NCT01794754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4.2 years

First QC Date

February 15, 2013

Last Update Submit

August 30, 2018

Conditions

Osteoarthritis in the Carpometacarpal (CMC) Joint

Keywords

Hand osteoarthritisCMC1-jointsurgeryoccupational therapyhand exercisesassistive devicesorthoses

Outcome Measures

Primary Outcomes (1)

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

    Two years

Secondary Outcomes (11)

  • Hand Pain at rest and in activity

    Two years

  • Number of painful hand joints.

    Two years

  • Joint mobility in 2-5 finger.

    Two years

  • Thumb flexion.

    Two years

  • Thumb abduction.

    Two years

  • +6 more secondary outcomes

Study Arms (2)

Control

OTHER

Care as usual

Other: Care as usual

Occupational therapy

EXPERIMENTAL

Occupational therapy

Other: Occupational therapy

Interventions

Care as usualOTHER
Control
Occupational therapyOTHER

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).

Occupational therapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CMC-OA who are referred for review for the need for surgery in the CMC joint.

You may not qualify if:

  • Persons with cognitive dysfunction
  • Persons who do not understand the Norwegian language
  • Persons with other diseases or injuries that may negatively impact hand function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Haugesund Rheumatism Hospital

Haugesund, 5504, Norway

Location

National resource center for rehabilitation in rheumatology

Oslo, 0319, Norway

Location

St Olavs Hospital

Trondheim, 7006, Norway

Location

Related Publications (4)

  • 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.

    PMID: 27842579BACKGROUND

  • 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.

    PMID: 28166750BACKGROUND

  • Tveter AT, Kleven L, Osteras N, Nossum R, Eide REM, Klokkeide A, Matre KH, Olsen M, Kjeken I. Is multimodal occupational therapy in addition to usual care cost-effective in people with thumb carpometacarpal osteoarthritis? A cost-utility analysis of a randomised controlled trial. BMJ Open. 2023 Jun 23;13(6):e063103. doi: 10.1136/bmjopen-2022-063103.

    PMID: 37355263DERIVED

  • 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.

    PMID: 33338325DERIVED

Related Links

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Tore K Kvien, PhD

    Research director, Diakonhjemmet Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 20, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2017

Study Completion

August 1, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(4)