RecruitingPhase 2Phase 3ACTRN12616000629437

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

Dimethylbiguanide (Metformin) Efficacy in FROzen Shoulder and Tendinopathy

Sponsor

Northern Sydney Local Health District - Professor David Sonnabend and Professor Lyn March

Enrollment

400 participants

Start Date

May 1, 2017

Study Type

Interventional

Conditions

Shoulder tendinopathy Frozen Shoulder

Summary

The Department of Orthopaedics and Traumatic Surgery at Royal North Shore Hospital is conducting research to test a new treatment for frozen shoulder and tendinopathy. The treatment being investigated is a drug called Metformin. Metformin is currently approved to treat Type 2 diabetes. It is not currently approved to treat frozen shoulder or tendinopathy. The aim of the study is to determine whether Metformin is effective in reducing pain and loss of movement, and speeding up recovery in patients suffering from a frozen shoulder or tendinopathy. Our investigations in the Department of Orthopaedics and Traumatic Surgery's laboratory at Royal North Shore Hospital have shown that this drug acts on the cause of the stiffness in these shoulder conditions and may be effective in reducing the pain and its duration. Results of research undertaken in our laboratory, also suggest that blood tests may help diagnose these conditions and indicate if a patient is recovering well. Current treatments for these conditions have limited success. It is therefore important that more research is done into new treatments, including drug treatments. Frozen shoulder and tendinopathy cause enormous pain, which can lead to loss of sleep, difficulty in dressing and toileting, and participating in occupational and recreational activities. This drug may enable patients to return to their usual activities more quickly. This research has been initiated by the study doctor, Professor Sonnabend, who is an orthopaedic surgeon at Royal North Shore Hospital. Patients are eligible for this study if they: * Are aged between 40 and 70; * Have shoulder pain in only one shoulder, which may or may not be following an injury; * Have pain at the ends of the range of movement of their shoulder in all directions; * Have a loss of movement in the shoulder; * Have had symptoms for less than 3 months; * Have an x-ray that is normal; * Are non-diabetic. Participants will be given either metformin or a placebo to take twice daily for 3 months. The one taken will be chosen randomly. Participants and the study doctor will not know which treatment a participant is receiving. Participation in the study will involve 4 medical appointments at Royal North Shore Hospital, which would be at least the usual number of visits that would be made to a specialist, but in addition to the consultations, questionnaires will be completed and blood samples will be taken. Participation in any research project is voluntary. This study will not cost participants anything.

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a drug called metformin — currently used to treat type 2 diabetes — can also treat frozen shoulder and shoulder tendinopathy (tendon pain). Researchers at Royal North Shore Hospital believe metformin may target the root cause of stiffness and pain in these shoulder conditions. Half of the participants will receive metformin, and half will receive a placebo (a look-alike pill with no active ingredient). Neither the patient nor the doctor will know which one is being taken. The study involves 4 visits over 3 months. You may be eligible if: - You are between 40 and 70 years old - You have pain and stiffness in one shoulder only - Your shoulder pain has been present for less than 6 months - You do not have diabetes or pre-diabetes - Your shoulder X-ray is normal - You are willing to attend 4 appointments at Royal North Shore Hospital You may NOT be eligible if: - You have diabetes, pre-diabetes, or impaired glucose tolerance - You have had previous shoulder surgery, steroid injections, or manipulation under anaesthesia - You have a torn rotator cuff on ultrasound or MRI - You have serious heart, kidney, or vascular problems - You are pregnant, breastfeeding, or could become pregnant - You have taken oral steroids in the last 3 months - You are currently taking fluoroquinolone antibiotics (e.g. ciprofloxacin) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention group will receive metformin tablets at a dose of 1000mg to 2000mg per day for 3 months. Participants will initially take 500mg metformin or placebo twice daily, increasing to 1000mg

The intervention group will receive metformin tablets at a dose of 1000mg to 2000mg per day for 3 months. Participants will initially take 500mg metformin or placebo twice daily, increasing to 1000mg twice daily after 10 days. (Participants who are unable to tolerate 2000mg per day may take a reduced dose of 1500mg daily instead, but no less.) Participants will have a diary to record that the drug has been taken, pain levels, pain relief and activity levels each day for the 3 months. Drug tablet return will be assessed by the hospital clinical trials pharmacist.