Clinical trial NCT04848324: Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection
Official title: Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
ultrasonography
hydrodissection
steroid injection
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Aim: Steroid injections are remarkably effective as a treatment for carpal tunnel syndrome (CTS) in the short term. The aim of this study was to determine whether hydrodissection would provide an additional clinical effect when used along with a corticosteroid in the short term.

Methods: A prospective cohort of patients with CTS were retrospectively evaluated. 28 patients were selected randomly who received ultrasound (US)-guided triamcinolone hydrodissection (3 mL) as intervention group and received US-guided triamcinolone injection (1 mL) as control group, from the data (case-control ratio 1:1). Outcome measures were the Boston Carpal Tunnel Questionnaire (BCTQ), hand grip strength (HGS), fhe cross-sectional area (CSA) of the median nerve and Short Form 12 (SF-12). Assessments were recorded at baseline, 1 and 4 weeks after injection.

Detailed description: Background: Steroid injections are remarkably effective as a treatment for carpal tunnel syndrome (CTS) in the short term.

Aim: To determine whether hydrodissection would provide an additional clinical effect when used along with a corticosteroid in the short term.

Methods: A prospective cohort of patients with CTS were retrospectively evaluated. 28 patients were selected randomly who received ultrasound (US)-guided triamcinolone hydrodissection (3 mL) as intervention group and received US-guided triamcinolone injection (1 mL) as control group, from the data (case-control ratio 1:1). Outcome measures were the Boston Carpal Tunnel Questionnaire (BCTQ), hand grip strength (HGS), fhe cross-sectional area (CSA) of the median nerve and Short Form 12 (SF-12). Assessments were recorded at baseline, 1 and 4 weeks after injection.

Eligibility criteria: Inclusion Criteria:

1. aged between 18-65
2. clinically diagnosed with CTS
3. electrophysiologically confirmed mild-to-moderate CTS
4. having typical CTS symptoms for at least 3 months
5. not benefiting from splinting and resting.

Exclusion Criteria:

1. electrophysiologically diagnosed with severe CTS
2. surgery history for CTS
3. presence of metabolic, endocrine and neoplastic disorders
4. presence of other neurological disorders (such as plexopathy, cervical radiculopathy, proximal median or ulnar neuropathy, polyneuropathy and mononeuritis multiplex)

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
timeFrame: baseline, change from baseline BCTQ at 1 and 4 weeks after injection
measure: Hand grip strength (HGS)
timeFrame: baseline, change from baseline HGS at 1 and 4 weeks after injection
measure: Cross-Sectional Area of the Median Nerve
timeFrame: baseline, change from baseline CSA at 1 and 4 weeks after injection
Secondary outcomes:
measure: Short Form 12 (SF-12)
timeFrame: baseline, change from baseline SF-12 at 1 and 4 weeks after injection
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Merve Orucu Atar
state: Cankaya
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
name: Merve Orucu Atar
role: PRINCIPAL_INVESTIGATOR
References: