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Clinical Trials/NCT02867904
NCT02867904
Terminated
Phase 4

Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery

Peter Chang1 site in 1 country12 target enrollmentMarch 2016

Overview

Phase
Phase 4
Intervention
Marcaine (4ml 0.5%, injection)
Conditions
Arthroscopic Shoulder Surgery
Sponsor
Peter Chang
Enrollment
12
Locations
1
Primary Endpoint
Disabilities of the Arm, Shoulder, and Hand Survey (DASH)
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
April 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peter Chang
Responsible Party
Sponsor Investigator
Principal Investigator

Peter Chang

Medical Student Researcher

University of South Dakota

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.

Arms & Interventions

Group A

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

Intervention: Marcaine (4ml 0.5%, injection)

Group B

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

Intervention: Methylprednisolone (40 mg depomedrol, 1ml, injection)

Group B

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

Intervention: Marcaine (4ml 0.5%, injection)

Outcomes

Primary Outcomes

Disabilities of the Arm, Shoulder, and Hand Survey (DASH)

Time Frame: 1 year

Secondary Outcomes

  • Active Range of Motion of Shoulder(Pre-operatively and Post-operatively at 2 weeks, 6 weeks, and 3 months)
  • Simple Assessment Numeric Evaluation (SANE)(1 year)
  • Western Ontario Rotator Cuff Survey (WORC)(1 year)
  • Marx Shoulder Activity Level Survey (MARX)(1 year)

Study Sites (1)

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