Clinical trial NCT02575729: Sonography-guided Steroid Injection for Carpal Tunnel Syndrome
Official title: Sonography-guided Steroid Injection for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carpal Tunnel Syndrome(CTS)
Keywords: carpal tunnel syndrome
local steroid injection
sonography
sonography-guided
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* with \>2 following symptoms :

  1. disrupt sleep result in nocturnal paresthesia.
  2. symptoms release by shaking hand.
  3. pain and paresthesia during grasping.
  4. 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.

Primary outcomes:
measure: QuickDASH
timeFrame: Change from Baseline data at 6 weeks
Secondary outcomes:
measure: Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS
timeFrame: Change from Baseline data at 6 weeks
measure: Record the neurological symptoms perceived by patient after injection according to their describtion
timeFrame: Change from Baseline data at 6 weeks
measure: Semmes-Weinstein Monofilament test(SWMT)
timeFrame: Change from Baseline data at 6 weeks
measure: 2-Point Discrimination test on 2nd digit
timeFrame: Change from Baseline data at 6 weeks
measure: Nerve conduction study done on the affected hand using Necolet Viking Quest
timeFrame: Change from Baseline data at 6 weeks
measure: Sonography examination done with patients sitting, elbow flexion and forearm supination placing on table
timeFrame: Change from Baseline data at 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Rehabilitation
name: Pong Ya-Ping, MD
role: STUDY_CHAIR
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