OsteoarthritisNCT00350896
Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA)
A study testing Thumb orthoses in people with Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted. Interventions: Thumb orthoses to be worn at night and usual care vs usual care. Outcome measures: Pain at 1 month assessed on visual analog scale is the main outcome measure. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Thumb orthoses
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 2005
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain at the base of the thumb 30 mm on VAS
- Patient aged 45 and < 75 years old
- At least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes
- joint space narrowing
- subchondral bone sclerosis
- subchondral cysts
- At least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the first web
Who cannot join
- Post traumatic osteoarthritis
- Cristal arthropathy
- Inflammatory arthritis
- Neurologic disorder involving upper limb
- Psychiatric disorder needing treatment adaptation in the last 3 months
- Hand or wrist trauma within the last 2 months
Show all 14Show fewer
- Previous hand surgery
- Unable to speak or write French
- Pregnancy
- Collagen diseases (Dupuytren, Marfan, Ehlers Danlos syndromes)
- Hand or wrist infiltration within 2 months
- Skin disease interfering with the wearing of the orthoses
- Having already worn a BTOA orthoses
- Having bilateral BTOA without predominant symptomatic side
About this study
Official title: Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb (BTOA)
The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted.
Interventions: Thumb orthoses to be worn at night and usual care vs usual care. Outcome measures: Pain at 1 month assessed on visual analog scale is the main outcome measure. Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.
Read the detailed description
The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted. Radiologically defined osteoarthritis of the hand has been estimated to represent 38% of women and 24.5% of men over 66 years of age but higher prevalence of 60-70% has also been reported. Of patients with radiological signs, 20 to 40% become symptomatic. For patients over 55 years of age, the distal interphalangeal joints are the most prevalent site of osteoarthritis (20%) determined radiologically and clinically, followed by the base of the thumb (8%) and proximal interphalangeal joints (5%). This prevalence increases with age, and the incidence peaks in perimenopausal women. Osteoarthritis in the base of the thumb (BTOA) concerns the trapeziometacarpal joint, with a possible secondary location at the trapezotrapezoidial and scaphotrapezial joints. BTOA induces a closure of the first web, which in turn causes an alteration of the thumb-index pinch and therefore a limitation in hand function. Pain induced by the compression of the thumb column during pinching could also lead to functional disability. Effect of a simple intervention such as wearing rest thumb orthoses on pain and disability is unknown.
- Conditions
- Osteoarthritis
- Being tested
- Thumb orthoses
- Keywords
- trapezotrapezoidial, scaphotrapezial, thumb, pain, orthoses, Osteoarthritis in the BTOA concerns the trapezometacarpal joint
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thumb orthosesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at 1 month assessed on visual analog scale is the main outcome measure.
Secondary outcomes (1)
Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startDec 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Serge Poiraudeau, MD, Phd, Principal investigator, Cochin Hospital AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350896
- Sponsor's protocol ID
- P020916
- Status last verified
- Jan 2006
- First submitted
- 10 Jul 2006
- Last updated
- 11 Jul 2006
- Results posted
- No
Publications
Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Mace Y, Beaudreuil J, Richette P, Ravaud P, Revel M, Poiraudeau S. Splint for base-of-thumb osteoarthritis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):661-9. doi: 10.7326/0003-4819-150-10-200905190-00003.
PubMed 19451573
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb (BTOA)
- ClinicalTrials.gov ID
- NCT00350896
- Acronym / sponsor ID
- P020916
- Conditions
- Osteoarthritis
- Keywords
- trapezotrapezoidial, scaphotrapezial, thumb, pain, orthoses, Osteoarthritis in the BTOA concerns the trapezometacarpal joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Dec 2005
- First posted
- 11 Jul 2006 (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 prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted.
Interventions: Thumb orthoses to be worn at night and usual care vs usual care. Outcome measures: Pain at 1 month assessed on visual analog scale is the main outcome measure. Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.
Detailed description
The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted. Radiologically defined osteoarthritis of the hand has been estimated to represent 38% of women and 24.5% of men over 66 years of age but higher prevalence of 60-70% has also been reported. Of patients with radiological signs, 20 to 40% become symptomatic. For patients over 55 years of age, the distal interphalangeal joints are the most prevalent site of osteoarthritis (20%) determined radiologically and clinically, followed by the base of the thumb (8%) and proximal interphalangeal joints (5%). This prevalence increases with age, and the incidence peaks in perimenopausal women. Osteoarthritis in the base of the thumb (BTOA) concerns the trapeziometacarpal joint, with a possible secondary location at the trapezotrapezoidial and scaphotrapezial joints. BTOA induces a closure of the first web, which in turn causes an alteration of the thumb-index pinch and therefore a limitation in hand function. Pain induced by the compression of the thumb column during pinching could also lead to functional disability. Effect of a simple intervention such as wearing rest thumb orthoses on pain and disability is unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pain at the base of the thumb 30 mm on VAS
- Patient aged 45 and < 75 years old
- At least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes
- joint space narrowing
- subchondral bone sclerosis
Key exclusion criteria (14 listed)
- Post traumatic osteoarthritis
- Cristal arthropathy
- Inflammatory arthritis
- Neurologic disorder involving upper limb
- Psychiatric disorder needing treatment adaptation in the last 3 months
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 |
|---|---|---|
| Thumb orthoses | Device | – |
Primary outcome
Pain at 1 month assessed on visual analog scale is the main outcome measure.
1 secondary outcome
Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.
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 11 Jul 2006.
- Derived from this study: PubMed 19451573Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Mace Y, Beaudreuil J, Richette P, Ravaud P, Revel M, Poiraudeau S. Splint for base-of-thumb osteoarthritis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):661-9. doi: 10.7326/0003-4819-150-10-200905190-00003.
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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.
Serge Poiraudeau, MD, Phd principal investigator
Cochin Hospital AP-HP
Questions about this trial
What is this clinical trial studying?
A study testing Thumb orthoses in people with Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris.
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 7 inclusion and 14 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 11 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain at 1 month assessed on visual analog scale is the main outcome measure.. 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 NCT00350896, which also lists 1 linked publication.
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 11 Jul 2006.