Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS.

Detailed Description
-----------------
This study was a prospective, randomized clinical trial. Patients with CTS were randomly treated with sonographically guided corticosteroid injection (group A); sonographically guided hydrodissection and corticosteroid injection (group B). Boston Carpal tunnel questionnaire, nerve conduction studies and VAS pain score were performed on initial visit and after 6 weeks and 12 weeks .

Official Title
-----------------
Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Drug: Triamcinolone Acetonide
* Drug: lidocaine hydrochloride
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of CTS The diagnosis of CTS was confirmed by electrophysiological tests. Exclusion Criteria: presence of thenar atrophy any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery history of distal radius fracture pregnancy or lactation regular use of systemic NSAIDs ,corticosteroids or diuretics known allergy to corticosteroids and local anesthetics. impaired cognitive function -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: steroid and hydrodissection<br>ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS | Drug: Triamcinolone Acetonide<br>* ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS<br>Drug: lidocaine hydrochloride<br>* ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS<br>Drug: normal saline<br>* ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS<br>|
| Active Comparator: steroid only<br>ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) | Drug: Triamcinolone Acetonide<br>* ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS<br>Drug: lidocaine hydrochloride<br>* ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in the scores on Boston Carpal tunnel Questionnaire (BQ) | The BQ was interviewed-administered to assess the severity of symptoms and functional status | 0, 6, 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in self reported pain intensity | patient were asked to indicate the intensity of their average level of pain for the wrist-hand region, using an 11-point scale, ranging from 0 to 10 (worst pain imaginable) | 0, 6, 12 weeks | 
| change from baseline in median nerve distal motor latency | the CMAPs were obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode was placed on the muscle belly, and the reference electrode was placed on the tendon insertion. The median nerve was stimulated 8 cm proximal to the active recording electrode. Distal motor latencies were measured from the onset of stimulus artifact to the onset of the CMAP | 0, 6, 12 weeks | 
| Change from Baseline in sensory nerve conduction velocity | SNAPs were obtained using an antidromic method and recorded by surface electrodes placed at the proximal and distal interphalangeal joints of the index finger for the median nerve and the same joints of the little finger for the ulnar nerve. The median nerves were stimulated at the wrist at a distance of 14 cm from the wrist to the active electrode. Distal sensory latencies were measured from the onset of the stimulus artifact to the onset of the SNAP. SNCV was calculated dividing the distance of 14 cm by the distal sensory latency. | 0, 6, 12 weeks |