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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01402011
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
WorkSafe BC
Information provided by (Responsible Party):
Helene Bertrand, University of British Columbia

Brief 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).


Condition or disease Intervention/treatment Phase
Rotator Cuff Tendinitis Procedure: 25% dextrose in shoulder entheses Procedure: .1% lidocaine in shoulder entheses Procedure: .1% lidocaine subcu. above shouldr enth. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomly allocated into 3 groups to receive injections of 25% dextrose in .1% lidocaine or .1% lidocaine in the shoulder entheses, the 3rd group received .1% lidocaine subcutaneously above the shoulder entheses.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: For the 25% dextrose and .1% lidocaine and the .1% lidocaine enthesis injections, only the pharmacist knew the contents of each participant's numbered bottle. For the .1% subcutaneous injections, both the pharmacist and the physician where aware of the contents. There was a small c on the label. Only one participant asked the meaning of this letter, and he was told it stood for "contents".
Primary Purpose: Treatment
Official Title: Rotator Cuff Tendinopathy: A Randomized and Blinded Comparison of Superficial and Deep Injection Methods
Study Start Date : November 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: 25% dextrose in shoulder entheses
25% dextrose and .1% lidocaine injected in the shoulder entheses (ligament and tendon insertions on the periosteum).
Procedure: 25% dextrose in shoulder entheses
injections of 1 mL of 25% dextrose and .1% lidocaine 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.
Other Names:
  • Prolotherapy
  • regenerative injection therapy

Active Comparator: .1% lidocaine in shoulder entheses
.1% lidocaine injected in the shoulder entheses (ligament and tendon insertions on the periosteum).
Procedure: .1% lidocaine in shoulder entheses
injections of 1 mL of .1% lidocaine 'ssolution 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.
Other Name: Active control injections

Placebo Comparator: .1% lidocaine subcu. above shouldr enth.
.1% lidocaine injected subcutaneously above the shoulder entheses (ligament and tendon insertions on the periosteum).
Procedure: .1% lidocaine subcu. above shouldr enth.
injections of 1 mL of .1% lidocaine 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.
Other Name: Placebo injections




Primary Outcome Measures :
  1. Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain [ Time Frame: 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.

  2. Change From Baseline of Visual Analog Pain Scale at 3 Months [ Time Frame: 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

  3. Change From Baseline in Maximum Pain Score at 9 Months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Rotator Cuff Ultrasound, Ultrasound Shoulder Pathology Rating Scale [ Time Frame: 20 minutes before first injection on first day of patient visit and at on average 9.4 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.

  2. Physical Examination of the Shoulder Scale [ Time Frame: 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

  3. Disabilities of the Arm Shoulder and Hand Questionnaire [ Time Frame: 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.

  4. Nine Month Satisfaction Questionnaire [ Time Frame: Nine months after first injection treatment appointment ]
    Phone call asking how satisfied were they with their treatment 10 = extremely satisfied, 0 = extremely dissatisfied )


Other Outcome Measures:
  1. Total Prescription Pain Medication Used [ Time Frame: 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.

  2. Visual Analog Pain Scale [ Time Frame: two months ]
    Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.

  3. Visual Analog Pain Scale [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402011


Locations
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Canada, British Columbia
Dr. Helene Bertrand Inc., 220-1940 Lonsdale Avenue
North Vancouver, British Columbia, Canada, V7M 2K2
Active shoulder clinics, West Vancouver sports and orthopedic physiotherapy, 210- 575 16th Street
West Vancouver, British Columbia, Canada, V7V 4Y1
Sponsors and Collaborators
University of British Columbia
WorkSafe BC
Investigators
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Principal Investigator: Helene Bertrand, MD, CCFP University of British Columbia, Vancouver Coastal Health Research Institute
Publications of Results:
Other Publications:
K. Dean Reeves, MD; Bradley D. Fullerton, MD, FAAPMR and Gaston Topol, MD Evidence-Based Regenerative Injection Therapy (Prolotherapy)in Sports Medicine sports Medicine Resource Manual 2008 Chapter 50.
David Rabago Prolotherapy for chronic musculoskeletal pain Complementary and alternative therapies in the aging population edited by Ronald Ross Watson chapter 2 15-44 Elsevier 2009

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Responsible Party: Helene Bertrand, M.D., C.M, CCFP, University of British Columbia
ClinicalTrials.gov Identifier: NCT01402011    
Other Study ID Numbers: H09-00911
RS2010-OG07 ( Other Grant/Funding Number: Worksafe BC )
First Posted: July 26, 2011    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified database Is now available on request to Doctor Helene Bertrand at heleneb@mail.UBC.ca
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will be available from January 2015 to January 2020
Access Criteria: This study was published in Archives Of Physical Medicine And Rehabilitation 2016 volume 97 pages 17 - 25 under the title: Dextrose Prolotherapy Versus Control Injections In Painful Rotator Cuff Tendinopathy
Keywords provided by Helene Bertrand, University of British Columbia:
Prolotherapy
regenerative injection therapy
dextrose injections
Additional relevant MeSH terms:
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Tendinopathy
Rotator Cuff Injuries
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Rupture
Shoulder Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action