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Completed

NCT Number: NCT02708693

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

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

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of CTS
  • The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion criteria

  • 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
  • known allergy to corticosteroids and local anesthetics.

Treatment and study plan

Triamcinolone Acetonide

Drug

ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)

Other names: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)

thermoplastic wrist splint

Device

thermoplastic wrist splint with wrist placed in a neutral position

Lidocaine Hydrochloride

Drug

ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)

Other names: lidocaine hydrochloride (Xylocaine)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 15, 2016
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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