CompletedNot Applicable

The Nor-Hand Study

Norway300 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range40 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

What they're measuring

Demographic factors

Timeframe: Baseline

Demographic factors

Timeframe: 3 year follow-up

Life style factors

Timeframe: Baseline

Life style factors

Timeframe: 3 year follow-up

Clinical disease variables

Timeframe: Baseline

Clinical disease variables

Timeframe: 3 year follow-up

EuroQol 5 dimensions

Timeframe: Baseline

EuroQol 5 dimensions

Timeframe: 3 year follow-up

Sleep disturbances

Timeframe: Baseline

Trial details

NCT IDNCT03083548

SponsorDiakonhjemmet Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Osteoarthritis trials

Plain-language summary

Who can participate

Age range40 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

What they're measuring

Demographic factors

Timeframe: Baseline

Demographic factors

Timeframe: 3 year follow-up

Life style factors

Timeframe: Baseline

Life style factors

Timeframe: 3 year follow-up

Clinical disease variables

Timeframe: Baseline

Clinical disease variables

Timeframe: 3 year follow-up

EuroQol 5 dimensions

Timeframe: Baseline

EuroQol 5 dimensions

Timeframe: 3 year follow-up

Sleep disturbances

Timeframe: Baseline