Skip to main content

Table 1 Inclusion and exclusion criteria

From: Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial

Inclusion Criteria Exclusion criteria
1. Male and non-pregnant female patients 18 years of age or older (women of child-bearing potential must have a negative serum pregnancy test performed within 1-14 days prior to the treatment procedure) suffering from NCST as diagnosed by X-ray, MRI and physical examination. 1. Patient has a history of uncontrolled severe hypertension (systolic pressure > 180 mmHg, diastolic pressure > 110 mmHg).
2. Patient has not responded to a standard course of non-pharmacological and non-surgical conservative treatment for a minimum of three weeks. The treatment above consists of: therapeutic exercise, and/or ultrasound, and/or iontophoresis, and/or cryotherapy, and/or immobilization or activity modification. 2. Patient has unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias.
3. Patient has not responded to pharmacological treatment (one course of the standard dose of prescribed analgesic or NSAID) and has had at least one subacromial steroid injection. 3. Patient has a white blood cell count less than 2,000 or greater than 15,000, or platelet count less than 50,000.
4. Diagnosis of supraspinatus tendinopathy is only in one shoulder. 4. Patient has a known bleeding disorder or is currently being treated with anticoagulant therapy.
5. Patient has free passive range of movement and at least 90 degrees active abduction in the affected shoulder. 5. Patient is currently being treated with a narcotic or NSAIDs and/or has used analgesics or NSAIDs within the 72 hours prior to the SV.
6. Patient is willing to participate in the study and return for all scheduled follow-up visits. 6. Patient has participated in any other shoulder pain treatment research study within 30 days prior to the SV.
7. Patient is capable of giving, and has given, written informed consent. 7. Patient had prior shoulder surgery
8. Patient received prior ESWT for any disease.
9. Patient is complaining of pain in both shoulders.
10. Patient has malignant tumors, irrespective of location.
11. Patient has a cardiac pacemaker implant.
12. Patient has anatomy that prevents the focusing of the device into the shoulder in the area of the supraspinatus tendon (e.g., extensive scarring, misalignment of previous fractures, non-unions or delayed fracture healing, congenital malformation, etc.).
13. Patient has any upper extremity neurological disorder as diagnosed from focused neurological exam and neurophysiological studies (e.g. thoracic outlet syndrome, reflex sympathetic dystrophy, etc.).
14. Patient has a full-thickness rotator cuff tear of any of the rotator cuff tendons as seen on MRI.
15. Patient has an acromiohumeral interval less than 7mm as measured on a standard AP X-ray, or severe symptomatic degenerative changes in the glenohumeral or acromioclavicular joint.
16. Patient has acute subacromial bursitis as diagnosed by MRI
17. Patient has generalized polyarthritis, rheumatoid arthritis.
18. Patient is allergic to local anaesthetic.
  1. SV, indicates screening visit; NCST, non-calcific supraspinatus tendinopathy; AP, Anteroposterior; NSAIDs, Non-Steroidal Anti-Inflammatory Drugs.