Clinical trial NCT06360510: Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome
Official title: Comparison of the Effectiveness of Ultrasound-guided 5% Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
betamethasone
% 5 dextrose
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that have carpal tunnel syndrome

Brief summary: The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS).

Detailed description: It is planned as an observational, single-center clinical study.A total of 28 patients diagnosed with mild-moderate carpal tunnel syndrome who meet the inclusion criteria will be included in the study.Patients who had been experiencing trigger finger symptoms for at least three month and who presented to the Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, affiliated with the Health Sciences University Faculty of Medicine.

Patients will be divided into two groups. One group will receive 5% dextrose, the other group will receive 1 session of local injection by mixing Celeston chronodose \[1ml/3 mg betamethasone acetate+3,947 mg betamethasone disodium phosphate (equivalent to 3 mg betamethasone)\] and 1 ml 2% prilocaine.

Evaluations will be made before injection, at weeks 4 and 12.

Eligibility criteria: Inclusion Criteria:

* Paresthesia and pain symptoms in the region corresponding to the distribution of the median nerve
* Detection of mild or moderate CTS by electromyography
* One or both of the Phalen test and/or Tinel sign are positive on physical examination
* Symptoms have persisted for at least 3 months

Exclusion Criteria:

* Those diagnosed with polyneuropathy, plexopathy, radiculopathy, thoracic outlet syndrome
* Having had surgery or any injection for carpal tunnel syndrome within the last year
* History of wrist fracture
* Those with rheumatoid arthritis, uncontrolled diabetes, gout, chronic renal failure, malignancy, active systemic infection
* Those with cognitive impairment
* Coagulopathy or bleeding tendency
* Pregnancy

Primary outcomes:
measure: vas
timeFrame: three months
Secondary outcomes:
measure: boston carpal tunnel syndrome questionnaire
timeFrame: three months
measure: median nerve cross sectional area
timeFrame: three months
measure: tinnel test positivity
timeFrame: three months
measure: phalen test positivity
timeFrame: three months
measure: duruöz hand index
timeFrame: three months
measure: global evaluation of treatment outcomes
timeFrame: three months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
References: