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

Phase 4

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Median nerve neural mobilization; Drug: Ibuprofen Arginine; Drug: Gabapentin 300mg

• Registration Number: NCT06781489
• Lead Sponsor: Universidad Europea de Madrid

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.

Study Timeline

• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-17
• Status Verified: 2025-02
• Study Start: 2025-02-19
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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 an Tinel sings.
• 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, kinesiophobia, 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Median nerve neural mobilization and oral gabapentin	Median nerve neural mobilization	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.
Median nerve neural mobilization and oral gabapentin	Gabapentin 300mg	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.
Ibuprofen arginine	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.
Median nerve neural mobilization and ibuprofen arginine	Median nerve neural mobilization	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.
Median nerve neural mobilization and ibuprofen arginine	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.

Primary Outcome Measures

Name	Time	Method
Distal upper limb pain	[Time Frame: Changes from baseline (measured immediately before the application of the first and last treatment) and 40 minutes after the application of the first and last treatment.]	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.

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Ciudad Hospitalaria Enrique Tejera; 🇻🇪 Valencia, Carabobo, Venezuela