Trial record 1 of 56 for:
Open Studies | "Occupational Therapy"
Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
This study is not yet open for participant recruitment.
Verified February 2013 by National Resource Center for Rehabilitation in Rheumatology
Sponsor:
National Resource Center for Rehabilitation in Rheumatology
Collaborators:
St. Olavs Hospital
Haukeland University Hospital
Information provided by (Responsible Party):
Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology
ClinicalTrials.gov Identifier:
NCT01794754
First received: February 15, 2013
Last updated: February 19, 2013
Last verified: February 2013
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Purpose
The purpose of the study is to investigate if occupational therapy may delay or prevent the need for surgery in the patients with carpometacarpal(CMC) osteoarthritis 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 | Intervention |
|---|---|
|
Osteoarthritis in the Carpometacarpal (CMC) Joint |
Other: Care as usual Other: Occupational therapy |
| Study Type: | Interventional |
| 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. |
Resource links provided by NLM:
Further study details as provided by National Resource Center for Rehabilitation in Rheumatology:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 180 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Control
Care as usual
|
Other: Care as usual |
|
Experimental: Occupational therapy
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794754
Locations
| Norway | |
| National resource center for rehabilitation in rheumatology | Not yet recruiting |
| Oslo, Norway, 0319 | |
| Contact: Ingvild Kjeken, PhD +4722454845 ingvild.kjeken@diakonsyk.no | |
| Contact: Kåre Birger Hagen, PhD +4722454855 k.b.hagen@medisin.uio.no | |
| Principal Investigator: Ingvild Kjeken, PhD | |
Sponsors and Collaborators
National Resource Center for Rehabilitation in Rheumatology
St. Olavs Hospital
Haukeland University Hospital
More Information
No publications provided
| Responsible Party: | Ingvild Kjeken, Senior researcher, National Resource Center for Rehabilitation in Rheumatology |
| ClinicalTrials.gov Identifier: | NCT01794754 History of Changes |
| Other Study ID Numbers: | 2012/2265-3 |
| Study First Received: | February 15, 2013 |
| Last Updated: | February 19, 2013 |
| Health Authority: | Norway: Regional Ethics Commitee |
Keywords provided by National Resource Center for Rehabilitation in Rheumatology:
|
Hand osteoarthritis CMC1-joint surgery occupational therapy |
hand exercises assistive devices orthoses |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013