Pain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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In the present investigation the pain reduction effects of a physiotherapy technique will be compared to those produced by two different pharmaceutical treatments and also by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

Detailed Description
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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), to those effects produced by an oral ibuprofen arginine pharmacological treatment, an oral gabapentin pharmacological treatment and the lack of treatment 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 4 different groups.

Official Title
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Pain Reduction and Changes in Upper Limb Function Produced by Physiotherapy, Ibuprofen Arginine, Gabapentin and the Absence of Treatment, in Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Other: Median nerve neural mobilization
* Drug: Ibuprofen Arginine
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Median nerve neural mobilization<br>Non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induced median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 4 weeks. | Other: Median nerve neural mobilization<br>* Manual therapy maneuver performed in the upper limb.<br>|
| Active Comparator: Ibuprofen arginine<br>Oral tablet pharmaceutical treatment. Participants will be treated with a maximum of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 4 weeks. | Drug: Ibuprofen Arginine<br>* Oral tablets<br>* Other names: Spedifen;|
| Active Comparator: Gabapentin<br>Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 1800 mg per day, subdivided in 3 intakes of 600 mg each 8 hours during a time lapse of 4 weeks. | Drug: Gabapentin<br>* oral capsules<br>* Other names: Neurontin;|
| No Intervention: Control group<br>Waiting list control group. Participants that belong to the no intervention arm will be assigned to a waiting list to receive treatment. The participants will not receive treatment for carpal tunnel syndrome during a time lapse of 4 weeks. After this period of time, participants will begin the best treatment available. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 each treatment) at 40 minutes after the application of treatment. Measures at baseline and after treatment will be performed 3 days a week during 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ibuprofen Arginine, Gabapentin, Median nerve neural mobilization, Physiotherapy, Pain management