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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 Gabapentin and the absence of 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), to those effects produced by Gabapentin and the absence of treatment, in subjects who suffer the signs and symptoms of 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | Participants will be treated with a maximum of 600 mg per day, subdivided in 2 intakes of 300 mg oral capsules each 12 hours during a time lapse of 4 weeks. |
|
| Control group | No Intervention | 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. | |
| Median nerve neural mobilization | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin oral capsules | Drug | Oral capsule pharmaceutical treatment. |
|
| 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 the first treatment) and immediately after the application of the last treatment at 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper limb function | Assessed through the quick Quick Disabilities of the Arm, Shoulder and Hand questionary (QuickDASH), 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Unda, PhD | Confederación Gallega de Discapacidad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciudad Hospitalaria Enrique Tejera | Valencia | Carabobo | 02001 | Venezuela |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30656171 | Background | Hesami O, Haghighatzadeh M, Lima BS, Emadi N, Salehi S. The effectiveness of gabapentin and exercises in the treatment of carpal tunnel syndrome: a randomized clinical trial. J Exerc Rehabil. 2018 Dec 27;14(6):1067-1073. doi: 10.12965/jer.1836420.210. eCollection 2018 Dec. | |
| 18381028 | Background | Taverner D, Lisbona MP, Segales N, Docampo E, Calvet J, Castro S, Benito P. [Efficacy of gabapentin in the treatment of carpal tunnel syndrome]. Med Clin (Barc). 2008 Mar 22;130(10):371-3. doi: 10.1157/13117468. Spanish. |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Median nerve neural mobilization | Other | Manual therapy maneuver performed in the upper limb. |
|
| Changes from baseline (measured immediately before the application of the first treatment), and 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?" | 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?" | 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?" | 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. 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; a score $\ge 37$ suggests clinical kinesiophobia. | Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment. |
| 28731977 | Background | Dosenovic S, Jelicic Kadic A, Miljanovic M, Biocic M, Boric K, Cavar M, Markovina N, Vucic K, Puljak L. Interventions for Neuropathic Pain: An Overview of Systematic Reviews. Anesth Analg. 2017 Aug;125(2):643-652. doi: 10.1213/ANE.0000000000001998. |
| 19587471 | Background | Erdemoglu AK. The efficacy and safety of gabapentin in carpal tunnel patients: open label trial. Neurol India. 2009 May-Jun;57(3):300-3. doi: 10.4103/0028-3886.53287. |
| 30002707 | Background | Sanz DR, Solano FU, Lopez DL, Corbalan IS, Morales CR, Lobo CC. Effectiveness of median nerve neural mobilization versus oral ibuprofen treatment in subjects who suffer from cervicobrachial pain: a randomized clinical trial. Arch Med Sci. 2018 Jun;14(4):871-879. doi: 10.5114/aoms.2017.70328. Epub 2017 Sep 26. |
| 28340157 | Background | Rodriguez-Sanz D, Calvo-Lobo C, Unda-Solano F, Sanz-Corbalan I, Romero-Morales C, Lopez-Lopez D. Cervical Lateral Glide Neural Mobilization Is Effective in Treating Cervicobrachial Pain: A Randomized Waiting List Controlled Clinical Trial. Pain Med. 2017 Dec 1;18(12):2492-2503. doi: 10.1093/pm/pnx011. |
| 29521045 | Background | Eren Y, Yavasoglu NG, Comoglu SS. The relationship between QDASH scale and clinical, electrophysiological findings in carpal tunnel syndrome. Adv Clin Exp Med. 2018 Jan;27(1):71-75. doi: 10.17219/acem/67947. |
| 25803249 | Background | Yucel H, Seyithanoglu H. Choosing the most efficacious scoring method for carpal tunnel syndrome. Acta Orthop Traumatol Turc. 2015;49(1):23-9. doi: 10.3944/AOTT.2015.13.0162. |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |