Trial Outcomes & Findings for Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone (NCT NCT03704584)
NCT ID: NCT03704584
Last Updated: 2022-10-12
Results Overview
Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants.
TERMINATED
PHASE4
62 participants
Pre injection, Post injection day, 2 weeks and at 6 weeks
2022-10-12
Participant Flow
Participants were enrolled between May 2019 and January 2020.
62 individuals were consented to participate in the study and 61 individuals of these took part in the study with a total of 74 digits randomized and injected in this study. Patients were assigned to treatment groups by means of randomizing the affected unit(s) they contributed to the study.
Unit of analysis: digits
Participant milestones
| Measure |
Treatment Group (Corticosteroid Injection Plus Lidocaine)
Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition
Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl).
|
Control Group (Corticosteroid Alone)
Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
|
|---|---|---|
|
Overall Study
STARTED
|
36 43
|
26 31
|
|
Overall Study
COMPLETED
|
35 42
|
26 31
|
|
Overall Study
NOT COMPLETED
|
1 1
|
0 0
|
Reasons for withdrawal
| Measure |
Treatment Group (Corticosteroid Injection Plus Lidocaine)
Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition
Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl).
|
Control Group (Corticosteroid Alone)
Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone
Baseline characteristics by cohort
| Measure |
Treatment Group (Corticosteroid Injection Plus Lidocaine)
n=42 Digits
Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition
Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl).
|
Control Group (Corticosteroid Alone)
n=31 Digits
Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
|
Total
n=73 Digits
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.00 years
STANDARD_DEVIATION 13 • n=5 Participants
|
68 years
STANDARD_DEVIATION 11 • n=7 Participants
|
65 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
26 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29 kg/m^2
STANDARD_DEVIATION 5 • n=5 Participants
|
32 kg/m^2
STANDARD_DEVIATION 9 • n=7 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Smoking Status
Current smoker
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Smoking Status
Quit > 3 months prior
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Smoking Status
Never a smoker
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Comorbidities
Psychological Diagnoses (Anxiety, Depression, PTSD, Bipolar Disorder)
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Comorbidities
Diabetes
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Comorbidities
Osteoarthritis
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Comorbidities
Inflammatory Arthritis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Quinnell grading system
0
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Quinnell grading system
1
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Quinnell grading system
2
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Quinnell grading system
3
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Quinnell grading system
4
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Quinnell grading system
Not recorded
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
History of Prior Finger Injections
Right
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
History of Prior Finger Injections
Left
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Finger Injected
Thumb
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Finger Injected
Index
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Finger Injected
Middle
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Finger Injected
Ring
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Finger Injected
Little
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Dominant Hand Injected
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre injection, Post injection day, 2 weeks and at 6 weeksPopulation: There was a total of 62 participants enrolled in the study. One patient withdrew after injection and has been excluded from analysis. Only 61 participants contributed data to the summary assessment. 35 in the treatment group and 26 in the control group. The total number of units (digits) analyzed was 73 (digits). 42 digits were analyzed in the treatment group and 31 digits in the control group. Due to time constraints at follow up study visits, data was not collected for 2 and 6 weeks.
Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants.
Outcome measures
| Measure |
Treatment Group (Corticosteroid Injection Plus Lidocaine)
n=42 Digits
Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition
Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl).
|
Control Group (Corticosteroid Alone)
n=31 Digits
Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
|
|---|---|---|
|
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Pre-Injection: How painful do you think the injection will be?
|
5.9 score on a scale
Standard Deviation 2.3
|
5.4 score on a scale
Standard Deviation 2.6
|
|
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Pre-Injection: How painful do you think it will be 1-minute after the injection?
|
4.4 score on a scale
Standard Deviation 2.6
|
3.2 score on a scale
Standard Deviation 2.7
|
|
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Pre-Injection: How nervous are you about the injection?
|
4.0 score on a scale
Standard Deviation 3.5
|
3.5 score on a scale
Standard Deviation 3.3
|
|
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Post-Injection: Actual pain of the needle
|
4.3 score on a scale
Standard Deviation 3.1
|
4.2 score on a scale
Standard Deviation 2.9
|
|
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Post-Injection: Actual pain of the medication
|
4.7 score on a scale
Standard Deviation 3.2
|
4.3 score on a scale
Standard Deviation 2.8
|
|
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Post-Injection: Actual pain 1-minute after the injection
|
1.7 score on a scale
Standard Deviation 2.2
|
1.7 score on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Post injection day (1-7), 2 weeks and at 6 weeks post interventionPopulation: 32 participants were seen for a 2-week follow-up and pain journal were collected. Other patients were non compliant with completion of their pain journal or were not seen at 2-weeks. Due to time constraints at follow up study visits, no other data was collected at 2 and 6 weeks post intervention.
Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented.
Outcome measures
| Measure |
Treatment Group (Corticosteroid Injection Plus Lidocaine)
n=20 Participants
Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition
Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl).
|
Control Group (Corticosteroid Alone)
n=12 Participants
Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
|
|---|---|---|
|
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Post injection day 1
|
3.7 score on a scale
Standard Deviation 2.2
|
3.7 score on a scale
Standard Deviation 3.0
|
|
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Post injection day 2
|
2.2 score on a scale
Standard Deviation 2.0
|
3.0 score on a scale
Standard Deviation 2.9
|
|
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Post injection day 3
|
1.7 score on a scale
Standard Deviation 1.9
|
2.6 score on a scale
Standard Deviation 2.6
|
|
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Post injection day 4
|
1.1 score on a scale
Standard Deviation 1.5
|
2.2 score on a scale
Standard Deviation 2.0
|
|
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Post injection day 5
|
1.0 score on a scale
Standard Deviation 1.4
|
2.0 score on a scale
Standard Deviation 2.2
|
|
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Post injection day 6
|
0.69 score on a scale
Standard Deviation 1.1
|
1.5 score on a scale
Standard Deviation 1.8
|
|
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Post injection day 7
|
0.58 score on a scale
Standard Deviation 0.95
|
1.6 score on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 2 weeks and at 6 weeks post interventionPopulation: Due to time constraints at study visits, the decision was made to not administer the QuickDASH surveys
The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated \[(sum of n responses/n) - 1\] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeks and at 6 weeks post interventionPopulation: Due to time constraints at study visits, the decision was made to not administer the PRWE questionnaire.
The Patient-Related Wrist Evaluation is a score for the measurement of pain and function after injury to the wrist. The PRWE is a 15-item questionnaire that allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Total Score = Sum of pain+ function scores (Best Score = 0, Worst Score = 100).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeks and at 6 weeks post interventionPopulation: Due to time constraints at study visits, the decision was made to not administer the ASES questionnaire.
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeks and at 6 weeks post interventionPopulation: Due to time constraints at study visits, the decision was made to not administer the SF-12 survey.
The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: End of follow up (6 weeks post intervention)The number of patients with subsequent reinjection and surgical operation was collected during follow up.
Outcome measures
| Measure |
Treatment Group (Corticosteroid Injection Plus Lidocaine)
n=35 Participants
Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition
Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl).
|
Control Group (Corticosteroid Alone)
n=26 Participants
Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
|
|---|---|---|
|
Number of Patients With Subsequent Reinjection and Surgical Operation
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment Group (Corticosteroid Injection Plus Lidocaine)
Control Group (Corticosteroid Alone)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place