Clinical trial NCT04328805: Ibuprofen and Neural Mobilization Treatment in Carpal Tunnel Syndrome.
Official title: Pain Reduction and Changes in Upper Limb Function Produced by Over the Counter Oral Ibuprofen and Median Nerve Neural Mobilization Versus the Lack of Treatment, in Carpal Tunnel Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Ibuprofen
Pain Management
Pain, Chronic
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 42
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: In the present investigation, the pain reduction effect of median nerve neural mobilization and oral ibuprofen treatments will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

Detailed description: The present randomized clinical trial will perform a comparison of the pain reduction effects produced by median nerve neural mobilization and oral ibuprofen treatments to the total lack of treatment in subjects diagnosed with carpal tunnel syndrome. 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 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 (or contraindication) to non steroidal anti inflammatory drugs (NSAID)
* 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 60 minutes after the application of the last treatment
Other outcomes:
Locations:
city: Valencia
country: Venezuela
facility: Ciudad Hospitalaria Enrique Tejera
state: Carabobo
Study officials:
affiliation: INSALUD
name: Carlos Perez, MD
role: STUDY_CHAIR
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