Oral Gabapentin in the Treatment of Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Oral Gabapentin Versus Control in the Treatment of Carpal Tunnel Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04285281
• Other study ID #: CE0072015-02-03
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2020
• Est. completion date: May 2020

Study information

• Verified date: February 2020
• Source: Universidad Europea de Madrid
• Contact: Francisco Unda, PhD
• Phone: 0034695634680
• Email: 5299559[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the present investigation the pain reduction effects of Gabapentin will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

Description:

The present randomized clinical trial will perform a comparison of the pain reduction effect produced by the application of an oral gabapentin (pharmaceutical) treatment, to the pain reduction effect produced by the lack of treatment in subjects diagnosed with carpal tunnel syndrome. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 2 different groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).

• Full understanding of written and spoken Spanish (language).

• Participants must freely consent to participate.

• The presence of positive Phalen an Tinel sings.

• The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

• The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, , deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• Gabapentin oral capsules
Oral capsule pharmaceutical treatment.

Locations

Country	Name	City	State
Venezuela	"Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández "	San Diego	Carabobo

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Venezuela, 

References & Publications (8)

Dosenovic S, Jelicic Kadic A, Miljanovic M, Biocic M, Boric K, Cavar M, Markovina N, Vucic K, Puljak L. Interventions for Neuropathic Pain: An Overview of Systematic Reviews. Anesth Analg. 2017 Aug;125(2):643-652. doi: 10.1213/ANE.0000000000001998. Review. — View Citation

Erdemoglu AK. The efficacy and safety of gabapentin in carpal tunnel patients: open label trial. Neurol India. 2009 May-Jun;57(3):300-3. doi: 10.4103/0028-3886.53287. — View Citation

Eren Y, Yavasoglu NG, Comoglu SS. The relationship between QDASH scale and clinical, electrophysiological findings in carpal tunnel syndrome. Adv Clin Exp Med. 2018 Jan;27(1):71-75. doi: 10.17219/acem/67947. — View Citation

Hesami O, Haghighatzadeh M, Lima BS, Emadi N, Salehi S. The effectiveness of gabapentin and exercises in the treatment of carpal tunnel syndrome: a randomized clinical trial. J Exerc Rehabil. 2018 Dec 27;14(6):1067-1073. doi: 10.12965/jer.1836420.210. eCollection 2018 Dec. — View Citation

Rodríguez-Sanz D, Calvo-Lobo C, Unda-Solano F, Sanz-Corbalán I, Romero-Morales C, López-López D. Cervical Lateral Glide Neural Mobilization Is Effective in Treating Cervicobrachial Pain: A Randomized Waiting List Controlled Clinical Trial. Pain Med. 2017 Dec 1;18(12):2492-2503. doi: 10.1093/pm/pnx011. — View Citation

Sanz DR, Solano FU, López DL, Corbalan IS, Morales CR, Lobo CC. Effectiveness of median nerve neural mobilization versus oral ibuprofen treatment in subjects who suffer from cervicobrachial pain: a randomized clinical trial. Arch Med Sci. 2018 Jun;14(4):871-879. doi: 10.5114/aoms.2017.70328. Epub 2017 Sep 26. — View Citation

Taverner D, Lisbona MP, Segalés N, Docampo E, Calvet J, Castro S, Benito P. [Efficacy of gabapentin in the treatment of carpal tunnel syndrome]. Med Clin (Barc). 2008 Mar 22;130(10):371-3. Spanish. — View Citation

Yücel H, Seyithanoglu H. Choosing the most efficacious scoring method for carpal tunnel syndrome. Acta Orthop Traumatol Turc. 2015;49(1):23-9. doi: 10.3944/AOTT.2015.13.0162. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distal upper limb pain	Assessed through the visual analog scale (VAS). The VAS is a psychometric response scale. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The VAS is the most frequently used method to assess pain intensity. The scale will be displayed as a horizontal 10-cm line labelled at each end by descriptors such as 'no pain' (the minimum and best outcome possible) and 'worse pain ever' (maximum and worst outcome possible). The participant will mark the line to indicate pain severity and it is simply quantified by measuring the distance in centimeters from 0 (no pain) to the patient's marked rating.	Changes from baseline (measured immediately before the application of each treatment) at 40 minutes after the application of treatment. Measures at baseline and after treatment will be performed 1 day a week during 4 weeks.
Secondary	Upper limb function	Assessed through the quick Quick Disabilities of the Arm, Shoulder and Hand questionary (QuickDASH), which is a shortened version of the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) instrument.The instrument administered to the participants will be a self-report questionnaire, that will rate the difficulty and interference of daily life on a 5 point Likert scale. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).	Changes from baseline (measured immediately before the application of the first treatment), and at 40 minutes after the application of the last treatment.