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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 16, 2021

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

Interventions

  • Drug: botulinum toxin A
    • 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
  • Drug: saline
    • 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

Arms, Groups and Cohorts

  • Experimental: Intra-articular botulinum toxin A and splinting
    • 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
  • Active Comparator: Intra-articular saline and splinting
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • Change in base-of-thumb pain 1 month post-injection
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: from injection to 3 months post-injection
    • 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
    • Time Frame: from 3 to 6 months post-injection
    • 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
    • Time Frame: from injection to 3 months post-injection
    • 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
    • Time Frame: from 3 to 6 months post-injection
    • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • François RANNOU, MD, PhD, Study Director, AP-HP , université Paris Descartes
    • Christelle NGUYEN, MD, PhD, Principal Investigator, AP-HP, université Paris Descartes

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.