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

NCT04285281 | Completed Phase 4 DMC

• 1 other identifier: CE0072015-02-03
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Gabapentin; Pain management; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Upper limb function

  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

  Measured immediately before the application of the first treatment

• Work Status post treatment

  Measured immediatly after the application of the last treatment.

• Change in Work Task (Job Type)

  Measured immediatly after the application of the last treatment.

• Tampa Scale for Kinesiophobia-17 (TSK-17)

  Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment.

Study Arms (3)

Gabapentin

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Median nerve neural mobilization

EXPERIMENTAL

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

Interventions

Median nerve neural mobilization OTHER

Manual therapy maneuver performed in the upper limb.

Median nerve neural mobilization

Gabapentin oral capsules DRUG

Oral capsule pharmaceutical treatment.

Also known as: Neurontin

Gabapentin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, 02001, Venezuela

Location

Related Publications (8)

• 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.

  PMID: 30656171 BACKGROUND

• 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.

  PMID: 18381028 BACKGROUND

• 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.

  PMID: 28731977 BACKGROUND

• 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.

  PMID: 19587471 BACKGROUND

• 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.

  PMID: 30002707 BACKGROUND

• 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.

  PMID: 28340157 BACKGROUND

• 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.

  PMID: 29521045 BACKGROUND

• 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.

  PMID: 25803249 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Agnosia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Francisco Unda, PhD

  Confederación Gallega de Discapacidad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedicine Doctorate Program Investigator

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 26, 2020
• Study Start: April 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 10, 2020
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)