Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
Primary Purpose
Osteoarthritis in the Carpometacarpal (CMC) Joint
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Care as usual
Occupational therapy
Sponsored by

About this trial
This is an interventional prevention trial for Osteoarthritis in the Carpometacarpal (CMC) Joint focused on measuring Hand osteoarthritis, CMC1-joint, surgery, occupational therapy, hand exercises, assistive devices, orthoses
Eligibility Criteria
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
Sites / Locations
- Haukeland University Hospital
- Haugesund Rheumatism Hospital
- National resource center for rehabilitation in rheumatology
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control
Occupational therapy
Arm Description
Care as usual
Occupational therapy
Outcomes
Primary Outcome Measures
Number of participants in each group who have received surgery.
Secondary Outcome Measures
Hand Pain at rest and in activity
Measured on Numeric Rating Scales, 0 - 10.
Number of painful hand joints.
Examination.
Joint mobility in 2-5 finger.
Flexion deficit in millimetre.
Thumb flexion.
Goniometer
Thumb abduction.
Pollexograph.
Grip strength.
Grip-It, measured in Newton)
Pinch strength
Grip-It, measured in Newton
Activity performance.
MAP-Hand - a patient reported outcome/questionnaire.
Hand and shoulder function
Quick-Dash, a patient reported outcome/questionnaire
Satisfaction with care.
On Numeric Rating Scales, 0 - 10.
Health related quality of life.
EQ5D, a patient reported outcome/questionnaire.
Full Information
NCT ID
NCT01794754
First Posted
February 15, 2013
Last Updated
August 30, 2018
Sponsor
National Resource Center for Rehabilitation in Rheumatology
Collaborators
St. Olavs Hospital, Haukeland University Hospital, Haugesund Rheumatism Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01794754
Brief Title
Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
Official Title
May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Resource Center for Rehabilitation in Rheumatology
Collaborators
St. Olavs Hospital, Haukeland University Hospital, Haugesund Rheumatism Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis in the Carpometacarpal (CMC) Joint
Keywords
Hand osteoarthritis, CMC1-joint, surgery, occupational therapy, hand exercises, assistive devices, orthoses
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Care as usual
Arm Title
Occupational therapy
Arm Type
Experimental
Arm Description
Occupational therapy
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Type
Other
Intervention Name(s)
Occupational therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants in each group who have received surgery.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Hand Pain at rest and in activity
Description
Measured on Numeric Rating Scales, 0 - 10.
Time Frame
Two years
Title
Number of painful hand joints.
Description
Examination.
Time Frame
Two years
Title
Joint mobility in 2-5 finger.
Description
Flexion deficit in millimetre.
Time Frame
Two years
Title
Thumb flexion.
Description
Goniometer
Time Frame
Two years
Title
Thumb abduction.
Description
Pollexograph.
Time Frame
Two years
Title
Grip strength.
Description
Grip-It, measured in Newton)
Time Frame
Two years
Title
Pinch strength
Description
Grip-It, measured in Newton
Time Frame
Two years
Title
Activity performance.
Description
MAP-Hand - a patient reported outcome/questionnaire.
Time Frame
Two years
Title
Hand and shoulder function
Description
Quick-Dash, a patient reported outcome/questionnaire
Time Frame
Two Years
Title
Satisfaction with care.
Description
On Numeric Rating Scales, 0 - 10.
Time Frame
Two years
Title
Health related quality of life.
Description
EQ5D, a patient reported outcome/questionnaire.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore K Kvien, PhD
Organizational Affiliation
Research director, Diakonhjemmet Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Haugesund Rheumatism Hospital
City
Haugesund
ZIP/Postal Code
5504
Country
Norway
Facility Name
National resource center for rehabilitation in rheumatology
City
Oslo
ZIP/Postal Code
0319
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27842579
Citation
Kjeken I, Eide RE, Klokkeide A, Matre KH, Olsen M, Mowinckel P, Andreassen O, 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. doi: 10.1186/s12891-016-1321-3. Erratum In: BMC Musculoskelet Disord. 2017 Feb 6;18(1):68.
Results Reference
background
PubMed Identifier
28166750
Citation
Kjeken I, Eide RE, Klokkeide A, Matre KH, Olsen M, Mowinckel P, Andreassen O, 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. No abstract available.
Results Reference
background
PubMed Identifier
33338325
Citation
Tveter AT, Osteras N, Nossum R, Eide REM, Klokkeide A, Matre KH, Olsen M, Kjeken I. Short-Term Effects of Occupational Therapy on Hand Function and Pain in Patients With Carpometacarpal Osteoarthritis: Secondary Analyses From a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2022 Jun;74(6):955-964. doi: 10.1002/acr.24543. Epub 2022 Apr 5.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5109819/
Description
Link to free full text of protocol in BMC musculoskeletal disorders
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5109819/
Description
Link to free full text of erratum protocol in BMC musculoskeletal disorders
Learn more about this trial
Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
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