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

NCT06781489 | Completed Phase 4 DMC

• 1 other identifier: CE0072015-02-08
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

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 40 minutes after the application of the last treatment.

Secondary Outcomes (1)

• Upper limb function

  Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment

Other Outcomes (4)

• 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.

Study Arms (3)

Median nerve neural mobilization and oral gabapentin

EXPERIMENTAL

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.

Other: Median nerve neural mobilization; Drug: Gabapentin 300mg

Median nerve neural mobilization and ibuprofen arginine

ACTIVE COMPARATOR

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.

Other: Median nerve neural mobilization; Drug: Ibuprofen Arginine

Ibuprofen arginine

ACTIVE COMPARATOR

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.

Drug: Ibuprofen Arginine

Interventions

Median nerve neural mobilization OTHER

Manual therapy maneuver performed in the upper limb

Median nerve neural mobilization and ibuprofen arginine; Median nerve neural mobilization and oral gabapentin

Gabapentin 300mg DRUG

Oral gabapentin capsule

Also known as: Neurontin

Median nerve neural mobilization and oral gabapentin

Ibuprofen Arginine DRUG

Oral ibuprofen arginine tablets

Also known as: Spedifen

Ibuprofen arginine; Median nerve neural mobilization and ibuprofen arginine

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 signs.
• 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

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Gabapentin; ibuprofen arginine

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

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, 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: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 19, 2025
• Primary Completion: March 20, 2025
• Study Completion: March 29, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)