Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
NCT ID: NCT01794754
Last Updated: 2018-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
180 participants
INTERVENTIONAL
2013-04-30
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcomes of Treatment for Trapeziometacarpal Osteoarthritis
NCT01724853
The Role of the Proprioceptive Training in Functional Recovery of Patient With Thumb Base Osteoarthritis
NCT04892589
Effectiveness of Proprioceptive Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis
NCT04777526
Predictive Outcomes for Selective Thumb Carpometacarpal Joint Denervation
NCT06467669
CMC I Stability Intraoperative
NCT03687775
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Care as usual
Care as usual
Occupational therapy
Occupational therapy
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Care as usual
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Persons who do not understand the Norwegian language
* Persons with other diseases or injuries that may negatively impact hand function
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Olavs Hospital
OTHER
Haukeland University Hospital
OTHER
Haugesund Rheumatism Hospital
OTHER
National Resource Center for Rehabilitation in Rheumatology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ingvild Kjeken
Senior researcher
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tore K Kvien, PhD
Role: STUDY_DIRECTOR
Research director, Diakonhjemmet Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Haukeland University Hospital
Bergen, , Norway
Haugesund Rheumatism Hospital
Haugesund, , Norway
National resource center for rehabilitation in rheumatology
Oslo, , Norway
St Olavs Hospital
Trondheim, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Link to free full text of protocol in BMC musculoskeletal disorders
Link to free full text of erratum protocol in BMC musculoskeletal disorders
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012/2265-3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.