Study on Triamcinolone Acetonide and Pulsed Radiofrequency for Chronic Shoulder Pain in Adults

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What is this study about?

This clinical trial is focused on studying chronic shoulder pain, a condition where individuals experience persistent pain in the shoulder area for more than three months. The study aims to compare two different treatments to see which is more effective in improving shoulder function and reducing pain. One treatment involves the use of a medication called triamcinolone acetonide, which is a type of corticosteroid. This medication is administered as a suspension for injection directly near the nerve that affects the shoulder. The other treatment being studied is called pulsed radiofrequency, a technique that uses electrical energy to reduce pain.

The purpose of the study is to evaluate which treatment is more effective in improving shoulder functionality and reducing pain in patients with chronic shoulder pain. Participants in the study will be randomly assigned to receive either the corticosteroid injection or the pulsed radiofrequency treatment. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving, to ensure unbiased results.

Throughout the study, participants will be assessed using various methods, including the Shoulder Pain and Disability Index (SPADI), which is a questionnaire that measures pain and disability related to shoulder issues. Other assessments will include scales for pain measurement, range of motion tests, and evaluations of overall quality of life. The study will help determine the most effective approach for managing chronic shoulder pain, potentially leading to better treatment options for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that shoulder pain has persisted for more than three months and that the patient is over 18 years old.

The patient must have signed an informed consent form to participate in the trial.

2 randomization

The patient is randomly assigned to one of two groups: one receiving a corticosteroid injection and the other undergoing pulsed radiofrequency treatment.

This process ensures that neither the patient nor the healthcare providers know which treatment is being administered, maintaining the double-blind nature of the trial.

3 treatment administration

For those in the corticosteroid group, a suspension for injection containing triamcinolone acetonide is administered via perineural use. The product used is TRIGON DEPOT 40 mg/ml.

The treatment aims to alleviate chronic shoulder pain by targeting the suprascapular nerve.

4 follow-up assessments

The patient’s shoulder functionality and pain levels are evaluated using the SPADI (Shoulder Pain and Disability Index) test.

Additional assessments include demographics, comorbidity, pain scales such as the Visual Analog Scale (VAS) and Numerical Verbal Scale (NVS), range of motion, and the amount of analgesics administered.

Psychological and quality-of-life measures are also taken, including the Hospital Anxiety and Depression Scale (HAD), EuroQol 5D (EQ-5D), and the Medical Outcomes Study Sleep Scale (MOS).

5 satisfaction and outcome evaluation

Patient satisfaction with the treatment is assessed, and the overall outcome of the intervention is evaluated.

The trial aims to determine the effectiveness of the suprascapular nerve block with corticosteroids compared to pulsed radiofrequency in improving shoulder functionality and reducing pain.

Who Can Join the Study?

Men and women who are scheduled to receive a suprascapular nerve block. This is a procedure to help relieve shoulder pain.
Must be older than 18 years.
Have shoulder pain that has lasted for more than 3 months.
Must sign a form that shows they understand the study and agree to participate.

Who Cannot Join the Study?

Patients who are not experiencing chronic shoulder pain cannot participate. Chronic shoulder pain means having shoulder pain that lasts for a long time.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hvhjriqh Db Lj Skoor Cabr I Sxzj Pfw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	11.04.2018

Trial locations

Investigated drugs:

Triamcinolone Acetonide

Corticosteroids are medications used to reduce inflammation and relieve pain. In this trial, they are administered to block the suprascapular nerve, which can help improve shoulder functionality and reduce chronic shoulder pain.

Pulsed Radiofrequency is a therapy that uses electrical energy to target nerves and reduce pain. In this trial, it is applied to the suprascapular nerve to help alleviate chronic shoulder pain and improve shoulder function.

Investigated diseases:

Arthralgia

Chronic Shoulder Pain – Chronic shoulder pain is a persistent discomfort in the shoulder region that lasts for an extended period, often more than three months. It can result from various causes, including injuries, overuse, or underlying conditions such as arthritis or tendonitis. The pain may be constant or intermittent and can affect the shoulder’s range of motion and functionality. Individuals with chronic shoulder pain may experience stiffness, swelling, and difficulty performing daily activities. The condition can lead to a decrease in quality of life due to the ongoing discomfort and limitations in movement.

Trial ID:

2024-519892-24-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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