Clinical trial NCT01794754: Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
Official title: May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis in the Carpometacarpal (CMC) Joint
Keywords: Hand osteoarthritis
CMC1-joint
surgery
occupational therapy
hand exercises
assistive devices
orthoses
Lead sponsor: National Resource Center for Rehabilitation in Rheumatology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Haukeland University Hospital
name: Haugesund Rheumatism Hospital
First posted: 2013-02-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of participants in each group who have received surgery.
timeFrame: Two years
Secondary outcomes:
measure: Hand Pain at rest and in activity
timeFrame: Two years
measure: Number of painful hand joints.
timeFrame: Two years
measure: Joint mobility in 2-5 finger.
timeFrame: Two years
measure: Thumb flexion.
timeFrame: Two years
measure: Thumb abduction.
timeFrame: Two years
measure: Grip strength.
timeFrame: Two years
measure: Pinch strength
timeFrame: Two years
measure: Activity performance.
timeFrame: Two years
measure: Hand and shoulder function
timeFrame: Two Years
measure: Satisfaction with care.
timeFrame: Two years
measure: Health related quality of life.
timeFrame: Two years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Haugesund
country: Norway
facility: Haugesund Rheumatism Hospital
city: Oslo
country: Norway
facility: National resource center for rehabilitation in rheumatology
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Research director, Diakonhjemmet Hospital
name: Tore K Kvien, PhD
role: STUDY_DIRECTOR
References:
citation: Kjeken I, Eide RE, Klokkeide A, Matre KH, Olsen M, Mowinckel P, Andreassen O, Darre S, Nossum R. Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2016 Nov 15;17(1):473. doi: 10.1186/s12891-016-1321-3.
citation: Kjeken I, Eide RE, Klokkeide A, Matre KH, Olsen M, Mowinckel P, Andreassen O, Darre S, Nossum R. Erratum to: Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Feb 6;18(1):68. doi: 10.1186/s12891-017-1433-4. No abstract available.
citation: Tveter AT, Osteras N, Nossum R, Eide REM, Klokkeide A, Matre KH, Olsen M, Kjeken I. Short-Term Effects of Occupational Therapy on Hand Function and Pain in Patients With Carpometacarpal Osteoarthritis: Secondary Analyses From a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2022 Jun;74(6):955-964. doi: 10.1002/acr.24543. Epub 2022 Apr 5.