Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

October 12, 2015 updated by: Chang Gung Memorial Hospital
Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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.
Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.
Other Names:
  • glucocorticoid preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QuickDASH
Time Frame: Change from Baseline data at 6 weeks
Change from Baseline data at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS
Time Frame: Change from Baseline data at 6 weeks
Change from Baseline data at 6 weeks
Record the neurological symptoms perceived by patient after injection according to their describtion
Time Frame: Change from Baseline data at 6 weeks
Change from Baseline data at 6 weeks
Semmes-Weinstein Monofilament test(SWMT)
Time Frame: Change from Baseline data at 6 weeks
Change from Baseline data at 6 weeks
2-Point Discrimination test on 2nd digit
Time Frame: Change from Baseline data at 6 weeks
Change from Baseline data at 6 weeks
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
Change from Baseline data at 6 weeks
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.
Change from Baseline data at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

October 12, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

September 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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