Ibuprofen and Neural Mobilization Treatment in Carpal Tunnel Syndrome.

NCT ID: NCT04328805

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2020-12-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome Ibuprofen Pain Management Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

ibuprofen tablets

Intervention Type DRUG

oral tablet

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Median nerve neural mobilization

Intervention Type OTHER

Manual therapy maneuver performed in the upper limb

Interventions

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ibuprofen tablets

oral tablet

Intervention Type DRUG

Median nerve neural mobilization

Manual therapy maneuver performed in the upper limb

Intervention Type OTHER

Other Intervention Names

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Advil

Eligibility Criteria

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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

* 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).
* Autoimmune inflammatory conditions or flu type symptoms.
* Allergy (or contraindication) 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 (body mass index over 30).
* Participants who are not employed.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Francisco Unda Solano

Biomedicine Doctorate Program Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Perez, MD

Role: STUDY_CHAIR

INSALUD

Locations

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Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, Venezuela

Site Status

Countries

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Venezuela

References

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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.

Reference Type BACKGROUND
PMID: 30810754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30502019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28316723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26433799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9627862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26327799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8176515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28731977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29559834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28734105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29521045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28115830 (View on PubMed)

Other Identifiers

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CE0072015-02-05

Identifier Type: -

Identifier Source: org_study_id

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