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Completed

NCT Number: NCT03072290

Corticosteroid Injection in Carpal Tunnel Syndrome

To compare the effectiveness of different dose of ultrasound guided steroid injection in patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in evlauation

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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

Primary location

Taipei veteran general hospital

Taipei, Taiwan

About this study

This is a prospective, single-blinded randomized controlled study to determine the efficacy of low dose corticosteroid in patient with CTS. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection with different dosage of triamcinolone acetonide (Shincort) mixed, 1ml 10mg (10mg/ml) or 1ml 40mg (40mg/ml) with 1 ml of 2% lidocaine hydrochloride. The follow up at 6 and 12 weeks includes Boston Carpal Tunnel Questionnaire, nerve conductive study and VAS pain score.

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 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

Treatment and study plan

Triamcinolone Acetonide

Drug

ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)

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

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 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 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. 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 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 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 self-reported pain intensity

    Time frame: at 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).

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2017
Registry last updated
Jul 30, 2019

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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