DEFROST: A clinical trial testing metformin as a treatment for frozen shoulder or shoulder tendinopathy.

Phase 2

Recruiting

• Conditions: Frozen Shoulder; Shoulder tendinopathy; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616000629437
• Lead Sponsor: orthern Sydney Local Health District - Professor David Sonnabend and Professor Lyn March

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Inclusion criteria for frozen shoulder:
* Patients aged between 40 and 70;
* Patients with unilateral shoulder pain (spontaneous or following minor trauma);
* Patients with pain at end of shoulder range of movement (ROM) in all directions with pain on the visual analogue scale (VAS) of greater than 4 out of 10;
* Patients with loss of glenohumeral ROM in at least 2 of 3 planes (flexion, abduction, extension);
* Patients with loss of greater than 20 per cent or 30 degrees external rotation in adduction compared with asymptomatic side;
* Patients with symptom duration of less than 6 months;
* Patients with normal x-ray;
* Patients with normal glucose tolerance ie not diabetic or recognised prediabetic;
* Patients taking background analgesics, non-steroidals, nutraceuticals (fish oil, glucosamine etc) will be allowed (to be continued at normal doses); and
* Patients who are willing to give written informed consent and are willing to comply with the study.

Inclusion criteria for shoulder tendinopathy:
* Patients aged between 40 and 70:
* Patients with unilateral shoulder pain, pain with rotator cuff (supraspinatus and/or infraspinatus) contraction against resistance, loss of ROM not to exceed 20 per cent in any direction, by comparison with asymptomatic side;
* Patients with normal x-ray;
* Patients with ultrasound or magnetic resonance imaging (MRI) evidence of in-tact but heterogeneous rotator cuff;
* Patients with normal glucose tolerance;
* Patients taking background analgesics, non-steroidals, nutraceuticals (fish oil, glucosamine etc) will be allowed (to be continued at stable doses); and
* Patients who are willing to give written informed consent and are willing to comply with the study.

Exclusion Criteria

* Patients with a rotator cuff disruption on ultrasound or MRI (ie full thickness or partial thickness cuff tear);
* Patients who have a known abnormality in glucose tolerance including impaired glucose tolerance, impaired fasting glucose, type 1 or type 2 diabetes mellitus;
* Patients with impaired renal function (estimated glomerular filtration rate (eGFR) less than 45mL per minute);
* Patients who have symptoms of frozen shoulder which have been present for more than 6 months;
* Patients who have had previous shoulder surgery, hydrodilatation or manipulation under anaesthesia procedure;
* Patients who have had a steroid injection into the affected shoulder
* Patients who have taken oral steroids within the last 3 months;
* Patients who are taking fluoroquinolones antibiotics, such as ciprofloxacin, levofloxacin, moxifloxacin;
* Women lactating, pregnant, or of child bearing potential who are not willing to avoid pregnancy during the study;
* Patients who have had an acute coronary syndrome (including myocardial infarction or unstable angina), peripheral vascular disease, transient ischaemic attack (TIA) or acute stroke within the preceding 6 months;
* Patients with clinically significant active cardiovascular disease including stable/unstable angina or heart failure (New York Heart Association (NYHA) class III and IV) at the discretion of the investigator;
* Patients with a history of pulmonary embolism within the last 3 months;
* Patients with planned major surgery, including dental surgery, during the study treatment period;
* Patients with planned radiological investigations requiring contrast within the study treatment period;
* Patients who have suspected or known abuse of narcotics or alcohol;
* Patients who have received an investigational new drug within the last 30 days;
* Patients with a cognitive impairment, intellectual disability, mental illness or history of psychological illness or condition such as to interfere with their ability to understand the requirements of the study and to answer clinical questions in the opinion of the coordinating investigator;
* Patients with a condition or illness that in the investigator's opinion would be unsuitable for participation in the study (due to limitations with active participation, compliance with the study drug treatment or follow-up).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with VAS pain score 2 or less out of 10.<br><br> [The primary timepoint is 3 months. In addition, measurements will be taken at baseline, 6 and 12 months from commencement of participation in trial.]