About this trial
Rotator cuff tears are among the most common direct and indirect causes of chronic shoulder pain. Patients with irreparable rotator cuff tears face a choice of pain management options. The principal treatments available for chronic shoulder pain associated with irreparable rotator cuff tears include arthroscopic tenotomy of the long head of the biceps tendon, shoulder arthroplasty, pharmacological treatment, and radiofrequency ablation of the suprascapular nerve.
Arthroscopic tenotomy of the long head of the biceps tendon is an established treatment for pain associated with massive irreparable rotator cuff tears, as supported by the available literature.
Radiofrequency ablation of the suprascapular nerve provides temporary pain control by destroying the sensory nerve fibres supplying the shoulder joint.
Tenotomy of the long head of the biceps tendon can be performed safely using a minimally invasive, ultrasound-guided outpatient procedure under local anaesthesia, without the general anaesthesia required for arthroscopy.
The aim of the study is to compare the reduction in pain intensity and the duration of analgesia following percutaneous tenotomy of the long head of the biceps tendon versus continuous radiofrequency ablation of the suprascapular nerve. Changes in shoulder mobility limitations following the two procedures will also be compared using the Constant-Murley score, which assesses shoulder function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >65 years.
Massive irreparable posterosuperior rotator cuff tears (Patte grade 3 and Goutallier grade 4 on MRI).
Disqualifiers
Absence of consent to participate in the study.
Psychiatric disorders and antidepressant treatment.
Uncontrolled cardiovascular disease.
Alcohol or psychoactive substance dependence.
Trial design
Parallel
Treatments tested in this trial
Percutaneous tenotomy of the long head of the biceps tendon (LHBT)
Procedure/SurgeryUnder continuous ultrasound guidance, the 18 G needle will be inserted into the LHBT sheath, where the local anaesthetic will be administered. The LHBT will then undergo repeated needle fenestration until tendon transection is visible or can be felt. LHBT continuity will be reassessed using ultrasound.
Ultrasound guided radiofrequency ablation of the suprascapular nerve
Procedure/SurgeryUnder ultrasound guidance, a radiofrequency ablation needle with a 10 mm active tip will be advanced to the anatomical location of the nerve. Sensory and motor stimulation will be performed to confirm that the needle tip is immediately adjacent to the nerve. Radiofrequency ablation will be performed at 80 °C for 60 seconds.
Treatment groups
Trial outcomes
Primary outcomes
Constant-Murley score at 1 month
Secondary outcomes
Constant-Murley score at 6 months
Constant-Murley score at 6 months following the procedure
Constant-Murley score at 12 months
Constant-Murley score at 12 months following the procedure
Numeric Rating Scale (NRS) at 1 month
Pain intensity reported as Numeric Rating Scale (NRS) score at 1 month following the procedure
Numeric Rating Scale (NRS) at 6 months
Pain intensity reported as Numeric Rating Scale (NRS) score at 6 months following the procedure
Locations
Sponsors and contacts
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