Carpal Tunnel SyndromeNCT04216147
Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
A study testing PNE and Surgery for CTS in people with Carpal Tunnel Syndrome, run by Universidad de Murcia.
Trial summary
The aim of this study is to compare the effectiveness of Percutaneous Needle Electrolysis (PNE) versus surgical treatment in the treatment of Carpal Tunnel Syndrome (CTS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- PNE and Surgery for CTS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 31 Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years.
- CTS diagnosed by Electromyography (EMG)
- Symptoms of CTS + EMG
Who cannot join
- Difficulty expressing your feelings properly
- Unsurpassed fear of needles
- History of adverse reactions to needles
- Epilepsy and / or allergies to metals.
- Difficulty expressing your feelings properly
- Existence of diffuse peripheral neuropathy or cervical radiculopathy
- History of potential concurrent cause of idiopathic CTS (such as diabetes, thyroid, chronic rheumatoid arthritis, renal failure with hemodialysis, pregnancy..)
About this study
The aim of this study is to compare the effectiveness of Percutaneous Needle Electrolysis (PNE) versus surgical treatment in the treatment of Carpal Tunnel Syndrome (CTS).
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- PNE, Surgery for CTS
- Keywords
- carpal tunnel syndrome, nerve compression syndrome, median nerve, physical therapy technique, percutaneous needle electrolysis
- Medical subject headings
- Carpal Tunnel Syndrome, Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNEOther
Percutaneous Needle Electrolysis: the application of galvanic current through an acupuncture needle.
Surgery for CTSProcedure or surgery
Median nerve release
| Study group | Role | What they receive |
|---|---|---|
| PNE group | Experimental | Patients received 4 sessions, separated one week between them. The treatment consisted the application of a galvanic current through an acupuncture needle (0,30x30mm). The approach were performed with a transverse axis with a needle in plane, being superficial and deep interface of medium nerve the target tissue. The parameters will be 2 mA (milliamps), 10 seconds, 3 impacts (3: 3: 3). Receives: Other: PNE |
| Surgery group | Experimental | Patients received surgery for median nerve release. Receives: Procedure: Surgery for CTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
Measured: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Secondary outcomes (6)
Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale
Describe the symptoms of the hand and wrist (pointing to them in a drawing), and using scales of 1 to 5 (1= No difficulty to do it; 5= I can´t do it), measure the difficulty of performing certain activities (writing, buttoning, holding a book ...)
Measured: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Change of pain level
Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be)
Measured: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Change of Semmes Weinstein Mini monofilament kit
Contact threshold, to assess if there is a decrease in sensitivity
Measured: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Change of the Hand Dynamometer
Hand grip force
Measured: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Changes of the Muscles strength by Kendall´s scale
Muscular strength of Opponens pollicis and Abductors policies. Scale of 0 to 5 (0=No visible or palpable contraction; 5=Full ROM against gravity, maximum resistance)
Measured: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)
12 questions self-administered. Assess quality of life, general health and well-being using scales of 1 to 5 (1= Ever; 5= Never)
Measured: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Dec 2015
- Primary completion1 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Antonio Garcia Vidal, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216147
- Sponsor's protocol ID
- 01/2014
- Status last verified
- Dec 2019
- First submitted
- 28 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04216147
- Acronym / sponsor ID
- 01/2014
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, nerve compression syndrome, median nerve, physical therapy technique, percutaneous needle electrolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 2 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.
The aim of this study is to compare the effectiveness of Percutaneous Needle Electrolysis (PNE) versus surgical treatment in the treatment of Carpal Tunnel Syndrome (CTS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNE group | Experimental | Other: PNEPatients received 4 sessions, separated one week between them. The treatment consisted the application of a galvanic current through an acupuncture needle (0,30x30mm). The approach were performed with a transverse axis with a needle in plane, being superficial and deep interface of medium nerve the target tissue. The parameters will be 2 mA (milliamps), 10 seconds, 3 impacts (3: 3: 3). |
| Surgery group | Experimental | Procedure: Surgery for CTSPatients received surgery for median nerve release. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years.
- CTS diagnosed by Electromyography (EMG)
- Symptoms of CTS + EMG
Key exclusion criteria (7 listed)
- Difficulty expressing your feelings properly
- Unsurpassed fear of needles
- History of adverse reactions to needles
- Epilepsy and / or allergies to metals.
- Difficulty expressing your feelings properly
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 |
|---|---|---|
| PNEPercutaneous Needle Electrolysis: the application of galvanic current through an acupuncture needle. | Other | PNE group |
| Surgery for CTSMedian nerve release | Procedure or surgery | Surgery group |
Primary outcome
Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
Time frame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
6 secondary outcomes
Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale
Time frame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Change of pain level
Time frame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Change of Semmes Weinstein Mini monofilament kit
Time frame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Change of the Hand Dynamometer
Time frame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Changes of the Muscles strength by Kendall´s scale
Time frame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)
Time frame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
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 2 Jan 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PNE and Surgery for CTS in people with Carpal Tunnel Syndrome, run by Universidad de Murcia.
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 3 inclusion and 7 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 of the Boston Questionnaire for Carpal Tunnel Syndrome (time frame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2020.