Clinical trial NCT06781489: Pain Reduction Caused by the Combined Treatment of Physiotherapy, Oral Gabapentin and Oral Ibuprofen Arginine.
Official title: Pain Reduction Caused by the Combined Treatment of Neural Mobilization, Oral Gabapentin and Oral Ibuprofen Arginine in the Treatment of Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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)

Primary outcomes:
measure: Distal upper limb pain
timeFrame: [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.]
Secondary outcomes:
measure: Upper limb function
timeFrame: Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment
Other outcomes:
Locations:
city: Valencia
country: Venezuela
facility: Ciudad Hospitalaria Enrique Tejera
state: Carabobo
Study officials:
name: Francisco Unda, PhD
role: PRINCIPAL_INVESTIGATOR
References: