Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain

Официальное название

Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study

Обзор

This study will contribute to the current literature that have compared joint injections with steroid versus ketorolac providing evidence for the use of ketorolac for SI joint pain. Currently steroid is the clinical standard for joint injections, however with repetitive use, steroid injections can damage the joint. Ketorolac is an alternative anti-inflammatory medication that does not cause the same joint damage and at a cheaper cost than steroid. The investigators hypothesize that ultrasound guided SI joint injections utilizing ketorolac provide the same pain relief as corticosteroid SI joint injections measured at 2, 6 and 12 weeks post injection. This would allow more frequent injections to control pain at a decreased cost to the healthcare system.

Подробное описание

The majority of people will suffer from low back pain at some point in their life with 15-25% of axial low back pain originating at the sacroiliac (SI) joint. This pain is thought to be due to inflammation of the SI joint capsule, ligaments or bone. Following conservative management strategies such as mobility work, core strengthening and physiotherapy, as well as pharmacologic management, an SI joint injection would be the next treatment modality. Corticosteroid injections are currently the standard of care for joint injections. The corticosteroid minimizes pain by interrupting the bodies inflammatory cascade primarily by inhibiting the phospholipase A2 enzyme. However, with repetitive use, steroids can cause cartilaginous damage of the joint. With chondrocyte dysfunction being a key part of early osteoarthritis, these injections may expedite the arthritic joint changes. Due to this damage, physicians try to spread out joint injections as far as possible to reduce this risk even if the patient begins to experience more severe joint pain.

One possible alternative to steroids is the use of ketorolac, an non-steroidal anti-inflammatory drug (NSAID). Ketorolac joint injections have been shown to have similar pain reducing effects to steroids when used for shoulder, knee, hip and carpometacarpal joint pain. They have also been used widely in the National Football League to treat musculoskeletal injuries and in the post-operative phase to reduce opioid usage to manage pain. NSAIDS provide analgesia by inhibiting the cyclooxygenase (COX) family of enzymes that are involved with formation of prostaglandins. These prostaglandins are inflammatory mediators that promote inflammation and activates nociceptive neurotransmitters. Although there are known side effects of NSAIDs including increasing propensity for GI bleeds, kidney and liver disease, joint injections may have less systemic side effects compared to their oral counterparts. Another benefit of Ketorolac is the fact it is significantly cheaper than steroids. With less chondrotoxic effects, perhaps Ketorolac injections could be administered more frequently, not allowing the patient to have increasing pain levels, at less cost to the health care system even with more frequent administration.

Вмешательства

• Препарат Methylprednisolone Injection
  Medication will be injected into SI joint under ultrasound guidance
• Препарат Ketorolac Injection
  Medication will be injected into SI joint under ultrasound guidance

Первичные конечные точки

• Sacroiliac (SI) joint pain [Срок оценки: 3 months following SI joint injection]

Критерии участия

Критерии включения

• SI joint pain for at least 3 months
• Age greater than 18
• Must have at least 3 special tests positive for SI joint pain on physical exam

Критерии исключения

• Previous back surgery
• Radicular leg pain
• Discogenic pain
• Myofascial pain syndrome
• Depression
• Systemic infection or localized infection at anticipated needle entry sites
• Cognitive impairment preventing informed consent or accurate collection of data
• Patient allergic to medication used
• NSAID contraindications including:
• Gastrointestinal bleeds
• Renal failure
• Symptomatic congestive heart failure
• Cirrhosis

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Michael G. DeGroote Pain Clinic — Hamilton

Публикации

• Park KD, Kim TK, Bae BW, Ahn J, Lee WY, Park Y. Ultrasound guided intra-articular ketorolac versus corticosteroid injection in osteoarthritis of the hip: a retrospective comparative study. Skeletal Radiol. 2015 Sep;44(9):1333-40. doi: 10.1007/s00256-015-2174-9. Epub 2015 Jun 3. PMID 26031217
• Aranke M, McCrudy G, Rooney K, Patel K, Lee CA, Hasoon J, Kaye AD. Minimally Invasive and Conservative Interventions for the Treatment of Sacroiliac Joint Pain: A Review of Recent Literature. Orthop Rev (Pavia). 2022 May 31;14(4):34098. doi: 10.52965/001c.34098. eCollection 2022. PMID 35769646
• Koh SH, Lee SC, Lee WY, Kim J, Park Y. Ultrasound-guided intra-articular injection of hyaluronic acid and ketorolac for osteoarthritis of the carpometacarpal joint of the thumb: A retrospective comparative study. Medicine (Baltimore). 2019 May;98(19):e15506. doi: 10.1097/MD.0000000000015506. PMID 31083191
• Shapiro PS, Rohde RS, Froimson MI, Lash RH, Postak P, Greenwald AS. The effect of local corticosteroid or ketorolac exposure on histologic and biomechanical properties of rabbit tendon and cartilage. Hand (N Y). 2007 Dec;2(4):165-72. doi: 10.1007/s11552-007-9042-6. Epub 2007 May 5. PMID 18780047
• Beitzel K, McCarthy MB, Cote MP, Apostolakos J, Russell RP, Bradley J, ElAttrache NS, Romeo AA, Arciero RA, Mazzocca AD. The effect of ketorolac tromethamine, methylprednisolone, and platelet-rich plasma on human chondrocyte and tenocyte viability. Arthroscopy. 2013 Jul;29(7):1164-74. doi: 10.1016/j.arthro.2013.04.006. PMID 23809450
• Cooke C, Osborne J, Jackson N, Keating P, Flynn J, Markel D, Chen C, Lemos S. Acetaminophen, bupivacaine, Duramorph, and Toradol: A comparison of chondrocyte viability and gene expression changes in osteoarthritic human chondrocytes. Knee. 2020 Dec;27(6):1746-1752. doi: 10.1016/j.knee.2020.10.019. Epub 2020 Nov 13. PMID 33197813
• Xu J, Qu Y, Li H, Jiang T, Zheng C, Wang B, Shen P. Effect of ketorolac in intra-articular injection analgesia for postoperative pain in patients undergoing shoulder arthroscopy: a pilot-controlled clinical study. J Pain Res. 2019 Jan 17;12:417-422. doi: 10.2147/JPR.S178413. eCollection 2019. PMID 30705607
• Taheri P, Dehghan F, Mousavi S, Solouki R. Comparison of Subacromial Ketorolac Injection versus Corticosteroid Injection in the Treatment of Shoulder Impingement Syndrome. J Res Pharm Pract. 2017 Oct-Dec;6(4):223-227. doi: 10.4103/jrpp.JRPP_17_57. PMID 29417082

Идентификаторы

NCT: NCT06081101 · McMaster_University_KVC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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