N/A N=78 Randomized Triple-blind Treatment

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

Rotator Cuff Tendinitis

Bottom Line

View on ClinicalTrials.gov: NCT01402011 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain — 7.3; 6.9; 6.9 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 25% dextrose in shoulder entheses (Procedure); .1% lidocaine in shoulder entheses (Procedure); .1% lidocaine subcu. above shouldr enth. (Procedure)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of British Columbia
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain	7.3; 6.9; 6.9	—
PRIMARY Change From Baseline of Visual Analog Pain Scale at 3 Months	3.0; 2.7; 2.7	—
PRIMARY Change From Baseline in Maximum Pain Score at 9 Months	2.9; 1.8; 1.3	—
SECONDARY Rotator Cuff Ultrasound, Ultrasound Shoulder Pathology Rating Scale	4.0; 4.3; 4.3; -0.3; -0.6; -0.6	—
SECONDARY Physical Examination of the Shoulder Scale	13.2; 13.1; 13; 11.4; 10.7; 12.9	—
SECONDARY Disabilities of the Arm Shoulder and Hand Questionnaire	72.4; 71.3; 69.6; 61.3; 54.7; 61	—
SECONDARY Nine Month Satisfaction Questionnaire	6.7; 4.7; 3.9	—

Summary

HYPOTHESIS: Prolotherapy, the injection of a growth promoting solution in injured ligaments and tendons of the shoulder is an effective treatment that decreases pain, increases functional capacity and promotes healing better and in less time than standard treatment with physiotherapy. OVERVIEW: 75 subjects with rotator cuff tendinopathy proven by ultrasound will be recruited and assigned randomly into one of three groups of 25 to receive one of these three different treatments: Group A (test): 25% dextrose with 0.1% lidocaine, injected into the tendons and ligaments Group B (control): 0.1% lidocaine injected in the rotator cuff tendons and ligaments Group C(control): 0.1% lidocaine injected subcutaneously above these structures All subjects will receive physiotherapy every other week for three months. To avoid placebo effects, patients, the radiologist and physiotherapist will not know to which treatment group the patients belong; the physician administering the injections will not be involved in assessing disability before or after treatment. (Note: The physician will know which patients belong to group C because it will be obvious: they are delivering a subcutaneous - versus a joint - injection). There will be three sets of injections - one set per month for 3 months. The patients' condition will be tracked for nine months after the first treatment, to monitor changes in 3 outcome measures: pain (VAS and Rx #s), function (DASH and PESS), and tendon healing (as assessed by ultrasound).

Eligibility Criteria

Inclusion Criteria

consecutive patients over 19 and less than 75 years of age

Exclusion Criteria

allergy to corn, as the dextrose solution is corn-based
allergy to local anesthetic
immune deficiency
conditions requiring anti-inflammatory medications including prednisone, corticosteroid injection less than eight weeks prior to the first set of injections
use of immune suppressants
symptomatic osteoarthritis of the gleno-humeral or acromio-clavicular joint
age over 75 or under 19
adhesive capsulitis based on a thorough physical examination, where shoulder flexion or abduction is below 100 °, horizontal adduction is below 30 °, the hand behind the back is below the waist, external rotation is less than 30 °
full thickness tear greater than 1.2 cm as seen on ultrasound
autoimmune disorders such as lupus or rheumatoid arthritis
neurological disorders including Parkinson, seizures, and dementias are excluded for patient safety during the procedures
HIV, viral hepatitis and other blood borne communicable diseases, to protect the investigators
calcium deposits greater than 8 mm in diameter
type III acromion as seen on x-ray
painful condition elsewhere in the body likely to cloud the subject's assessment of his shoulder pain
no evidence of tendinopathy as seen on ultrasound
uncontrolled diabetes: A1C > 7

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01402011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.