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Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.

ABSTRACT: In the absence of disease-modifying interventions for hand osteoarthritis (OA), occupational therapy (OT) comprising patient education, hand exercises, assistive devices and orthoses are considered as core treatments, whereas surgery are recommended for those with severe carpometacarpal (CMC1) OA. However, even though CMC1 surgery may reduce pain and improve function, the risk of adverse effects is high, and randomized controlled trials comparing surgery with non-surgical interventions are warranted. This multicentre randomized controlled trial aims to address the following questions: Does OT in the period before surgical consultation reduce the need for surgery in CMC1-OA? What are patients' motivation and reasons for wanting CMC1-surgery? Are there differences between departments of rheumatology concerning the degree of CMC1-OA, pain and functional limitations in patients who are referred for surgical consultation for CMC1 surgery? Is the Measure of Activity Performance of the Hand a reliable measure in patients with CMC1-OA? Do patients with CMC1-OA with and without affection of the distal and proximal interphalangeal finger joints differ with regard to symptoms and function? Do the degree of CMC1-OA, symptoms and functional limitations significantly predict improvement after 2 years following OT or CMC1-surgery? Is OT more cost-effective than surgery in the management of CMC1-OA?All persons referred for surgical consultation due to their CMC1-OA at one of three Norwegian departments of rheumatology are invited to participate. Those who agree attend a clinical assessment and report their symptoms, function and motivation for surgery in validated outcome measures, before they are randomly selected to receive OT in the period before surgical consultation (estimated n?=?180). The primary outcome will be the number of participants in each group who have received surgical treatment after 2 years. Secondary and tertiary outcomes are pain, function and satisfaction with care over the 2-year trial period. Outcomes will be collected at baseline, 4, 18 and 24 months. The main analysis will be on an intention-to-treat basis, using logistic regression, comparing the number of participants in each group who have received surgical treatment after 2 years.The findings will improve the evidence-based management of HOA.NCT01794754 . First registrated February 15th 2013.

SUBMITTER: Kjeken I

PROVIDER: S-EPMC5109819 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.

Kjeken Ingvild I Eide Ruth Else Mehl RE Klokkeide Åse Å Matre Karin Hoegh KH Olsen Monika M Mowinckel Petter P Andreassen Øyvor Ø Darre Siri S Nossum Randi R

BMC musculoskeletal disorders 20161115 1

<h4>Background</h4>In the absence of disease-modifying interventions for hand osteoarthritis (OA), occupational therapy (OT) comprising patient education, hand exercises, assistive devices and orthoses are considered as core treatments, whereas surgery are recommended for those with severe carpometacarpal (CMC1) OA. However, even though CMC1 surgery may reduce pain and improve function, the risk of adverse effects is high, and randomized controlled trials comparing surgery with non-surgical inte ...[more]

PMID: 27842579

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Project description:Occupational therapists may have an added value in the care of patients with Parkinson's disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson's disease.A multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson's disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as well as a process evaluation.This is the first large-scale trial specifically evaluating occupational therapy in Parkinson's disease. It is expected to generate important new information about the possible added value of occupational therapy on daily functioning of patients with Parkinson's disease.Clinicaltrials.gov: NCT01336127.

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Dataset Information

Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.

Publications

Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.

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