Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Resource Center for Rehabilitation in Rheumatology
Sponsor:
Collaborators:
St. Olavs Hospital
Haukeland University Hospital
Haugesund Sanitetsforenings Revmatismesykehus
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: April 3, 2014
Last verified: April 2014
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794754

Locations
Norway
National resource center for rehabilitation in rheumatology 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
Haugesund Sanitetsforenings Revmatismesykehus
  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: April 3, 2014
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 September 16, 2014