Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05438277
Other study ID # IRB 7001-XP
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2020
Est. completion date September 30, 2022

Study information

Verified date February 2023
Source Campbell Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.


Description:

Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space. Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.


Recruitment information / eligibility

Status Completed
Enrollment 421
Est. completion date September 30, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Subacromial or glenohumeral shoulder pain to be treated with steroid injection - Fluent in written and oral English - Willing and able to provide written consent - Willing to complete follow up pain scores (visual analog score) Exclusion Criteria: - Unable to provide written consent - Chronic pain syndrome - Unwilling to complete follow up pain scores (visual analog score)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methylprednisolone (MPA)
injection into subacromial or glenohumeral space with MPA
Triamcinolone Acetonide (TA)
injection into subacromial or glenohumeral space with TA

Locations

Country Name City State
United States Campbell Clinic Germantown Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Campbell Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of a Flare Reaction A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain. Post-injection day 1 through 7
See also
  Status Clinical Trial Phase
Recruiting NCT04930393 - Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients N/A
Completed NCT03717753 - Rotator Cuff Pathway N/A
Completed NCT04454671 - Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment N/A
Completed NCT06274827 - Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises N/A
Not yet recruiting NCT05413213 - Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder N/A
Not yet recruiting NCT05043844 - Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder N/A
Recruiting NCT02903719 - The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection. Phase 4
Completed NCT02554968 - Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Recruiting NCT02242630 - Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis N/A
Active, not recruiting NCT02843269 - Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM N/A
Completed NCT02631395 - The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball N/A
Completed NCT01733914 - Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain Phase 2
Completed NCT01885377 - SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain N/A
Completed NCT01205542 - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function N/A
Completed NCT01843660 - An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain Phase 4
Completed NCT00743600 - Ultrasound Evaluation of the Rotator Cable and Associated Structures. N/A
Completed NCT00679887 - Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points Phase 1/Phase 2
Completed NCT04058522 - Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection N/A
Completed NCT03353272 - The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain N/A