Osteoarthritis in the Carpometacarpal (CMC) JointNCT01794754
Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
A study testing Care as usual and Occupational therapy in people with Osteoarthritis in the Carpometacarpal (CMC) Joint, run by National Resource Center for Rehabilitation in Rheumatology at 4 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis in the Carpometacarpal (CMC) Joint
- What is being tested?
- Care as usual and Occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesNorway
- Study dates
- Apr 2013to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CMC-OA who are referred for review for the need for surgery in the CMC joint.
Who cannot join
- Persons with cognitive dysfunction
- Persons who do not understand the Norwegian language
- Persons with other diseases or injuries that may negatively impact hand function
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland University Hospital
Bergen, 5021
Haugesund Rheumatism Hospital
Haugesund, 5504
National resource center for rehabilitation in rheumatology
Oslo, 0319
St Olavs Hospital
Trondheim, 7006
About this study
Official title: May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.
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.
Read the 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.
- Being tested
- Care as usual, Occupational therapy
- Keywords
- Hand osteoarthritis, CMC1-joint, surgery, occupational therapy, hand exercises, assistive devices, orthoses
- Medical subject headings
- Capillary Malformations, Congenital, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care as usualOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Care as usual Receives: Other: Care as usual |
| Occupational therapy | Experimental | Occupational therapy Receives: Other: Occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each group who have received surgery.
Measured: Two years
Secondary outcomes (11)
Hand Pain at rest and in activity
Measured on Numeric Rating Scales, 0 - 10.
Measured: Two years
Number of painful hand joints.
Examination.
Measured: Two years
Joint mobility in 2-5 finger.
Flexion deficit in millimetre.
Measured: Two years
Thumb flexion.
Goniometer
Measured: Two years
Thumb abduction.
Pollexograph.
Measured: Two years
Grip strength.
Grip-It, measured in Newton)
Measured: Two years
Pinch strength
Grip-It, measured in Newton
Measured: Two years
Activity performance.
MAP-Hand - a patient reported outcome/questionnaire.
Measured: Two years
Hand and shoulder function
Quick-Dash, a patient reported outcome/questionnaire
Measured: Two Years
Satisfaction with care.
On Numeric Rating Scales, 0 - 10.
Measured: Two years
Health related quality of life.
EQ5D, a patient reported outcome/questionnaire.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis in the Carpometacarpal (CMC) JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Resource Center for Rehabilitation in Rheumatology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, Haugesund Rheumatism Hospital
- Responsible party
- Principal investigator, Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology
- Investigators
- Tore K Kvien, PhD, Study director, Research director, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794754
- Sponsor's protocol ID
- 2012/2265-3
- Status last verified
- Aug 2018
- First submitted
- 15 Feb 2013
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27842579Kjeken 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.
PubMed 28166750Tveter 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.
PubMed 37355263Tveter 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.
PubMed 33338325
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01794754
- Acronym / sponsor ID
- 2012/2265-3
- Keywords
- Hand osteoarthritis, CMC1-joint, surgery, occupational therapy, hand exercises, assistive devices, orthoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Resource Center for Rehabilitation in RheumatologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, Haugesund Rheumatism Hospital
- Study start
- Apr 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Care as usualCare as usual |
| Occupational therapy | Experimental | Other: Occupational therapyOccupational therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with CMC-OA who are referred for review for the need for surgery in the CMC joint.
Key exclusion criteria (3 listed)
- Persons with cognitive dysfunction
- Persons who do not understand the Norwegian language
- Persons with other diseases or injuries that may negatively impact hand function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care as usual | Other | Control |
| Occupational therapyOccupational 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). | Other | Occupational therapy |
Primary outcome
Number of participants in each group who have received surgery.
Time frame: Two years
11 secondary outcomes
Hand Pain at rest and in activity
Time frame: Two years
Number of painful hand joints.
Time frame: Two years
Joint mobility in 2-5 finger.
Time frame: Two years
Thumb flexion.
Time frame: Two years
Thumb abduction.
Time frame: Two years
Grip strength.
Time frame: Two years
Pinch strength
Time frame: Two years
Activity performance.
Time frame: Two years
Hand and shoulder function
Time frame: Two Years
Satisfaction with care.
Time frame: Two years
Health related quality of life.
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Background: PubMed 27842579Kjeken 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.
- Background: PubMed 28166750Kjeken 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.
- Derived from this study: PubMed 37355263Tveter 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.
- Derived from this study: PubMed 33338325Tveter 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.
- Link to free full text of protocol in BMC musculoskeletal disordersLink provided by the sponsor.
- Link to free full text of erratum protocol in BMC musculoskeletal disordersLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tore K Kvien, PhD study director
Research director, Diakonhjemmet Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care as usual and Occupational therapy in people with Osteoarthritis in the Carpometacarpal (CMC) Joint, run by National Resource Center for Rehabilitation in Rheumatology at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in each group who have received surgery. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01794754, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.