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Pain Reduction Produced by Different Treatments in Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04119739
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : March 31, 2020
Information provided by (Responsible Party):
Francisco Unda Solano, Universidad Europea de Madrid

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Median nerve neural mobilization Drug: Ibuprofen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pain Reduction Produced by Physiotherapy, Ibuprofen, and the Absence of Treatment, in Carpal Tunnel Syndrome
Estimated Study Start Date : April 14, 2020
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : July 20, 2020

Arm Intervention/treatment
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
Manual therapy maneuver performed in the upper limb.

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
Oral tablets
Other Name: Advil

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.

Primary Outcome Measures :
  1. Distal upper limb pain [ Time Frame: Changes from baseline (measured immediately before the application of each treatment) at 40 minutes after the application of treatment. Measures at baseline and after treatment will be performed 3 days a week during 4 weeks. ]
    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.

Secondary Outcome Measures :
  1. Upper limb function [ Time Frame: Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment. ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 an Tinel sings.
  • The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

  • The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, 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 ibuprofen, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04119739

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Contact: Francisco Unda Solano, PHD 0034695634680

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"Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández "
San Diego, Carabobo, Venezuela, 02006
Sponsors and Collaborators
Francisco Unda Solano
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Principal Investigator: Francisco Unda Solano, PHD

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Responsible Party: Francisco Unda Solano, Biomedicine Doctorate Program Investigator, Universidad Europea de Madrid Identifier: NCT04119739    
Other Study ID Numbers: CE0072015-02-02
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Unda Solano, Universidad Europea de Madrid:
Median nerve neural mobilization
Waiting list control group
Pain management
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action