Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

August 30, 2018 updated by: Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology

May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital
      • Haugesund, Norway, 5504
        • Haugesund Rheumatism Hospital
      • Oslo, Norway, 0319
        • National resource center for rehabilitation in rheumatology
      • Trondheim, Norway, 7006
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Care as usual
Other: Care as usual
Experimental: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants in each group who have received surgery.
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Pain at rest and in activity
Time Frame: Two years
Measured on Numeric Rating Scales, 0 - 10.
Two years
Number of painful hand joints.
Time Frame: Two years
Examination.
Two years
Joint mobility in 2-5 finger.
Time Frame: Two years
Flexion deficit in millimetre.
Two years
Thumb flexion.
Time Frame: Two years
Goniometer
Two years
Thumb abduction.
Time Frame: Two years
Pollexograph.
Two years
Grip strength.
Time Frame: Two years
Grip-It, measured in Newton)
Two years
Pinch strength
Time Frame: Two years
Grip-It, measured in Newton
Two years
Activity performance.
Time Frame: Two years
MAP-Hand - a patient reported outcome/questionnaire.
Two years
Hand and shoulder function
Time Frame: Two Years
Quick-Dash, a patient reported outcome/questionnaire
Two Years
Satisfaction with care.
Time Frame: Two years
On Numeric Rating Scales, 0 - 10.
Two years
Health related quality of life.
Time Frame: Two years
EQ5D, a patient reported outcome/questionnaire.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Resource Center for Rehabilitation in Rheumatology

Collaborators

Haukeland University Hospital
St. Olavs Hospital
Haugesund Rheumatism Hospital

Investigators

  • Study Director: Tore K Kvien, PhD, Research director, Diakonhjemmet Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/2265-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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