Pain Reduction Caused by the Combined Treatment of Physiotherapy, Oral Gabapentin and Oral Ibuprofen Arginine.

NCT ID: NCT06781489

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-19
• Study Completion Date: 2025-03-29

Brief Summary

In the present investigation the pain reduction effects of a physiotherapy technique combined with gabapentin and ibuprofen arginine will be compared to those produced by an ibuprofen arginine (only) 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 (group 1) 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 versus (group 2) median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral ibuprofen arginine treatment, to those effects produced by (group 3) ibuprofen arginine (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.

Conditions

Carpal Tunnel Syndrome

Study Design

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

Study Groups

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. Additionally, subjects will be treated with a Gabapentin 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.

Group Type: EXPERIMENTAL

Median nerve neural mobilization

Intervention Type: OTHER

Manual therapy maneuver performed in the upper limb

Gabapentin 300mg

Intervention Type: DRUG

Oral gabapentin capsule

Median nerve neural mobilization and ibuprofen arginine

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. Additionally, subjects will be treated with an ibuprofen arginine maximum dose of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 2 weeks.

Group Type: ACTIVE_COMPARATOR

Median nerve neural mobilization

Intervention Type: OTHER

Manual therapy maneuver performed in the upper limb

Ibuprofen Arginine

Intervention Type: DRUG

Oral ibuprofen arginine tablets

Ibuprofen arginine

Subjects will be treated with an ibuprofen arginine maximum dose of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 2 weeks.

Group Type: ACTIVE_COMPARATOR

Ibuprofen Arginine

Intervention Type: DRUG

Oral ibuprofen arginine tablets

Interventions

Median nerve neural mobilization

Manual therapy maneuver performed in the upper limb

Intervention Type: OTHER

Gabapentin 300mg

Oral gabapentin capsule

Intervention Type: DRUG

Ibuprofen Arginine

Oral ibuprofen arginine tablets

Intervention Type: DRUG

Other Intervention Names

Neurontin; Spedifen

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 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).

• 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

Locations

Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, Venezuela

Countries

Venezuela

Other Identifiers

CE0072015-02-08

Identifier Type: -

Identifier Source: org_study_id