Carpal Tunnel SyndromePhase 4NCT06778798
Gabapentin and Neural Mobilization Pain Reduction Effect Compared to Only Gabapentine
A Phase 4 study testing Median nerve neural mobilization and oral gabapentin and Gabapentin 300mg in people with Carpal Tunnel Syndrome, run by Universidad Europea de Madrid at 1 site in Venezuela.
Trial summary
In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical gabapentin treatment will be compared to those produced by gabapentin (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Median nerve neural mobilization and oral gabapentin and Gabapentin 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteVenezuela
- Study dates
- 19 Feb 2025to 25 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 and Tinel signs.
- The presence of carpal tunnel syndrome signs and symptoms
Who cannot join
- The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, metabolic neuropathy, obesity (body mass index over 30), participants who are not employed, 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)
Trial locations and contacts
1 site in 1 country.
Venezuela1 site
Ciudad Hospitalaria Enrique Tejera
Valencia, Carabobo, 02001
About this study
Official title: Pain Reduction of an Oral Gabapentin and Median Nerve Neural Mobilization Combined Treatment Compared to Only Oral Gabapentin in Subjects Who Suffer Carpal Tunnel Syndrome
In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical gabapentin treatment will be compared to those produced by gabapentin (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.
Read the detailed description
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 gabapentin treatment, to those effects produced by a gabapentin (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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Median nerve neural mobilization and oral gabapentin, Gabapentin 300mg
- Keywords
- Gabapentin, Median nerve neural mobilization, Pain
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Median nerve neural mobilization and oral gabapentinCombination product
Manual therapy maneuver performed in the upper limb combined with gabapentin oral capsules.
Gabapentin 300mgDrug
Also called Neurontin
Gabapentin oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Median nerve neural mobilization and oral gabapentin | 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 a Gabapentin 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 2 weeks. Receives: Combination Product: Median nerve neural mobilization and oral gabapentin |
| Gabapentin | Active comparator | Gabapentin 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 2 weeks. Receives: Drug: Gabapentin 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (5)
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).
Measured: 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.]
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: 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: 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: 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.
Measured: Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start19 Feb 2025
- Primary completion18 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Unda Solano, Universidad Europea de Madrid
- Investigators
- Francisco Unda, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778798
- Sponsor's protocol ID
- CE0072015-02-06
- Status last verified
- Dec 2025
- First submitted
- 12 Jan 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reduction of an Oral Gabapentin and Median Nerve Neural Mobilization Combined Treatment Compared to Only Oral Gabapentin in Subjects Who Suffer Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06778798
- Acronym / sponsor ID
- CE0072015-02-06
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Gabapentin, Median nerve neural mobilization, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical gabapentin treatment will be compared to those produced by gabapentin (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.
Detailed description
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 gabapentin treatment, to those effects produced by a gabapentin (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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Median nerve neural mobilization and oral gabapentin | Experimental | Combination Product: Median nerve neural mobilization and oral gabapentinMedian 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 a Gabapentin 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 2 weeks. |
| Gabapentin | Active comparator | Drug: Gabapentin 300mgGabapentin 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 2 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 and Tinel signs.
- The presence of carpal tunnel syndrome signs and symptoms
Key exclusion criteria (1 listed)
- The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, metabolic neuropathy, obesity (body mass index over 30), participants who are not employed, 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Median nerve neural mobilization and oral gabapentinManual therapy maneuver performed in the upper limb combined with gabapentin oral capsules. | Combination product | Median nerve neural mobilization and oral gabapentin |
| Gabapentin 300mgAlso: NeurontinGabapentin oral capsules | Drug | Gabapentin |
Primary outcome
Distal upper limb pain
Time frame: 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.
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.
5 secondary outcomes
Upper limb function
Time frame: 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.]
Work Status at baseline
Time frame: Measured immediately before the application of the first treatment
Work Status post treatment
Time frame: Measured immediatly after the application of the last treatment.
Change in Work Task (Job Type)
Time frame: Measured immediatly after the application of the last treatment.
Tampa Scale for Kinesiophobia-17 (TSK-17)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Unda, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Median nerve neural mobilization and oral gabapentin and Gabapentin 300mg in people with Carpal Tunnel Syndrome, run by Universidad Europea de Madrid at 1 site in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distal upper limb pain (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.