Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint

• Sponsor: University of Florida (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03232749
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Arm: 1
• Actual Duration (Months): 13.6
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Glenohumeral Joint	Procedure: intraarticular corticosteroid injections (IACSI); Drug: corticosteroid injections; Device: Ultrasound	Phase 4

Detailed Description

The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
• Actual Study Start Date: Apr 18, 2018
• Actual Primary Completion Date: Jun 6, 2019
• Actual Study Completion Date: Jun 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: symptomatic primary osteoarthritis of the shoulder Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder	Procedure: intraarticular corticosteroid injections (IACSI); ultrasound-guided IACSI will be administered; Drug: corticosteroid injections; Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder; Other Names: Methylprednisolone, Depo-medrol ; Device: Ultrasound; ultrasound-guided IACSI

Outcome Measures

Primary Outcome Measures

1. ASES Scores at Each Time Point [Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months]

   ASES (American Shoulder & Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).

2. Visual Analog Scale Scores at Each Time Point. [Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months]

   VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.

3. SST (Simple Shoulder Test) Scores at Each Time Point [Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months]

   SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute.

• those who have failed previous treatment including over-the-counter analgesics and activity modification

• have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder.

Exclusion Criteria:

• Patients will be excluded from the study for any of the following reasons:

• Post traumatic osteoarthritis

• Inflammatory osteoarthritis

• Imaging confirmed rotator cuff tear

• Prior ipsilateral shoulder surgery

• Memory loss or inability to complete study measures

• History of allergy to injection medications

• Diabetic patients with patient-reported fasting blood glucose >200

• Prior injection in the ipsilateral shoulder within three months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF and Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida	United States	32611
2	UF Health Orthopaedics and Sports Medicine Institute	Gainesville	Florida	United States	32611

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Bradley Schoch, M.D., Faculty

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 26, 2018
• Informed Consent Form - Aug 2, 2017

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03232749
• Other Study ID Numbers: IRB201700603-A; OCR18320
• First Posted: Jul 28, 2017
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Osteoarthritis; Methylprednisolone; Methylprednisolone Acetate

Study Results

Participant Flow

Arm/Group Title	Symptomatic Primary Osteoarthritis of the Shoulder
Arm/Group Description	Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
Period Title: Overall Study
STARTED	25
COMPLETED	21
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Symptomatic Primary Osteoarthritis of the Shoulder
Arm/Group Description	Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
Overall Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 32%
>=65 years	17 68%
Sex: Female, Male (Count of Participants)
Female	11 44%
Male	14 56%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	ASES Scores at Each Time Point
Description	ASES (American Shoulder & Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).
Time Frame	Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Outcome Measure Data

Analysis Population Description

All participants did not return for all outcome measure time points

Arm/Group Title	Symptomatic Primary Osteoarthritis of the Shoulder
Arm/Group Description	Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
Measure Participants	25
Baseline ASES score	48.52 (13.18)
2 Week ASES score	79.72 (23.32)
1 Month ASES scrore	73.86 (28.24)
2 Month ASES score	28.60 (28.57)
3 Month ASES score	71.78 (22.34)
6 Month ASES score	61.48 (25.78)

2. Primary Outcome

Title	Visual Analog Scale Scores at Each Time Point.
Description	VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.
Time Frame	Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months

Outcome Measure Data

Analysis Population Description

All participants did not return for all outcome measure time points

Arm/Group Title	Symptomatic Primary Osteoarthritis of the Shoulder
Arm/Group Description	Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
Measure Participants	25
Baseline VAS score	4.54 (2.62)
Post-injection VAS score	1.86 (1.80)
2 Weeks VAS score	1.18 (1.59)
1 Month VAS score	2.05 (2.06)
2 Month VAS score	2.56 (2.97)
3 Month VAS score	2.50 (2.38)
6 Month VAS score	2.44 (3.05)

3. Primary Outcome

Title	SST (Simple Shoulder Test) Scores at Each Time Point
Description	SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)
Time Frame	Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Outcome Measure Data

Analysis Population Description

All participants did not return for all outcome measure time points

Arm/Group Title	Symptomatic Primary Osteoarthritis of the Shoulder
Arm/Group Description	Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
Measure Participants	25
Baseline SST Score	5.29 (2.46)
2 Week SST Score	8.40 (2.36)
1 Month SST Score	7.32 (3.82)
2 Month SST Score	5.92 (3.43)
3 Month SST Score	6.73 (3.32)
6 Month SST Score	7.00 (2.73)

Adverse Events

Time Frame	6 months
Arm/Group Title	Symptomatic Primary Osteoarthritis of the Shoulder
Arm/Group Description	Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI
All Cause Mortality
	Symptomatic Primary Osteoarthritis of the Shoulder
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	Symptomatic Primary Osteoarthritis of the Shoulder
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Symptomatic Primary Osteoarthritis of the Shoulder
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.