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Completed

NCT Number: NCT02575729

Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).

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Key information

About this study

Material and methods: We have enrolled 26 ideopathic carpal tunnel syndrome patients (minimal to moderate according to Padua's classification).Thirteen patients were allocated in sonography approach group( sonography-guided local wrist injection, SAG) and the 13 patients were placed in direct approach group(direct local injection without using sonography, DAG). One , 3 and 6 months later after injection, we performed the outcome measures, including Boston symptom and functional scale, QuickDASH, nerve conduction study and sonography. If the patients receive the second injections, we will follow their treatment outcome by phone regularly at 1,3 and 6 months after first injection. If the patients were referred to surgery, the failures of local injection were considered and we will stop follow up them. After performing all assessment, we will compare the outcomes between the two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • with >2 following symptoms :
  • disrupt sleep result in nocturnal paresthesia.
  • symptoms release by shaking hand.
  • pain and paresthesia during grasping.
  • any sensory symptom on first, 2th, 3th and partial 4th fingers.
  • symptoms >1month.
  • Padua's classification : minimal, mild, moderate)
  • meet one of three diagnosis criteria of carpal tunnel syndrome.

Exclusion criteria

  • any history can cause periphery nerve disease.
  • affected side had fracture or paralysis.
  • had accepted operation for carpal tunnel syndrome before.
  • pregnant
  • wrist or hand sprain, ulnar nerve disease cervical nerve root disease, multiple neuropathy or nerve anastomosis.
  • Padua's classification: severe, extreme.
  • ultrasonography show space occupying.
  • patient taking anticoagulants.
  • severe systemic disease.
  • wrist's skin or wrist joint has infection.
  • can't complete the 6 months' follow up.
  • allergy to steroid.
  • has cognition disorder.

Treatment and study plan

Betamethasone

Drug

Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.

Other names: glucocorticoid preparation

Primary outcomes

  1. QuickDASH

    Time frame: Change from Baseline data at 6 weeks

Secondary outcomes

  1. Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS

    Time frame: Change from Baseline data at 6 weeks

  2. Record the neurological symptoms perceived by patient after injection according to their describtion

    Time frame: Change from Baseline data at 6 weeks

  3. Semmes-Weinstein Monofilament test(SWMT)

    Time frame: Change from Baseline data at 6 weeks

  4. 2-Point Discrimination test on 2nd digit

    Time frame: Change from Baseline data at 6 weeks

  5. Nerve conduction study done on the affected hand using Necolet Viking Quest

    Time frame: Change from Baseline data at 6 weeks

    We will record the latency, amplitude and conduction velocity retrieved from nerve conduction study of both motor neurons and sensory neuron

  6. Sonography examination done with patients sitting, elbow flexion and forearm supination placing on table

    Time frame: Change from Baseline data at 6 weeks

    The test will done twice and will record the average data of both the cross-section area and the bowing distance of transverse ligament of wrist.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 15, 2015
Registry last updated
Oct 15, 2015

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

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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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