Study Comparing Injection Therapy with Triamcinolone Acetonide and Triamcinolone Hexacetonide to Surgery for Carpal Tunnel Syndrome in Adults

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What is this study about?

This clinical trial is focused on studying Carpal Tunnel Syndrome, a condition that causes pain, numbness, and tingling in the hand and arm. The study is comparing two treatment strategies to see which is more effective. One strategy involves using an initial treatment with injections, specifically using medications called Kenacort-T (containing triamcinolone acetonide), Trica, and Lederspan (both containing triamcinolone hexacetonide). These medications are given as injections to help reduce inflammation and relieve symptoms. The other strategy involves surgery as the primary treatment option.

The purpose of the study is to determine if the injection treatment strategy is as effective as the surgery-first approach. Participants in the study will receive either the injection treatment or surgery and will be monitored over a period of 12 months to assess the success of the treatment. The study will also look at the outcomes after 3, 6, and 24 months to gather more information about the long-term effects of each treatment strategy.

Throughout the study, participants will have regular check-ups to evaluate their symptoms and overall health. The study will also track any side effects and how the treatments impact daily activities and work performance. This research aims to provide valuable insights into the best treatment options for managing Carpal Tunnel Syndrome effectively.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of carpal tunnel syndrome (CTS). This includes reviewing patient history and conducting a neurophysiological examination if not done within the last six months.

The assessment ensures symptoms are mild to moderate, affecting daily life or sleep.

2 treatment strategy assignment

Participants are assigned to one of two treatment strategies. The first strategy involves initial ultrasound-guided injection therapy, using up to two injections of triamcinolone acetonide or triamcinolone hexacetonide.

The second strategy involves surgery as the primary treatment.

3 injection therapy

For those in the injection therapy group, the medication is administered as a suspension for injection. The dosage is either 20 mg/ml or 40 mg/ml, depending on the specific product used.

The effect of the injection is assessed at scheduled clinical visits.

4 surgical intervention

If the injection therapy does not achieve the desired effect, surgery may be considered as a subsequent step.

Participants in the surgery group undergo the procedure as the primary treatment.

5 follow-up assessments

Follow-up assessments are conducted at 3, 6, 12, and 24 months to evaluate the success of the treatment. The primary goal is to achieve a symptom score of 1.5 or less on the Boston Carpal Tunnel Questionnaire.

Secondary assessments include work performance, health care utilization, and patient-reported symptoms and function.

6 adverse events monitoring

Throughout the study, any adverse events are monitored and recorded to ensure participant safety.

This includes tracking any side effects from the injections or surgical procedures.

7 final evaluation

A final evaluation is conducted at the end of the study period to determine the overall success of the treatment strategy.

The study aims to conclude by December 31, 2032.

Who Can Join the Study?

Must be an adult (18 years of age or older).
Have a history that suggests Carpal Tunnel Syndrome (CTS). This means having symptoms or experiences that point to this condition.
Have had a neurophysiological examination within the last 6 months. This is a test that checks how well your nerves and muscles are working.
Have a diagnosis of CTS based on either:
- Classic, probable, or possible symptoms, along with test results that match CTS.
- If test results are normal, then classic or probable symptoms, plus positive findings from a physical exam or symptoms that occur at night.
Experience mild to moderate symptoms. This means symptoms that come and go, interfere with daily life, or disturb sleep.

Who Cannot Join the Study?

Patients who are under 18 years old or over 65 years old cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Diakonhjemmet Sykehus AS	Oslo	Norway
Martina Hansens Hospital AS	Gjettum	Norway
Awrlabru Ubxtyobrkf Hbguascs	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.04.2022

Trial locations

Investigated drugs:

Ultrasound-Guided Injection Therapy
This therapy involves using ultrasound technology to guide the injection of medication directly into the carpal tunnel area. The goal is to reduce inflammation and relieve pressure on the median nerve, which can help alleviate symptoms of carpal tunnel syndrome. In this trial, patients may receive up to two injections as part of their treatment strategy.

Surgery
Surgery for carpal tunnel syndrome typically involves a procedure called carpal tunnel release. This surgery aims to relieve pressure on the median nerve by cutting the ligament that forms the roof of the carpal tunnel. It is considered when other treatments, like injections, do not provide sufficient relief. In this trial, surgery is used as a primary treatment strategy for some patients.

Investigated diseases:

Carpal tunnel syndrome

Carpal Tunnel Syndrome – This condition occurs when the median nerve, which runs from the forearm into the palm of the hand, becomes pressed or squeezed at the wrist. It often results in numbness, tingling, and weakness in the hand and arm. The symptoms typically start gradually and may occur more frequently at night. As the condition progresses, individuals may experience a decrease in grip strength and difficulty with fine motor tasks. Over time, the muscles at the base of the thumb may weaken. If left unaddressed, the symptoms can become persistent and more severe.

Trial ID:

2024-511223-34-00

NCT ID:

NCT05306548

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Injection Therapy with Triamcinolone Acetonide and Triamcinolone Hexacetonide to Surgery for Carpal Tunnel Syndrome in Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?