Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome

NCT04246216 | Completed DMC

• 1 other identifier: URJC0209201911819
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes in pain intensity between baseline and follow-up periods

  An 11-point Numerical Pain Rating Scale (NPRS, 0: no pain - 10: maximum pain) will be used to assess the patients' current level of hand pain and the worst and lowest level of pain experienced in the preceding week.

  Baseline and 1, 3, 6 and 12 months after the intervention.

Secondary Outcomes (3)

• Changes in hand function between baseline and follow-up periods

  Baseline and 1, 3, 6 and 12 months after the intervention.

• Changes in severity between baseline and follow-up periods

  Baseline and 1, 3, 6 and 12 months after the intervention.

• Changes in patient self-perceived improvement between baseline and follow-up periods

  Baseline and 1, 3, 6 and 12 months after the intervention.

Study Arms (2)

Percutaneous Electrical Nerve Stimulation

EXPERIMENTAL

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.

Procedure: Percutaneous Electrical Nerve Stimulation

Surgery

ACTIVE COMPARATOR

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.

Procedure: Endoscopic surgery of the carpal tunnel

Interventions

Percutaneous Electrical Nerve Stimulation 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.

Percutaneous Electrical Nerve Stimulation

Endoscopic surgery of the carpal tunnel 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.

Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

César Fernández-de-las-Peñas

Alcorcón, Alcorcon, Madrid, 28922, Spain

Location

Related Publications (1)

• Fernandez-de-Las-Penas C, Ortega-Santiago R, De-la-Llave-Rincon AI, Cleland JA, Pareja JA, Fahandezh-Saddi-Diaz H, Arias-Buria JL. Ultrasound-guided percutaneous electrical nerve stimulation versus surgery for women with unilateral carpal tunnel syndrome: A randomized parallel-group trial. Eur J Pain. 2023 Aug;27(7):860-870. doi: 10.1002/ejp.2117. Epub 2023 Apr 7.

  PMID: 36987682 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• César Fernández-de-las-Peñas

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full proffessor

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: March 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

ES (1)