Completed

May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.

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What is being tested

Care as usual

+ Occupational therapy

Other
Who is being recruted

From 18 to 100 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorNational Resource Center for Rehabilitation in Rheumatology
Last updated: August 31, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population, and approximately 68% of people between the ages of 71 and 80 years have radiographic OA in the carpometacarpal (CMC) joint. Currently, there is no cure for hand OA. However, several studies have demonstrated that hand exercises and CMC-orthoses may reduce pain and improve grip strength, and in a recent study, assistive devices improved activity performance and satisfaction with performance in people with hand-OA. Still, most people do not receive any such treatment, but those with severe CMC-OA are often referred for surgery in this joint. The effect of occupational therapy to prevent or delay need for surgery CMC-OA has been investigated in a small study with 33 participants, but randomised controlled trails (RCT) of good quality are needed.

NCT01794754
Principal SponsorNational Resource Center for Rehabilitation in Rheumatology
Last updated: August 31, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Patients with CMC-OA who are referred for review for the need for surgery in the CMC joint
3 exclusion criteria prevent from participating
Persons who do not understand the Norwegian language
Persons with cognitive dysfunction
Persons with other diseases or injuries that may negatively impact hand function

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Care as usual

Group II

Experimental
Occupational therapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Haukeland University Hospital

Bergen, NorwayOpen Haukeland University Hospital in Google Maps

Haugesund Rheumatism Hospital

Haugesund, Norway

National resource center for rehabilitation in rheumatology

Oslo, Norway

St Olavs Hospital

Trondheim, Norway
Completed4 Study Centers