Pain Reduction Produced by Different Treatments in Carpal Tunnel Syndrome

Francisco Unda Solano

Status and phase: Completed; Phase 4

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Ibuprofen Arginine; Other: Median nerve neural mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04119739

CE0072015-02-02

Details and patient eligibility

About

Pain reduction effects of the median nerve neural mobilization technique (a physiotherapy treatment) will be compared to those produced by a pharmaceutical treatment and the absence of treatment, in subjects who suffer carpal tunnel syndrome.

Full description

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of median nerve neural mobilization (non invasive and non pharmaceutical physiotherapy treatment), to the pain reduction effect produced by an oral ibuprofen treatment or the lack of treatment (waiting list control group) 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 3 different groups.

Enrollment: 117 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
  • Upper limb surgery or trauma
  • Pregnancy
  • 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, ibuprofen or ibuprofen arginine
  • Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
  • Metabolic neuropathy.
  • Obesity (body mass index over 30).
  • Participants who are not employed.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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117 participants in 3 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

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.