Pain Reduction Produced by Different Treatments in Carpal Tunnel Syndrome

Phase 4CompletedNCT04119739

Francisco Unda Solano117 enrolled

Overview

Pain reduction effects of the median nerve neural mobilization technique (a physiotherapy treatment) will be compared to those produced by a pharmaceutical treatment and the absence of treatment, in subjects who suffer carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of median nerve neural mobilization (non invasive and non pharmaceutical physiotherapy treatment), to the pain reduction effect produced by an oral ibuprofen treatment or the lack of treatment (waiting list control group) in subjects diagnosed with 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

117

Conditions

Carpal Tunnel Syndrome

Interventions

Median nerve neural mobilizationOTHER

Manual therapy maneuver performed in the upper limb.

Ibuprofen ArginineDRUG

Oral tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 * Upper limb surgery or trauma * Pregnancy * 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, ibuprofen or ibuprofen arginine * Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive). * Metabolic neuropathy. * Obesity (body mass index over 30). * Participants who are not employed.

Locations (1)

Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, Venezuela

Outcomes

Primary Outcomes

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.

Time frame: Changes from baseline (measured immediately before the application of the first treatment) and 40 minutes after the application of the last treatment.

Secondary Outcomes

Upper limb function

Assessed through the Quick- Disabilities of the Arm, Shoulder and Hand (Quick- DASH) questionary, which is a shortened version of the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) 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).

Time frame: Changes from baseline (measured immediately before the application of the first treatment) and at 40 minutes after the application of the last treatment.

Data from ClinicalTrials.gov

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