Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Phase 3

Completed

• Conditions: Carpal Tunnel Syndrome(CTS)
• Interventions: Drug: betamethasone

• Registration Number: NCT02575729
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-09
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-10-12
• Last Update Submitted: 2015-10-12
• Study First Posted: 2015-10-15
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inject betamethasone by sonography	betamethasone	Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease by sonography- guided. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand.
Inject betamethasone directly	betamethasone	Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease directly. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand.

Primary Outcome Measures

Name	Time	Method
QuickDASH	Change from Baseline data at 6 weeks

Secondary Outcome Measures

Name	Time	Method
2-Point Discrimination test on 2nd digit	Change from Baseline data at 6 weeks
Nerve conduction study done on the affected hand using Necolet Viking Quest	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
Sonography examination done with patients sitting, elbow flexion and forearm supination placing on table	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.
Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS	Change from Baseline data at 6 weeks
Record the neurological symptoms perceived by patient after injection according to their describtion	Change from Baseline data at 6 weeks
Semmes-Weinstein Monofilament test(SWMT)	Change from Baseline data at 6 weeks