Trial Outcomes & Findings for Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement (NCT NCT03913702)

Results Overview

The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-01-03

Participant Flow

Early termination due to inadequate patient enrollment.

Participant milestones

Participant milestones
Measure	Ketorolac Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%) Ketorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).	Methylprednisolone Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%) Methylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=1 Participants Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%) Ketorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).	Methylprednisolone Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%) Methylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: No data collected.

The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: No data collected.

The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: No data collected.

The ASES is a self-assessment score, ranging between 0 and 100, (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: No data collected.

The range of motion is a function-related measure, that reflects the extent of shoulder movement (measured in degrees, in forward flexion, and abduction with internal/external rotation of the shoulder)

Outcome measures

Outcome data not reported

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Methylprednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeremy Somerson

University of Texas Medical Branch Galveston

Phone: 409-747-5701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place