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

NCT ID: NCT04285281

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-08-10

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.

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Gabapentin oral capsules

Intervention Type: DRUG

Oral capsule pharmaceutical treatment.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Median nerve neural mobilization

Intervention Type: OTHER

Manual therapy maneuver performed in the upper limb.

Interventions

Gabapentin oral capsules

Oral capsule pharmaceutical treatment.

Intervention Type: DRUG

Median nerve neural mobilization

Manual therapy maneuver performed in the upper limb.

Intervention Type: OTHER

Other Intervention Names

Neurontin

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Francisco Unda Solano

Biomedicine Doctorate Program Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Unda, PhD

Role: PRINCIPAL_INVESTIGATOR

Confederación Gallega de Discapacidad

Locations

Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, Venezuela

Countries

Venezuela

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

CE0072015-02-03

Identifier Type: -

Identifier Source: org_study_id