Clinical trial NCT04119739: Pain Reduction Produced by Different Treatments in Carpal Tunnel Syndrome
Official title: Pain Reduction Produced by Physiotherapy, Ibuprofen Arginine, and the Absence of Treatment, in Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Keywords: Ibuprofen
Median nerve neural mobilization
Waiting list control group
Physiotherapy
Pain management
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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, kinesiophobia

  * 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).

Primary outcomes:
measure: Distal upper limb pain
timeFrame: Changes from baseline (measured immediately before the application of the first and last treatment) and 40 minutes after the application of the first and last treatment.
Secondary outcomes:
measure: Upper limb function
timeFrame: Changes from baseline (measured immediately before the application of the first treatment) and at 40 minutes after the application of the last treatment.
Other outcomes:
Locations:
city: Valencia
country: Venezuela
facility: Ciudad Hospitalaria Enrique Tejera
state: Carabobo
Study officials:
name: Francisco Unda Solano, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sanz DR, Solano FU, Lopez DL, Corbalan IS, Morales CR, Lobo CC. Effectiveness of median nerve neural mobilization versus oral ibuprofen treatment in subjects who suffer from cervicobrachial pain: a randomized clinical trial. Arch Med Sci. 2018 Jun;14(4):871-879. doi: 10.5114/aoms.2017.70328. Epub 2017 Sep 26.
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