Carpal Tunnel SyndromeNCT02891512
Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome
A study testing ELF and Xinepa® in people with Carpal Tunnel Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The purpose of the study is to determine the effectiveness of the treatment with very low frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated signs such as sensitivity disorders that affect the first three fingers and half of the fourth finger of the hand in patients with carpal… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- ELF and Xinepa®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to Jan 2016
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of carpal tunnel syndrome
Who cannot join
- Pregnancy;
- Pacemaker or other metallic implants;
- Systemic infectious disorders;
- Neoplastic disorders;
- Epilepsy;
- Severe heart disease.
- Known hypersensitivity to the components of Xinepa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome: Randomized Double-blind Controlled Clinical Trial.
The purpose of the study is to determine the effectiveness of the treatment with very low frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated signs such as sensitivity disorders that affect the first three fingers and half of the fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (= Xinepa).
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- ELF, Xinepa®, Placebo Xinepa®
- Keywords
- Magnetic Fields, Pain, Paresthesia, Visual Analogue Scale
- Medical subject headings
- Carpal Tunnel Syndrome, Pain, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELFOther
Very low frequency magnetic fields (ELF) at intensity of 100 mT and a frequency of 1-80 Hz. Protocol (antiedema-antinflammatory): 12 sessions, 3 times a week for 4 consecutive weeks, each session lasted 30 minutes.
Xinepa®Other
2 tablets of Xinepa daily (morning and evening) for 1 month.
Placebo Xinepa®Other
2 tablets of Xinepa placebo daily (morning and evening) for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| ELF and Xinepa® | Experimental | The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues. Xinepa® is a dietary supplement containing alpha-lipoic acid, N-acetyl-L-carnitine, turmeric, vitamins B, E and C. They have an antioxidant and anti-inflammatory action on nervous system and they act on cellular energy metabolism. Receives: Other: ELF; Other: Xinepa® |
| ELF and Placebo Xinepa® | Placebo comparator | The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues. Xinepa® without its specific activity for the condition being treated. Receives: Other: ELF; Other: Placebo Xinepa® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.
Measured: baseline, 4 weeks, 12 weeks
Secondary outcomes (5)
Change of Semmes-Weinstein Monofilaments of light touch and pressure sensation test from baseline to 12 weeks
Involves the use of five monofilaments of different colours that identify the levels of decrease in sensitivity, measurable, necessary for the evaluation of the perception of the surface touch.
Measured: baseline, 4 weeks, 12 weeks
Change of Boston Carpal Tunnel Questionnaire from baseline to 12 weeks
It consists of two scales, the scale of the severity of symptoms (SSS) and functional status scale (FSS). The first includes the first 11 questions relating to: the intensity of pain during the day and night, lasting pain during the day, sleep, weakness, tingling sensation during the night and its frequency and abilities. Each question provides a metric scale ranging from 1 (absence of symptoms) to 5 (severe symptoms). The second scale includes the last eight questions concerning activities such as writing, buttoning clothes, hold a book while reading, hold up the phone, clean, carry bags, open the lid of a jar.
Measured: baseline, 4 weeks, 12 weeks
Change of the measurement of the grip strength trough the Jamar dynamometer from baseline to 12 weeks
It consists of a manometer with a double scale to recorder static force in kilos and pounds and a handle with 5 different positions of increasing amplitude from 3.5 cm to 8.8 cm. The patient holds the dynamometer and performs a grip at maximum force. The final score originates from the average of three measurements taken for each position of the handle.
Measured: baseline, 4 weeks, 12 weeks
Change of the measurement of the pinch strength trough the Pinch Gauges dynamometer from baseline to 12 weeks
It consists of a manometer with a double scale to recorder static force in kilos and libbre and two caliper levers with the tips away from each other of 2.2 cm/ 1.9 cm. Three types of pliers are evaluated: side, three tips, tip against tip. The patient holds the dynamometer and performs a grip at maximum force. The final score originates from the average of three measurements taken for each type of tongs.
Measured: baseline, 4 weeks, 12 weeks
Change of electroneurography from baseline to 12 months
It allows the study of nerve of the median nerve (speed of motor-sentitive run and latency).
Measured: baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionAug 2015
- Study completionJan 2016
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.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, University of Roma La Sapienza
- Investigators
- Vincenzo Maria Saraceni, Study director, Umberto I hospital, Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891512
- Sponsor's protocol ID
- 2545/15
- Status last verified
- Nov 2016
- First submitted
- 31 Aug 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome: Randomized Double-blind Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02891512
- Acronym / sponsor ID
- 2545/15
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Magnetic Fields, Pain, Paresthesia, Visual Analogue Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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 purpose of the study is to determine the effectiveness of the treatment with very low frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated signs such as sensitivity disorders that affect the first three fingers and half of the fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (= Xinepa).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELF and Xinepa® | Experimental | Other: ELF, Other: Xinepa®The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues. Xinepa® is a dietary supplement containing alpha-lipoic acid, N-acetyl-L-carnitine, turmeric, vitamins B, E and C. They have an antioxidant and anti-inflammatory action on nervous system and they act on cellular energy metabolism. |
| ELF and Placebo Xinepa® | Placebo comparator | Other: ELF, Other: Placebo Xinepa®The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues. Xinepa® without its specific activity for the condition being treated. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of carpal tunnel syndrome
Key exclusion criteria (7 listed)
- Pregnancy;
- Pacemaker or other metallic implants;
- Systemic infectious disorders;
- Neoplastic disorders;
- Epilepsy;
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 |
|---|---|---|
| ELFVery low frequency magnetic fields (ELF) at intensity of 100 mT and a frequency of 1-80 Hz. Protocol (antiedema-antinflammatory): 12 sessions, 3 times a week for 4 consecutive weeks, each session lasted 30 minutes. | Other | ELF and Placebo Xinepa®, ELF and Xinepa® |
| Xinepa®2 tablets of Xinepa daily (morning and evening) for 1 month. | Other | ELF and Xinepa® |
| Placebo Xinepa®2 tablets of Xinepa placebo daily (morning and evening) for 1 month. | Other | ELF and Placebo Xinepa® |
Primary outcome
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.
5 secondary outcomes
Change of Semmes-Weinstein Monofilaments of light touch and pressure sensation test from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of Boston Carpal Tunnel Questionnaire from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of the measurement of the grip strength trough the Jamar dynamometer from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of the measurement of the pinch strength trough the Pinch Gauges dynamometer from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of electroneurography from baseline to 12 months
Time frame: baseline, 4 weeks, 12 weeks
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 22 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Vincenzo Maria Saraceni study director
Umberto I hospital, Sapienza University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELF and Xinepa® in people with Carpal Tunnel Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
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 1 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 22 Nov 2016. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks (time frame: baseline, 4 weeks, 12 weeks). 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 22 Nov 2016.