Comparison of Suprascapular Nerve Block with Triamcinolone Acetonide Versus Pulsed Radiofrequency in Chronic Shoulder Pain: A Double-Blind Randomized Trial

The primary objective of this double-blind randomized clinical trial is to evaluate the **improvement in shoulder functionality and pain** in patients with chronic shoulder pain, as measured by the Shoulder Pain and Disability Index (SPADI) test. This study compares the efficacy of a suprascapular nerve block with corticosteroids versus pulsed radiofrequency. The clinical relevance of this objective lies in determining the most effective treatment modality for enhancing shoulder function and reducing pain, which is crucial for improving the quality of life in patients suffering from chronic shoulder pain.

Secondary objectives include:

• Pain assessment using the Visual Analog Scale (VAS) and Numerical Verbal Scale (NVS).
• Assessment of both active and passive mobility; range of motion of the shoulder, including elevation, abduction, and external rotation.
• Assessment of the reduction in the need for analgesics.
• Assessment of anxiety and quality of life using the Hospital Anxiety and Depression (HAD) scale and EuroQoL.
• Assessment of sleep quality using the Medical Outcomes Study (MOS) scale.
• Assessment of patient satisfaction with the treatment received.
• Comparison of safety between both techniques.

The clinical trial focuses on individuals experiencing **chronic shoulder pain**, specifically evaluating the effectiveness of suprascapular nerve block with corticosteroids versus pulsed radiofrequency. The study population includes both men and women over the age of 18, all of whom have been experiencing shoulder pain for more than three months. Participants are required to have signed an informed consent form. The trial does not involve a vulnerable population, and both male and female subjects are included. The sponsor has not provided information regarding the total number of participants. The selection criteria ensure that participants are scheduled for a suprascapular nerve block due to shoulder pain, aligning with the study's objective to assess improvements in shoulder functionality and pain using the SPADI test.

The clinical trial is designed to evaluate the **efficacy** of suprascapular nerve block with corticosteroids versus pulsed radiofrequency in patients with **chronic shoulder pain**. This study is a double-blind, randomized, controlled trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thus minimizing bias. The trial is categorized as a low interventional clinical trial and is expected to conclude by January 1, 2026, with recruitment having commenced on April 11, 2018.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed based on criteria such as age over 18 years, shoulder pain lasting more than three months, and the provision of informed consent. The primary endpoint of the study is the improvement in shoulder functionality and pain, measured by the Shoulder Pain and Disability Index (SPADI). Secondary endpoints include assessments of demographics, comorbidity, pain scales, range of motion, analgesic use, anxiety and depression scales, quality of life, sleep quality, and patient satisfaction.

The expected duration of participant involvement is aligned with the trial's overall timeline, with regular follow-up visits scheduled to monitor progress and collect data. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted. Conditions that may lead to early termination from the study include withdrawal of consent, adverse events, or any situation where continued participation is deemed not in the participant's best interest. The trial employs **triamcinolone acetonide** as the active substance, administered as a suspension for injection, with a maximum daily dose of 80 mg and a treatment period not exceeding one month.

The clinical trial involves the administration of **TRIGON DEPOT 40 mg/ml suspension for injection**, which contains the active substance **triamcinolone acetonide**. This pharmaceutical form is a suspension intended for injection, specifically for **perineural use**. The dosage of triamcinolone acetonide is set at a maximum of 80 mg per day, with the total dose not exceeding 80 mg. The treatment period is limited to a single day. The suspension is manufactured by Bristol-Myers Squibb SA and is classified under the ATC code H02AB08, indicating its categorization as a corticosteroid. The chemical origin of the active substance ensures its consistency and efficacy in the trial.

In this double-blind randomized clinical trial, the experimental treatment with triamcinolone acetonide is compared against a non-experimental treatment involving pulsed radiofrequency. The objective is to evaluate the improvement in shoulder functionality and pain in patients with chronic shoulder pain, specifically targeting the suprascapular nerve. The trial does not include any placebo or additional comparator treatments beyond the pulsed radiofrequency. Participant compliance with the dosing schedule is monitored to ensure adherence to the protocol and to accurately assess the efficacy of the treatments under investigation.

The efficacy of the intervention in the clinical trial will be assessed primarily through the **Shoulder Pain and Disability Index (SPADI)**, a validated quality-of-life questionnaire specifically designed to evaluate pain and disability associated with shoulder pathology. This primary endpoint will provide a comprehensive measure of improvement in shoulder functionality and pain in patients with chronic shoulder pain. Secondary endpoints will include a range of additional parameters to further evaluate efficacy. These include demographic data, comorbidity, the Visual Analog Scale (VAS), the Numerical Verbal Scale (NVS), range of motion, the amount of analgesics administered, the Hospital Anxiety and Depression Scale (HAD), the EuroQol 5D (EQ-5D), the Medical Outcomes Study Sleep Scale (MOS), and a satisfaction assessment. These secondary measures will offer a broader understanding of the intervention's impact on various aspects of patient health and quality of life. The trial is designed as a double-blind randomized clinical trial, comparing the efficacy of suprascapular nerve block with corticosteroids versus pulsed radiofrequency in patients with chronic shoulder pain. The trial is categorized as a low interventional clinical trial, with an estimated end date of January 1, 2026.