Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
Recruitment status was Recruiting
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.
Osteoarthritis in the Carpometacarpal (CMC) Joint
Other: Care as usual
Other: Occupational therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.|
- Number of participants in each group who have received surgery. [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Hand Pain at rest and in activity [ Time Frame: Two years ] [ Designated as safety issue: No ]Measured on Numeric Rating Scales, 0 - 10.
- Number of painful hand joints. [ Time Frame: Two years ] [ Designated as safety issue: No ]Examination.
- Joint mobility in 2-5 finger. [ Time Frame: Two years ] [ Designated as safety issue: No ]Flexion deficit in millimetre.
- Thumb flexion. [ Time Frame: Two years ] [ Designated as safety issue: No ]Goniometer
- Thumb abduction. [ Time Frame: Two years ] [ Designated as safety issue: No ]Pollexograph.
- Grip strength. [ Time Frame: Two years ] [ Designated as safety issue: No ]Grip-It, measured in Newton)
- Pinch strength [ Time Frame: Two years ] [ Designated as safety issue: No ]Grip-It, measured in Newton
- Activity performance. [ Time Frame: Two years ] [ Designated as safety issue: No ]MAP-Hand - a patient reported outcome/questionnaire.
- Hand and shoulder function [ Time Frame: Two Years ] [ Designated as safety issue: No ]Quick-Dash, a patient reported outcome/questionnaire
- Satisfaction with care. [ Time Frame: Two years ] [ Designated as safety issue: No ]On Numeric Rating Scales, 0 - 10.
- Health related quality of life. [ Time Frame: Two years ] [ Designated as safety issue: No ]EQ5D, a patient reported outcome/questionnaire.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794754
|National resource center for rehabilitation in rheumatology||Recruiting|
|Oslo, Norway, 0319|
|Contact: Ingvild Kjeken, PhD +4722454845 firstname.lastname@example.org|
|Contact: Kåre Birger Hagen, PhD +4722454855 email@example.com|
|Principal Investigator: Ingvild Kjeken, PhD|