Pain Reduction Caused by the Combined Treatment of Physiotherapy, Oral Gabapentin and Oral Ibuprofen Arginine.

European University

Status and phase: Completed; Phase 4

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Gabapentin 300mg; Other: Median nerve neural mobilization; Drug: Ibuprofen Arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT06781489

CE0072015-02-08

Details and patient eligibility

About

In the present investigation the pain reduction effects of a physiotherapy technique combined with gabapentin and ibuprofen arginine will be compared to those produced by an ibuprofen arginine (only) 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 (group 1) the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral gabapentin treatment versus (group 2) median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral ibuprofen arginine treatment, to those effects produced by (group 3) ibuprofen arginine (only) treatment. 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 2 different groups.

Enrollment: 129 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 signs.
• 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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129 participants in 3 patient groups

Median nerve neural mobilization and oral gabapentin

Experimental group

Description:

Median nerve neural mobilization, non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induce median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 2 weeks. Additionally, subjects will be treated with a Gabapentin 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 2 weeks.

Treatment:

Other: Median nerve neural mobilization

Drug: Gabapentin 300mg

Median nerve neural mobilization and ibuprofen arginine

Active Comparator group

Description:

Median nerve neural mobilization, non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induce median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 2 weeks. Additionally, subjects will be treated with an ibuprofen arginine maximum dose of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 2 weeks.

Treatment:

Drug: Ibuprofen Arginine

Other: Median nerve neural mobilization

Ibuprofen arginine

Active Comparator group

Description:

Subjects will be treated with an ibuprofen arginine maximum dose of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 2 weeks.

Treatment:

Drug: Ibuprofen Arginine