Base-of-thumb OsteoarthritisPhase 2/3RHIBOTNCT03187626
Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis
A Phase 2/3 study testing botulinum toxin A and saline in people with Base-of-thumb Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Base-of-thumb Osteoarthritis
- What is being tested?
- botulinum toxin A and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2018to 23 Apr 2021
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
- Pain involving the base-of-thumb
- X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
- 1990 American College of Rheumatology classification criteria for hand osteoarthritis adapted to base-of-thumb osteoarthritis
- Medical examination
Show all 9Show fewer
- Written consent
- Health insurance
- For women of childbearing age, a negative urinary pregnancy test
Who cannot join
- History of thumb surgery
- History of inflammatory or crystal-associated rheumatic disease
- Neurological disorders involving the hands other than carpien canal syndrom
- Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
- Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
- Hand or wrist trauma ≤ 2 months
Show all 14Show fewer
- Hand or wrist intra-articular injections ≤ 2 months
- Contra-indication to botulinum toxin A injection or to splinting
- Cognitive or behavioral disorders making the assessment impossible
- Participant unable to speak, read and write french
- Bilateral BTOA without predominant symptomatic side
- Pregnancy and breast feeding
- Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected minors or adults, guardianship or trusteeship, etc.)
- Patient with epilepsy
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Paris, Paris, 75014
About this study
Official title: Short-term Efficacy of a Single Ultrasound-guided Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis: a Randomized Controlled Double-blind Pilot Study
The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis.
Read the detailed description
Base-of-thumb osteoarthritis is a common condition affecting middle-age persons. Base-of-thumb osteoarthritis induces pain and hand-specific limitations in activities. For short and midterm effects, therapeutic options usually include splinting, exercise therapy and intra-articular injections of glucocorticoids or hyaluronic acid. However, evidence of efficacy of intra-articular therapies in base-of-thumb osteoarthritis and international guidelines are inconsistent. Recently, the use of intra-articular botulinum toxin A as a pain killer has raised intense interest. The exact mechanisms of pain modulation by botulinum toxin A in osteoarthritis are unclear. It has been suggested that botulinum toxin A could directly reduce peripheral sensitization and indirectly reduce central sensitization. Indeed, recent studies suggest an inhibitory role of botulinum toxin A on the release of mediators involved in nociception, such as P substance, calcitonin gene-related peptide and glutamate. Open and randomized controlled trials of botulinum toxin A in knee osteoarthritis support short to mid-term positive clinical effects on pain. However, no study has reported results for base-of-thumb osteoarthritis
- Conditions
- Base-of-thumb Osteoarthritis
- Being tested
- botulinum toxin A, saline
- Keywords
- Base-of-thumb osteoarthritis, Botulinum toxin A, Intra-articular therapy, Randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin ADrug
Also called Botox®, Allergan
Ultrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
salineDrug
Ultrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular botulinum toxin A and splinting | Experimental | Ultrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly Receives: Drug: botulinum toxin A |
| Intra-articular saline and splinting | Active comparator | Ultrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in base-of-thumb pain 3 months post-injection
Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain)
Measured: 3 months post injection
Secondary outcomes (12)
Change in base-of-thumb pain 1 month post-injection
Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain)
Measured: 1 month post injection
Change in base-of-thumb pain 6 months post-injection
Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain)
Measured: 6 months post injection
Change in hand function 3 months post-injection
Mean change from baseline in average hand-specific limitations in activities in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0 no limitations - 90 maximal limitations)
Measured: 3 months post injection
Change in hand function 6 months post-injection
Mean change from baseline in average hand-specific limitations in activities in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0 no limitations - 90 maximal limitations)
Measured: 6 months post injection
Change in patient's global assessment 3 months post-injection
Mean change from baseline in patient's global assessment on a self-administered 11-point numeric rating scale (0 worst possible - 100 best possible)
Measured: 3 months post-injection
Change in patient's global assessment 6 months post-injection
Mean change from baseline in patient's global assessment on a self-administered 11-point numeric rating scale (0 worst possible - 100 best possible)
Measured: 6 months post-injection
Percentage of OARSI responders 3 months post-injection
OARSI response is defined as an improvement in pain (0 to 100 numeric rating scale) or in function (0 to 90 Cochin Hand Function Scale) ≥ 50% and absolute change ≥ 20/100 on pain numeric rating scale or ≥ 9/90 on Cochin Hand Function Scale respectively , or improvement in at least 2 of the 3 following items: 1/ pain ≥ 20% and absolute change ≥ 10/100, 2/ function ≥ 20% and absolute change ≥ 9/90, 3/ patient's global assessment (0 to 100 numeric rating scale) ≥ 20% and absolute change ≥ 10/100
Measured: 3 months post-injection
Percentage of OARSI responders 6 months post-injection
OARSI response is defined as an improvement in pain (0 to 100 numeric rating scale) or in function (0 to 90 Cochin Hand Function Scale) ≥ 50% and absolute change ≥ 20/100 on pain numeric rating scale or ≥ 9/90 on Cochin Hand Function Scale respectively , or improvement in at least 2 of the 3 following items: 1/ pain ≥ 20% and absolute change ≥ 10/100, 2/ function ≥ 20% and absolute change ≥ 9/90, 3/ patient's global assessment (0 to 100 numeric rating scale) ≥ 20% and absolute change ≥ 10/100
Measured: 6 months post-injection
Analgesics consumption at 3 months
Self-reported consumption of analgesics (non-opioid, weak and strong opioids) using a self-administered 4-class scale (never; several times a month; several times a week; daily)
Measured: from injection to 3 months post-injection
Analgesics consumption at 6 months
Self-reported consumption of analgesics (non-opioid, weak and strong opioids) using a self-administered 4-class scale (never; several times a month; several times a week; daily)
Measured: from 3 to 6 months post-injection
Non-steroidal anti-inflammatory drugs consumption at 3 months
Self-reported consumption of non-steroidal anti-inflammatory drugs using a self-administered 4-class scale (never; several times a month; several times a week; daily)
Measured: from injection to 3 months post-injection
Non-steroidal anti-inflammatory drugs consumption at 6 months
Self-reported consumption of non-steroidal anti-inflammatory drugs using a self-administered 4-class scale (never; several times a month; several times a week; daily)
Measured: from 3 to 6 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start29 Nov 2018
- Primary completion16 Feb 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
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
- François RANNOU, MD, PhD, Study director, AP-HP , université Paris DescartesChristelle NGUYEN, MD, PhD, Principal investigator, AP-HP, université Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187626
- Sponsor's protocol ID
- P160404
- Acronym
- RHIBOT
- Status last verified
- Aug 2025
- First submitted
- 13 Jun 2017
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gil C, Abdoul H, Campagna R, Guerini H, Ieong E, Chagny F, Bedin C, Roren A, Lefevre-Colau MM, Poiraudeau S, Feydy A, Rannou F, Nguyen C. Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT). BMJ Open. 2018 Jun 30;8(6):e022337. doi: 10.1136/bmjopen-2018-022337.
PubMed 29961037Nguyen C, Abdoul H, Campagna R, Guerini H, Jilet L, Bedin C, Chagny F, Couraud G, Daste C, Drape JL, Flechon R, Gil C, Guerin C, Lefevre-Colau MM, Poiraudeau S, Randriamampandry E, Roren A, Feydy A, Rannou F. Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis: a double-blind, randomised, controlled, phase 3 trial (RHIBOT). Lancet Rheumatol. 2022 Jul;4(7):e480-e489. doi: 10.1016/S2665-9913(22)00129-1.
PubMed 38294016
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy of a Single Ultrasound-guided Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis: a Randomized Controlled Double-blind Pilot Study
- ClinicalTrials.gov ID
- NCT03187626
- Acronym / sponsor ID
- RHIBOT / P160404
- Conditions
- Base-of-thumb Osteoarthritis
- Keywords
- Base-of-thumb osteoarthritis, Botulinum toxin A, Intra-articular therapy, Randomized trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 15 Jun 2017 (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 primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis.
Detailed description
Base-of-thumb osteoarthritis is a common condition affecting middle-age persons. Base-of-thumb osteoarthritis induces pain and hand-specific limitations in activities. For short and midterm effects, therapeutic options usually include splinting, exercise therapy and intra-articular injections of glucocorticoids or hyaluronic acid. However, evidence of efficacy of intra-articular therapies in base-of-thumb osteoarthritis and international guidelines are inconsistent. Recently, the use of intra-articular botulinum toxin A as a pain killer has raised intense interest. The exact mechanisms of pain modulation by botulinum toxin A in osteoarthritis are unclear. It has been suggested that botulinum toxin A could directly reduce peripheral sensitization and indirectly reduce central sensitization. Indeed, recent studies suggest an inhibitory role of botulinum toxin A on the release of mediators involved in nociception, such as P substance, calcitonin gene-related peptide and glutamate. Open and randomized controlled trials of botulinum toxin A in knee osteoarthritis support short to mid-term positive clinical effects on pain. However, no study has reported results for base-of-thumb osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular botulinum toxin A and splinting | Experimental | Drug: botulinum toxin AUltrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly |
| Intra-articular saline and splinting | Active comparator | Drug: salineUltrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old
- Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
- Pain involving the base-of-thumb
- X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
- 1990 American College of Rheumatology classification criteria for hand osteoarthritis adapted to base-of-thumb osteoarthritis
Key exclusion criteria (14 listed)
- History of thumb surgery
- History of inflammatory or crystal-associated rheumatic disease
- Neurological disorders involving the hands other than carpien canal syndrom
- Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
- Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
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 |
|---|---|---|
| botulinum toxin AAlso: Botox®, AllerganUltrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly | Drug | Intra-articular botulinum toxin A and splinting |
| salineUltrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly | Drug | Intra-articular saline and splinting |
Primary outcome
Change in base-of-thumb pain 3 months post-injection
Time frame: 3 months post injection
Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain)
12 secondary outcomes
Change in base-of-thumb pain 1 month post-injection
Time frame: 1 month post injection
Change in base-of-thumb pain 6 months post-injection
Time frame: 6 months post injection
Change in hand function 3 months post-injection
Time frame: 3 months post injection
Change in hand function 6 months post-injection
Time frame: 6 months post injection
Change in patient's global assessment 3 months post-injection
Time frame: 3 months post-injection
Change in patient's global assessment 6 months post-injection
Time frame: 6 months post-injection
Percentage of OARSI responders 3 months post-injection
Time frame: 3 months post-injection
Percentage of OARSI responders 6 months post-injection
Time frame: 6 months post-injection
Analgesics consumption at 3 months
Time frame: from injection to 3 months post-injection
Analgesics consumption at 6 months
Time frame: from 3 to 6 months post-injection
Non-steroidal anti-inflammatory drugs consumption at 3 months
Time frame: from injection to 3 months post-injection
Non-steroidal anti-inflammatory drugs consumption at 6 months
Time frame: from 3 to 6 months post-injection
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 5 Sep 2025.
- Results publication: PubMed 29961037Gil C, Abdoul H, Campagna R, Guerini H, Ieong E, Chagny F, Bedin C, Roren A, Lefevre-Colau MM, Poiraudeau S, Feydy A, Rannou F, Nguyen C. Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT). BMJ Open. 2018 Jun 30;8(6):e022337. doi: 10.1136/bmjopen-2018-022337.
- Derived from this study: PubMed 38294016Nguyen C, Abdoul H, Campagna R, Guerini H, Jilet L, Bedin C, Chagny F, Couraud G, Daste C, Drape JL, Flechon R, Gil C, Guerin C, Lefevre-Colau MM, Poiraudeau S, Randriamampandry E, Roren A, Feydy A, Rannou F. Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis: a double-blind, randomised, controlled, phase 3 trial (RHIBOT). Lancet Rheumatol. 2022 Jul;4(7):e480-e489. doi: 10.1016/S2665-9913(22)00129-1.
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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.
François RANNOU, MD, PhD study director
AP-HP , université Paris Descartes
Christelle NGUYEN, MD, PhD principal investigator
AP-HP, université Paris Descartes
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 botulinum toxin A and saline in people with Base-of-thumb 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 9 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 5 Sep 2025. 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. 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?
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?
Change in base-of-thumb pain 3 months post-injection (time frame: 3 months post injection). 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 NCT03187626, which also lists 2 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 5 Sep 2025.