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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

Pre injection, Post injection day, 2 weeks and at 6 weeks

Results posted on

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

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

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

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=99 Participants
68 years
STANDARD_DEVIATION 11 • n=107 Participants
65 years
STANDARD_DEVIATION 12 • n=206 Participants
Sex: Female, Male
Female
16 Participants
n=99 Participants
14 Participants
n=107 Participants
30 Participants
n=206 Participants
Sex: Female, Male
Male
19 Participants
n=99 Participants
12 Participants
n=107 Participants
31 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=99 Participants
6 Participants
n=107 Participants
16 Participants
n=206 Participants
Race (NIH/OMB)
White
24 Participants
n=99 Participants
20 Participants
n=107 Participants
44 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Region of Enrollment
United States
35 participants
n=99 Participants
26 participants
n=107 Participants
61 participants
n=206 Participants
Body Mass Index (BMI)
29 kg/m^2
STANDARD_DEVIATION 5 • n=99 Participants
32 kg/m^2
STANDARD_DEVIATION 9 • n=107 Participants
30.6 kg/m^2
STANDARD_DEVIATION 7.1 • n=206 Participants
Smoking Status
Current smoker
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Smoking Status
Quit > 3 months prior
8 Participants
n=99 Participants
5 Participants
n=107 Participants
13 Participants
n=206 Participants
Smoking Status
Never a smoker
27 Participants
n=99 Participants
20 Participants
n=107 Participants
47 Participants
n=206 Participants
Comorbidities
Psychological Diagnoses (Anxiety, Depression, PTSD, Bipolar Disorder)
5 Participants
n=99 Participants
5 Participants
n=107 Participants
10 Participants
n=206 Participants
Comorbidities
Diabetes
6 Participants
n=99 Participants
5 Participants
n=107 Participants
11 Participants
n=206 Participants
Comorbidities
Osteoarthritis
7 Participants
n=99 Participants
5 Participants
n=107 Participants
12 Participants
n=206 Participants
Comorbidities
Inflammatory Arthritis
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Quinnell grading system
0
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Quinnell grading system
1
11 Participants
n=99 Participants
9 Participants
n=107 Participants
20 Participants
n=206 Participants
Quinnell grading system
2
13 Participants
n=99 Participants
9 Participants
n=107 Participants
22 Participants
n=206 Participants
Quinnell grading system
3
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Quinnell grading system
4
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Quinnell grading system
Not recorded
6 Participants
n=99 Participants
4 Participants
n=107 Participants
10 Participants
n=206 Participants
History of Prior Finger Injections
Right
22 Participants
n=99 Participants
21 Participants
n=107 Participants
43 Participants
n=206 Participants
History of Prior Finger Injections
Left
13 Participants
n=99 Participants
5 Participants
n=107 Participants
18 Participants
n=206 Participants
Finger Injected
Thumb
10 Participants
n=99 Participants
5 Participants
n=107 Participants
15 Participants
n=206 Participants
Finger Injected
Index
7 Participants
n=99 Participants
2 Participants
n=107 Participants
9 Participants
n=206 Participants
Finger Injected
Middle
9 Participants
n=99 Participants
13 Participants
n=107 Participants
22 Participants
n=206 Participants
Finger Injected
Ring
5 Participants
n=99 Participants
4 Participants
n=107 Participants
9 Participants
n=206 Participants
Finger Injected
Little
4 Participants
n=99 Participants
2 Participants
n=107 Participants
6 Participants
n=206 Participants
Dominant Hand Injected
25 Participants
n=99 Participants
20 Participants
n=107 Participants
45 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Pre injection, Post injection day, 2 weeks and at 6 weeks

Population: 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

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 intervention

Population: 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

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 intervention

Population: 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 intervention

Population: 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 intervention

Population: 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 intervention

Population: 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

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group (Corticosteroid Alone)

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. Charles Daly

Emory University

Phone: 404-919-6168

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place