Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome

Universidad Rey Juan Carlos

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Procedure: Endoscopic surgery of the carpal tunnel; Procedure: Percutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04246216

URJC0209201911819

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Percutaneous Electrical Nerve Stimulation

Experimental group

Description:

The experimental group will receive 3 sessions (once per week) of ultrasound-guided Percutaneous Electrical Nerve Stimulation targeted the median nerve. Once the median nerve is ultrasound identified, the needles will be left in situ at the identified points connected to an electrostimulator (ES-160 ITO co.) applying a biphasic continuous waveform, at low frequency (2 Hz)19 and with 250 microseconds pulse duration for 30mins.

Treatment:

Procedure: Percutaneous Electrical Nerve Stimulation

Surgery

Active Comparator group

Description:

The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.

Treatment:

Procedure: Endoscopic surgery of the carpal tunnel