Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02575729

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome(CTS)	Drug: betamethasone	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inject betamethasone by sonography 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.	Drug: betamethasone Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly. Other Names: glucocorticoid preparation
Active Comparator: Inject betamethasone directly 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.	Drug: betamethasone Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly. Other Names: glucocorticoid preparation

Arm

Intervention/Treatment

Experimental: Inject betamethasone by sonography

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.

Drug: betamethasone

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

Other Names:

glucocorticoid preparation

Active Comparator: Inject betamethasone directly

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.

Drug: betamethasone

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

Other Names:

glucocorticoid preparation

Outcome Measures

Primary Outcome Measures

QuickDASH [Change from Baseline data at 6 weeks]

Secondary Outcome Measures

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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.