Base-of-thumb Osteoarthritis
Conditions
Keywords
Base-of-thumb osteoarthritis, Botulinum toxin A, Intra-articular therapy, Randomized trial
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
Interventions
DRUGbotulinum 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
DRUGsaline
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
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in base-of-thumb pain 3 months post-injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in base-of-thumb pain 6 months post-injection | 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 | 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 | 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 | 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 | 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) |
| Change in base-of-thumb pain 1 month post-injection | 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) |
| Percentage of OARSI responders 6 months post-injection | 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 | 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 | 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 | 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 | 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) |
| Percentage of OARSI responders 3 months post-injection | 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 |
Countries
France
Outcome results
None listed