Clinical trial NCT03196817: Non-surgical Treatment of Carpal Tunnel Syndrome: Night Splint Versus Local Corticosteroid Infiltration
Official title: Non-surgical Treatment of Carpal Tunnel Syndrome: Night Splint Versus Local Corticosteroid Infiltration: Clinical Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Keywords: Random Allocation
Injections
Orthotic Devices
Lead sponsor: Hospital Alvorada
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: This study will be developed in the service of medical residency of surgery and microsurgery of the hand of Alvorada hospital (São Paulo - SP).

The Study Design is Randomized clinical trial according to the CONSORT STATEMENT (http://www.consort-statement.org) standards.

The number of participants will initially be 84 patients.

Inclusion criteria:

Adult patients 40 years of age or older with four or more of the following clinical signs and symptoms suggested by Graham et al. (CTS-6):

1. Paresthesia in the territory of the median nerve.
2. Nocturnal paresthesia of the hand
3. Atrophy of the tenar musculature
4. Positive Tinel Signal
5. Positive Phalen Test
6. Loss of discrimination of 2 points

All patients will be diagnosed with electromyography (EMG). All participants will sign an Research Ethics Committee of this institution, after reading and explaining the study proposal.

Criteria for non-inclusion:

Previous treatment with corticosteroids and felling in the last 6 months Previous surgical treatment Associated traumatic or non-traumatic pathologies Hypersensitivity to corticosteroids. CTS secondary to another pathology. Refusal to Research Ethics Committe. Fixed paresthesia

Randomization and Allocation:

The allocation of patients to the infiltration or nocturnal orthosis groups will be performed using opaque and numbered envelopes on their outer face with consecutive numbers. The draw of the method, for each envelope, will be done randomly and sequentially, using randomization software (available at: http://www.random.org), after the randomization, the envelopes will be sealed. The sealed envelope, containing the patient's allocation group, will be opened only at the doctor's office after verification of the criteria for inclusion and signing of the Research Ethics Committee signature. The randomization procedure was performed by a person not directly involved in the study.

Sampe Size:

Considering the difference of 30% in the improvement of nocturnal paresthesia, 95% confidence interval and statistical power of 80%, we calculated a sample of 84 patients. At 6 months

Interventions

The patients included in this study will be attended at the Santa Cruz IV Ambulatory of hand surgery outpatient clinic. Patients with a diagnosis of CTS will be referred for evaluation in this outpatient clinic.

After confirmation of the diagnosis of CTS with the presence of four or more of the six criteria proposed by Graham and confirmation by the EMG and application of the inclusion and non inclusion criteria in the study, eligible patients will be informed about the nature and purpose of the study, by reading the Research Ethics Committee of this institution; after signing will be registered. Only after signing the Research Ethics Committee and the patient's registration will the opaque and sealed envelope containing the patient's allocation be opened. Patients in the nocturnal orthoses group will receive prescriptions for the purchase of the orthosis and guidance on use at the same moment of randomization. Patients in the infiltration group will be referred to the Hospital Alvorada de Moema to perform the infiltration at the same moment of randomization.

Infiltration technique:

Patient seated, with elbow resting on the table, supine wrist, relaxed in dorsiflexion, after asepsis and antisepsis care a needle will be inserted located on the ulnar border of the radial flexor tendon of the carpus, with an angle of 30º directed to the carpal tunnel , with an association of betamethasone dipropionate, betamethasone disodium phosphate {diprospan®}, plus lidocaine (xylocaina®).

Night immobilization:

During the night time, the patient will wear a forearm-palmar splint, where the wrist will remain in the 15th degree of extension, until its removal in the morning. The nocturnal orthosis should be used by study period .

Outcomes

Primary Outcomes:

1. Remission of nocturnal paresthesia after intervention - Evaluation to verify remission of nocturnal paresthesia, referred by the patient at the time of initial care.
2. 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. This is a self-reported questionnaire that assesses the severity of symptoms and the functional status of patients.

Secondary Outcome Measures:

1. Visual Analogue Scale - EVA Pain Evaluation - 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. The patient was asked to register his pain with a stroke on that line joining the two bars. The gauging of the pain was performed by measuring the distance between the initial bar and the trait performed by the patient.
2. Graham Criteria - CTS-6 Assessment of improvement of graham's cervix, which are signs and symptoms used for the diagnosis of CTS

Eligibility 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

Primary outcomes:
measure: Remission of symptoms
timeFrame: 6 months
measure: Boston Questionnaire (Levine)
timeFrame: 6 months
Secondary outcomes:
measure: Visual Analogue Scale - EVA Pain Evaluation
timeFrame: 6 months
measure: Graham Criteria - CTS-6
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Jesus Queiroz junior
Study officials:
affiliation: Hospital Alvorada
name: Non-surgical T Infiltration
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.