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Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb

Primary Purpose

Rhizarthrosis

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Botulinum toxin

Placebo

About this trial

This is an interventional treatment trial for Rhizarthrosis

Eligibility Criteria

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

Inclusion Criteria:

Patient >18 years old
Patient with rhizarthrosis objectified by interrogation, radiography with at least 2 of the following criteria: osteophyte, joint space narrowing, subchondral sclerosis or geode
Patient who has had an X-ray of the wrist (face, profile and Kapandji incidence) to estimate the severity of the rhizarthrosis.
Patient with signed informed consent.
Visual analog scale (VAS) of pain > 4
Failure of well-conducted drug treatments with level 1 and 2 analgesics, anti-inflammatory drugs and orthotic devices
Patients must have stopped all corticosteroid or non-steroidal anti-inflammatory drugs therapy within the last 48 hours.
Patient affiliated with a Social Security plan
Patient who can understand the study instructions
Patient on effective contraception for more than one month according to the marketing authorization (Pill, intrauterine device, vaginal ring, contraceptive skin patch, hormonal subcutaneous implant)
Infertile patients in connection with surgery (tubal ligation, oophorectomy, adnexectomy, hysterectomy)

Exclusion Criteria:

History of surgery of the thumb column
Patient who has received an intra-articular trapezoidal metacarpal injection of corticoids, botulinum toxin or hyaluronic acid or other product within the last 6 months.
Patient who has received a Botulinum toxin injection at any site within the last 3 months
Myasthenia or Lambert-Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe respiratory disorder or severe swallowing disorder
Patients with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose)
Patient with an infection or inflammation at the injection site concerned
Pregnant or breastfeeding women (a urine pregnancy test will be performed)
Patients with chronic inflammatory joint disease or microcrystalline pathology
Current participation or less than 30 days of participation in a clinical drug trial
Any medical or psychiatric condition that could prevent the proper understanding and conduct of the treatment and study (adult under guardianship)
Patient who wishes to discontinue contraception during the study
Patients at high risk of bleeding complications from the intra-articular injection (hemophilia, anticoagulant treatment, etc.)

Sites / Locations

CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

botulinum toxin

placebo

Arm Description

50 IU of botulinum toxin

50 IU of placebo

Outcomes

Primary Outcome Measures

Visual Analogue Scale at 3 months

Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.

Secondary Outcome Measures

Dreiser test evaluation

Dreiser test evaluation (functional index evaluation) at 3 months

adverse events

Collecting adverse events

Visual Analogue Scale at 8 weeks

Evaluation of pain by Visual Analogue Scale at 8 weeks. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.

intake of analgesic and anti-inflammatory drugs during the study period

Evaluate the intake of analgesic and anti-inflammatory drugs during the study period: collection of the consumption of analgesics and non-steroidal anti-inflammatory drugs in the patient's diary (international non-proprietary name, dosage, date and time) from the injection at Month 0 to the evaluation at Month 3

sleep quality

sleep quality (Spiegel sleep questionnaire ) at 3 months

quality of life

quality of life (SF-36 scale -) at 3 months. a score for each dimension of the SF-36 was calculated, ranging from 0 to 100. A low score reflects a perception of poor health, loss of function, and presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain

Full Information

NCT ID

NCT04829565

First Posted

March 29, 2021

Last Updated

March 31, 2021

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT04829565

Brief Title

Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb

Official Title

Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 29, 2021 (Anticipated)

Primary Completion Date

June 29, 2022 (Anticipated)

Study Completion Date

June 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Only 4 randomized controlled clinical trials have been published to date to assess the short-term effectiveness of intra-articular Botulinum Toxin injection on pain, function and quality of life in patients suffering from chronic knee pain related or not to knee osteoarthritis and also in the context of ankle osteoarthritis. The analgesic properties and the reported safety make intra-articular Botulinum toxin a strong candidate in the treatment of symptomatic manifestations of osteoarthritis disease and more particularly in certain locations such as the trapezo-metacarpal joint. Investigators hypothesize that injection of intra-articular Botulinum toxin into the trapezo-metacarpal joint will be of benefit in reducing pain and improving function in patients with rhizarthrosis. Investigators will begin a monocentric randomized controlled trial comparing intra-articular injections of Botulinum toxin and placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhizarthrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

botulinum toxin

Arm Type

Experimental

Arm Description

50 IU of botulinum toxin

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

50 IU of placebo

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin

Intervention Description

echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of botulinum toxin 50 IU

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of placebo

Primary Outcome Measure Information:

Title

Visual Analogue Scale at 3 months

Description

Time Frame

3 months after the injection

Secondary Outcome Measure Information:

Title

Dreiser test evaluation

Description

Dreiser test evaluation (functional index evaluation) at 3 months

Time Frame

3 months after the injection

Title

adverse events

Description

Collecting adverse events

Time Frame

through study completion, an average of 3 months

Title

Visual Analogue Scale at 8 weeks

Description

Evaluation of pain by Visual Analogue Scale at 8 weeks. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.

Time Frame

8 weeks after the injection

Title

intake of analgesic and anti-inflammatory drugs during the study period

Description

Time Frame

from the injection at Month 0 to the evaluation at Month 3, assessed up to 3 months

Title

sleep quality

Description

sleep quality (Spiegel sleep questionnaire ) at 3 months

Time Frame

3 months after the injection

Title

quality of life

Description

Time Frame

3 months after the injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient >18 years old Patient with rhizarthrosis objectified by interrogation, radiography with at least 2 of the following criteria: osteophyte, joint space narrowing, subchondral sclerosis or geode Patient who has had an X-ray of the wrist (face, profile and Kapandji incidence) to estimate the severity of the rhizarthrosis. Patient with signed informed consent. Visual analog scale (VAS) of pain > 4 Failure of well-conducted drug treatments with level 1 and 2 analgesics, anti-inflammatory drugs and orthotic devices Patients must have stopped all corticosteroid or non-steroidal anti-inflammatory drugs therapy within the last 48 hours. Patient affiliated with a Social Security plan Patient who can understand the study instructions Patient on effective contraception for more than one month according to the marketing authorization (Pill, intrauterine device, vaginal ring, contraceptive skin patch, hormonal subcutaneous implant) Infertile patients in connection with surgery (tubal ligation, oophorectomy, adnexectomy, hysterectomy) Exclusion Criteria: History of surgery of the thumb column Patient who has received an intra-articular trapezoidal metacarpal injection of corticoids, botulinum toxin or hyaluronic acid or other product within the last 6 months. Patient who has received a Botulinum toxin injection at any site within the last 3 months Myasthenia or Lambert-Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe respiratory disorder or severe swallowing disorder Patients with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose) Patient with an infection or inflammation at the injection site concerned Pregnant or breastfeeding women (a urine pregnancy test will be performed) Patients with chronic inflammatory joint disease or microcrystalline pathology Current participation or less than 30 days of participation in a clinical drug trial Any medical or psychiatric condition that could prevent the proper understanding and conduct of the treatment and study (adult under guardianship) Patient who wishes to discontinue contraception during the study Patients at high risk of bleeding complications from the intra-articular injection (hemophilia, anticoagulant treatment, etc.)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre Blanc

Phone

0492039655

Ext

+33

blanc.p@chu-nice.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Roux

Phone

0492035779

Ext

+33

roux.c@chu-nice.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Blanc

Organizational Affiliation

Centre Hospitalier Universitaire de Nice

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Nice

City

Nice

State/Province

Paca

ZIP/Postal Code

06000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre Blanc

Phone

0492039655

Ext

+33

blanc.p@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Christian Roux

Phone

0492035779

Ext

+33

roux.c@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Stéphane Glenet

12. IPD Sharing Statement

Learn more about this trial

Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb

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