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CompletedNCT04328805Updated Dec 11, 2025

Ibuprofen and Neural Mobilization Treatment in Carpal Tunnel Syndrome.

A Phase 4 interventional study of ibuprofen tablets and Median nerve neural mobilization in Carpal Tunnel Syndrome, Ibuprofen and Pain Management, sponsored by Universidad Europea de Madrid. Completed at 1 site in Venezuela. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by Universidad Europea de Madrid · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

In the present investigation, the pain reduction effect of median nerve neural mobilization and oral ibuprofen treatments will be compared to those produced by the absence of 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 median nerve neural mobilization and oral ibuprofen treatments to the total lack of treatment in subjects diagnosed with carpal tunnel syndrome. 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.

02

Conditions studied

  • Carpal Tunnel Syndrome
  • Ibuprofen
  • Pain Management
  • Pain, Chronic
03

In context

Carpal Tunnel Syndrome

587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

This study's enrollment of 123 is above the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Universidad Europea de Madrid is the lead sponsor of 99 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Recent skin injuries or infections (in the affected upper limb).
  • inflammatory conditions or flu type symptoms.
  • Allergy (or ) to non steroidal anti inflammatory drugs (NSAID)
  • Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
  • Metabolic neuropathy.
  • Obesity ( over 30).
  • Participants who are not employed.
Terms in these criteria, in plain language(3)

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
123 participants (actual)

Study arms

  • Active comparator
    Ibuprofen

    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 tablets

  • No intervention
    Control group

    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.

  • Experimental
    Median nerve neural mobilization

    Median nerve neural mobilization 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

Interventions

  • oral tablet

    Also known as: Advil

  • OtherMedian nerve neural mobilization

    Manual therapy maneuver performed in the upper limb

06

What researchers measure

Primary outcomes

  1. 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 100-mm 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 millimeters 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 60 minutes after the application of the last treatment.

Secondary outcomes

  1. 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).

    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

  2. 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

  3. 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.

  4. 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.

  5. 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.

07

Study locations

1 site
  • Ciudad Hospitalaria Enrique Tejera
    Valencia, Carabobo 02001, Venezuela
08

References and documents

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 30810754 ↗
  • Weinheimer 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 30502019 ↗
  • Riasi 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 28316723 ↗
  • Hadianfard M, Bazrafshan E, Momeninejad H, Jahani N. Efficacies of Acupuncture and Anti-inflammatory Treatment for Carpal Tunnel Syndrome. J Acupunct Meridian Stud. 2015 Oct;8(5):229-35. doi: 10.1016/j.jams.2014.11.005. Epub 2014 Nov 29. PubMed 26433799 ↗
  • Davis 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 9627862 ↗
  • Giuliani E, Bianchi A, Marcuzzi A, Landi A, Barbieri A. Ibuprofen timing for hand surgery in ambulatory care. Acta Ortop Bras. 2015 Jul-Aug;23(4):188-91. doi: 10.1590/1413-78522015230400736. PubMed 26327799 ↗
  • Banta CA. A prospective, nonrandomized study of iontophoresis, wrist splinting, and antiinflammatory medication in the treatment of early-mild carpal tunnel syndrome. J Occup Med. 1994 Feb;36(2):166-8. doi: 10.1097/00043764-199402000-00012. PubMed 8176515 ↗
  • 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. PubMed 28731977 ↗
  • Calvo-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 29559834 ↗
  • Rodriguez-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 28734105 ↗
  • 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. PubMed 29521045 ↗
  • Shin 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 28115830 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Dec 2020, 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.

Registered
Mar 29, 2020
First posted
Mar 31, 2020
StartActual
Sep 23, 2020
Primary completionActual
Dec 26, 2020
CompletionActual
Dec 29, 2020
Last update
Dec 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04328805
Lead sponsor
Universidad Europea de Madrid
Responsible party
Francisco Unda Solano (Biomedicine Doctorate Program Investigator, Universidad Europea de Madrid) — Principal investigator
First posted
Mar 31, 2020
Start date
Sep 23, 2020
Primary completion
Dec 26, 2020
Completion
Dec 29, 2020
Last update
Dec 11, 2025

Study contacts

Carlos Perez, MD
study chair · INSALUD

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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