A Comparative Study of Triamcinolone Acetonide and Triamcinolone Hexacetonide Injection Strategies Versus Surgical Intervention in Carpal Tunnel Syndrome

The primary objective of the study is to assess if the success rate of a treatment strategy involving initial **ultrasound-guided injection** therapy, with up to two injections, followed by scheduled clinical assessment and subsequent surgery if necessary, is non-inferior to a strategy where surgery is the primary treatment. This evaluation is conducted 12 months after the first intervention. The clinical relevance of this objective lies in determining whether a less invasive approach can achieve comparable outcomes to surgery, potentially offering a safer and more cost-effective treatment option for patients with **Carpal Tunnel Syndrome**.

Secondary objectives include:

• Estimating if the success rate of the injection strategy is non-inferior to primary surgery over different time perspectives.
• Estimating the success rate of one and two **steroid injections**.
• Assessing the proportion of patients requiring secondary surgery in the injection arm.
• Evaluating the cost-effectiveness and health economic impact of the treatment strategies.
• Comparing the safety of the two study arms.
• Assessing predictors of patient outcomes.
• Evaluating the environmental impact of the study interventions and treatment strategies.

The clinical trial focuses on **Carpal Tunnel Syndrome** and involves a study population comprising adults aged 18 years and older. Both male and female participants are included, with no vulnerable populations selected. The trial does not specify the total number of participants, as the sponsor has not provided this information. Participants were selected based on a history indicating Carpal Tunnel Syndrome, with a neurophysiological examination conducted within the past six months. The diagnosis is confirmed through classic, probable, or possible symptoms, alongside neurophysiological findings consistent with the syndrome, or through classic symptoms with positive physical exam findings and/or nighttime symptoms in cases of normal neurophysiological results. The study targets individuals experiencing mild to moderate symptoms that intermittently interfere with everyday life or disturb sleep. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate treatment strategies for **Carpal Tunnel Syndrome**. It is a randomized, double-blind, controlled trial with a primary objective to assess the non-inferiority of an initial ultrasound-guided injection therapy strategy compared to primary surgical intervention. The trial will span approximately 10 years, with an estimated end date of December 31, 2032. Participants will be involved for a maximum treatment period of 104 weeks, with the possibility of early termination if adverse events occur or if the participant withdraws consent.

Study visits are structured to include an initial screening visit to confirm eligibility based on criteria such as age (≥18 years), patient history, and neurophysiological examination results. Following the inclusion visit, participants will undergo scheduled clinical assessments to evaluate treatment effects. Follow-up visits are planned at 3, 6, 12, and 24 months to monitor treatment outcomes, including the success rate of the intervention as defined by the Boston Carpal Tunnel Questionnaire Symptom Score. The end-of-study visit will occur at the conclusion of the participant's involvement, or earlier if the study is terminated for that individual.

Participants will receive either **triamcinolone acetonide** or **triamcinolone hexacetonide** via injection, with a maximum daily dose of 20 mg and a total dose not exceeding 40 mg. The trial will monitor primary endpoints such as successful treatment outcomes after one year, while secondary endpoints will include treatment success at various intervals, work performance, healthcare utilization, and adverse events. The trial is categorized as a Phase IV clinical trial, ensuring that the investigational medicinal products are used according to their marketing authorization terms.

The clinical trial involves the administration of **Kenacort-T 40 mg/ml**, a **suspension for injection** containing the active substance **triamcinolone acetonide**. This pharmaceutical form is designed for injection and is provided by Bristol-Myers Squibb AB. The maximum daily dose is 20 mg, with a total maximum dose of 40 mg over the treatment period. The treatment is administered via injection, with a maximum treatment period of 104 weeks. The formulation is not pediatric-specific and is chemically derived.

Another treatment used in the trial is **Trica 20 mg/ml**, also a **suspension for injection**. This product contains **triamcinolone hexacetonide** as the active substance and is manufactured by Esteve Pharmaceuticals GmbH. Similar to Kenacort-T, the maximum daily dose is 20 mg, with a total maximum dose of 40 mg. The administration route is injection, and the treatment period can extend up to 104 weeks. This formulation is also chemically derived and not intended for pediatric use.

The third treatment option in the trial is **Lederspan 20 mg/ml**, a **suspension for injection** containing **triamcinolone hexacetonide**. Produced by Viatris AS, this treatment shares the same dosing parameters as the other two products, with a maximum daily dose of 20 mg and a total maximum dose of 40 mg. The administration is via injection, and the treatment duration is up to 104 weeks. This product is chemically derived and not formulated for pediatric use.

All treatments in the trial are administered through injection, and participant compliance is monitored throughout the study. The trial aims to compare the effectiveness of these treatments in managing Carpal Tunnel Syndrome, with a focus on the success rate of initial ultrasound-guided injection therapy versus primary surgical intervention.

Efficacy in the clinical trial for Carpal Tunnel Syndrome will be assessed using both primary and secondary endpoints. The primary endpoint is defined as a successful treatment outcome after one year, measured by achieving a Boston Carpal Tunnel Questionnaire Symptom Score of ≤ 1.5. Secondary endpoints include successful treatment results at 3, 6, and 24 months, as well as after one and two injections. Additionally, the trial will evaluate the number of patients in the injection arm who undergo surgery at various time points, including 3 weeks, 3, 6, 12, and 24 months. Other secondary endpoints involve work performance, healthcare utilization, adverse events, patient-reported measures of symptoms and function, ultrasound and nerve conduction study (NCS) measures, and emitted CO2-equivalents per treatment strategy pathway.

The efficacy parameters will be collected and analyzed at specified intervals throughout the study, with patient-reported outcomes and clinical assessments forming a significant part of the data collection process. The trial aims to determine if the treatment strategy involving initial ultrasound-guided injection therapy is non-inferior to a primary surgical approach, with evaluations conducted 12 months after the first intervention. The study is designed to provide comprehensive insights into the effectiveness of different treatment strategies for Carpal Tunnel Syndrome over a prolonged period.