Pain Reduction Produced by Different Treatments in Carpal Tunnel Syndrome

NCT04119739 | Completed Phase 4 DMC

• 1 other identifier: CE0072015-02-02
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome

Keywords

Ibuprofen; Median nerve neural mobilization; Waiting list control group; Physiotherapy; Pain management

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 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.

  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

  Changes from baseline (measured immediately before the application of the first treatment) and at 40 minutes after the application of the last treatment.

Other Outcomes (4)

• 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.

Study Arms (3)

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.

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.

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.

Interventions

Median nerve neural mobilization OTHER

Manual therapy maneuver performed in the upper limb.

Median nerve neural mobilization

Ibuprofen Arginine DRUG

Oral tablets

Also known as: Spedifen, FASPIC

Ibuprofen Arginine

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:

• 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 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.

Sponsors & Collaborators

• Francisco Unda Solano: 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

• Choi 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.

  PMID: 30521680 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

• 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

• Sanz 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.

  PMID: 30002707 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

• Basson 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.

  PMID: 28704626 BACKGROUND

• Ballestero-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.

  PMID: 27842937 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

• 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

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Agnosia

Interventions

ibuprofen arginine

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

Study Officials

• Francisco Unda Solano, PHD

  PRINCIPAL INVESTIGATOR

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: SPONSOR INVESTIGATOR
• PI Title: Biomedicine Doctorate Program Investigator

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: October 8, 2019
• Study Start: April 14, 2020
• Primary Completion: July 20, 2020
• Study Completion: July 28, 2020
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)