search
Back to results

Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis (RHIBOT)

Primary Purpose

Base-of-thumb Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
botulinum toxin A
saline
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Base-of-thumb Osteoarthritis focused on measuring Base-of-thumb osteoarthritis, Botulinum toxin A, Intra-articular therapy, Randomized trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • Written consent
  • Health insurance
  • For women of childbearing age, a negative urinary pregnancy test

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intra-articular botulinum toxin A and splinting

Intra-articular saline and splinting

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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
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
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)
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)
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)
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)

Full Information

First Posted
June 13, 2017
Last Updated
June 26, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
search

1. Study Identification

Unique Protocol Identification Number
NCT03187626
Brief Title
Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis
Acronym
RHIBOT
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
February 16, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Base-of-thumb Osteoarthritis
Keywords
Base-of-thumb osteoarthritis, Botulinum toxin A, Intra-articular therapy, Randomized trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-articular botulinum toxin A and splinting
Arm Type
Experimental
Arm Description
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
Arm Title
Intra-articular saline and splinting
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
botulinum toxin A
Other Intervention Name(s)
Botox®, Allergan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in base-of-thumb pain 3 months post-injection
Description
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)
Time Frame
3 months post injection
Secondary Outcome Measure Information:
Title
Change in base-of-thumb pain 1 month post-injection
Description
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)
Time Frame
1 month post injection
Title
Change in base-of-thumb pain 6 months post-injection
Description
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)
Time Frame
6 months post injection
Title
Change in hand function 3 months post-injection
Description
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)
Time Frame
3 months post injection
Title
Change in hand function 6 months post-injection
Description
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)
Time Frame
6 months post injection
Title
Change in patient's global assessment 3 months post-injection
Description
Mean change from baseline in patient's global assessment on a self-administered 11-point numeric rating scale (0 worst possible - 100 best possible)
Time Frame
3 months post-injection
Title
Change in patient's global assessment 6 months post-injection
Description
Mean change from baseline in patient's global assessment on a self-administered 11-point numeric rating scale (0 worst possible - 100 best possible)
Time Frame
6 months post-injection
Title
Percentage of OARSI responders 3 months post-injection
Description
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
Time Frame
3 months post-injection
Title
Percentage of OARSI responders 6 months post-injection
Description
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
Time Frame
6 months post-injection
Title
Analgesics consumption at 3 months
Description
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)
Time Frame
from injection to 3 months post-injection
Title
Analgesics consumption at 6 months
Description
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)
Time Frame
from 3 to 6 months post-injection
Title
Non-steroidal anti-inflammatory drugs consumption at 3 months
Description
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)
Time Frame
from injection to 3 months post-injection
Title
Non-steroidal anti-inflammatory drugs consumption at 6 months
Description
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)
Time Frame
from 3 to 6 months post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Written consent Health insurance For women of childbearing age, a negative urinary pregnancy test Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François RANNOU, MD, PhD
Organizational Affiliation
AP-HP , université Paris Descartes
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christelle NGUYEN, MD, PhD
Organizational Affiliation
AP-HP, université Paris Descartes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29961037
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis

We'll reach out to this number within 24 hrs