OsteoarthritisNCT03083548
The Nor-Hand Study
An observational study of Osteoarthritis and Pain, run by Diakonhjemmet Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Pain, Inflammation
- What is being tested?
- Imaging, Physical examinations and Questionnnaires
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2016to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Nor-Hand Study: An Observational Cohort of Hand Osteoarthritis Patients
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.
- Conditions
- Osteoarthritis, Pain, Inflammation, Image, Body
- Being tested
- Imaging, Physical examinations, Questionnnaires
- Medical subject headings
- Osteoarthritis, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic 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 examinationsDiagnostic test
Joint assessment of hands and feet, pain sensitization test and functional tests
QuestionnnairesDiagnostic test
Self-reported demographic factors, clinical variables and OA history and symptoms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Imaging; Diagnostic Test: Physical examinations; Diagnostic Test: Questionnnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic factors
Self-reported relationship status, education, employment, hand tasks in work/previous work, birth place
Measured: Baseline
Demographic factors
Self-reported relationship status, social network, education, employment
Measured: 3 year follow-up
Life style factors
Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
Measured: Baseline
Life style factors
Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
Measured: 3 year follow-up
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
Measured: Baseline
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
Measured: 3 year follow-up
EuroQol 5 dimensions
Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
Measured: Baseline
EuroQol 5 dimensions
Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
Measured: 3 year follow-up
Sleep disturbances
Self-reported sleep disturbances
Measured: Baseline
Sleep disturbances
Self-reported sleep disturbances
Measured: 3 year follow-up
Michigan Hand Outcomes Questionnaire (MHOQ)
Aesthetic damage subscale
Measured: Baseline
Michigan Hand Outcomes Questionnaire (MHOQ)
All subscales
Measured: 3 year follow-up
Localization of joint pain (homonculus)
Self-reported pain during the last 24 hours and previous 6 weeks
Measured: Baseline
Localization of joint pain (homonculus)
Self-reported pain during the last 24 hours and previous 6 weeks
Measured: 3 year follow-up
Self-reported joint pain, hand pain, feet pain, fatigue, disease activity
Numeric Rating Scale (0-10)
Measured: Baseline
Self-reported joint pain, hand pain, feet pain, fatigue, disease activity
Numeric Rating Scale (0-10)
Measured: 3 year follow-up
Australian/Canadian hand index (AUSCAN)
Self-reported hand pain, stiffness and physical function
Measured: Baseline
Australian/Canadian hand index (AUSCAN)
Self-reported hand pain, stiffness and physical function
Measured: 3 year follow-up
Western Ontario and McMaster Universities Arthrtis Index (WOMAC)
Self-reported knee/hip pain, stiffness and physical function
Measured: Baseline
Western Ontario and McMaster Universities Arthrtis Index (WOMAC)
Self-reported knee/hip pain, stiffness and physical function
Measured: 3 year follow-up
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Modified version to assess constant and intermittent pain in patients with hand OA (self-reported)
Measured: Baseline
McGill Questionnaire
Modified version to assess hand OA pain characteristics (self-reported)
Measured: Baseline
PainDetect
Modified version to assess neuropathic hand pain (self-reported)
Measured: Baseline
PainDetect
Modified version to assess neuropathic hand pain (self-reported)
Measured: 3 year follow-up
Brief Approach/Avoidance Coping Questionnaire (BACQ)
Self-reported approach-oriented and avoidance oriented coping
Measured: Baseline
Pain catastrophizing scale
Self-reported magnification, rumination, helplessness
Measured: Baseline
Pain catastrophizing scale
Self-reported magnification, rumination, helplessness
Measured: 3 year follow-up
Self-efficacy scales
Self-reported ability influence pain and symptoms
Measured: Baseline
Self-efficacy scales
Self-reported ability influence pain and symptoms
Measured: 3 year follow-up
Foot Function Index
Self-reported pain in feet, disability, activity restrictions
Measured: Baseline
Foot Function Index
Self-reported pain in feet, disability, activity restrictions
Measured: 3 year follow-up
Hormonal factors in women
Menopause
Measured: Baseline
Hormonal factors in women
Menarche, menopause, gynecological operations, hormone treatment, pregnancies, breastfeeding
Measured: 3 year follow-up
Use of shoewear
The use of shoes with varying type of forefoot and heels
Measured: 3 year follow-up
Global health assessment
The evaluation of the global health on Visual analogue scale (VAS)
Measured: 3 year follow-up
Pain Sensitivity Questionnaire
Pain in different daily-life situations, normally leading to no or little pain
Measured: 3 year follow-up
Fibromyalgia symptoms
ACR criteria for fibromyalgia
Measured: 3 year follow-up
Short form 12 Energy
One question from Short form 12 about poor energy
Measured: 3 year follow-up
Brief Illness Perception Questionnaire
Illness perception related to their hand OA disease and symptoms
Measured: 3 year follow-up
Height
Examination of height in standing position (performed by medical student)
Measured: Baseline
Height
Examination of height in standing position (performed by medical student)
Measured: 3 year follow-up
Weight
Examination of weight in light-weighted clothes (performed by medical student)
Measured: Baseline
Weight
Examination of weight in light-weighted clothes (performed by medical student)
Measured: 3 year follow-up
Hip/waist circumference
Examination of hip and waist circumference (performed by medical student)
Measured: Baseline
Hip/waist circumference
Examination of hip and waist circumference (performed by medical student)
Measured: 3 year follow-up
Blood pressure
Examination of blood pressure after rest (performed by medical student)
Measured: Baseline
Blood pressure
Examination of blood pressure after rest (performed by medical student)
Measured: 3 year follow-up
Heart rate
Examination heart rate after rest (performed by medical student)
Measured: Baseline
Heart rate
Examination heart rate after rest (performed by medical student)
Measured: 3 year follow-up
Comorbidity questionnaires and medications
Self-reported comorbidities and medications
Measured: Baseline
Comorbidity questionnaires and medications
Self-reported comorbidities and medications
Measured: 3 year follow-up
Hair sample
Small hair sample is collected from the back of the patients´ head for quantification of cortisol
Measured: Baseline
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
Measured: Baseline
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
Measured: 3 year follow-up
Grip strength
Bilateral measurement of grip strength using Jamar dynamometer
Measured: Baseline, follow-up
Grip strength
Bilateral measurement of grip strength using Jamar dynamometer
Measured: 3 year follow-up
Moberg Pick-Up test
Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)
Measured: Baseline
Moberg Pick-Up test
Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)
Measured: 3 year follow-up
Chair Stand test
Number of chair stands during 30 sec
Measured: 3 year follow-up
40 m walking test
Time in sec for 40 m walking
Measured: 3 year follow-up
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
Measured: Baseline
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
Measured: 3 year follow-up
Ultrasound examination
Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
Measured: Baseline
Ultrasound examination
Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
Measured: 3 year follow-up
Fluorescence Optical Imaging
Examination of altered microcirculation in the hands
Measured: Baseline
Fluorescence Optical Imaging
Examination of altered microcirculation in the hands
Measured: 3 year follow-up
Conventional radiographs
Hands (frontal), feet (frontal, oblique and side images)
Measured: Baseline
Conventional radiographs
Hands (frontal), feet (frontal, oblique and side images)
Measured: 3 year follow-up
MRI
MRI of dominant hand
Measured: Baseline
MRI
MRI of dominant hand
Measured: 3 year follow-up
CT
CT of dominant hand
Measured: Baseline
Biobank
Collection of whole blood, serum, plasma and urine
Measured: Baseline
Biobank
Collection of whole blood, serum, plasma and urine
Measured: 3 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startApr 2016
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida Kristin Haugen, Diakonhjemmet Hospital
- Investigators
- Ida K Haugen, MD, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083548
- Sponsor's protocol ID
- DIA2017-1
- Status last verified
- Sep 2025
- First submitted
- 8 Mar 2017
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klingenberg L, Haugen IK, Hammer HB, Maugesten O, Mathiessen A, Gloersen M. Associations between synovitis and radiographic osteoarthritis progression in the first carpometacarpal and interphalangeal joints: results from the Nor-Hand study. RMD Open. 2026 Aug 20;12(3):e007074. doi: 10.1136/rmdopen-2026-007074.
PubMed 42624616Fjellstad CM, Mathiessen A, Slatkowsky-Christensen B, Kvien TK, Hammer HB, Haugen IK. Associations Between Ultrasound-Detected Synovitis, Pain, and Function in Interphalangeal and Thumb Base Osteoarthritis: Data From the Nor-Hand Cohort. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1530-1535. doi: 10.1002/acr.24047.
PubMed 31421023Gloersen M, Steen Pettersen P, Kvien TK, Haugen IK. Validation of the Intermittent and Constant Osteoarthritis Pain Questionnaire in Patients with Hand Osteoarthritis: Results from the Nor-Hand Study. J Rheumatol. 2019 Jun;46(6):645-651. doi: 10.3899/jrheum.180835. Epub 2019 Mar 15.
PubMed 30877221Steen Pettersen P, Neogi T, Magnusson K, Berner Hammer H, Uhlig T, Kvien TK, Haugen IK. Peripheral and Central Sensitization of Pain in Individuals With Hand Osteoarthritis and Associations With Self-Reported Pain Severity. Arthritis Rheumatol. 2019 Jul;71(7):1070-1077. doi: 10.1002/art.40850. Epub 2019 May 14.
PubMed 30741501Gloersen M, Mulrooney E, Mathiessen A, Hammer HB, Slatkowsky-Christensen B, Faraj K, Isaksen T, Neogi T, Kvien TK, Magnusson K, Haugen IK. A hospital-based observational cohort study exploring pain and biomarkers in patients with hand osteoarthritis in Norway: The Nor-Hand protocol. BMJ Open. 2017 Sep 24;7(9):e016938. doi: 10.1136/bmjopen-2017-016938.
PubMed 28947452
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nor-Hand Study: An Observational Cohort of Hand Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT03083548
- Acronym / sponsor ID
- DIA2017-1
- Conditions
- Osteoarthritis, Pain, Inflammation, Image, Body
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand osteoarthritis | – | Diagnostic Test: Imaging, Diagnostic Test: Physical examinations, Diagnostic Test: QuestionnnairesMen 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age between 40-70 years at screening
- Proven hand OA by clinical examination and/or ultrasound
- Capable of understanding and signing an informed consent form
- Provided a written informed consent to participate in the study
Key exclusion criteria (7 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingConventional radiographs (hands/feet), CT of dominant hand, MRI of dominant hand, ultrasound (hands/shoulder/feet/hips/knees), fluorescence optical imaging of hands | Diagnostic test | Hand osteoarthritis |
| Physical examinationsJoint assessment of hands and feet, pain sensitization test and functional tests | Diagnostic test | Hand osteoarthritis |
| QuestionnnairesSelf-reported demographic factors, clinical variables and OA history and symptoms | Diagnostic test | Hand osteoarthritis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 42624616Klingenberg L, Haugen IK, Hammer HB, Maugesten O, Mathiessen A, Gloersen M. Associations between synovitis and radiographic osteoarthritis progression in the first carpometacarpal and interphalangeal joints: results from the Nor-Hand study. RMD Open. 2026 Aug 20;12(3):e007074. doi: 10.1136/rmdopen-2026-007074.
- Derived from this study: PubMed 31421023Fjellstad CM, Mathiessen A, Slatkowsky-Christensen B, Kvien TK, Hammer HB, Haugen IK. Associations Between Ultrasound-Detected Synovitis, Pain, and Function in Interphalangeal and Thumb Base Osteoarthritis: Data From the Nor-Hand Cohort. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1530-1535. doi: 10.1002/acr.24047.
- Derived from this study: PubMed 30877221Gloersen M, Steen Pettersen P, Kvien TK, Haugen IK. Validation of the Intermittent and Constant Osteoarthritis Pain Questionnaire in Patients with Hand Osteoarthritis: Results from the Nor-Hand Study. J Rheumatol. 2019 Jun;46(6):645-651. doi: 10.3899/jrheum.180835. Epub 2019 Mar 15.
- Derived from this study: PubMed 30741501Steen Pettersen P, Neogi T, Magnusson K, Berner Hammer H, Uhlig T, Kvien TK, Haugen IK. Peripheral and Central Sensitization of Pain in Individuals With Hand Osteoarthritis and Associations With Self-Reported Pain Severity. Arthritis Rheumatol. 2019 Jul;71(7):1070-1077. doi: 10.1002/art.40850. Epub 2019 May 14.
- Derived from this study: PubMed 28947452Gloersen M, Mulrooney E, Mathiessen A, Hammer HB, Slatkowsky-Christensen B, Faraj K, Isaksen T, Neogi T, Kvien TK, Magnusson K, Haugen IK. A hospital-based observational cohort study exploring pain and biomarkers in patients with hand osteoarthritis in Norway: The Nor-Hand protocol. BMJ Open. 2017 Sep 24;7(9):e016938. doi: 10.1136/bmjopen-2017-016938.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ida K Haugen, MD, PhD principal investigator
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Pain, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic factors (time frame: Baseline). The study lists 73 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03083548, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.