Base-of-thumb OsteoarthritisPhase 2/3RHIBOTIINCT06902805
Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
A Phase 2/3 study testing OnabotulinumtoxinA in people with Base-of-thumb Osteoarthritis and Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Base-of-thumb Osteoarthritis, Osteoarthritis
- What is being tested?
- OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2025to Nov 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Individuals aged at least 18 years;
- Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);
- Pain involving the base of the thumb;
- X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;
- 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.
- Patient able to give written informed consent prior to participation in the study
- Affiliation with a mode of social security (profit or being entitled).
- Negative pregnancy test in women of childbearing potential
Who cannot join
- • Secondary osteoarthritis;
- History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;
- Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;
- Contra-indication to onabotulinumtoxinA;
- Neurological disorders involving the hands other than carpal tunnel syndrome;
- Collagen disorders involving the hands;
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- Osteoarthritis predominating at the scaphotrapezial joint on x-ray;
- Bilateral trapezometacarpial osteoarthritis without a predominant painful side;
- Hand or wrist trauma for up to 2 months;
- Intra-articular treatments for up to 2 months;
- Use of IM, IV or oral corticosteroids for up to 2 months.
- Protected adults (including individual under guardianship by court order)
- Pregnant women and lactation; lack of contraception for women of childbearing potential
- Patient participating in another investigational therapeutic study
- Patient unable to speak and read french
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis du Pr François Rannou, Hôpital Cochin
Paris, Île-de-France Region, 75014
Christelle Nguyen, MD, PhD, 01 58 41 29 45 ext. +33, christelle.nguyen2@aphp.fr
About this study
Official title: Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms
The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.
Read the detailed description
The base of the thumb is a frequent location of osteoarthritis. Base-of-thumb osteoarthritis affects middle-aged and older individuals and results in base-of-thumb pain and limitations in hand-specific activities. For the medium and long term, evidence suggests that splinting could reduce pain and improve hand function. For the short term, a combination of conservative treatments is recommended, with small-to-moderate treatment effect. However, use of intra-articular treatments (e.g., glucocorticoids and hyaluronan) for the short and medium term is currently debated. Use of intra-articular botulinum toxin A injection as a pain modulator in joint diseases has recently raised interest. Botulinum toxin A is a neurotoxin produced by Clostridium botulinum that inhibits acetylcholine release into the synaptic cleft in cholinergic nerve terminals. Additionally, treatment with botulinum toxin A showed intrinsic antinociceptive effects in various animal models of joint diseases.
In a pilot single-centred randomized controlled trial of 60 participants with painful base-of-thumb osteoarthritis, the investigators compared the effects of a single intra-articular injection of onabotulinumtoxinA (Botox® ) with those of a single intra-articular injection of normal saline on base-of-thumb pain, and found a significant reduction in pain.
Several perspectives raised from this pilot study. Like in the treatment of spasticity, repeated courses of intra-articular injections onabotulinumtoxinA may be necessary to obtain sustained analgesic effects over time. A replication of these findings in a multicentred setting, analysis of cost-effectiveness and description of safety at longer term are also needed before the official recommendation of this treatment. In RHIBOT II, the investigators hypothesize that 2 ultrasound-guided intra-articular injections of onabotulinumtoxinA, as an add-on therapy to custom-made rigid splinting, could reduce base-of-thumb pain at 6 months after the first injection.
- Conditions
- Base-of-thumb Osteoarthritis, Osteoarthritis
- Being tested
- OnabotulinumtoxinA, Normal saline (placebo)
- Keywords
- base-of-thumb osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
intra-articular injection
Normal saline (placebo)Drug
intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| 2 intra-articular injections of onabotulinumtoxinA | Experimental | Not described Receives: Drug: OnabotulinumtoxinA |
| 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline | Experimental | Not described Receives: Drug: OnabotulinumtoxinA; Drug: Normal saline (placebo) |
| 2 intra-articular injections of normal saline | Placebo comparator | Not described Receives: Drug: Normal saline (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Base-of-thumb pain on a self-administered 11-point numeric rating scale
French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)
Measured: 6 months
Secondary outcomes (6)
Base-of-thumb pain on a self-administered 11-point numeric rating scale
French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)
Measured: 1 and 12 months
Hand-specific activity limitations on the self-administered Cochin Hand Function Scale
mean change from baseline in hand-specific activity limitations in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0: no limitations to 90: maximal limitations) at 6 and 12 months
Measured: 6 and 12 months
patient global assessment on a self-administered 11-point numeric rating scale
mean change from baseline in patient global assessment on a self-administered 11-point numeric rating scale (0: worst possible condition to 100: best possible condition) at 6 and 12 months
Measured: 6 and 12 months
health-related quality of life on the self-administered EQ-5D-5L questionnaire
mean change from baseline in health-related quality of life on the self-administered EQ-5D-5L questionnaire (0: death, 1: best quality of life) at 6 and 12 months
Measured: 6 and 12 months
Osteoarthritis Research Society International-Outcome Measures in Rheumatology response
Osteoarthritis Research Society International-Outcome Measures in Rheumatology response (Response / No response)
Measured: 6 and 12 months
estimated total costs and incremental cost-utility ratio
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start3 Dec 2025
- Primary completionMay 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Base-of-thumb 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christelle NGUYEN, MD,PhD, Principal investigator, Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902805
- Sponsor's protocol ID
- APHP230823
- Acronym
- RHIBOTII
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms
- ClinicalTrials.gov ID
- NCT06902805
- Acronym / sponsor ID
- RHIBOTII / APHP230823
- Conditions
- Base-of-thumb Osteoarthritis, Osteoarthritis
- Keywords
- base-of-thumb osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- 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 main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.
Detailed description
The base of the thumb is a frequent location of osteoarthritis. Base-of-thumb osteoarthritis affects middle-aged and older individuals and results in base-of-thumb pain and limitations in hand-specific activities. For the medium and long term, evidence suggests that splinting could reduce pain and improve hand function. For the short term, a combination of conservative treatments is recommended, with small-to-moderate treatment effect. However, use of intra-articular treatments (e.g., glucocorticoids and hyaluronan) for the short and medium term is currently debated. Use of intra-articular botulinum toxin A injection as a pain modulator in joint diseases has recently raised interest. Botulinum toxin A is a neurotoxin produced by Clostridium botulinum that inhibits acetylcholine release into the synaptic cleft in cholinergic nerve terminals. Additionally, treatment with botulinum toxin A showed intrinsic antinociceptive effects in various animal models of joint diseases.
In a pilot single-centred randomized controlled trial of 60 participants with painful base-of-thumb osteoarthritis, the investigators compared the effects of a single intra-articular injection of onabotulinumtoxinA (Botox® ) with those of a single intra-articular injection of normal saline on base-of-thumb pain, and found a significant reduction in pain.
Several perspectives raised from this pilot study. Like in the treatment of spasticity, repeated courses of intra-articular injections onabotulinumtoxinA may be necessary to obtain sustained analgesic effects over time. A replication of these findings in a multicentred setting, analysis of cost-effectiveness and description of safety at longer term are also needed before the official recommendation of this treatment. In RHIBOT II, the investigators hypothesize that 2 ultrasound-guided intra-articular injections of onabotulinumtoxinA, as an add-on therapy to custom-made rigid splinting, could reduce base-of-thumb pain at 6 months after the first injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 intra-articular injections of onabotulinumtoxinA | Experimental | Drug: OnabotulinumtoxinA |
| 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline | Experimental | Drug: OnabotulinumtoxinA, Drug: Normal saline (placebo) |
| 2 intra-articular injections of normal saline | Placebo comparator | Drug: Normal saline (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Individuals aged at least 18 years;
Key exclusion criteria (15 listed)
- • Secondary osteoarthritis;
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 |
|---|---|---|
| OnabotulinumtoxinAintra-articular injection | Drug | 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline, 2 intra-articular injections of onabotulinumtoxinA |
| Normal saline (placebo)intra-articular injection | Drug | 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline, 2 intra-articular injections of normal saline |
Primary outcome
Base-of-thumb pain on a self-administered 11-point numeric rating scale
Time frame: 6 months
French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)
6 secondary outcomes
Base-of-thumb pain on a self-administered 11-point numeric rating scale
Time frame: 1 and 12 months
Hand-specific activity limitations on the self-administered Cochin Hand Function Scale
Time frame: 6 and 12 months
patient global assessment on a self-administered 11-point numeric rating scale
Time frame: 6 and 12 months
health-related quality of life on the self-administered EQ-5D-5L questionnaire
Time frame: 6 and 12 months
Osteoarthritis Research Society International-Outcome Measures in Rheumatology response
Time frame: 6 and 12 months
estimated total costs and incremental cost-utility ratio
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Base-of-thumb Osteoarthritis
Recruiting
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Thumb Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
Active, not recruiting
A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
Osteoarthritis Thumb
Not yet recruitingObservational study
Thumb Muscle Activation During First Dorsal Interosseous Activities of Daily Living in Thumb Base Osteoarthritis
Trapeziometacarpal Osteoarthritis
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.
Christelle NGUYEN, MD,PhD principal investigator
Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OnabotulinumtoxinA in people with Base-of-thumb Osteoarthritis and Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle NGUYEN, MD, PhD (01 58 41 29 45 ext. +33, christelle.nguyen2@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Base-of-thumb pain on a self-administered 11-point numeric rating scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.