Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01794754|
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : August 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis in the Carpometacarpal (CMC) Joint||Other: Care as usual Other: Occupational therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||August 2018|
Care as usual
Other: Care as usual
Experimental: Occupational therapy
Other: 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).
- Number of participants in each group who have received surgery. [ Time Frame: Two years ]
- Hand Pain at rest and in activity [ Time Frame: Two years ]Measured on Numeric Rating Scales, 0 - 10.
- Number of painful hand joints. [ Time Frame: Two years ]Examination.
- Joint mobility in 2-5 finger. [ Time Frame: Two years ]Flexion deficit in millimetre.
- Thumb flexion. [ Time Frame: Two years ]Goniometer
- Thumb abduction. [ Time Frame: Two years ]Pollexograph.
- Grip strength. [ Time Frame: Two years ]Grip-It, measured in Newton)
- Pinch strength [ Time Frame: Two years ]Grip-It, measured in Newton
- Activity performance. [ Time Frame: Two years ]MAP-Hand - a patient reported outcome/questionnaire.
- Hand and shoulder function [ Time Frame: Two Years ]Quick-Dash, a patient reported outcome/questionnaire
- Satisfaction with care. [ Time Frame: Two years ]On Numeric Rating Scales, 0 - 10.
- Health related quality of life. [ Time Frame: Two years ]EQ5D, a patient reported outcome/questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794754
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Haugesund Rheumatism Hospital|
|Haugesund, Norway, 5504|
|National resource center for rehabilitation in rheumatology|
|Oslo, Norway, 0319|
|St Olavs Hospital|
|Trondheim, Norway, 7006|
|Study Director:||Tore K Kvien, PhD||Research director, Diakonhjemmet Hospital|