Gabapentin and Neural Mobilization Pain Reduction Effect Compared to Only Gabapentine

Pain Reduction of an Oral Gabapentin and Median Nerve Neural Mobilization Combined Treatment Compared to Only Oral Gabapentin in Subjects Who Suffer Carpal Tunnel Syndrome

In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical gabapentin treatment will be compared to those produced by gabapentin (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Combination product: Median nerve neural mobilization and oral gabapentin; Drug: Gabapentin 300mg

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) combined with a pharmaceutical oral gabapentin treatment, to those effects produced by a gabapentin (only) treatment. 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• 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: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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 signs.
• 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, allergy to ibuprofen arginine, 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Median nerve neural mobilization and oral gabapentin; Median nerve neural mobilization, non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induce median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 2 weeks. This arm will also receive a Gabapentin Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 600 mg per day, subdivided in 2 intakes of 300 mg each 12 hours during a time lapse of 2 weeks.	Combination product: Median nerve neural mobilization and oral gabapentin; Manual therapy maneuver performed in the upper limb combined with gabapentin oral capsules.
Active Comparator: Gabapentin; Gabapentin Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 600 mg per day, subdivided in 2 intakes of 300 mg each 12 hours during a time lapse of 2 weeks.	Drug: Gabapentin 300mg; Gabapentin oral capsules; 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.	Through study completion, an average of 2 weeks. Changes from baseline (measured immediately before the application of the first treatment) and 40 minutes after the application of the last treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb function	Assessed through the QuickDASH questionary, which is a shortened version of the 30-item DASH (Disabilities of the Arm, Shoulder and Hand) 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).	Through study completion, an average of 2 weeks.Changes from baseline (measured immediately before the application of the first treatment) 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. It's a widely used and vailidaded clinical and research instrument. 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.	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

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Actual): March 18, 2025
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 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; Gabapentin; Median nerve neural mobilization
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Carpal Tunnel Syndrome; 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: CE0072015-02-06

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