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NCT01794754 Clinical Trial

Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

Osteoarthritis in the Carpometacarpal (CMC) Joint Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01794754
Other study ID # 2012/2265-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date August 2018

Study information
Verified date August 2018
Source National Resource Center for Rehabilitation in Rheumatology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate if occupational therapy may delay or prevent the need for surgery in patients with carpometacarpal(CMC) osteoarthritis (OA) who are scheduled for surgery in the CMC-joint.

Our study hypothesis is that compared to participants in the intervention group, significantly more participants in the control group have received CMC-surgery after two years.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date August 2018
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Patients with CMC-OA who are referred for review for the need for surgery in the CMC joint.

Exclusion Criteria:

- Persons with cognitive dysfunction

- Persons who do not understand the Norwegian language

- Persons with other diseases or injuries that may negatively impact hand function

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Care as usual

• Occupational therapy
Occupational therapy in the waiting period before surgery. Occupational therapy comprises orthoses for the CMC-joint, hand exercises, and use of alternative working methods and assistive devices. The participants are encouraged to perform hand exercises three times a week for the first 12 weeks, and to use orthosis as much as possible, both during daytime (day orthosis) and night time (night orthosis).

Locations
Country Name City State
Norway Haukeland University Hospital Bergen
Norway Haugesund Rheumatism Hospital Haugesund
Norway National resource center for rehabilitation in rheumatology Oslo
Norway St Olavs Hospital Trondheim

Sponsors (4)
Lead Sponsor Collaborator
National Resource Center for Rehabilitation in Rheumatology Haugesund Rheumatism Hospital, Haukeland University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Kjeken I, Eide RE, Klokkeide Å, Matre KH, Olsen M, Mowinckel P, Andreassen Ø, Darre S, Nossum R. Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2016 Nov 15;17(1):473. Erratum in: BMC Musculoskelet Disord. 2017 Feb 6;18(1):68. — View Citation

Kjeken I, Eide RE, Klokkeide Å, Matre KH, Olsen M, Mowinckel P, Andreassen Ø, Darre S, Nossum R. Erratum to: Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Feb 6;18(1):68. doi: 10.1186/s12891-017-1433-4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants in each group who have received surgery. Two years
Secondary Hand Pain at rest and in activity Measured on Numeric Rating Scales, 0 - 10. Two years
Secondary Number of painful hand joints. Examination. Two years
Secondary Joint mobility in 2-5 finger. Flexion deficit in millimetre. Two years
Secondary Thumb flexion. Goniometer Two years
Secondary Thumb abduction. Pollexograph. Two years
Secondary Grip strength. Grip-It, measured in Newton) Two years
Secondary Pinch strength Grip-It, measured in Newton Two years
Secondary Activity performance. MAP-Hand - a patient reported outcome/questionnaire. Two years
Secondary Hand and shoulder function Quick-Dash, a patient reported outcome/questionnaire Two Years
Secondary Satisfaction with care. On Numeric Rating Scales, 0 - 10. Two years
Secondary Health related quality of life. EQ5D, a patient reported outcome/questionnaire. Two years

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