Trial Outcomes & Findings for Study of 25% Dextrose Injections in Shoulder Ligaments and Tendons to Promote Their Healing (NCT NCT01402011)

Results Overview

Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. The maximum pain level among the 3 different activities was recorded.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

20 minutes before first injection on first day of patient visit

Results posted on

2018-08-14

Participant Flow

Between October 2010 and April 2012 advertisements for those between 19 and 75 years, with shoulder pain greater than 3 months, were placed in tennis courts, gymnasia, the Lions Gate Hospital Ultrasound Department, and sent to local physicians.

Clinical check R/O:unqualified participants. 77 were probable participants, pending results from their diagnostic ultrasound (delayed treatment period). 77 were ultimately enrolled in the study.

Participant milestones

Participant milestones
Measure	25% Dextrose in Ligaments and Tendons 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine in Ligaments and Tendons .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.
Delayed Treatment Period STARTED	29	23	26
Delayed Treatment Period COMPLETED	28	23	26
Delayed Treatment Period NOT COMPLETED	1	0	0
Active Treatment Period STARTED	28	23	26
Active Treatment Period COMPLETED	27	20	26
Active Treatment Period NOT COMPLETED	1	3	0
Nine Month Follow-up STARTED	27	20	26
Nine Month Follow-up COMPLETED	27	19	26
Nine Month Follow-up NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	25% Dextrose in Ligaments and Tendons 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine in Ligaments and Tendons .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Delayed Treatment Period Withdrawal by Subject	1	0
Active Treatment Period Withdrawal by Subject	1	3
Nine Month Follow-up Withdrawal by Subject	0	1

Baseline Characteristics

Study of 25% Dextrose Injections in Shoulder Ligaments and Tendons to Promote Their Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	25% Dextrose in Ligaments and Tendons n=27 Participants 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine in Ligaments and Tendons n=20 Participants .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 Participants .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.	Total n=73 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 13.5 • n=5 Participants	51.1 years STANDARD_DEVIATION 9.2 • n=7 Participants	49.0 years STANDARD_DEVIATION 11.9 • n=5 Participants	51 years STANDARD_DEVIATION 11.78 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants	46 Participants n=4 Participants
Shoulder symptom duration	61 months STANDARD_DEVIATION 81 • n=5 Participants	131 months STANDARD_DEVIATION 155 • n=7 Participants	101 months STANDARD_DEVIATION 115 • n=5 Participants	76 months STANDARD_DEVIATION 166 • n=4 Participants

PRIMARY outcome

Timeframe: 20 minutes before first injection on first day of patient visit

Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. The maximum pain level among the 3 different activities was recorded.

Outcome measures

Outcome measures
Measure	.1% Lidocaine in Ligaments and Tendons n=19 Participants .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 Participants .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.	25% Dextrose in Ligaments and Tendons n=27 Participants 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain	6.9 units on a scale Standard Deviation 0.5	6.9 units on a scale Standard Deviation 0.4	7.3 units on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: baseline and three months

Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. Maximum of pain scores rest, work, sport recorded. Calculated as pain at baseline - pain at 3 months. VAS scale is from 0 = no pain to 10 = maximum pain

Outcome measures

Outcome measures
Measure	.1% Lidocaine in Ligaments and Tendons n=19 Participants .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 Participants .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.	25% Dextrose in Ligaments and Tendons n=27 Participants 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Change From Baseline of Visual Analog Pain Scale at 3 Months	2.7 units on a scale Standard Deviation 0.7	2.7 units on a scale Standard Deviation 0.6	3.0 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: baseline and 9 months

Participants were asked about pain at rest, at work, doing sports. The maximum pain reported on a scale ranging from 0 (no pain at all) to 10 (extreme pain) was recorded for each participant. Maximum of pain scores rest, work, sport recorded. Calculated as pain at baseline - pain at 9 months.

Outcome measures

Outcome measures
Measure	.1% Lidocaine in Ligaments and Tendons n=19 Participants .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 Participants .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.	25% Dextrose in Ligaments and Tendons n=27 Participants 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Change From Baseline in Maximum Pain Score at 9 Months	1.8 units on a scale Standard Deviation 0.7	1.3 units on a scale Standard Deviation 0.6	2.9 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 20 minutes before first injection on first day of patient visit and at on average 9.4 months

Population: Three of the 25% dextrose in ligaments and tendons group did not show up for their ultrasound appointment at nine months.

From Brose et al. "shoulder ultrasound abnormalities, physical examination findings, and pain in manual wheelchair users with spinal cord injury" Arch Phys Med Rehabil 2008 Nov, 89: 2086-93 appendix 2. rates biceps tendinopathy (0-6), supraspinatus tendinopathy (0-5), greater tuberosity the cortical surface (0-3), dynamics supraspinatus impingement (0-3), dynamic subscapularis/ biceps/ coracoid impingement (0-3). The total score ranged from 0 to 20 with higher scores indicating a worse outcome. The change was calculated by taking the final score - the baseline score.

Outcome measures

Outcome measures
Measure	.1% Lidocaine in Ligaments and Tendons n=19 Participants .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 Participants .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.	25% Dextrose in Ligaments and Tendons n=24 Participants 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Rotator Cuff Ultrasound, Ultrasound Shoulder Pathology Rating Scale Baseline	4.3 units on a scale Standard Deviation 0.5	4.3 units on a scale Standard Deviation 0.4	4.0 units on a scale Standard Deviation 0.4
Rotator Cuff Ultrasound, Ultrasound Shoulder Pathology Rating Scale change at 9.4 +/- 2.2 months	-0.6 units on a scale Standard Deviation 0.5	-0.6 units on a scale Standard Deviation 0.4	-0.3 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 20 minutes before first injection on first day of patient visit and at 3 months

From Steven W. Brose, DO, Michael L. Boninger, MD, Bradley Fullerton, MD, Thane McCann, MD, From: Jennifer L. Collinger, BSE, Bradley G. Impink, BSE, Trevor A. Dyson-Hudson, MD Shoulder ultrasound abnormalities, physical examination findings, and pain in manual wheelchair users with spinal cord injury. Arch Phys Med Rehabil 2008 Nov; 89:2086-93, appendix 1 12 parameters of shoulder examination: Biceps tendon/bicipital groove tenderness, Supraspinatus tendon/greater tuberosity tenderness Acromioclavicular joint tenderness Resisted external rotation. Resisted internal rotation. Supraspinatus test. Painful Arc Test. Neer impingement sign. Hawkins-Kennedy impingement sign. O'Brien Active Compression Test for AC Joint Pathology O'Brien Active Compression Test for Labral Pathology impingement sign. each test scored 0 = no pain, 1 = tenderness, 2 = pain. All 12 scores added. Range 0-24. Higher scores = more pathology

Outcome measures

Outcome measures
Measure	.1% Lidocaine in Ligaments and Tendons n=19 Participants .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 Participants .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.	25% Dextrose in Ligaments and Tendons n=27 Participants 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Physical Examination of the Shoulder Scale Baseline	13.1 units on a scale Standard Deviation 3.7	13 units on a scale Standard Deviation 3.5	13.2 units on a scale Standard Deviation 4.8
Physical Examination of the Shoulder Scale 3 months	10.7 units on a scale Standard Deviation 5.3	12.9 units on a scale Standard Deviation 3.9	11.4 units on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: 20 minutes before the first injection and at 3 months

http://www.dash.iwh.on.ca/assets/images/pdfs/DASH\_quest06.pdf 30 questions assessing ability to use shoulder in everyday activities, each question scored 1 to 5, where one is normal, no problem and five is unable to perform. No data was collected at 9 months. The score ranges from 30 to 150. Higher scores represent worse outcomes.

Outcome measures

Outcome measures
Measure	.1% Lidocaine in Ligaments and Tendons n=19 Participants .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 Participants .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.	25% Dextrose in Ligaments and Tendons n=27 Participants 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Disabilities of the Arm Shoulder and Hand Questionnaire Baseline	71.3 units on a scale Standard Deviation 19.4	69.6 units on a scale Standard Deviation 22.9	72.4 units on a scale Standard Deviation 21.6
Disabilities of the Arm Shoulder and Hand Questionnaire 3 months	54.7 units on a scale Standard Deviation 16.2	61 units on a scale Standard Deviation 18.4	61.3 units on a scale Standard Deviation 17.2

SECONDARY outcome

Timeframe: Nine months after first injection treatment appointment

Phone call asking how satisfied were they with their treatment 10 = extremely satisfied, 0 = extremely dissatisfied )

Outcome measures

Outcome measures
Measure	.1% Lidocaine in Ligaments and Tendons n=19 Participants .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 Participants .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula.	25% Dextrose in Ligaments and Tendons n=27 Participants 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Nine Month Satisfaction Questionnaire	4.7 units on a scale Standard Deviation 4.1	3.9 units on a scale Standard Deviation 3.1	6.7 units on a scale Standard Deviation 3.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 20 minutes before first injection on first day of patient visit

Total amount of narcotic pain medication prescribed. Data were not collected at 1,2,3 and 6 months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: two months

Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: one month

Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. Maximum of pain scores rest, work, sport is recorded.

Outcome measures

Outcome data not reported

Adverse Events

25% Dextrose in Ligaments and Tendons

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

.1% Lidocaine in Ligaments and Tendons

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

.1% Lidocaine Subcutaneous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	25% Dextrose in Ligaments and Tendons n=27 participants at risk 25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine in Ligaments and Tendons n=20 participants at risk .1% lidocaine injected in the shoulder ligaments and tendons shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.	.1% Lidocaine Subcutaneous n=26 participants at risk .1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder. shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
Musculoskeletal and connective tissue disorders Frozen Shoulder Development	0.00% 0/27 • 1 year	5.0% 1/20 • Number of events 1 • 1 year	0.00% 0/26 • 1 year

Additional Information

Dr. Helene Bertrand, M.D., CCFP, LM

University of British Columbia Department of family practice

Phone: 604-985-5381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place