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

NCT ID: NCT04025203

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Median nerve neural mobilization

Intervention Type OTHER

Manual therapy maneuver performed in the upper limb.

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.

Group Type ACTIVE_COMPARATOR

Ibuprofen Arginine

Intervention Type DRUG

Oral tablets

Gabapentin

Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 600 mg per day, subdivided in 2 intakes of 300 mg each 12 hours during a time lapse of 4 weeks.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

oral capsules

Interventions

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Median nerve neural mobilization

Manual therapy maneuver performed in the upper limb.

Intervention Type OTHER

Ibuprofen Arginine

Oral tablets

Intervention Type DRUG

Gabapentin

oral capsules

Intervention Type DRUG

Other Intervention Names

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Spedifen Neurontin

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Francisco Unda Solano

OTHER

Sponsor Role lead

Responsible Party

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Francisco Unda Solano

Biomedicine Doctorate Program Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Francisco Unda, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, Venezuela

Site Status

Countries

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Venezuela

References

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Other Identifiers

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CE0072015-02-01

Identifier Type: -

Identifier Source: org_study_id

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