Pain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome
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|ClinicalTrials.gov Identifier: NCT04025203|
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : October 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Other: Median nerve neural mobilization Drug: Ibuprofen Arginine Drug: Gabapentin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pain Reduction and Changes in Upper Limb Function Produced by Physiotherapy, Ibuprofen Arginine, Gabapentin and the Absence of Treatment, in Carpal Tunnel Syndrome|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||November 30, 2019|
Experimental: Median nerve neural mobilization
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
Manual therapy maneuver performed in the upper limb.
Active Comparator: Ibuprofen arginine
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
Other Name: Spedifen
Active Comparator: Gabapentin
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.
Other Name: Neurontin
No Intervention: Control group
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.
- Distal upper limb pain [ Time Frame: 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. ]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.
- Upper limb function [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025203
|Contact: Francisco Unda, PhDfirstname.lastname@example.org|
|Ciudad Hospitalaria Enrique Tejera||Recruiting|
|Valencia, Carabobo, Venezuela, 2001|
|Contact: Carlos A Perez, MD 00584144177932 Dr.email@example.com|
|Principal Investigator: Carlos A Perez, MD|
|Sub-Investigator: Edgar J Sayago, PT|
|Sub-Investigator: Marian V Montilla, PT|
|Principal Investigator:||Francisco Unda, PhD|