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NCT Number: NCT01794754

Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis in the Carpometacarpal (CMC) Joint Capillary Malformations, Congenital, 1

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care as usual

Other

Occupational Therapy

Other

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).

Primary outcomes

  1. Number of participants in each group who have received surgery.

    Time frame: Two years

Secondary outcomes

  1. Hand Pain at rest and in activity

    Time frame: Two years

    Measured on Numeric Rating Scales, 0 - 10.

  2. Number of painful hand joints.

    Time frame: Two years

    Examination.

  3. Joint mobility in 2-5 finger.

    Time frame: Two years

    Flexion deficit in millimetre.

  4. Thumb flexion.

    Time frame: Two years

    Goniometer

  5. Thumb abduction.

    Time frame: Two years

    Pollexograph.

  6. Grip strength.

    Time frame: Two years

    Grip-It, measured in Newton)

  7. Pinch strength

    Time frame: Two years

    Grip-It, measured in Newton

  8. Activity performance.

    Time frame: Two years

    MAP-Hand - a patient reported outcome/questionnaire.

  9. Hand and shoulder function

    Time frame: Two Years

    Quick-Dash, a patient reported outcome/questionnaire

  10. Satisfaction with care.

    Time frame: Two years

    On Numeric Rating Scales, 0 - 10.

  11. Health related quality of life.

    Time frame: Two years

    EQ5D, a patient reported outcome/questionnaire.

Sponsors and collaborators

Lead sponsor

National Resource Center for Rehabilitation in Rheumatology

Other

Collaborators

  • Haugesund Rheumatism Hospital
  • Haukeland University Hospital
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Feb 20, 2013
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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