In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical gabapentin treatment will be compared to those produced by gabapentin (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.
The present randomized clinical trial will perform a comparison of 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, to those effects produced by a gabapentin (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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
72
Manual therapy maneuver performed in the upper limb combined with gabapentin oral capsules.
Gabapentin oral capsules
Ciudad Hospitalaria Enrique Tejera
Valencia, Carabobo, Venezuela
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: Through study completion, an average of 2 weeks. Changes from baseline (measured immediately before the application of the first treatment) and 40 minutes after the application of the last treatment.
Upper limb function
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).
Time frame: Through study completion, an average of 2 weeks.Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment.]
Work Status at baseline
This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Do you currently work?"
Time frame: Measured immediately before the application of the first treatment
Work Status post treatment
This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Do you currently work?"
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Time frame: Measured immediatly after the application of the last treatment.
Change in Work Task (Job Type)
This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Did you change your job type or task?"
Time frame: Measured immediatly after the application of the last treatment.
Tampa Scale for Kinesiophobia-17 (TSK-17)
The Tampa Scale for Kinesiophobia-17 (TSK-17) is a 17-item questionnaire designed to assess the fear of movement and re-injury (kinesiophobia). Items are rated on a 4-point Likert scale (ranging from "strongly disagree" to "strongly agree"), yielding a total score that reflects the severity of pain-related fear avoidance beliefs. It's a widely used and vailidaded clinical and research instrument. The standard total score range for the Tampa Scale for Kinesiophobia (TSK-17) is 17 to 68. It is calculated by summing 17 items, each scored 1-4, with four items reverse-scored. Higher scores indicate greater fear of movement.
Time frame: Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment.