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In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical ibuprofen arginine treatment will be compared to those produced by ibuprofen (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 ibuprofen arginine treatment, to those effects produced by a ibuprofen arginine (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Median nerve neural mobilization and oral ibuprofen arginine | Experimental | Median nerve neural mobilization, non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induce median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 2 weeks. This arm will also receive an oral ibuprofen arginine 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 2 weeks |
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| Ibuprofen arginine | Active Comparator | Participants will be treated with a maximum of 1200 mg of oral ibuprofen arginine tablets per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 2 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| median nerve neural mobilization combined with oral ibuprofen arginine | Combination Product | Manual therapy maneuver performed in the upper limb combined with ibuprofen arginine oral tablets |
| 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. | 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 |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Unda, PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciudad Hospitalaria Enrique Tejera | Valencia | Carabobo | 02001 | Venezuela |
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| Ibuprofen Arginine | Drug | Ibuprofen arginine oral tablets |
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| 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. |
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. 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. | Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment. |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C106674 | ibuprofen arginine |
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