Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 88 for:    Open Studies | "Occupational Therapy"
Previous Study | Return to List | Next Study

Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by National Resource Center for Rehabilitation in Rheumatology
Sponsor:
Collaborators:
St. Olavs Hospital
Haukeland University Hospital
Haugesund Rheumatism 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: March 31, 2017
Last verified: March 2017
  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: 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 ]

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.


Estimated Enrollment: 180
Study Start Date: April 2013
Estimated Study Completion Date: December 2019
Estimated 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

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
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

Contacts
Contact: Ingvild Kjeken, PhD +4798802614 ingvild.kjeken@diakonsyk.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Ruth-Else M Eide, BSc    +47 55 97 50 00    ruth.else.mehl.eide@helse-bergen.no   
Haugesund Rheumatism Hospital Recruiting
Haugesund, Norway, 5504
Contact: Åse Klokkeide, BSc    +47 52 80 50 00    ase.klokkeide@hsr.no   
National resource center for rehabilitation in rheumatology Active, not recruiting
Oslo, Norway, 0319
St Olavs Hospital Recruiting
Trondheim, Norway, 7006
Contact: Randi Nossum, MSc    +47 815 55 850    randi.nossum@stolav.no   
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 31, 2017
Individual Participant Data  
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 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 April 28, 2017