Oral Gabapentin and Median Nerve Mobilization in the Treatment of Carpal Tunnel Syndrome

Oral Gabapentin and Median Nerve Neural Mobilization Versus Control in the Treatment of Carpal Tunnel Syndrome

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by Gabapentin and the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Median nerve neural mobilization; Drug: Gabapentin oral capsules

Detailed Description

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by Gabapentin and the absence of treatment, in subjects who suffer the signs and symptoms of 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 3 different groups.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• Venezuela
  • Carabobo
    • Valencia, Carabobo, Venezuela, 02001
      • Ciudad Hospitalaria Enrique Tejera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 and Tinel sign.
• 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, metabolic neuropathy, obesity (body mass index over 30), participants who are not employed, 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Median nerve neural mobilization; Non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induced median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 4 weeks.	Other: Median nerve neural mobilization; Manual therapy maneuver performed in the upper limb.
No Intervention: Control group; Participants that belong to the no intervention arm will be assigned to a waiting list to receive treatment. The participants will not receive treatment for carpal tunnel syndrome during a time lapse of 4 weeks. After this period of time, participants will begin the best treatment available.
Active Comparator: Gabapentin; Participants will be treated with a maximum of 600 mg per day, subdivided in 2 intakes of 300 mg oral capsules each 12 hours during a time lapse of 4 weeks.	Drug: Gabapentin oral capsules; Oral capsule pharmaceutical treatment.; Other Names: Neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 the first treatment) and immediately after the application of the last treatment at 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Work Status at baseline	This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Do you currently work?"	Measured immediately before the application of the first treatment
Work Status post treatment	This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Do you currently work?"	Measured immediatly after the application of the last treatment.
Change in Work Task (Job Type)	This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Did you change your job type or task?"	Measured immediatly after the application of the last treatment.
Tampa Scale for Kinesiophobia-17 (TSK-17)	The Tampa Scale for Kinesiophobia-17 (TSK-17) is a 17-item questionnaire designed to assess the fear of movement and re-injury (kinesiophobia). Items are rated on a 4-point Likert scale (ranging from "strongly disagree" to "strongly agree"), yielding a total score that reflects the severity of pain-related fear avoidance beliefs. The standard total score range for the Tampa Scale for Kinesiophobia (TSK-17) is 17 to 68. It is calculated by summing 17 items, each scored 1-4, with four items reverse-scored. Higher scores indicate greater fear of movement; a score $\ge 37$ suggests clinical kinesiophobia.	Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment.

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Principal Investigator: Francisco Unda, PhD, Confederación Gallega de Discapacidad

Publications and helpful links

General Publications

• Sanz DR, Solano FU, Lopez 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.
• 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.
• 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.
• 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.
• Taverner D, Lisbona MP, Segales 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. doi: 10.1157/13117468. Spanish.
• 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.
• Rodriguez-Sanz D, Calvo-Lobo C, Unda-Solano F, Sanz-Corbalan I, Romero-Morales C, Lopez-Lopez 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.
• Yucel 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 10, 2020

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 23, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain management; Gabapentin; Physiotherapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neurobehavioral Manifestations; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Carpal Tunnel Syndrome; Agnosia; Amino Acids, Peptides, and Proteins; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Amines; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Gabapentin
• Other Study ID Numbers: CE0072015-02-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No