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

NCT01402011 | Completed Results

• 2 other identifiers: H09-00911RS2010-OG07
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

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).

Conditions

Rotator Cuff Tendinitis

Keywords

Prolotherapy; regenerative injection therapy; dextrose injections

Outcome Measures

Primary Outcomes (3)

• Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain

  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.

  20 minutes before first injection on first day of patient visit

• Change From Baseline of Visual Analog Pain Scale at 3 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

  baseline and three months

• Change From Baseline in Maximum Pain Score at 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.

  baseline and 9 months

Secondary Outcomes (4)

• Rotator Cuff Ultrasound, Ultrasound Shoulder Pathology Rating Scale

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

• Physical Examination of the Shoulder Scale

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

• Disabilities of the Arm Shoulder and Hand Questionnaire

  20 minutes before the first injection and at 3 months

• Nine Month Satisfaction Questionnaire

  Nine months after first injection treatment appointment

Other Outcomes (3)

• Total Prescription Pain Medication Used

  20 minutes before first injection on first day of patient visit

• Visual Analog Pain Scale

  two months

• Visual Analog Pain Scale

  one month

Study Arms (3)

25% dextrose in shoulder entheses

EXPERIMENTAL

25% dextrose and .1% lidocaine injected in the shoulder entheses (ligament and tendon insertions on the periosteum).

Procedure: 25% dextrose in shoulder entheses

.1% lidocaine in shoulder entheses

ACTIVE COMPARATOR

.1% lidocaine injected in the shoulder entheses (ligament and tendon insertions on the periosteum).

Procedure: .1% lidocaine in shoulder entheses

.1% lidocaine subcu. above shouldr enth.

PLACEBO COMPARATOR

.1% lidocaine injected subcutaneously above the shoulder entheses (ligament and tendon insertions on the periosteum).

Procedure: .1% lidocaine subcu. above shouldr enth.

Interventions

25% dextrose in shoulder entheses PROCEDURE

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.

Also known as: Prolotherapy, regenerative injection therapy

25% dextrose in shoulder entheses

.1% lidocaine in shoulder entheses PROCEDURE

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.

Also known as: Active control injections

.1% lidocaine in shoulder entheses

.1% lidocaine subcu. above shouldr enth. PROCEDURE

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.

Also known as: Placebo injections

.1% lidocaine subcu. above shouldr enth.

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive patients over 19 and less than 75 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• WorkSafe BC: collaborator

Study Sites (2)

Dr. Helene Bertrand Inc., 220-1940 Lonsdale Avenue

North Vancouver, British Columbia, V7M 2K2, Canada

Location

Active shoulder clinics, West Vancouver sports and orthopedic physiotherapy, 210- 575 16th Street

West Vancouver, British Columbia, V7V 4Y1, Canada

Location

Related Publications (16)

• Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21.

  PMID: 20970844 BACKGROUND

• Silverstein B, Welp E, Nelson N, Kalat J. Claims incidence of work-related disorders of the upper extremities: Washington state, 1987 through 1995. Am J Public Health. 1998 Dec;88(12):1827-33. doi: 10.2105/ajph.88.12.1827.

  PMID: 9842381 BACKGROUND

• Stovitz SD, Johnson RJ. NSAIDs and musculoskeletal treatment: what is the clinical evidence? Phys Sportsmed. 2003 Jan;31(1):35-52. doi: 10.3810/psm.2003.01.160.

  PMID: 20086440 BACKGROUND

• Cohen DB, Kawamura S, Ehteshami JR, Rodeo SA. Indomethacin and celecoxib impair rotator cuff tendon-to-bone healing. Am J Sports Med. 2006 Mar;34(3):362-9. doi: 10.1177/0363546505280428. Epub 2005 Oct 6.

  PMID: 16210573 BACKGROUND

• Gaujoux-Viala C, Dougados M, Gossec L. Efficacy and safety of steroid injections for shoulder and elbow tendonitis: a meta-analysis of randomised controlled trials. Ann Rheum Dis. 2009 Dec;68(12):1843-9. doi: 10.1136/ard.2008.099572. Epub 2008 Dec 3.

  PMID: 19054817 BACKGROUND

• Lewis JS. Rotator cuff tendinopathy/subacromial impingement syndrome: is it time for a new method of assessment? Br J Sports Med. 2009 Apr;43(4):259-64. doi: 10.1136/bjsm.2008.052183. Epub 2008 Oct 6.

  PMID: 18838403 BACKGROUND

• Mansat P, Cofield RH, Kersten TE, Rowland CM. Complications of rotator cuff repair. Orthop Clin North Am. 1997 Apr;28(2):205-13. doi: 10.1016/s0030-5898(05)70280-7.

  PMID: 9113716 BACKGROUND

• Brislin KJ, Field LD, Savoie FH 3rd. Complications after arthroscopic rotator cuff repair. Arthroscopy. 2007 Feb;23(2):124-8. doi: 10.1016/j.arthro.2006.09.001.

  PMID: 17276218 BACKGROUND

• Liu X, Luo F, Pan K, Wu W, Chen H. High glucose upregulates connective tissue growth factor expression in human vascular smooth muscle cells. BMC Cell Biol. 2007 Jan 16;8:1. doi: 10.1186/1471-2121-8-1.

  PMID: 17224075 BACKGROUND

• Fullerton BD. High-resolution ultrasound and magnetic resonance imaging to document tissue repair after prolotherapy: a report of 3 cases. Arch Phys Med Rehabil. 2008 Feb;89(2):377-85. doi: 10.1016/j.apmr.2007.09.017.

  PMID: 18226666 BACKGROUND

• 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.

  BACKGROUND

• Scarpone M, Rabago DP, Zgierska A, Arbogast G, Snell E. The efficacy of prolotherapy for lateral epicondylosis: a pilot study. Clin J Sport Med. 2008 May;18(3):248-54. doi: 10.1097/JSM.0b013e318170fc87.

  PMID: 18469566 BACKGROUND

• Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Altern Ther Health Med. 2000 Mar;6(2):68-74, 77-80.

  PMID: 10710805 BACKGROUND

• Reeves KD, Hassanein K. Randomized, prospective, placebo-controlled double-blind study of dextrose prolotherapy for osteoarthritic thumb and finger (DIP, PIP, and trapeziometacarpal) joints: evidence of clinical efficacy. J Altern Complement Med. 2000 Aug;6(4):311-20. doi: 10.1089/10755530050120673.

  PMID: 10976977 BACKGROUND

• 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

  BACKGROUND

• Bertrand H, Reeves KD, Bennett CJ, Bicknell S, Cheng AL. Dextrose Prolotherapy Versus Control Injections in Painful Rotator Cuff Tendinopathy. Arch Phys Med Rehabil. 2016 Jan;97(1):17-25. doi: 10.1016/j.apmr.2015.08.412. Epub 2015 Aug 22.

  PMID: 26301385 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Glucose; Prolotherapy; Lidocaine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Complementary Therapies; Therapeutics; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Helene Bertrand, M.D., CCFP, LM
• Organization: University of British Columbia Department of family practice

dr.hbertrand@gmail.com

604-985-5381

Study Officials

• Helene Bertrand, MD, CCFP

  University of British Columbia, Vancouver Coastal Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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".
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., C.M, CCFP

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: July 26, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 14, 2018
• Results First Posted: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

CA (2)