Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Chang Gung Medical Foundation

Status and phase: Completed; Phase 3

Conditions: Carpal Tunnel Syndrome(CTS)

Treatments: Drug: betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02575729

NMRPG8A0051

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Inject betamethasone by sonography

Experimental group

Description:

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.

Treatment:

Drug: betamethasone

Inject betamethasone directly

Active Comparator group

Description:

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.

Treatment:

Drug: betamethasone