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

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ClinicalTrials.gov 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

Sponsor:

Information provided by (Responsible Party):

João Carlos Belloti, Hospital Alvorada

Study Description

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 Design

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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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Carpal tunnel syndrome

MedlinePlus related topics: Carpal Tunnel Syndrome Steroids

Drug Information available for: Betamethasone Betamethasone dipropionate Sodium phosphate, dibasic

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsies Roussy Levy Syndrome

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

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.
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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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): NCT03196817

Locations

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Brazil
Jesus Queiroz junior
São Paulo, Brazil, 03325000

Sponsors and Collaborators

Hospital Alvorada

Investigators

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Principal Investigator:	Non-surgical T Infiltration	Hospital Alvorada

More Information

Publications:

Chen PC, Chuang CH, Tu YK, Bai CH, Chen CF, Liaw M. A Bayesian network meta-analysis: Comparing the clinical effectiveness of local corticosteroid injections using different treatment strategies for carpal tunnel syndrome. BMC Musculoskelet Disord. 2015 Nov 19;16:363. doi: 10.1186/s12891-015-0815-8. Review. Erratum in: BMC Musculoskelet Disord. 2015;16(1):394.

Ly-Pen D, Andréu JL, Millán I, de Blas G, Sánchez-Olaso A. Comparison of surgical decompression and local steroid injection in the treatment of carpal tunnel syndrome: 2-year clinical results from a randomized trial. Rheumatology (Oxford). 2012 Aug;51(8):1447-54. doi: 10.1093/rheumatology/kes053. Epub 2012 Mar 30.

Meems M, Den Oudsten B, Meems BJ, Pop V. Effectiveness of mechanical traction as a non-surgical treatment for carpal tunnel syndrome compared to care as usual: study protocol for a randomized controlled trial. Trials. 2014 May 22;15:180. doi: 10.1186/1745-6215-15-180.

Graham B, Regehr G, Naglie G, Wright JG. Development and validation of diagnostic criteria for carpal tunnel syndrome. J Hand Surg Am. 2006 Jul-Aug;31(6):919-24.

Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-de Jong B. Randomised controlled trial of local corticosteroid injections for carpal tunnel syndrome in general practice. BMC Fam Pract. 2010 Jul 29;11:54. doi: 10.1186/1471-2296-11-54.

Ucan H, Yagci I, Yilmaz L, Yagmurlu F, Keskin D, Bodur H. Comparison of splinting, splinting plus local steroid injection and open carpal tunnel release outcomes in idiopathic carpal tunnel syndrome. Rheumatol Int. 2006 Nov;27(1):45-51. Epub 2006 Jul 27.

Carlson H, Colbert A, Frydl J, Arnall E, Elliot M, Carlson N. Current options for nonsurgical management of carpal tunnel syndrome. Int J Clin Rheumtol. 2010 Feb;5(1):129-142.

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Responsible Party:	João Carlos Belloti, Clinical Professor, Hospital Alvorada
ClinicalTrials.gov Identifier:	NCT03196817 History of Changes
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 Injections Orthotic Devices

Additional relevant MeSH terms:

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Carpal Tunnel Syndrome Syndrome Disease Pathologic Processes Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Betamethasone Betamethasone Valerate	Betamethasone-17,21-dipropionate Betamethasone benzoate Lidocaine Betamethasone sodium phosphate Anesthetics, Local Anesthetics 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

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