Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Percutaneous Electrical Nerve Stimulation

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.

Group Type EXPERIMENTAL

Percutaneous Electrical Nerve Stimulation

Intervention Type PROCEDURE

Experimental: Percutaneous Electrical Nerve Stimulation 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.

Surgery

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.

Group Type ACTIVE_COMPARATOR

Endoscopic surgery of the carpal tunnel

Intervention Type PROCEDURE

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.

Interventions

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Percutaneous Electrical Nerve Stimulation

Experimental: Percutaneous Electrical Nerve Stimulation 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.

Intervention Type PROCEDURE

Endoscopic surgery of the carpal tunnel

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No