Ibuprofen and Neural Mobilization Treatment in Carpal Tunnel Syndrome.

NCT04328805 | Completed Phase 4 DMC

• 1 other identifier: CE0072015-02-05
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome; Ibuprofen; Pain Management; Pain, Chronic

Outcome Measures

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.

  Changes from baseline (measured immediately before the application of the first treatment) and 60 minutes after the application of the last treatment.

Secondary Outcomes (5)

• Upper limb function

  Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment

• Work Status at baseline

  Measured immediately before the application of the first treatment

• Work Status post treatment

  Measured immediatly after the application of the last treatment.

• Change in Work Task (Job Type)

  Measured immediatly after the application of the last treatment.

• Tampa Scale for Kinesiophobia-17 (TSK-17)

  Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment.

Study Arms (3)

Ibuprofen

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.

Drug: ibuprofen tablets

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.

Median nerve neural mobilization

EXPERIMENTAL

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

ibuprofen tablets DRUG

oral tablet

Also known as: Advil

Ibuprofen

Median nerve neural mobilization OTHER

Manual therapy maneuver performed in the upper limb

Median nerve neural mobilization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, 02001, Venezuela

Location

Related Publications (12)

• 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.

  PMID: 30810754 BACKGROUND

• 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.

  PMID: 30502019 BACKGROUND

• 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.

  PMID: 28316723 BACKGROUND

• 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.

  PMID: 26433799 BACKGROUND

• 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.

  PMID: 9627862 BACKGROUND

• 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.

  PMID: 26327799 BACKGROUND

• 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.

  PMID: 8176515 BACKGROUND

• 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.

  PMID: 28731977 BACKGROUND

• 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.

  PMID: 29559834 BACKGROUND

• 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.

  PMID: 28734105 BACKGROUND

• 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.

  PMID: 29521045 BACKGROUND

• 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.

  PMID: 28115830 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Agnosia; Chronic Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Carlos Perez, MD

  INSALUD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedicine Doctorate Program Investigator

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: March 31, 2020
• Study Start: September 23, 2020
• Primary Completion: December 26, 2020
• Study Completion: December 29, 2020
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)