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Pain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT04025203
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Unda Solano, Universidad Europea de Madrid

Brief Summary:
In the present investigation the pain reduction effects of a physiotherapy technique will be compared to those produced by two different pharmaceutical treatments and also by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

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

Detailed Description:
The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by an oral ibuprofen arginine pharmacological treatment, an oral gabapentin pharmacological treatment and the lack of treatment 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 4 different groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pain Reduction and Changes in Upper Limb Function Produced by Physiotherapy, Ibuprofen Arginine, Gabapentin and the Absence of Treatment, in Carpal Tunnel Syndrome
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019


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 arginine
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
Oral tablets
Other Name: Spedifen

Active Comparator: Gabapentin
Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 1800 mg per day, subdivided in 3 intakes of 600 mg each 8 hours during a time lapse of 4 weeks.
Drug: Gabapentin
oral capsules
Other Name: Neurontin

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 QuickDASH questionary, which is a shortened version of the 30-item DASH (Disabilities of the Arm, Shoulder and Hand) 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).



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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
Criteria

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 gabapentin, allergy to ibuprofen arginine, 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 ClinicalTrials.gov identifier (NCT number): NCT04025203


Contacts
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Contact: Francisco Unda, PhD 0034695634680 5299559@gmail.com

Locations
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Venezuela
Ciudad Hospitalaria Enrique Tejera Recruiting
Valencia, Carabobo, Venezuela, 2001
Contact: Carlos A Perez, MD    00584144177932    Dr.cperezt@gmail.com   
Principal Investigator: Carlos A Perez, MD         
Sub-Investigator: Edgar J Sayago, PT         
Sub-Investigator: Marian V Montilla, PT         
Sponsors and Collaborators
Francisco Unda Solano
Investigators
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Principal Investigator: Francisco Unda, PhD

Publications:

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Responsible Party: Francisco Unda Solano, Biomedicine Doctorate Program Investigator, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT04025203     History of Changes
Other Study ID Numbers: CE0072015-02-01
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
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:
Ibuprofen Arginine
Gabapentin
Median nerve neural mobilization
Physiotherapy
Pain management
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Ibuprofen
Ibuprofen arginine
Gabapentin
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents