorbidities and medications
  • Comorbidity questionnaires and medications [ Time Frame: 3 year follow-up ]
    Self-reported comorbidities and medications
  • Hair sample [ Time Frame: Baseline ]
    Small hair sample is collected from the back of the patients´ head for quantification of cortisol
  • 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
  • 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
  • Grip strength [ Time Frame: Baseline, follow-up ]
    Bilateral measurement of grip strength using Jamar dynamometer
  • Grip strength [ Time Frame: 3 year follow-up ]
    Bilateral measurement of grip strength using Jamar dynamometer
  • Moberg Pick-Up test [ Time Frame: Baseline ]
    Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)
  • 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)
  • Chair Stand test [ Time Frame: 3 year follow-up ]
    Number of chair stands during 30 sec
  • 40 m walking test [ Time Frame: 3 year follow-up ]
    Time in sec for 40 m walking
  • 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
  • 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
  • Ultrasound examination [ Time Frame: Baseline ]
    Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
  • Ultrasound examination [ Time Frame: 3 year follow-up ]
    Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
  • Fluorescence Optical Imaging [ Time Frame: Baseline ]
    Examination of altered microcirculation in the hands
  • Fluorescence Optical Imaging [ Time Frame: 3 year follow-up ]
    Examination of altered microcirculation in the hands
  • Conventional radiographs [ Time Frame: Baseline ]
    Hands (frontal), feet (frontal, oblique and side images)
  • Conventional radiographs [ Time Frame: 3 year follow-up ]
    Hands (frontal), feet (frontal, oblique and side images)
  • MRI [ Time Frame: Baseline ]
    MRI of dominant hand
  • MRI [ Time Frame: 3 year follow-up ]
    MRI of dominant hand
  • CT [ Time Frame: Baseline ]
    CT of dominant hand
  • Biobank [ Time Frame: Baseline ]
    Collection of whole blood, serum, plasma and urine
  • Biobank [ Time Frame: 3 year follow-up ]
    Collection of whole blood, serum, plasma and urine
Original Primary Outcome Measures
 (submitted: March 13, 2017)
  • Demographic factors [ Time Frame: Baseline ]
    Self-reported relationship status, employment, hand tasks in work/previous work, birth place
  • Life style factors [ Time Frame: Baseline ]
    Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
  • 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, menopause
  • EuroQol 5 dimensions [ Time Frame: Baseline ]
    Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
  • Sleep disturbances [ Time Frame: Baseline ]
    Self-reported sleep disturbances
  • Michigan Hand Outcomes Questionnaire (MHOQ) aesthetic damage subscale [ Time Frame: Baseline ]
    Self-reported aesthetic damage
  • Localization of joint pain (homonculus) [ Time Frame: Baseline ]
    Self-reported pain during the last 24 hours and previous 6 weeks
  • Numeric Rating Scales [ Time Frame: Baseline ]
    Self-report joint pain last 24 hours, hand pain last 24 hours, feet pain last 24 hours, fatigue last 24 hours, disease activity of hand OA last 24 hours
  • Australian/Canadian hand index (AUSCAN) [ Time Frame: Baseline ]
    Self-reported hand pain, stiffness and physical function
  • Western Ontario and McMaster Universities Arthrtis Index (WOMAC) [ Time Frame: Baseline ]
    Self-reported knee/hip pain, stiffness and physical function
  • 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)
  • McGill Questionnaire [ Time Frame: Baseline ]
    Modified version to assess hand OA pain characteristics (self-reported)
  • PainDetect [ Time Frame: Baseline ]
    Modified version to assess neuropathic hand pain (self-reported)
  • Brief Approach/Avoidance Coping Questionnaire (BACQ) [ Time Frame: Baseline ]
    Self-reported approach-oriented and avoidance oriented coping
  • Pain catastrophizing scale [ Time Frame: Baseline ]
    Self-reported magnification, rumination, helplessness
  • Self-efficacy scales [ Time Frame: Baseline ]
    Self-reported ability influence pain and symptoms
  • Foot Function Index [ Time Frame: Baseline ]
    Self-reported pain in feet, disability, activity restrictions
  • Medical assessments [ Time Frame: Baseline ]
    Height, weight, hip and waist circumference, blood pressure, heart rate
  • Comorbidity questionnaires and medications [ Time Frame: Baseline ]
    Self-reported comorbidities and medications
  • Hair sample [ Time Frame: Baseline ]
    Small hair sample is collected from the back of the patients´ head for quantification of cortisol
  • 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
  • Functional tests [ Time Frame: Baseline ]
    Grip strength by Jamar dynamometer, Moberg Pick-up test
  • 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
  • Ultrasound examination [ Time Frame: Baseline ]
    Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
  • Fluorescence Optical Imaging [ Time Frame: Baseline ]
    Examination of altered microcirculation in the hands
  • Conventional radiographs [ Time Frame: Baseline ]
    Hands (frontal), feet (frontal, oblique and side images)
  • MRI [ Time Frame: Baseline ]
    MRI of dominant hand
  • CT [ Time Frame: Baseline ]
    CT of dominant hand
  • Biobank [ Time Frame: Baseline ]
    Collection of whole blood, serum, plasma and urine
Change History Complete list of historical versions of study NCT03083548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Nor-Hand Study
Official Title The Nor-Hand Study: An Observational Cohort of Hand Osteoarthritis Patients
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, urine, plasma and whole-blood
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.
Condition
  • Osteoarthritis
  • Pain
  • Inflammation
  • Image, Body
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
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Diagnostic Test: Imaging
  • Diagnostic Test: Physical examinations
  • Diagnostic Test: Questionnnaires
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 13, 2017)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2025
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03083548
Other Study ID Numbers DIA2017-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ida Kristin Haugen, Diakonhjemmet Hospital
Study Sponsor Diakonhjemmet Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ida K Haugen, MD, PhD Diakonhjemmet Hospital
PRS Account Diakonhjemmet Hospital
Verification Date November 2019