Ketorolac in Upper Extremity Tendinopathy and Arthropathy

Official title

Single Blind RCT to Evaluate the Effect of Ketorolac in Upper Extremity Tendinopathy and Arthropathy

Overview

Osteoarthritis (OA) and inflammatory conditions of the tendons and joints of the shoulder, elbow, hand, and wrist are common yet disabling diseases. Standard management utilizes conservative measures to minimize pain and improve function. Conservative pharmacological management commonly includes corticosteroid and ketorolac injections which have been well investigated as a modality of pain control and improved function in large joint OA. However, fewer studies yielding mixed results on the duration of symptomatic relief exist for arthropathy and tendinopathy of these joints. The goal of this study is to evaluate the efficacy of ketorolac and triamcinolone injections for common shoulder, elbow, wrist, and hand tendinopathy or arthropathy. Participants will be blinded to the treatment received. The duration of an individual participant's participation in this study is 24 weeks. During this time period, patients will be asked to return to the clinic for an in-person follow-up 6 weeks after the injection with either ketorolac or triamcinolone) in order to assess participants' outcomes. All work related to this project will take place at the Emory Sports Medicine Complex, Emory Executive Park, Emory Musculoskeletal Institute, the Emory University Orthopaedic and Spine Hospital, and the Emory Saint Joseph's Hospital. This study will add to existing knowledge by providing further insight into how wrist arthropathy should be most optimally and conservatively managed.

Detailed description

Osteoarthritis (OA) and inflammatory conditions of the tendons and joints of the upper extremity are common yet disabling diseases. These pathologic processes are progressive and painful leading to significant impairments in quality of life. Diagnosed patients experience a profound reduction of strength and dexterity hindering all activities of daily living. For a majority of the aforementioned shoulder, elbow, and hand/wrist arthropathies and tendinopathies, no curative treatments exist. Standard management utilizes conservative measures to minimize pain and improve function. These non-surgical treatments include physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs), orthosis, occupational protective equipment, and intra-articular injections.

Corticosteroid injections have been well investigated as a modality of pain control and improved function in large joint OA, however, fewer studies with mixed results on the duration of symptomatic relief exist for OA or tendinopathy of the smaller structures of the upper extremities. Furthermore, intra-articular corticosteroid injections are not without side effects. Adverse effects such as intra-articular infection, intra-articular calcification, skin atrophy, hypopigmentation, and tendinopathy have been reported.

NSAIDs, such as ketorolac, are widely used in OA to provide analgesia and reduce the underlying inflammatory process. The literature demonstrates that intra-articular NSAID injections are effective in reducing pain and functional disability in patients with knee and hip OA, however, randomized controlled trials involving the upper extremity are lacking. The goal of this study is to evaluate the efficacy of ketorolac and triamcinolone injections for common shoulder, elbow, hand, and wrist tendinopathy or arthropathy.

Interventions

• Drug Triamcinolone injection to the shoulder, elbow, wrist, or hand
  Triamcinolone is a corticosteroid that decreases the inflammatory process by inhibiting the release of arachidonic acid from phospholipids.
• Drug Ketorolac injection to the shoulder, elbow, wrist, or hand
  Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that reduces inflammation by inhibiting Cyclo-oxygenase (COX)-2 dependent prostaglandin release via the cyclooxygenase pathway.

Primary outcome measures

• Changes in Visual Analog Scale (VAS) pain score [Time frame: Baseline, 6 weeks, 24 weeks]

Secondary outcome measures (5)

• Changes in the patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: Baseline, 6 weeks, 24 weeks]
• Changes in Hand subjectivity value [Time frame: Baseline, 6 weeks, 24 weeks]
• Changes in the quick disabilities-arm-shoulder-hand (DASH) assessment [Time frame: Baseline, 6 weeks, 24 weeks]
• Changes in Grip Strength [Time frame: Baseline, 6 weeks, 24 weeks]
• Changes in Key Pinch [Time frame: Baseline, 6 weeks, 24 weeks]

Eligibility criteria

Inclusion criteria

• Age 18 or older,
• symptomatic tendinopathy or arthropathy of the shoulder, elbow, hand, or wrist who have not undergone prior surgical treatment for their condition.
• Diagnoses may include trigger finger, De Quervain's tenosynovitis, radiocarpal osteoarthritis, first carpometacarpal (CMC) joint osteoarthritis, metacarpophalangeal joint osteoarthritis, or proximal interphalangeal joint osteoarthritis.

Exclusion criteria

• Patients under the age of 18,
• Patients who have undergone prior triamcinolone or ketorolac injections within the past 6 months,
• Patients who have undergone prior surgical treatment for their hand condition,
• Patients with allergy or contraindication to triamcinolone or ketorolac injection,
• Patients with an active infection at the treatment site \[active infection defined as cellulitis, purulence, fever, chills, or presence of elevated inflammatory markers, ie. white blood cells (WBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)\].

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Emory Saint Joseph's Hospital — Atlanta
• Emory University Orthopaedic and Spine Center — Atlanta
• 12 Executive Park Drive — Atlanta
• Emory University Orthopaedic and Spine Hospital — Atlanta

Identifiers

NCT: NCT05292339 · STUDY00003892

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗