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

F

Francisco Unda Solano

Status and phase

Unknown
Phase 4

Conditions

Carpal Tunnel Syndrome

Treatments

Drug: Gabapentin
Other: Median nerve neural mobilization
Drug: Ibuprofen Arginine

Study type

Interventional

Funder types

Other

Identifiers

NCT04025203
CE0072015-02-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 4 patient groups

Median nerve neural mobilization
Experimental group
Description:
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.
Treatment:
Other: Median nerve neural mobilization
Ibuprofen arginine
Active Comparator group
Description:
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.
Treatment:
Drug: Ibuprofen Arginine
Gabapentin
Active Comparator group
Description:
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.
Treatment:
Drug: Gabapentin
Control group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Francisco Unda, PhD

Data sourced from clinicaltrials.gov

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