Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

NCT ID: NCT01794754

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis in the Carpometacarpal (CMC) Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Care as usual

Group Type OTHER

Care as usual

Intervention Type OTHER

Occupational therapy

Occupational therapy

Group Type EXPERIMENTAL

Occupational therapy

Intervention Type 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).

Interventions

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Care as usual

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Haugesund Rheumatism Hospital

OTHER

Sponsor Role collaborator

National Resource Center for Rehabilitation in Rheumatology

OTHER

Sponsor Role lead

Responsible Party

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Ingvild Kjeken

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tore K Kvien, PhD

Role: STUDY_DIRECTOR

Research director, Diakonhjemmet Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Haugesund Rheumatism Hospital

Haugesund, , Norway

Site Status

National resource center for rehabilitation in rheumatology

Oslo, , Norway

Site Status

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 27842579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28166750 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37355263 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33338325 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5109819/

Link to free full text of protocol in BMC musculoskeletal disorders

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5109819/

Link to free full text of erratum protocol in BMC musculoskeletal disorders

Other Identifiers

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2012/2265-3

Identifier Type: -

Identifier Source: org_study_id

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