An interventional study of Percutaneous Electrical Nerve Stimulation and Endoscopic surgery of the carpal tunnel in Carpal Tunnel Syndrome, sponsored by Universidad Rey Juan Carlos. Completed at 1 site in Spain. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Universidad Rey Juan Carlos is the lead sponsor of 111 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.
Changes in hand function between baseline and follow-up periods
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.
Changes in severity between baseline and follow-up periods
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.
Changes in patient self-perceived improvement between baseline and follow-up periods
. Subjects self-perceived improvement will be assessed using a Global Rating of Change (GROC) which consists of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better). It has been reported that scores of +4 and +5 are indicative of moderate changes in patient status, whereas scores of +6 and +7 indicate large changes in the status of the patient.
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Rey Juan Carlos