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Completed

NCT Number: NCT03187626

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Paris, 75014, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin A

Drug

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

Other names: Botox®, Allergan

Saline

Drug

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 outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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)

  10. 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)

  11. 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)

  12. 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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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

Acronym: RHIBOT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2017
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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