Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

Официальное название

Botulinum Toxin Injection in the Management of Thumb Carpometacarpal Arthritis: a Randomized Controlled Trial

Обзор

The purpose of this clinical trial is to gather information on the safety and effectiveness of botulinum toxin injection (or Botox) in the treatment of thumb joint pain/arthritis. People with thumb joint pain or arthritis usually receive steroid injections to help with the pain. However, this medicine does not always work well and also carries known important side effects. There is currently no alternative to this injection medicine. This clinical trial seeks to investigate botulinum toxin as a possible alternative to steroid injection. The difference between Botox and steroid injections is that they are different medicines and work in different ways. Botox, as it is being used in this study, is not FDA-approved. It is therefore considered an investigational medicine.

Подробное описание

Thumb carpometacarpal (CMC) osteoarthritis (OA) is one of the most common conditions treated by hand surgeons in the US. The treatment algorithm includes a stepwise strategy starting with conservative management and escalating to operative interventions when nonoperative measures fail to control pain or there is progression to a painful joint. Intra-articular injection of steroids represents a mainstay in the treatment approach for patients with thumb CMC OA, but despite its ubiquity, the American College of Rheumatology only conditionally recommends steroid injections due to a lack of evidence. Additionally, steroid injections carry significant risks, including the possibility of tissue atrophy, skin hypopigmentation, and joint arthropathy. As a result, alternative means have been sought to better treat pain and potentially delay the need for surgery. Botulinum toxin (BoNT) may be one such alternative.

BoNT is produced by Clostridium botulinum and exerts temporary neuromodulation by rapidly and strongly binding to presynaptic cholinergic nerve terminals. BoNT has also been shown to inhibit the secretion of pain mediators from the nerve endings of the dorsal root ganglia, reduce local inflammation around nerve endings, deactivate sodium channels, and perform retrograde axonal transport. Due to the growing evidence of efficacy in treating neuropathic pain, the use of BoNT has become incorporated in the management of chronic migraines, trigeminal neuralgia, spinal cord injuries, and post-stroke pain syndrome. Additionally, intra-articular BoNT injections were shown to decrease pain in patients with knee and shoulder refractory arthritis.

The investigators propose that intra-articular BoNT injections may decrease pain in patients with thumb CMC OA through the chemical denervation of articular pain fibers.

Вмешательства

• Препарат Botulinum toxin
  Patients in this group will receive an injection of Botulinum toxin.
• Препарат Standard-of-care corticosteroid injections
  Patients in this group will receive an injection of corticosteroid injections, which are considered standard of care.

Первичные конечные точки

• Thumb Pain [Срок оценки: Post-injection VAS scores will then be taken at each subsequent follow-up visit: 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).]

Вторичные конечные точки (2)

• Grip Strength [Срок оценки: 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).]
• Thumb range of motion [Срок оценки: 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).]

Критерии участия

Критерии включения

• Adult patients (> 18 years old) with a diagnosis of thumb CMC OA
• Diagnosis of thumb CMC OA
• History, clinical exam, and radiographic findings, as done in prior studies on this topic.
• Subjective: thumb or wrist pain at rest or with activity, joint stiffness
• Exam: basal joint tenderness, decreased mobility, deformity, instability
• Radiograph: joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts, Eaton-Littler stage.
• Failed conservative management with oral pain medication and splinting for at least 3 months.

Критерии исключения

• Severe osteoarthritis (Eaton-Littler stage 4) or too large osteophytes to allow for injection into the joint space Inflammatory arthritis
• Any concomitant hand conditions (i.e. carpal tunnel, trigger finger, etc)
• Prior significant hand trauma related to the thumb or first CMC joint
• Prior intervention or hand surgery
• Patients with fibromyalgia or complex regional pain syndrome (CRPS)
• Pregnant and breastfeeding patients will also be excluded. We also will exclude individuals attempting to conceive or who could become pregnant within 6-months of treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• 235 Plain Street — Providence

Публикации

• Haara MM, Heliovaara M, Kroger H, Arokoski JP, Manninen P, Karkkainen A, Knekt P, Impivaara O, Aromaa A. Osteoarthritis in the carpometacarpal joint of the thumb. Prevalence and associations with disability and mortality. J Bone Joint Surg Am. 2004 Jul;86(7):1452-7. doi: 10.2106/00004623-200407000-00013. PMID 15252092
• Weiss AC, Goodman AD. Thumb Basal Joint Arthritis. J Am Acad Orthop Surg. 2018 Aug 15;26(16):562-571. doi: 10.5435/JAAOS-D-17-00374. PMID 29969109
• Pickrell BB, Eberlin KR. Thumb Basal Joint Arthritis. Clin Plast Surg. 2019 Jul;46(3):407-413. doi: 10.1016/j.cps.2019.02.010. PMID 31103085
• Trellu S, Dadoun S, Berenbaum F, Fautrel B, Gossec L. Intra-articular injections in thumb osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. Joint Bone Spine. 2015 Oct;82(5):315-9. doi: 10.1016/j.jbspin.2015.02.002. Epub 2015 Mar 14. PMID 25776442
• Jankovic J, Brin MF. Therapeutic uses of botulinum toxin. N Engl J Med. 1991 Apr 25;324(17):1186-94. doi: 10.1056/NEJM199104253241707. No abstract available. PMID 2011163
• Singh JA. Use of botulinum toxin in musculoskeletal pain. F1000Res. 2013 Feb 15;2:52. doi: 10.12688/f1000research.2-52.v2. eCollection 2013. PMID 24715952
• Cote TR, Mohan AK, Polder JA, Walton MK, Braun MM. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005 Sep;53(3):407-15. doi: 10.1016/j.jaad.2005.06.011. PMID 16112345

Идентификаторы

NCT: NCT05990881 · 2006564-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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