Carpal Tunnel SyndromePhase 4NCT04119739
Pain Reduction Produced by Different Treatments in Carpal Tunnel Syndrome
A Phase 4 study testing Median nerve neural mobilization and Ibuprofen Arginine in people with Carpal Tunnel Syndrome, run by Francisco Unda Solano at 1 site in Venezuela.
Trial summary
Pain reduction effects of the median nerve neural mobilization technique (a physiotherapy treatment) will be compared to those produced by a pharmaceutical treatment and the absence of treatment, in subjects who suffer carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Median nerve neural mobilization and Ibuprofen Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteVenezuela
- Study dates
- 14 Apr 2020to 28 Jul 2020
- 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
- No healthy volunteers
- 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
- Upper limb surgery or trauma
- Pregnancy
- Deformities of the (affected) upper limb
Show all 13Show fewer
- Recent skin injuries or infections (in the affected upper limb)
- Autoimmune inflammatory conditions or flu type symptoms.
- Allergy to gabapentin, ibuprofen or ibuprofen arginine
- Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
- Metabolic neuropathy.
- Obesity (body mass index over 30).
- Participants who are not employed.
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 Produced by Physiotherapy, Ibuprofen Arginine, and the Absence of Treatment, in Carpal Tunnel Syndrome
Pain reduction effects of the median nerve neural mobilization technique (a physiotherapy treatment) will be compared to those produced by a pharmaceutical treatment and the absence of treatment, in subjects who suffer 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 median nerve neural mobilization (non invasive and non pharmaceutical physiotherapy treatment), to the pain reduction effect produced by an oral ibuprofen treatment or the lack of treatment (waiting list control group) 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 3 different groups.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Median nerve neural mobilization, Ibuprofen Arginine
- Keywords
- Ibuprofen, Median nerve neural mobilization, Waiting list control group, Physiotherapy, Pain management
- Medical subject headings
- Carpal Tunnel Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Median nerve neural mobilizationOther
Manual therapy maneuver performed in the upper limb.
Ibuprofen ArginineDrug
Also called Spedifen, FASPIC
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Median nerve neural mobilization |
| Ibuprofen Arginine | Active comparator | 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. Receives: Drug: Ibuprofen Arginine |
| Control group | No intervention | 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. |
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: Changes from baseline (measured immediately before the application of the first treatment) and 40 minutes after the application of the last treatment.
Secondary outcomes (1)
Upper limb function
Assessed through the Quick- Disabilities of the Arm, Shoulder and Hand (Quick- DASH) questionary, 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).
Measured: Changes from baseline (measured immediately before the application of the first treatment) and at 40 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 posted8 Oct 2019
- Study start14 Apr 2020
- Primary completion20 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Unda Solano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Unda Solano, Universidad Europea de Madrid
- Investigators
- Francisco Unda Solano, PHD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119739
- Sponsor's protocol ID
- CE0072015-02-02
- Status last verified
- Dec 2025
- First submitted
- 6 Oct 2019
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.
PubMed 30810754Choi GH, Wieland LS, Lee H, Sim H, Lee MS, Shin BC. Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome. Cochrane Database Syst Rev. 2018 Dec 2;12(12):CD011215. doi: 10.1002/14651858.CD011215.pub2.
PubMed 30521680Weinheimer K, Michelotti B, Silver J, Taylor K, Payatakes A. A Prospective, Randomized, Double-Blinded Controlled Trial Comparing Ibuprofen and Acetaminophen Versus Hydrocodone and Acetaminophen for Soft Tissue Hand Procedures. J Hand Surg Am. 2019 May;44(5):387-393. doi: 10.1016/j.jhsa.2018.10.014. Epub 2018 Nov 27.
PubMed 30502019Riasi H, Rajabpour Sanati A, Salehi F, Salehian H, Ghaemi K. Analyzing the therapeutic effects of short wrist splint in patients with carpal tunnel syndrome (CTS) under ibuprofen treatment from an EMG-NCV perspective. J Med Life. 2015;8(Spec Iss 4):154-158.
PubMed 28316723Davis PT, Hulbert JR, Kassak KM, Meyer JJ. Comparative efficacy of conservative medical and chiropractic treatments for carpal tunnel syndrome: a randomized clinical trail. J Manipulative Physiol Ther. 1998 Jun;21(5):317-26.
PubMed 9627862Sanz 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.
PubMed 30002707Calvo-Lobo C, Unda-Solano F, Lopez-Lopez D, Sanz-Corbalan I, Romero-Morales C, Palomo-Lopez P, Seco-Calvo J, Rodriguez-Sanz D. Is pharmacologic treatment better than neural mobilization for cervicobrachial pain? A randomized clinical trial. Int J Med Sci. 2018 Mar 8;15(5):456-465. doi: 10.7150/ijms.23525. eCollection 2018.
PubMed 29559834Rodriguez-Sanz D, Lopez-Lopez D, Unda-Solano F, Romero-Morales C, Sanz-Corbalan I, Beltran-Alacreu H, Calvo-Lobo C. Effects of Median Nerve Neural Mobilization in Treating Cervicobrachial Pain: A Randomized Waiting List-Controlled Clinical Trial. Pain Pract. 2018 Apr;18(4):431-442. doi: 10.1111/papr.12614. Epub 2017 Nov 20.
PubMed 28734105Basson A, Olivier B, Ellis R, Coppieters M, Stewart A, Mudzi W. The Effectiveness of Neural Mobilization for Neuromusculoskeletal Conditions: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Sep;47(9):593-615. doi: 10.2519/jospt.2017.7117. Epub 2017 Jul 13.
PubMed 28704626Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.
PubMed 27842937Shin D, Lee SJ, Ha YM, Choi YS, Kim JW, Park SR, Park MK. Pharmacokinetic and pharmacodynamic evaluation according to absorption differences in three formulations of ibuprofen. Drug Des Devel Ther. 2017 Jan 4;11:135-141. doi: 10.2147/DDDT.S121633. eCollection 2017.
PubMed 28115830Eren 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.
PubMed 29521045
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reduction Produced by Physiotherapy, Ibuprofen Arginine, and the Absence of Treatment, in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04119739
- Acronym / sponsor ID
- CE0072015-02-02
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Ibuprofen, Median nerve neural mobilization, Waiting list control group, Physiotherapy, Pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Francisco Unda SolanoUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 8 Oct 2019 (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.
Pain reduction effects of the median nerve neural mobilization technique (a physiotherapy treatment) will be compared to those produced by a pharmaceutical treatment and the absence of treatment, in subjects who suffer carpal tunnel syndrome.
Detailed description
The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of median nerve neural mobilization (non invasive and non pharmaceutical physiotherapy treatment), to the pain reduction effect produced by an oral ibuprofen treatment or the lack of treatment (waiting list control group) 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 3 different groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Median nerve neural mobilization | Experimental | Other: Median nerve neural mobilizationNon 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. |
| Ibuprofen Arginine | Active comparator | Drug: Ibuprofen ArginineOral 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not 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 (13 listed)
- The lack to meet inclusion criterions, the presence of cognitive impairment.
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 mobilizationManual therapy maneuver performed in the upper limb. | Other | Median nerve neural mobilization |
| Ibuprofen ArginineAlso: Spedifen, FASPICOral tablets | Drug | Ibuprofen Arginine |
Primary outcome
Distal upper limb pain
Time frame: 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.
1 secondary outcome
Upper limb function
Time frame: Changes from baseline (measured immediately before the application of the first treatment) and at 40 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 10 Dec 2025.
- Background: PubMed 30810754Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.
- Background: PubMed 30521680Choi GH, Wieland LS, Lee H, Sim H, Lee MS, Shin BC. Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome. Cochrane Database Syst Rev. 2018 Dec 2;12(12):CD011215. doi: 10.1002/14651858.CD011215.pub2.
- Background: PubMed 30502019Weinheimer K, Michelotti B, Silver J, Taylor K, Payatakes A. A Prospective, Randomized, Double-Blinded Controlled Trial Comparing Ibuprofen and Acetaminophen Versus Hydrocodone and Acetaminophen for Soft Tissue Hand Procedures. J Hand Surg Am. 2019 May;44(5):387-393. doi: 10.1016/j.jhsa.2018.10.014. Epub 2018 Nov 27.
- Background: PubMed 28316723Riasi H, Rajabpour Sanati A, Salehi F, Salehian H, Ghaemi K. Analyzing the therapeutic effects of short wrist splint in patients with carpal tunnel syndrome (CTS) under ibuprofen treatment from an EMG-NCV perspective. J Med Life. 2015;8(Spec Iss 4):154-158.
- Background: PubMed 9627862Davis PT, Hulbert JR, Kassak KM, Meyer JJ. Comparative efficacy of conservative medical and chiropractic treatments for carpal tunnel syndrome: a randomized clinical trail. J Manipulative Physiol Ther. 1998 Jun;21(5):317-26.
- Background: PubMed 30002707Sanz 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.
- Background: PubMed 29559834Calvo-Lobo C, Unda-Solano F, Lopez-Lopez D, Sanz-Corbalan I, Romero-Morales C, Palomo-Lopez P, Seco-Calvo J, Rodriguez-Sanz D. Is pharmacologic treatment better than neural mobilization for cervicobrachial pain? A randomized clinical trial. Int J Med Sci. 2018 Mar 8;15(5):456-465. doi: 10.7150/ijms.23525. eCollection 2018.
- Background: PubMed 28734105Rodriguez-Sanz D, Lopez-Lopez D, Unda-Solano F, Romero-Morales C, Sanz-Corbalan I, Beltran-Alacreu H, Calvo-Lobo C. Effects of Median Nerve Neural Mobilization in Treating Cervicobrachial Pain: A Randomized Waiting List-Controlled Clinical Trial. Pain Pract. 2018 Apr;18(4):431-442. doi: 10.1111/papr.12614. Epub 2017 Nov 20.
- Background: PubMed 28704626Basson A, Olivier B, Ellis R, Coppieters M, Stewart A, Mudzi W. The Effectiveness of Neural Mobilization for Neuromusculoskeletal Conditions: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Sep;47(9):593-615. doi: 10.2519/jospt.2017.7117. Epub 2017 Jul 13.
- Background: PubMed 27842937Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.
- Background: PubMed 28115830Shin D, Lee SJ, Ha YM, Choi YS, Kim JW, Park SR, Park MK. Pharmacokinetic and pharmacodynamic evaluation according to absorption differences in three formulations of ibuprofen. Drug Des Devel Ther. 2017 Jan 4;11:135-141. doi: 10.2147/DDDT.S121633. eCollection 2017.
- Background: PubMed 29521045Eren 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.
- 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 Solano, 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 Ibuprofen Arginine in people with Carpal Tunnel Syndrome, run by Francisco Unda Solano 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 13 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 10 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: 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?
On the ClinicalTrials.gov record for NCT04119739, which also lists 12 linked publications.
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 10 Dec 2025.