Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.

Recruitment Participants will be recruited from patients attending the CMKP Pain Clinic who have been diagnosed with an inoperable rotator cuff tear. During their pain clinic visit, patients will receive information about the study and an informed consent form for participation in the clinical study. They will have the opportunity to ask questions and will receive comprehensive answers.

Randomisation and blinding

Patients will be randomly assigned to one of two groups:

• LHBT group: ultrasound-guided percutaneous tenotomy of the long head of the biceps tendon will be performed.
• CRF group: ultrasound-guided conventional radiofrequency ablation of the suprascapular nerve will be performed.

Randomisation will be performed using www.randomizer.org, with equal numbers of participants allocated to the two groups.

Blinding will be achieved by placing the randomisation number on the envelope containing the study documents. The research team member who assesses pain intensity and the Constant-Murley score before and after the procedure will not be involved in performing the procedures and will be unaware of the patient's group allocation.

Patient data will be recorded in a database protected against access by third parties. The data will include demographic and clinical characteristics (age, height, body weight, comorbidities, substance use, and analgesic doses), as well as procedural details (the selected technique and procedure duration).

Procedural management Percutaneous tenotomy of the long head of the biceps tendon LHBT

1. Ultrasound will be used to identify the LHBT proximal to the pectoralis major tendon and the adjacent arterial vessels.
2. The patient and ultrasound probe will be draped, and the patient's skin will be disinfected.
3. A 10 mL Luer-lock syringe will be filled with 10 mL of 1% lidocaine, and an 18 G needle will be attached.
4. Under 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.
5. The needle will be withdrawn.
6. LHBT continuity will be reassessed using ultrasound. Ultrasound guided radiofrequency ablation of the suprascapular nerve
7. Ultrasound will be used to identify the suprascapular notch, where the suprascapular nerve is located.
8. The ultrasound probe will be draped, and the patient's skin will be disinfected.
9. Under ultrasound guidance, a radiofrequency ablation needle with a 10 mm active tip will be advanced to the anatomical location of the nerve.
10. Sensory and motor stimulation will be performed to confirm that the needle tip is immediately adjacent to the nerve.
11. Local anaesthetic will be administered.
12. Radiofrequency ablation will be performed at 80 °C for 60 seconds.
13. The needle will be withdrawn.
14. One millilitre of pentoxifylline, diluted 1:1 with normal saline, will be administered.

Assessment of pain and quality of recovery Pain intensity will be assessed using the numerical rating scale (NRS, 0-10) at predefined time points.

Range of motion and quality of recovery will be assessed using the validated Polish version of the Constant-Murley score at predefined time points.

6. Assessment time points Patients will be assessed before the procedure and at 1, 6, and 12 months after the procedure, using the NRS and the Constant-Murley score.

Assessment schedule: baseline (0 months), 1 month, 6 months, and 12 months. 7. Statistical analysis The collected data will be analysed using statistical methods appropriate for continuous and categorical variables. The distribution of continuous variables will be assessed using the Shapiro-Wilk test and graphical methods. Data will be presented as the mean ± standard deviation or the median and interquartile range, depending on their distribution. The primary analysis of the efficacy of the two interventions will use repeated measurements of the Constant-Murley score and NRS obtained before the procedure and at 1, 6, and 12 months. A linear mixed-effects model for repeated measurements will be fitted, including group, time, and the group × time interaction. If the assumptions for parametric analyses are not met, appropriate non-parametric methods will be used. Statistical significance will be defined as p \< 0.05.

The sample size was estimated for the primary endpoint, namely the between-group difference in the Constant-Murley score. Assuming a clinically important difference of 10 points, a significance level of α = 0.05, 80% power, a standard deviation of 15 points, and a potential loss to follow-up of 10%, the planned enrolment is 30 patients per group, for a total of 60 patients.