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Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794754
First Posted: February 20, 2013
Last Update Posted: August 7, 2017
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.
Collaborators:
St. Olavs Hospital
Haukeland University Hospital
Haugesund Rheumatism Hospital
Information provided by (Responsible Party):
Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology
  Purpose

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 Intervention
Osteoarthritis in the Carpometacarpal (CMC) Joint Other: Care as usual Other: Occupational therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology:

Primary Outcome Measures:
  • Number of participants in each group who have received surgery. [ Time Frame: Two years ]

Secondary Outcome Measures:
  • 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.


Enrollment: 180
Actual Study Start Date: April 2013
Estimated Study Completion Date: December 2019
Primary Completion Date: June 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
Norway
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
Sponsors and Collaborators
National Resource Center for Rehabilitation in Rheumatology
St. Olavs Hospital
Haukeland University Hospital
Haugesund Rheumatism Hospital
Investigators
Study Director: Tore K Kvien, PhD Research director, Diakonhjemmet Hospital
  More Information

Additional Information:
Publications:
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
First Submitted: February 15, 2013
First Posted: February 20, 2013
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ingvild Kjeken, 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