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Completed

NCT Number: NCT04025203

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, 2001, Venezuela

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 sign.
  • 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, metabolic neuropathy, obesity (body mass index over 30), participants who are not employed, 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).

Treatment and study plan

Median nerve neural mobilization

Other

Manual therapy maneuver performed in the upper limb.

Ibuprofen Arginine

Drug

Oral tablets

Other names: Spedifen

Gabapentin

Drug

oral capsules

Other names: Neurontin

Primary outcomes

  1. Distal upper limb pain

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

    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 outcomes

  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).

Other outcomes

  1. Work Status at baseline

    Time frame: Measured immediately before the application of the first treatment

    This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Do you currently work?"

  2. Work Status post treatment

    Time frame: Measured immediatly after the application of the last treatment.

    This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Do you currently work?"

  3. Change in Work Task (Job Type)

    Time frame: Measured immediatly after the application of the last treatment.

    This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Did you change your job type or task?"

  4. The Tampa Scale for Kinesiophobia-17 (TSK-17)

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

    The Tampa Scale for Kinesiophobia-17 (TSK-17) is a 17-item questionnaire designed to assess the fear of movement and re-injury (kinesiophobia). Items are rated on a 4-point Likert scale (ranging from "strongly disagree" to "strongly agree"), yielding a total score that reflects the severity of pain-related fear avoidance beliefs. It's a widely used and vailidaded clinical and research instrument. The standard total score range for the Tampa Scale for Kinesiophobia (TSK-17) is 17 to 68. It is calculated by summing 17 items, each scored 1-4, with four items reverse-scored. Higher scores indicate greater fear of movement

Sponsors and collaborators

Lead sponsor

Francisco Unda Solano

Other

Registry information

Official study title

Pain Reduction and Changes in Upper Limb Function Produced by Physiotherapy, Ibuprofen Arginine, Gabapentin and the Absence of Treatment, in Carpal Tunnel Syndrome

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2019
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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