Intra-Operative Corticosteroid Injection During Arthroscopic Shoulder Surgery

NCT ID: NCT02867904

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-04-30

Brief Summary

The purpose of this study is to assess the efficacy of intra-operative subacromial corticosteroid injections in patients undergoing arthroscopic shoulder surgery on quality of life scores and activity level when compared to a control group.

Detailed Description

This study is designed to assess whether a subacromial injection of corticosteroids at the time of arthroscopic shoulder surgery influences quality of life scores and activity level when compared to a control group. The hypothesis is that intra-operative subacromial corticosteroid injection after arthroscopic subacromial decompression surgery will provide a more rapid improvement in quality of life scores and activity levels in the post-operative period compared with controls. The study will be a placebo-controlled, double-blind prospective study. All patients necessitating arthroscopic shoulder surgery presenting to Dr. Keith Baumgarten's clinics are eligible for participation. If the patient meets the inclusion criteria, then informed consent will be obtained for participation in this study. Each patient will undergo a standard shoulder exam to assess active range of motion and complete demographics and pre-operative patient determined outcomes surveys (1. Disabilities of the Arm, Shoulder, and Hand (DASH) 2. Simple Assessment Numeric Evaluation (SANE) 3. Western Ontario Rotator Cuff (WORC)) and the Marx shoulder activity level survey (MARX). Patients will then undergo arthroscopic shoulder surgery. After arthroscopic surgery the experimental group will undergo a subacromial corticosteroid injection + marcaine while the control group will undergo a subacromial marcaine injection. Outcomes will be assessed using the same quality of life surveys and an activity level survey at post-operative visits at the time intervals: 2 weeks and 3 months and by U.S. mail at 5 months and 1 year. Active range of motion will be assessed at post-operative visits: 2 weeks, 6 weeks, and 3 months. Subjects that meet criteria to undergo arthroscopic shoulder surgery will be provided informed consent to receiving either a subacromial corticosteroid injection or placebo injection at the end of surgery. Patients will be expected to complete all pre- and post-operative quality of life surveys and activity level surveys. It will take less than 20 minutes to complete all listed surveys at each pre- and post-operative visit. Active range of motion will be assessed at each post-operative visit and subjects will be expected to take part in this physical examination as well. The duration of subject participation is 1 year from the date of initial surgery.

Conditions

Arthroscopic Shoulder Surgery; Intra-articular Debridement; Subacromial Decompression; Acromioplasty; Acromioclavicular Joint Resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

After arthroscopic surgery the control group (Group A) will undergo a subacromial marcaine injection (standard of care).

Group Type: PLACEBO_COMPARATOR

Marcaine (4ml 0.5%, injection)

Intervention Type: DRUG

Control

Group B

After arthroscopic surgery the experimental group (Group B) will undergo a subacromial corticosteroid injection+marcaine.

Group Type: EXPERIMENTAL

Methylprednisolone (40 mg depomedrol, 1ml, injection)

Intervention Type: DRUG

Experimental Drug

Marcaine (4ml 0.5%, injection)

Intervention Type: DRUG

Control

Interventions

Methylprednisolone (40 mg depomedrol, 1ml, injection)

Experimental Drug

Intervention Type: DRUG

Marcaine (4ml 0.5%, injection)

Control

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years-old or older
• Male patients
• Female patients
• Patients able to speak and understand written English
• Patients presenting to the orthopedic institute clinic with shoulder pain and necessitating the procedure of arthroscopic shoulder surgery
• Specific arthroscopic procedures include: intra-articular debridement, decompression, acromioplasty, and acromioclavicular joint resection

Exclusion Criteria

• Patients undergoing arthroscopic shoulder surgery that includes other interventions (i.e. rotator cuff repair; labral repair, etc)
• Patients with adhesive capsulitis
• Patients with significant cervical spine symptoms and/or pathology
• Patients having a history of receiving chronic pain treatment
• Patients who are currently pregnant or who become pregnant before surgery
• Patients who cannot speak or understand written english
• Patients who are under the age of 18 years of age
• As per exclusionary criteria if a subject is pregnant they will not be eligible for participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peter Chang

OTHER

Sponsor Role: lead

Responsible Party

Peter Chang

Medical Student Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Orthopedic Institute

Sioux Falls, South Dakota, United States

Countries

United States

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Other Identifiers

2016.128

Identifier Type: -

Identifier Source: org_study_id