- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04115644
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid.
Specific Aim 1:
Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies.
The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.
Study Overview
Status
Intervention / Treatment
Detailed Description
The proposed study is a three arm, double-blinded, prospective randomized controlled clinical trial with follow-up immediately after the injection and at day 2, and weeks 1, 2, 4, 6, and 12. In this study investigators will compare the effectiveness of ketorolac compared to corticosteroid.
Subjects being seen for a rotator cuff injury will be randomized into one of three treatment groups pertaining to their pathology. The intervention will begin once the subject has consented and answered the Baseline Outcome Shoulder Questionnaire. The Baseline Outcome Questionnaire consists of the Visual Analog Score, American Shoulder and Elbow Score, Single Assessment Numeric Evaluation, Pittsburgh Sleep Quality Index, Short Form-12, and questions pertaining to patient characteristics, injury characteristics, co-morbidities, patient history, medications, and demographics.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- John Hopkins Shoulder & Sports Medicine
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Rotator Cuff Tendinitis
- Atraumatic Rotator Cuff Tear
- Rotator Cuff Tear Arthropathy
- Subjects who speak English
Exclusion Criteria:
- Age: < 18 years old
- Prior Shoulder Surgery
- Fracture
- Acute Traumatic Rotator Cuff Tear
- Infection
- Uncontrolled Diabetes Mellitus (HbA1c >8)
- Recent Prior Shoulder Injection in either the Subacromial space
- Workers Compensation
- History of Gastric Ulcers
- Tumor Involving the Shoulder Region
- Prior history of gastrointestinal bleeding, allergic reactions, impaired renal function, seizures or cardiac arrhythmias
- Subject unable to provide informed consent
- Subjects who don't speak English
- Patients who are pregnant or lactating at time of screening or are of child bearing age
- Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response.
- Patients with any bleeding disorders.
- Patients with severe renal failure.
- Patients likely to have severe problems maintaining follow-up, including patients diagnosed with severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
- Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Group 1 (control)
will receive an injection of 5 cc 0.25% Marcaine without epinephrine
|
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Other Names:
|
Experimental: Group 2 (ketorolac)
will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
|
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Other Names:
Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Other Names:
|
Other: Group 3 (kenalog)
Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.
Group 3 is standard of care
|
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Other Names:
Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: Baseline - pre-injection
|
Pain as measured by the Visual Analog Scale prior to first injection.
The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
|
Baseline - pre-injection
|
Visual Analog Scale
Time Frame: Baseline - immediately after the injection
|
Pain as measured by the Visual Analog Scale after first injection.
The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
|
Baseline - immediately after the injection
|
Visual Analog Scale
Time Frame: Day 2
|
Pain as measured by the Visual Analog Scale.
The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
|
Day 2
|
Visual Analog Scale
Time Frame: Week 1
|
Pain as measured by the Visual Analog Scale.
The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
|
Week 1
|
Visual Analog Scale
Time Frame: Week 2
|
Pain as measured by the Visual Analog Scale.
The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
|
Week 2
|
Visual Analog Scale
Time Frame: Week 4
|
Pain as measured by the Visual Analog Scale.
The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
|
Week 4
|
Visual Analog Scale
Time Frame: Week 6
|
Pain as measured by the Visual Analog Scale.
The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
|
Week 6
|
Visual Analog Scale
Time Frame: Week 12
|
Pain as measured by the Visual Analog Scale.
The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
|
Week 12
|
American Shoulder and Elbow Score (ASES)
Time Frame: Baseline
|
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score.
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living.
One pain scale is worth 50 points, and activities of daily living worth 50 points.
A higher score indicates a better outcome.
|
Baseline
|
American Shoulder and Elbow Score (ASES)
Time Frame: Week 6
|
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score.
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living.
One pain scale is worth 50 points, and activities of daily living worth 50 points.
A higher score indicates a better outcome.
|
Week 6
|
American Shoulder and Elbow Score (ASES)
Time Frame: Week 12
|
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score.
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living.
One pain scale is worth 50 points, and activities of daily living worth 50 points.
A higher score indicates a better outcome.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single Assessment Numeric Evaluation (SANE)
Time Frame: Baseline
|
Measure the patient's self-reported function on a scale of 0 to 100
|
Baseline
|
Single Assessment Numeric Evaluation (SANE)
Time Frame: Week 6
|
Measure the patient's self-reported function on a scale of 0 to 100
|
Week 6
|
Single Assessment Numeric Evaluation (SANE)
Time Frame: Week 12
|
Measure the patient's self-reported function on a scale of 0 to 100
|
Week 12
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline
|
Sleep quality as measured by the Pittsburgh Sleep Quality Index
|
Baseline
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Week 6
|
Sleep quality as measured by the Pittsburgh Sleep Quality Index
|
Week 6
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Week 12
|
Sleep quality as measured by the Pittsburgh Sleep Quality Index
|
Week 12
|
Short Form 12 (SF-12)
Time Frame: Baseline
|
General health survey as measured by the Short Form 12 (SF-12)
|
Baseline
|
Short Form 12 (SF-12)
Time Frame: Week 6
|
General health survey as measured by the Short Form 12 (SF-12)
|
Week 6
|
Short Form 12 (SF-12)
Time Frame: Week 12
|
General health survey as measured by the Short Form 12 (SF-12)
|
Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Khazzam, MD, UT Southwestern Medical Center
Publications and helpful links
General Publications
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Gould D, Kelly D, Goldstone L, Gammon J. Examining the validity of pressure ulcer risk assessment scales: developing and using illustrated patient simulations to collect the data. J Clin Nurs. 2001 Sep;10(5):697-706. doi: 10.1046/j.1365-2702.2001.00525.x.
- Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
- Koester MC, Dunn WR, Kuhn JE, Spindler KP. The efficacy of subacromial corticosteroid injection in the treatment of rotator cuff disease: A systematic review. J Am Acad Orthop Surg. 2007 Jan;15(1):3-11. doi: 10.5435/00124635-200701000-00002.
- Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):587-94. doi: 10.1067/mse.2002.127096.
- Blair B, Rokito AS, Cuomo F, Jarolem K, Zuckerman JD. Efficacy of injections of corticosteroids for subacromial impingement syndrome. J Bone Joint Surg Am. 1996 Nov;78(11):1685-9. doi: 10.2106/00004623-199611000-00007.
- Penning LI, de Bie RA, Walenkamp GH. The effectiveness of injections of hyaluronic acid or corticosteroid in patients with subacromial impingement: a three-arm randomised controlled trial. J Bone Joint Surg Br. 2012 Sep;94(9):1246-52. doi: 10.1302/0301-620X.94B9.28750.
- Karthikeyan S, Kwong HT, Upadhyay PK, Parsons N, Drew SJ, Griffin D. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement. J Bone Joint Surg Br. 2010 Jan;92(1):77-82. doi: 10.1302/0301-620X.92B1.22137.
- Min KS, St Pierre P, Ryan PM, Marchant BG, Wilson CJ, Arrington ED. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. J Shoulder Elbow Surg. 2013 May;22(5):595-601. doi: 10.1016/j.jse.2012.08.026. Epub 2012 Nov 22.
- Adebajo AO, Nash P, Hazleman BL. A prospective double blind dummy placebo controlled study comparing triamcinolone hexacetonide injection with oral diclofenac 50 mg TDS in patients with rotator cuff tendinitis. J Rheumatol. 1990 Sep;17(9):1207-10.
- Alvarez CM, Litchfield R, Jackowski D, Griffin S, Kirkley A. A prospective, double-blind, randomized clinical trial comparing subacromial injection of betamethasone and xylocaine to xylocaine alone in chronic rotator cuff tendinosis. Am J Sports Med. 2005 Feb;33(2):255-62. doi: 10.1177/0363546504267345.
- Choi WD, Cho DH, Hong YH, Noh JH, Lee ZI, Byun SD. Effects of subacromial bursa injection with corticosteroid and hyaluronidase according to dosage. Ann Rehabil Med. 2013 Oct;37(5):668-74. doi: 10.5535/arm.2013.37.5.668. Epub 2013 Oct 29.
- Marder RA, Kim SH, Labson JD, Hunter JC. Injection of the subacromial bursa in patients with rotator cuff syndrome: a prospective, randomized study comparing the effectiveness of different routes. J Bone Joint Surg Am. 2012 Aug 15;94(16):1442-7. doi: 10.2106/JBJS.K.00534.
- Balasubramaniam P, Prathap K. The effect of injection of hydrocortisone into rabbit calcaneal tendons. J Bone Joint Surg Br. 1972 Nov;54(4):729-34. No abstract available.
- Kapetanos G. The effect of the local corticosteroids on the healing and biomechanical properties of the partially injured tendon. Clin Orthop Relat Res. 1982 Mar;(163):170-9.
- Oxlund H. The influence of a local injection of cortisol on the mechanical properties of tendons and ligaments and the indirect effect on skin. Acta Orthop Scand. 1980 Apr;51(2):231-8. doi: 10.3109/17453678008990791.
- Wiggins ME, Fadale PD, Barrach H, Ehrlich MG, Walsh WR. Healing characteristics of a type I collagenous structure treated with corticosteroids. Am J Sports Med. 1994 Mar-Apr;22(2):279-88. doi: 10.1177/036354659402200221.
- Wei AS, Callaci JJ, Juknelis D, Marra G, Tonino P, Freedman KB, Wezeman FH. The effect of corticosteroid on collagen expression in injured rotator cuff tendon. J Bone Joint Surg Am. 2006 Jun;88(6):1331-8. doi: 10.2106/JBJS.E.00806.
- Dogan N, Erdem AF, Gundogdu C, Kursad H, Kizilkaya M. The effects of ketorolac and morphine on articular cartilage and synovium in the rabbit knee joint. Can J Physiol Pharmacol. 2004 Jul;82(7):502-5. doi: 10.1139/y04-066.
- Jean YH, Wen ZH, Chang YC, Hsieh SP, Tang CC, Wang YH, Wong CS. Intra-articular injection of the cyclooxygenase-2 inhibitor parecoxib attenuates osteoarthritis progression in anterior cruciate ligament-transected knee in rats: role of excitatory amino acids. Osteoarthritis Cartilage. 2007 Jun;15(6):638-45. doi: 10.1016/j.joca.2006.11.008. Epub 2007 Jan 2.
- Itzkowitch D, Ginsberg F, Leon M, Bernard V, Appelboom T. Peri-articular injection of tenoxicam for painful shoulders: a double-blind, placebo controlled trial. Clin Rheumatol. 1996 Nov;15(6):604-9. doi: 10.1007/BF02238552.
- Kenaolg Package Insert. July 2014; Available from: http://packageinserts.bms.com/pi/pi_kenalog-40.pdf.
- Ketorolac: Drug Class and Mechanism. 2014; Available from: http://www.medicinenet.com/ketorolac-oral/article.htm
- Ogbru, O. Marcaine - Drug Class and Mechanism. 6/27/2014; Available from: http://www.medicinenet.com/bupivicaine-injection/article.htm.
- Kenalog: Drug Summary. Available from: http://www.pdr.net/drug-summary/kenalog-40?druglabelid=2494
- Hawker, G.A., et al. Measures of Adult Pain. 2011; Available from: http://onlinelibrary.wiley.com/doi/10.1002/acr.20543/pdf
- Gerstenfeld LC, Al-Ghawas M, Alkhiary YM, Cullinane DM, Krall EA, Fitch JL, Webb EG, Thiede MA, Einhorn TA. Selective and nonselective cyclooxygenase-2 inhibitors and experimental fracture-healing. Reversibility of effects after short-term treatment. J Bone Joint Surg Am. 2007 Jan;89(1):114-25. doi: 10.2106/JBJS.F.00495.
- Ho ML, Chang JK, Wang GJ. Effects of ketorolac on bone repair: A radiographic study in modeled demineralized bone matrix grafted rabbits. Pharmacology. 1998 Sep;57(3):148-59. doi: 10.1159/000028236.
- O'Keefe RJ, Tiyapatanaputi P, Xie C, Li TF, Clark C, Zuscik MJ, Chen D, Drissi H, Schwarz E, Zhang X. COX-2 has a critical role during incorporation of structural bone allografts. Ann N Y Acad Sci. 2006 Apr;1068:532-42. doi: 10.1196/annals.1346.012.
- Haws MJ, Kucan JO, Roth AC, Suchy H, Brown RE. The effects of chronic ketorolac tromethamine (toradol) on wound healing. Ann Plast Surg. 1996 Aug;37(2):147-51. doi: 10.1097/00000637-199608000-00005.
- Prisk V, Huard J. Muscle injuries and repair: the role of prostaglandins and inflammation. Histol Histopathol. 2003 Oct;18(4):1243-56. doi: 10.14670/HH-18.1243.
- Radi ZA, Khan NK. Effects of cyclooxygenase inhibition on bone, tendon, and ligament healing. Inflamm Res. 2005 Sep;54(9):358-66. doi: 10.1007/s00011-005-1367-4.
- Sucato DJ, Lovejoy JF, Agrawal S, Elerson E, Nelson T, McClung A. Postoperative ketorolac does not predispose to pseudoarthrosis following posterior spinal fusion and instrumentation for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2008 May 1;33(10):1119-24. doi: 10.1097/BRS.0b013e31816f6a2a.
- Pradhan BB, Tatsumi RL, Gallina J, Kuhns CA, Wang JC, Dawson EG. Ketorolac and spinal fusion: does the perioperative use of ketorolac really inhibit spinal fusion? Spine (Phila Pa 1976). 2008 Sep 1;33(19):2079-82. doi: 10.1097/BRS.0b013e31818396f4.
- Glassman SD, Rose SM, Dimar JR, Puno RM, Campbell MJ, Johnson JR. The effect of postoperative nonsteroidal anti-inflammatory drug administration on spinal fusion. Spine (Phila Pa 1976). 1998 Apr 1;23(7):834-8. doi: 10.1097/00007632-199804010-00020.
- Park SY, Moon SH, Park MS, Oh KS, Lee HM. The effects of ketorolac injected via patient controlled analgesia postoperatively on spinal fusion. Yonsei Med J. 2005 Apr 30;46(2):245-51. doi: 10.3349/ymj.2005.46.2.245.
- Mullis BH, Copland ST, Weinhold PS, Miclau T, Lester GE, Bos GD. Effect of COX-2 inhibitors and non-steroidal anti-inflammatory drugs on a mouse fracture model. Injury. 2006 Sep;37(9):827-37. doi: 10.1016/j.injury.2005.12.018. Epub 2006 Feb 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Rotator Cuff Injuries
- Tendinopathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anesthetics, Local
- Ketorolac
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- Bupivacaine
Other Study ID Numbers
- STU 092014-097
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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