Clinical trial NCT04246216: Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome
Official title: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Median Nerve for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is evidence supporting that physical therapy interventions can be effective for the management of patients with CTS. No consensus on the best approach exist. It seems clear that the median nerve is affected in several ways (compression, inflammation, excursion) in carpal tunnel syndrome. Percutaneous Electrical Nerve Stimulation is a treatment approach consisting of the application of an electrical current throughout needling filaments placed close to the nerve, in this case the median nerve. The purpose of this clinical trial is to compare changes in function, symptom severity and the intensity of pain after the application of Percutaneous Electrical Nerve Stimulation vs. endoscopic surgery in women with CTS at short- and long-term follow-up periods.


Eligibility criteria: Inclusion Criteria:

* pain and paresthesia in the median nerve distribution
* positive Tinel sign,
* positive Phalen sign,
* symptoms had to have persisted for at least 6 months
* deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy

Exclusion Criteria:

* any sensory/motor deficit related to the ulnar or radial nerve;
* older than 65 years of age;
* previous surgical intervention, steroid injections or physical therapy intervention
* multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
* history of neck, shoulder, or upper limb trauma (whiplash);
* history of any systemic disease causing CTS (eg, diabetes mellitus, thyroid disease);
* history of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
* pregnancy;

Primary outcomes:
measure: Changes in pain intensity between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention.
Secondary outcomes:
measure: Changes in hand function between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention.
measure: Changes in severity between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention.
measure: Changes in patient self-perceived improvement between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention.
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: César Fernández-de-las-Peñas
state: Alcorcon, Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: César Fernández-de-las-Peñas
role: PRINCIPAL_INVESTIGATOR
References: