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Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02708693
Recruitment Status : Completed
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of steroid injection alone using clinical and electrophysiological parameters in patients with carpal tunnel syndrome

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Triamcinolone Acetonide Device: thermoplastic wrist splint Drug: lidocaine hydrochloride Not Applicable

Detailed Description:
This is a prospective, single-blinded randomized controlled study. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection and group receiving ultrasound guided corticosteroid injection and splinting. The steroid injection was using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine). The inclusion criteria included an age of more than 18 years and typical signs of CTS according to American Academy of Neurology criteria lasting for at least 3 months. The diagnosis of CTS was confirmed by electrophysiological tests.The exclusion criteria included the following: presence of thenar atrophy; existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; 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 or carpal tunnel surgery; history of distal radius fracture; pregnancy or lactation; regular use of systemic NSAIDs or corticosteroids; and known allergy to corticosteroids and local anesthetics.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014


Arm Intervention/treatment
Experimental: experimental: steroid injection and splinting
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint
Drug: Triamcinolone Acetonide
ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)
Other Name: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)

Device: thermoplastic wrist splint
thermoplastic wrist splint with wrist placed in a neutral position

Drug: lidocaine hydrochloride
ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Other Name: lidocaine hydrochloride (Xylocaine)

Active Comparator: steroid injection
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Drug: Triamcinolone Acetonide
ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)
Other Name: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)

Drug: lidocaine hydrochloride
ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Other Name: lidocaine hydrochloride (Xylocaine)




Primary Outcome Measures :
  1. Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ). [ Time Frame: at 2, 6, 12 weeks ]
    The BQ was interviewed-administered to assess the severity of symptoms and functional status.


Secondary Outcome Measures :
  1. Change from Baseline in Median nerve distal motor latency [ Time Frame: at 2, 6, 12 weeks ]
    or the motor studies, 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

  2. Change from Baseline in sensory nerve conduction velocity [ Time Frame: at 2, 6, 12 weeks ]
    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.

  3. Change from Baseline in compound muscle action potential amplitude (CMAP) [ Time Frame: at 2, 6, 12 weeks ]
    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. The amplitude of CMAP were measured from baseline to negative peak.

  4. Change from Baseline in sensory nerve action potential amplitudes. [ Time Frame: at 2, 6, 12 weeks ]
    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. The amplitude of SNAP were measured from baseline to negative peak.

  5. Change from Baseline in self-reported pain intensity [ Time Frame: at 2, 6, 12 weeks ]
    Patients were asked to indicate the intensity of their average level of pain for the wrist-hand region within the past 1 week, using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).

  6. change from Baseline in Cross sectional area [ Time Frame: at 2, 6, 12 weeks ]
    The CSA of the median nerve was measured using ultrasound at 2 levels: at the carpal tunnel inlet (CSA-I; immediately prior to the proximal margin of the flexor retinaculum) and in the mid-carpal tunnel (CSA-M; at the level of the pisiform bone and scaphoid tubercle). The CSA within the surrounding hyperechoic rim was measured. The CSA was measured using a continuous boundary trace of the nerve and was directly calculated using the area measurement software included with the ultrasonography device

  7. change from Baseline in flattening ratio [ Time Frame: at 2, 6, 12 weeks ]
    The flattening ratio was measured only at the mid-tunnel (FR-M) using ultrasound. FR was calculated by dividing the horizontal diameter of the nerve by the vertical diameter.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. clinical diagnosis of CTS
  2. The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

  1. presence of thenar atrophy
  2. existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
  3. prior steroid injection into the affected carpal tunnel or carpal tunnel surgery
  4. history of distal radius fracture
  5. pregnancy or lactation
  6. regular use of systemic NSAIDs or corticosteroids
  7. known allergy to corticosteroids and local anesthetics.

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02708693     History of Changes
Other Study ID Numbers: 2012-05-021A
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: April 2013

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Lidocaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents