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Ketorolac in Upper Extremity Tendinopathy and Arthropathy

Primary Purpose

Osteoarthritis, Tendinopathy, Arthropathy

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone injection to the shoulder, elbow, wrist, or hand
Ketorolac injection to the shoulder, elbow, wrist, or hand
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring First Carpometacarpal Joint, Ketoralac, metacarpophalangeal joint osteoarthritis, trigger finger, De Quervain's tenosynovitis, radiocarpal osteoarthritis, Triamcinolone, Upper extremity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 or older,
  • symptomatic tendinopathy or arthropathy of the 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)].

Sites / Locations

  • Emory Saint Joseph's HospitalRecruiting
  • Emory University Orthopaedic and Spine CenterRecruiting
  • 12 Executive Park DriveRecruiting
  • Emory University Orthopaedic and Spine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Triamcinolone injection to the shoulder, elbow, wrist, or hand

Ketorolac injection to the shoulder, elbow, wrist, or hand

Arm Description

Participants will receive the triamcinolone injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.

Participants will receive the Ketoralac injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.

Outcomes

Primary Outcome Measures

Changes in Visual Analog Scale (VAS) pain score
Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The visual analog scale or visual analog scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain).

Secondary Outcome Measures

Changes in the patient-Reported Outcomes Measurement Information System (PROMIS)
The Upper Extremity Patient-Reported Outcomes Measurement Information System (PROMIS) is a patient outcomes questionnaire that will be completed by the study participant at every visit. Questions pertaining to pain interference subjective score (series of questions pertaining to different aspects of daily living: e.g. How much did the pain interfere with your day-to-day activities? Rated from "Not at all" to "Very much".
Changes in Hand subjectivity value
Participants will provide ratings of their subjective hand function from 0 to 100
Changes in the quick disabilities-arm-shoulder-hand (DASH) assessment
The Quick DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. It is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high-performance sport/music or work modules (four items, scored 1-5).
Changes in Grip Strength
All strength measures will be evaluated using a handgrip and key pinch dynamometer. Patients will be instructed to position the upper arm vertically with the elbow flexed at 90 degrees and the forearm and wrist in a neutral position. For grip strength, the patient will be instructed to squeeze the handle of the dynamometer as hard as possible and the force will be measured and recorded.
Changes in Key Pinch
All strength measures will be evaluated using a handgrip and key pinch dynamometer. Patients will be instructed to position the upper arm vertically with the elbow flexed at 90 degrees and the forearm and wrist in a neutral position. For assessment of key pinch strength, the patient will be instructed to squeeze the thumb digit pad against the lateral aspect of the proximal interphalangeal joint of the index finger.

Full Information

First Posted
March 15, 2022
Last Updated
March 23, 2023
Sponsor
Emory University
Collaborators
American Association for Hand Surgery: AAHS
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1. Study Identification

Unique Protocol Identification Number
NCT05292339
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
American Association for Hand Surgery: AAHS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Tendinopathy, Arthropathy
Keywords
First Carpometacarpal Joint, Ketoralac, metacarpophalangeal joint osteoarthritis, trigger finger, De Quervain's tenosynovitis, radiocarpal osteoarthritis, Triamcinolone, Upper extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triamcinolone injection to the shoulder, elbow, wrist, or hand
Arm Type
Active Comparator
Arm Description
Participants will receive the triamcinolone injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.
Arm Title
Ketorolac injection to the shoulder, elbow, wrist, or hand
Arm Type
Active Comparator
Arm Description
Participants will receive the Ketoralac injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone injection to the shoulder, elbow, wrist, or hand
Other Intervention Name(s)
Triamcinolone
Intervention Description
Triamcinolone is a corticosteroid that decreases the inflammatory process by inhibiting the release of arachidonic acid from phospholipids.
Intervention Type
Drug
Intervention Name(s)
Ketorolac injection to the shoulder, elbow, wrist, or hand
Other Intervention Name(s)
Ketoralac
Intervention Description
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 Measure Information:
Title
Changes in Visual Analog Scale (VAS) pain score
Description
Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The visual analog scale or visual analog scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain).
Time Frame
Baseline, 6 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Changes in the patient-Reported Outcomes Measurement Information System (PROMIS)
Description
The Upper Extremity Patient-Reported Outcomes Measurement Information System (PROMIS) is a patient outcomes questionnaire that will be completed by the study participant at every visit. Questions pertaining to pain interference subjective score (series of questions pertaining to different aspects of daily living: e.g. How much did the pain interfere with your day-to-day activities? Rated from "Not at all" to "Very much".
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Changes in Hand subjectivity value
Description
Participants will provide ratings of their subjective hand function from 0 to 100
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Changes in the quick disabilities-arm-shoulder-hand (DASH) assessment
Description
The Quick DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. It is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high-performance sport/music or work modules (four items, scored 1-5).
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Changes in Grip Strength
Description
All strength measures will be evaluated using a handgrip and key pinch dynamometer. Patients will be instructed to position the upper arm vertically with the elbow flexed at 90 degrees and the forearm and wrist in a neutral position. For grip strength, the patient will be instructed to squeeze the handle of the dynamometer as hard as possible and the force will be measured and recorded.
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Changes in Key Pinch
Description
All strength measures will be evaluated using a handgrip and key pinch dynamometer. Patients will be instructed to position the upper arm vertically with the elbow flexed at 90 degrees and the forearm and wrist in a neutral position. For assessment of key pinch strength, the patient will be instructed to squeeze the thumb digit pad against the lateral aspect of the proximal interphalangeal joint of the index finger.
Time Frame
Baseline, 6 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)].
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul A. Ghareeb, MD
Phone
404-778-3350
Email
paul.ghareeb@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A. Ghareeb, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda L Dempsey
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul A. Ghareeb, MD
Phone
404-778-3350
Email
paul.ghareeb@emory.edu
Facility Name
Emory University Orthopaedic and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda L Demsey, MD
Phone
404-778-6381
Email
amanda.l.dempsey@emory.edu
Facility Name
12 Executive Park Drive
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul A. Ghareeb, MD
Phone
404-778-3350
Email
paul.ghareeb@emory.edu
Facility Name
Emory University Orthopaedic and Spine Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul A. Ghareeb, MD
Phone
404-778-3350
Email
paul.ghareeb@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Ketorolac in Upper Extremity Tendinopathy and Arthropathy

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