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

This study has been completed.
Sponsor:
Collaborator:
Work Safe BC
Information provided by (Responsible Party):
Helene Bertrand, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01402011
First received: June 20, 2011
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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 Intervention
Rotator Cuff Tendinitis
Procedure: shoulder injections

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prolotherapy in the Treatment of Rotator Cuff Tendinopathy, a Randomized Double-blind Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Visual analog pain scale [ Time Frame: 20 minutes before first injection on first day of patient visit ] [ Designated as safety issue: No ]
    Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.

  • Visual analog pain scale [ Time Frame: one month ] [ Designated as safety issue: No ]
    Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.

  • Visual analog pain scale [ Time Frame: two months ] [ Designated as safety issue: No ]
    Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.

  • Visual analog pain scale [ Time Frame: three months ] [ Designated as safety issue: No ]
    Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.

  • Visual analog pain scale [ Time Frame: six months ] [ Designated as safety issue: No ]
    Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.


Secondary Outcome Measures:
  • Rotator cuff ultrasound, ultrasound shoulder pathology rating scale [ Time Frame: 20 minutes before first injection on first day of patient visit and at six months ] [ Designated as safety issue: No ]
    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 to Bross at the cortical surface (0-3), dynamics supraspinatus impingement (0-3), dynamic subscapularis/ biceps/ coracoid impingement (0-3)

  • Physical Examination of the Shoulder Scale [ Time Frame: 20 minutes before first injection on first day of patient visit, 1,2,3, and six months ] [ Designated as safety issue: No ]
    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 scored:0=no pain, 1= tender, 2= pain

  • Disabilities of the arm shoulder and hand questionnaire [ Time Frame: Immediately after first injection, 1,2,3, six months ] [ Designated as safety issue: No ]
    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.

  • Nine Month questionnaire [ Time Frame: Nine months after first injection treatment appointment ] [ Designated as safety issue: No ]
    Phone call asking: how much pain they had (none, mild, moderate, severe), whether shoulder pain was affecting their ability to perform the activities of daily living (ADLs) (yes or no), how would they rate the shoulder pain now (none, mild, moderate, severe), how satisfied were they with their treatment (extremely satisfied, satisfied, neutral, dissatisfied, extremely dissatisfied ), whether they used other therapies for shoulder pain since completion of treatment (yes or no), which ones?, how much time did they spend off work because of their shoulder pain?

  • total prescription pain medication used [ Time Frame: 20 minutes before first injection on first day of patient visit, six months ] [ Designated as safety issue: No ]
    Total amount of narcotic pain medication prescribed


Enrollment: 72
Study Start Date: November 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25% dextrose in ligaments and tendons
25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons.
Procedure: 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.
Other Names:
  • Prolotherapy
  • regenerative injection therapy
Active Comparator: .1% lidocaine in ligaments and tendons
.1% lidocaine injected in the shoulder ligaments and tendons
Procedure: 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.
Other Names:
  • Prolotherapy
  • regenerative injection therapy
Placebo Comparator: .1% lidocaine subcutaneous
.1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder.
Procedure: 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.
Other Names:
  • Prolotherapy
  • regenerative injection therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 74 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402011

Locations
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
Work Safe BC
Investigators
Principal Investigator: Helene Bertrand, MD, CCFP University of British Columbia, Vancouver Coastal Health Research Institute
  More Information

Additional Information:
Publications:

Responsible Party: Helene Bertrand, M.D., C.M, CCFP, University of British Columbia
ClinicalTrials.gov Identifier: NCT01402011     History of Changes
Other Study ID Numbers: H09-00911, RS2010-OG07
Study First Received: June 20, 2011
Last Updated: September 2, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Prolotherapy
regenerative injection therapy
dextrose injections

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014