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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Crossover Assignment|
|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|
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
- 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.
- 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
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
|Jesus Queiroz junior|
|São Paulo, Brazil, 03325000|
|Principal Investigator:||Non-surgical T Infiltration||Hospital Alvorada|