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Trial record 1 of 3 for:    "Tenosynovitis" | "Antiemetics"
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Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone

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ClinicalTrials.gov Identifier: NCT03704584
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Charles A Daly, MD, Emory University

Brief Summary:
The clinical trial is a randomized control trial to compare the efficacy of a combined lidocaine and corticosteroid (CS) injection versus a corticosteroid injection (CS) alone on pain, range of motion, and patient reported outcomes for the treatment of common upper extremity tendinopathies and nerve entrapments that are often treated with a combination of these injectates.

Condition or disease Intervention/treatment Phase
Tenosynovitis Drug: Treatment Group (corticosteroid injection plus lidocaine) Drug: Control Group (corticosteroid alone) Phase 4

Detailed Description:

A tendon is a type of tissue that connects your muscles to your bones. These tissues help control actions such as running, jumping, grasping, and lifting. Without tendons it would be difficult to control the movement of your body. A protective layer known as synovium covers tendons. This sheath produces fluid, which keeps the tendon lubricated and moving properly. Inflammation or swelling of the sheath is known as tendon sheath inflammation or tenosynovitis. This condition is often treated with an injection into or around the sheath. This injection often consists of a corticosteroid with or without lidocaine. Corticosteroid(CS) are drugs that decrease inflammation and are given for a number of orthopaedic conditions to decrease symptoms of the underlying disease. Lidocaine is also a drug that blocks the pain response, although it only blocks it momentarily. The study aims to determine if corticosteroid injection alone is as effective as corticosteroid combined with lidocaine for the relief of tenosynovitis of the upper extremity.

The study plans to enroll 1000 pts with tendinopathies of upper extremities and nerve entrapments and will be followed up in clinic 2 weeks and 6 weeks after the injection. During the clinic visits the Visual Analog Scale for pain (VAS-pain), range of motion (ROM), strength, and patient reported outcome data will be collected and any complications will be noted. Patients will also utilize a pain journal to track VAS-pain over the first 7 post-injection days.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, unblinded controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: Treatment Group (corticosteroid injection plus lidocaine)
Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition
Drug: Treatment Group (corticosteroid injection plus lidocaine)
Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl).
Other Names:
  • depo-medrol
  • kenolog

Control Group (corticosteroid alone)
Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Drug: Control Group (corticosteroid alone)
Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
Other Name: Methylprednisolone acetate injectable suspension




Primary Outcome Measures :
  1. Change in pain scores from the Visual Analog Pain Scale (VAS-pain) at the time of injection and during follow up in the corticosteroid plus lidocaine group as compared to the corticosteroid alone group [ Time Frame: Post injection day (1-7), 2 weeks and at 6 weeks ]
    Pain assessment will be assessed before performing the injection, at the time of injection, and at each subsequent follow up visit using the Visual Analog Pain Scale (VAS-pain). The pain VAS is self‐completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10‐cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Pain will be assessed at rest and active movement of the affected joint. Cut points for VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available.

  2. Change in the Range of Motion (ROM) at the time of injection and during follow up in the corticosteroid plus lidocaine group as compared to the corticosteroid alone group [ Time Frame: Post injection day (1-7), 2 weeks and at 6 weeks ]
    ROM assessment will take place at each clinic follow up with a hand-held goniometer. This will be done by assessing the total flexion-extension arc of the wrist, elbow, and shoulder, the total pronation-supination arc at the wrist, and the adduction-abduction arc of the wrist and shoulder. ROM will be assessed on the contralateral side prior to injection

  3. Change in the Patient-Rated Wrist Evaluation (PRWE) at the time of injection and during follow up in the corticosteroid plus lidocaine group as compared to the corticosteroid alone group [ Time Frame: Post injection day (1-7), 2 weeks and at 6 weeks ]
    The Patient-Related Wrist Evaluation is a score for the measurement of pain and function after injury to the wrist. The PRWE is a 15-item questionnaire that allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Total Score = Sum of pain+ function scores (Best Score = 0, Worst Score = 100).

  4. Change in the American Shoulder and Elbow Surgeons Shoulder Score (ASES) at the time of injection and during follow up in the corticosteroid plus lidocaine group as compared to the corticosteroid alone group [ Time Frame: Post injection day (1-7), 2 weeks and at 6 weeks ]
    The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)

  5. Change in the Short Form Health Survey (SF-12) scores at the time of injection and during follow up in the corticosteroid plus lidocaine group as compared to the corticosteroid alone group [ Time Frame: Post injection day (1-7), 2 weeks and at 6 weeks ]
    The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.

  6. Change in the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores at the time of injection and during follow up in the corticosteroid plus lidocaine group as compared to the corticosteroid alone group [ Time Frame: Post injection day (1-7), 2 weeks and at 6 weeks ]
    The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined.

  7. Change in 10 point likert scale of pain scores before the injection and after the injection and during follow up in the corticosteroid plus lidocaine group as compared to the corticosteroid alone group [ Time Frame: Pre Injection; 1 minute after the injection, Post injection day (1-7), 2 weeks and at 6 weeks ]
    A 10 point likert scale is administered to assess the pain before and after the injection and to assess the complications at the follow up visits. The 10 point likert scale asks the participants to rate the pain from 0 (no pain) 5 (moderate pain) to 10 worst possible pain. Higher scores indicates more pain.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult clinical patients of Emory upper extremity surgeons undergoing injection for treatment of the following who are willing to participate in the study will be included in the study: Tenosynovitis of the upper extremity, including but not limited to, the shoulder, biceps, elbow, wrist, thumb, carpometacarpal, midcarpal, elbow, and small joints of the hand.
  • Between the ages of 18 years and 95 years.
  • For trigger finger: patients with a diagnosis of stenosing tenosynovitis based on a history of triggering and the presence of tenderness over the A1 pulley upon clinical examination. All patients, based on the Quinnell grading of trigger finger will be included.

Exclusion Criteria:

  • Patients who are minors, vulnerable subjects, or who are not willing to consent to participate in the study.
  • Allergies to glucocorticoids, current daily use of glucocorticoids or strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, and meperidine), severe diabetic neuropathy of the hand influencing pain perception, rheumatoid arthritis, and neurological or psychiatric diseases, potentially influencing pain perception.
  • Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704584


Contacts
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Contact: Charles Daly, MD 404-919-6168 charles.a.daly@emory.edu

Locations
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United States, Georgia
Emory Clinic A, Clifton Road Clinic Recruiting
Atlanta, Georgia, United States, 30322
Contact: Charles Daly, MD    404-919-6168    charles.a.daly@emory.edu   
Principal Investigator: Charles Daly, MD         
12 Executive Park Drive Recruiting
Atlanta, Georgia, United States, 30329
Contact: Charles Daly, MD    404-919-6168    charles.a.daly@emory.edu   
Principal Investigator: Charles Daly, MD         
Emory Healthcare Orthopaedics and Spine Center Recruiting
Atlanta, Georgia, United States, 30329
Contact: Chalrles Daly, MD    404-919-6168    charles.a.daly@emory.edu   
Principal Investigator: Charles Daly, MD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Charles Daly, MD Emory University

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Responsible Party: Charles A Daly, MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03704584     History of Changes
Other Study ID Numbers: IRB00104900
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Charles A Daly, MD, Emory University:
orthopedic disorders
corticosteroids(CS)
Lidocaine
Injections
Additional relevant MeSH terms:
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Tenosynovitis
Antiemetics
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Lidocaine
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists