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The Nijmegen randomised, singleblind, controlled trial on the effect of a multidisciplinary self-management programme in people with OsteoArthritis of the Hands

The Nijmegen randomised, singleblind, controlled trial on the effect of a multidisciplinary self-management programme in people with OsteoArthritis of the Hands - NOAH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32309
Enrollment
150
Registered
2007-12-20
Start date
2008-01-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arthritis osteoarthritis

Interventions

Multidisciplinary self-management treatment (occupational therapist and a specialized nurse) existing of four group sessions, 2.5 hours each. The content of the treatment program includes informatio
principles of joint protection
education about active coping strategies
range of motion and strengthening exercises
and, if considered necessary, advice about orthoses in patients with OA of CMC I. Depending on the results of the randomization procedure patients follow an additional booster session. In the addit

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Hand OA according to the ACR classification tree for symptomatic Hand OA: Hand pain, aching, or stiffness during most days and 3 or 4 of the following features: Hard tissue enlargement of 2 or more of 10 selected joints* Hard tissue enlargement of 2 or more DIP joints Fewer than 3 swollen MCP joints Deformity of at least 1 of 10 selected joints* * The 10 selected joints are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands. - Score at AUSCAN > 1 ; - Pain in hand(s) is main problem; - Refered by a rheuamtologist (secundary care);

Exclusion criteria

Exclusion criteria: - Other rheumatic diseases like rheumatoid artritis, fibromyalgia, gout, psoriatic arthritis; - Compression syndrome of n. medianus; - Psychiatric problems; - Prothesis of one or more joints of the hand/wrist; - Red flags - Persons who are not willing to participate in a group intervention - insufficient ability to read and communicate in Dutch to fullfill questionnaires

Design outcomes

Primary

MeasureTime frame
The difference in percentage patients that is clinical responder in pain (Visual Analogue Scale (VAS)), physical functioning (The Australian Canadian (AUSCAN) questionnaire for Hand OA) and self perceived effect (patient global assessment (PGA)) according to the OMERACT OARSI responders criteria.

Secondary

MeasureTime frame
Handfunction - Dutch AIMS2 subscale hand and fingers Quality of Life / impact of hand OA - The Canadian Occupational Performance Measure (COPM) ). A *patient oriented* measurement designed to identify the perceived main problems of patients - Impact of handproblems: Subscale of the Dutch-AIMS2: - SF-36 questionnaire Pain - Pain Coping Inventory (PCI); - Tender joint count (hand joints). Overig - Self-efficacy: Arthritis self-efficacy scale and Dutch General Self-efficacy scale; - Gripstrength in Nm: pinch and gripstrength.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)