Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis in the Carpometacarpal (CMC) Joint

Intervention / Treatment
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* Other: Care as usual
* Other: Occupational therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Care as usual | Other: Care as usual<br> <br> |
| Experimental: Occupational therapy<br>Occupational therapy | Other: Occupational therapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in each group who have received surgery. |  | Two years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, Hand osteoarthritis, CMC1-joint, occupational therapy, hand exercises, assistive devices, orthoses