Oral Gabapentin and Median Nerve Mobilization in the Treatment of Carpal Tunnel Syndrome

European University

Status and phase: Completed; Phase 4

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Gabapentin oral capsules; Other: Median nerve neural mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04285281

CE0072015-02-03

Details and patient eligibility

About

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 Gabapentin and 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 Gabapentin and the absence of treatment, in subjects who suffer the signs and symptoms of 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.

Enrollment: 126 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 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, 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

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126 participants in 3 patient groups

Gabapentin

Active Comparator group

Description:

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

Treatment:

Drug: Gabapentin oral capsules

Control group

No Intervention group

Description:

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.

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