Carpal Tunnel SyndromeNCT04246216
Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome
A study testing Percutaneous Electrical Nerve Stimulation and Endoscopic surgery of the carpal tunnel in people with Carpal Tunnel Syndrome, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Percutaneous Electrical Nerve Stimulation and Endoscopic surgery of the carpal tunnel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Median Nerve for Carpal Tunnel Syndrome
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
- Being tested
- Percutaneous Electrical Nerve Stimulation, Endoscopic surgery of the carpal tunnel
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Electrical Nerve StimulationProcedure or surgery
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.
Endoscopic surgery of the carpal tunnelProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endoscopic surgery of the carpal tunnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1, 3, 6 and 12 months after the intervention.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1, 3, 6 and 12 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Mar 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- César Fernández-de-las-Peñas, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246216
- Sponsor's protocol ID
- URJC0209201911819
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36987682
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Median Nerve for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04246216
- Acronym / sponsor ID
- URJC0209201911819
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Electrical Nerve Stimulation | Experimental | Procedure: Percutaneous Electrical Nerve StimulationThe 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 | Active comparator | Procedure: Endoscopic surgery of the carpal tunnelThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Electrical Nerve StimulationExperimental: 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. | Procedure or surgery | Percutaneous Electrical Nerve Stimulation |
| Endoscopic surgery of the carpal tunnelThe 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 or surgery | Surgery |
Primary outcome
Changes in pain intensity between baseline and follow-up periods
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.
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.
3 secondary outcomes
Changes in hand function between baseline and follow-up periods
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.
Changes in severity between baseline and follow-up periods
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
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 36987682Fernandez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
César Fernández-de-las-Peñas principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Electrical Nerve Stimulation and Endoscopic surgery of the carpal tunnel in people with Carpal Tunnel Syndrome, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain intensity between baseline and follow-up periods (time frame: Baseline and 1, 3, 6 and 12 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04246216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.