A Phase 4 interventional study of Median nerve neural mobilization and Ibuprofen Arginine in Carpal Tunnel Syndrome, sponsored by Francisco Unda Solano. Completed at 1 site in Venezuela. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Francisco Unda Solano · Phase 4, Interventional, and Supportive care
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.
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.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's enrollment of 196 is above the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Francisco Unda Solano is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 600 mg per day, subdivided in 2 intakes of 300 mg each 12 hours during a time lapse of 4 weeks.
Drug: Gabapentin
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.
Manual therapy maneuver performed in the upper limb.
Oral tablets
Also known as: Spedifen
oral capsules
Also known as: Neurontin
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: 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: 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?"
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.
The 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.
Plan to share: No
Ran from Aug 2019 to primary completion in Nov 2019, 3 months.
Of 28 non-industry phase 4 interventional studies under Carpal Tunnel Syndrome, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's 3 months is below that.
Counting every sponsor, half of 28 studies reached it within 7 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Francisco Unda Solano