Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone

NCT03704584 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00104900
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

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.

Conditions

Tenosynovitis

Keywords

orthopedic disorders; corticosteroids(CS); Lidocaine; Injections

Outcome Measures

Primary Outcomes (7)

• 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

  Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants.

  Pre injection, Post injection day, 2 weeks and at 6 weeks

• Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7

  Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented.

  Post injection day (1-7), 2 weeks and at 6 weeks post intervention

• Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

  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.

  2 weeks and at 6 weeks post intervention

• Patient-Rated Wrist Evaluation (PRWE) Score at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

  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).

  2 weeks and at 6 weeks post intervention

• American Shoulder and Elbow Surgeons Shoulder Score (ASES) at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

  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)

  2 weeks and at 6 weeks post intervention

• Short Form Health Survey (SF-12) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

  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.

  2 weeks and at 6 weeks post intervention

• Number of Patients With Subsequent Reinjection and Surgical Operation

  The number of patients with subsequent reinjection and surgical operation was collected during follow up.

  End of follow up (6 weeks post intervention)

Study Arms (2)

Treatment Group (corticosteroid injection plus lidocaine)

ACTIVE COMPARATOR

Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition

Drug: Treatment Group: Corticosteroid injection; Drug: Treatment Group: Lidocaine

Control Group (corticosteroid alone)

OTHER

Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition

Drug: Control Group (corticosteroid alone)

Interventions

Treatment Group: Corticosteroid injection DRUG

Subjects will receive a corticosteroid injection that is 40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone.

Also known as: depo-medrol, kenalog

Treatment Group (corticosteroid injection plus lidocaine)

Control Group (corticosteroid alone) DRUG

Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .

Also known as: Methylprednisolone acetate injectable suspension

Control Group (corticosteroid alone)

Treatment Group: Lidocaine DRUG

Subjects will receive an injection of lidocaine (1% lidocaine HCl).

Also known as: Xylocaine

Treatment Group (corticosteroid injection plus lidocaine)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory Clinic A, Clifton Road Clinic

Atlanta, Georgia, 30322, United States

Location

12 Executive Park Drive

Atlanta, Georgia, 30329, United States

Location

Emory Healthcare Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Tenosynovitis; Musculoskeletal Diseases

Interventions

Methylprednisolone Acetate; Triamcinolone Acetonide; Control Groups; Adrenal Cortex Hormones; Lidocaine

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triamcinolone; Steroids, Fluorinated; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Charles Daly
• Organization: Emory University

charles.a.daly@emory.edu

404-919-6168

Study Officials

• Charles Daly, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, unblinded controlled clinical trial

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: May 14, 2019
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: October 12, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)