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Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02575729
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
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).

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 Type : Interventional  (Clinical Trial)
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 : August 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014


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 Name: 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 Name: glucocorticoid preparation




Primary Outcome Measures :
  1. QuickDASH [ Time Frame: Change from Baseline data at 6 weeks ]

Secondary Outcome Measures :
  1. Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS [ Time Frame: Change from Baseline data at 6 weeks ]
  2. Record the neurological symptoms perceived by patient after injection according to their describtion [ Time Frame: Change from Baseline data at 6 weeks ]
  3. Semmes-Weinstein Monofilament test(SWMT) [ Time Frame: Change from Baseline data at 6 weeks ]
  4. 2-Point Discrimination test on 2nd digit [ Time Frame: Change from Baseline data at 6 weeks ]
  5. 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

  6. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575729


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Pong Ya-Ping, MD Rehabilitation

Publications:

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02575729     History of Changes
Other Study ID Numbers: NMRPG8A0051
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: September 2015

Keywords provided by Chang Gung Memorial Hospital:
carpal tunnel syndrome
local steroid injection
sonography
sonography-guided

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Glucocorticoids
Betamethasone
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone-17,21-dipropionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Anti-Asthmatic Agents
Respiratory System Agents