Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting for base-of-thumb osteoarthritis on pain at 3 months

Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated with splinting for base-of-thumb osteoarthritis on pain at 3 months: A randomized placebo-controlled pilot study - RHIBOT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003939-38-FR

Enrollment

Registered

2017-06-15

Start date

2017-12-19

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients referred to our Physical Medicine Rehabilitation Department of a tertiary care center in Paris, France, for the management of Base-of-thumb osteoarthritis (BTOA) MedDRA version: 20.0 Level: LLT Classification code 10062893 Term: Rhizarthrosis System Organ Class: 100000004859

Interventions

Trade Name: BOTOX Product Name: BOTOX Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Toxine botulinique de type A Other descriptive name: Toxine botulinique A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient aged >/= 18 years Symptoms involving the base-of-thumb Mean base-of-thumb pain intensity in the previous 48 hours on NRS >/= 30 Radiographic evidence of at least 2 of 4 radiographic items: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts Physical examination findings consistent with BTOA Written consent Health cover Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42

Exclusion criteria

Exclusion criteria: - History of thumb surgery - History of inflammatory or crystal-associated rheumatic disease involving the hands - Neurological disorders involving the hands - Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases - Ostearthritis affecting the scaphotrapezial joint - Hand or wrist trauma </= 2 months - Hand or wrist intra-articular injections </= 2 months - Contra-indications to BTA injections or splinting - Cognitive or behavioral disorders making the assessment impossible - Inability to speak or write French - Bilateral rhizarthrosis without dominant affected site - Pregnancy and breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy on pain at 3 months of a single ultrasound-guided intra-articular injection of (botulinum toxin A) BTA associated with splinting to a single ultrasound-guided intra-articular injection of saline associated with splinting in patients with painful Base-of-thumb osteoarthritis (BTOA);Secondary Objective: To compare the efficacy of a single ultrasound-guided intra-articular injection of BTA associated to splinting to a single ultrasound-guided intra-articular injection of saline associated to splinting in patients with BTOA on pain at 1 and 6 months and hand-specific limitations in activities at 3 and 6 months. Data regarding co-interventions and safety will be collected at 1, 3 and 6 months.;Primary end point(s): Primary outcome - Mean base-of-thumb pain intensity in the previous 48 hours on an 11-point numeric rating scale (NRS, 0 = no pain, 100 = maximal pain) at 3 months Secondary outcomes - Mean base-of-thumb pain intensity in the previous 48 hours on NRS at 1 and 6 months, compared to inclusion. - Hand-specific limitations in activities, compared to inclusion, on Cochin Hand Function Scale (CHFS, 0 = no limitations in activities, 90 = maximal limitations in activities) at 3 and 6 months : Ref Poiraudeau S. et al., Osteoarthritis Cartilage. 2001(6):570-7. - Patient self assessment of health improvement. - Analgesics and non-steroidal anti-inflammatory drugs consumption at 1, 3 and 6 months;Timepoint(s) of evaluation of this end point: At 3 months	—

Measure

Time frame

Main Objective: To compare the efficacy on pain at 3 months of a single ultrasound-guided intra-articular injection of (botulinum toxin A) BTA associated with splinting to a single ultrasound-guided intra-articular injection of saline associated with splinting in patients with painful Base-of-thumb osteoarthritis (BTOA);Secondary Objective: To compare the efficacy of a single ultrasound-guided intra-articular injection of BTA associated to splinting to a single ultrasound-guided intra-articular injection of saline associated to splinting in patients with BTOA on pain at 1 and 6 months and hand-specific limitations in activities at 3 and 6 months. Data regarding co-interventions and safety will be collected at 1, 3 and 6 months.;Primary end point(s): Primary outcome - Mean base-of-thumb pain intensity in the previous 48 hours on an 11-point numeric rating scale (NRS, 0 = no pain, 100 = maximal pain) at 3 months Secondary outcomes - Mean base-of-thumb pain intensity in the previous 48 hours on NRS at 1 and 6 months, compared to inclusion. - Hand-specific limitations in activities, compared to inclusion, on Cochin Hand Function Scale (CHFS, 0 = no limitations in activities, 90 = maximal limitations in activities) at 3 and 6 months : Ref Poiraudeau S. et al., Osteoarthritis Cartilage. 2001(6):570-7. - Patient self assessment of health improvement. - Analgesics and non-steroidal anti-inflammatory drugs consumption at 1, 3 and 6 months;Timepoint(s) of evaluation of this end point: At 3 months

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes - Mean base-of-thumb pain intensity in the previous 48 hours on NRS at 1 and 6 months - Hand-specific limitations in activities on Cochin Hand Function Scale (CHFS, 0 = no limitations in activities, 90 = maximal limitations in activities) at 3 and 6 months : Ref Poiraudeau S. et al., Osteoarthritis Cartilage. 2001(6):570-7. - Analgesics and non-steroidal anti-inflammatory drugs consumption at 1, 3 and 6 months - Total knee replacement at 1, 3 and 6 months ;Timepoint(s) of evaluation of this end point: At 1, 3 and 6 months	—

Measure

Time frame

Secondary end point(s): Secondary outcomes - Mean base-of-thumb pain intensity in the previous 48 hours on NRS at 1 and 6 months - Hand-specific limitations in activities on Cochin Hand Function Scale (CHFS, 0 = no limitations in activities, 90 = maximal limitations in activities) at 3 and 6 months : Ref Poiraudeau S. et al., Osteoarthritis Cartilage. 2001(6):570-7. - Analgesics and non-steroidal anti-inflammatory drugs consumption at 1, 3 and 6 months - Total knee replacement at 1, 3 and 6 months ;Timepoint(s) of evaluation of this end point: At 1, 3 and 6 months

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Countries

France

Contacts

Public ContactDRCI Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

josephine.braun@aphp.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026