Clinical trial NCT05292339: Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Official title: Single Blind RCT to Evaluate the Effect of Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis
Tendinopathy
Arthropathy
Keywords: First Carpometacarpal Joint
Ketoralac
metacarpophalangeal joint osteoarthritis
trigger finger
De Quervain's tenosynovitis
radiocarpal osteoarthritis
Triamcinolone
Upper extremity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Association for Hand Surgery: AAHS
First posted: 2022-03-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 \[active infection defined as cellulitis, purulence, fever, chills, or presence of elevated inflammatory markers, ie. white blood cells (WBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)\].

Primary outcomes:
measure: Changes in Visual Analog Scale (VAS) pain score
timeFrame: Baseline, 6 weeks, 24 weeks
Secondary outcomes:
measure: Changes in the patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Changes in Hand subjectivity value
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Changes in the quick disabilities-arm-shoulder-hand (DASH) assessment
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Changes in Grip Strength
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Changes in Key Pinch
timeFrame: Baseline, 6 weeks, 24 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Orthopaedic and Spine Center
state: Georgia
city: Atlanta
country: United States
facility: 12 Executive Park Drive
state: Georgia
city: Atlanta
country: United States
facility: Emory University Orthopaedic and Spine Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Paul A. Ghareeb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Amanda L Dempsey
role: PRINCIPAL_INVESTIGATOR
References: