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Non-surgical Treatment of Carpal Tunnel Syndrome: Night Splint Versus Local Corticosteroid Infiltration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03196817
Recruitment Status : Unknown
Verified June 2017 by João Carlos Belloti, Hospital Alvorada.
Recruitment status was:  Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):
João Carlos Belloti, Hospital Alvorada

Brief Summary:

Carpal tunnel syndrome (CTS) is the most common neuropathic compression syndrome of the upper limbs, caused by compression of the median nerve in the wrist. There is no gold standard for establishing the diagnosis of STC. The diagnosis can be based on clinical findings and electrodiagnostic tests. Treatment options can be divided into surgical and non-surgical procedures. Surgical interventions include open carpal tunnel release, mini incision or release of the endoscopic carpal tunnel. Nonsurgical include daily activities modification, oral anti-inflammatory drugs (NSAIDs), oral corticosteroids, splints, corticosteroid injections or other options (laser therapy, ultrasound or acupuncture)

The aim of this study is to compare randomly, conservative treatment for CTS with night splint of the wrist versus local infiltration of corticosteroids after a min-imum period of six months follow-up.

Patients will be divided into two groups: night orthesis group that will receive the prescription to purchase the orthesis and guide the use of it; and infiltration group of patients will be referred to the Moema Alvorada Hospital to carry out infiltration. These patients will be evaluated before application, one week, one month, three months and six months after intervention.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: betamethasone dipropionate, betamethasone disodium phosphate and lidocaine 2% Device: Wrist splinting Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Non-surgical Treatment of Carpal Tunnel Syndrome: Night Splint Versus Local Corticosteroid Infiltration: Clinical Randomized Trial
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : May 1, 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Carpal tunnel injection
Carpal tunnel injection (infiltration) group of patients will be referred to the Hospital Alvorada to carry out steroid injection. The injection in carpal tunnel will be an association of 6.43 mg of betamethasone dipropionate, 2.63 mg of betamethasone disodium phosphate and 0.5 ml plus lidocaine 2%, totaling 1.5 ml.
Drug: betamethasone dipropionate, betamethasone disodium phosphate and lidocaine 2%
6.43 mg of betamethasone dipropionate, 2.63 mg of betamethasone disodium phosphate and 0.5 ml plus lidocaine 2%
Other Name: Steroid injection

Active Comparator: Wrist splinting
Wrist splinting will be use in the nigth time, remain the wrist in the 15th degree in extension, until its removal in the morning.
Device: Wrist splinting
Splinting only at night to maintain the wrist positioned in 15 degrees of extensionin.
Other Name: wrist splints

Primary Outcome Measures :
  1. Remission of symptoms [ Time Frame: 6 months ]
    Remission of nocturnal paresthesia referred by the patient at six months the follow up.

  2. Boston Questionnaire (Levine) [ Time Frame: 6 months ]
    A questionnaire developed for the purpose of evaluating the severity of symptoms and the degree of manual ability of patients with CTS.

Secondary Outcome Measures :
  1. Visual Analogue Scale - EVA Pain Evaluation [ Time Frame: 6 months ]
    The analogical visual scale of pain is formed by two bars, joined by a line with ten centimeters, that mark the beginning and the end. The start bar is "0" and indicates no pain. The end bar is the "10" and indicates the maximum pain.

  2. Graham Criteria - CTS-6 [ Time Frame: 6 months ]
    Assessment of improvement of graham's cervix, which are signs and symptoms used for the diagnosis of CTS

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients aged 40 years or more,
  • Have the diagnosis confirmed with electromyography (EMG),
  • Four or more than six of the following clinical signs and symptoms suggested by Graham et al (CTS-6):

    • Paraesthesia in the territory of the median nerve.
    • Night hand paresthesia
    • Atrophy of thenar muscles
    • Positive Tinel Sign
    • Phalen Test Positive
    • Loss of two point discrimination
  • Sign a Research Ethics Committe, after reading and explanation of the proposed study.

Non-inclusion criteria:

  • Pretreatment with corticosteroids and splint
  • Prior surgical treatment
  • Traumatic or nontraumatic pathologies associated
  • Hypersensitivity to corticosteroids
  • CTS secondary to other pathology
  • Refusal to sign a Research Ethics Committe.
  • Fixed Paresthesia

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 identifier (NCT number): NCT03196817

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Jesus Queiroz junior
São Paulo, Brazil, 03325000
Sponsors and Collaborators
Hospital Alvorada
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Principal Investigator: Non-surgical T Infiltration Hospital Alvorada

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Responsible Party: João Carlos Belloti, Clinical Professor, Hospital Alvorada Identifier: NCT03196817    
Other Study ID Numbers: HAMJQ01
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by João Carlos Belloti, Hospital Alvorada:
Random Allocation
Orthotic Devices
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action