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

NCT03196817 | Unknown Phase 4 DMC

• 1 other identifier: HAMJQ01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Random Allocation; Injections; Orthotic Devices

Outcome Measures

Primary Outcomes (2)

• Remission of symptoms

  Remission of nocturnal paresthesia referred by the patient at six months the follow up.

  6 months

• Boston Questionnaire (Levine)

  A questionnaire developed for the purpose of evaluating the severity of symptoms and the degree of manual ability of patients with CTS.

  6 months

Secondary Outcomes (2)

• Visual Analogue Scale - EVA Pain Evaluation

  6 months

• Graham Criteria - CTS-6

  6 months

Study Arms (2)

Carpal tunnel injection

ACTIVE COMPARATOR

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%

Wrist splinting

ACTIVE COMPARATOR

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

Interventions

betamethasone dipropionate, betamethasone disodium phosphate and lidocaine 2% DRUG

6.43 mg of betamethasone dipropionate, 2.63 mg of betamethasone disodium phosphate and 0.5 ml plus lidocaine 2%

Also known as: Steroid injection

Carpal tunnel injection

Wrist splinting DEVICE

Splinting only at night to maintain the wrist positioned in 15 degrees of extensionin.

Also known as: wrist splints

Wrist splinting

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Pretreatment with corticosteroids and splint
• Prior surgical treatment
• Traumatic or nontraumatic pathologies associated
• Hypersensitivity to corticosteroids
• CTS secondary to other pathology

Sponsors & Collaborators

• Hospital Alvorada: lead

Study Sites (1)

Jesus Queiroz junior

São Paulo, 03325000, Brazil

Location

Related Publications (7)

• 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.

  PMID: 26585378 BACKGROUND

• Ly-Pen D, Andreu JL, Millan I, de Blas G, Sanchez-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.

  PMID: 22467087 BACKGROUND

• 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.

  PMID: 24886455 BACKGROUND

• 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.

  PMID: 16886290 BACKGROUND

• 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.

  PMID: 20670438 BACKGROUND

• 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. doi: 10.1007/s00296-006-0163-y. Epub 2006 Jul 27.

  PMID: 16871409 BACKGROUND

• 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. doi: 10.2217/IJR.09.63.

  PMID: 20490348 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

betamethasone-17,21-dipropionate; betamethasone sodium phosphate; Steroids

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Non-surgical T Infiltration

  Hospital Alvorada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: June 23, 2017
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)