Refractory Carpal Tunnel SyndromePhase 4NCT00277563
Short and Long Term Exposure to Unique, Time-Varying Pulsed Electro-Magnetic Fields in Refractory Carpal Tunnel Syndrome
A Phase 4 study testing reduction of pain scores by magnetic energy in people with Refractory Carpal Tunnel Syndrome and Neurpathic Pain, run by Weintraub, Michael I., MD, FACP, FAAN at 1 site in United States.
Trial summary
Pulsed electromagnetic fields (PEMF) have been approved by FDA and are utilized currently in treating non-union fractures, neurogenic bladder and musculoskeletal pains. Based on 2 prior pilot studies (open label) demonstrating reduction in neuropathic pain from carpal tunnel syndrome we decided to perform a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Carpal Tunnel Syndrome, Neurpathic Pain, Neuromodulaton
- What is being tested?
- reduction of pain scores by magnetic energy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jul 2005
- Phase
- Phase 4
- 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
- Intractable neuropathic pain in median nerve innervated hand for at least 3 months;
- Abnormal neurological examination compatible with diagnosis of CTS
Who cannot join
- Post-surgical failures,
- Pregnancy,
- Pts with pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael I. Weintraub MD, PC
Briarcliff, New York, 10510
About this study
Official title: Short and Long Term Exposure to Unique, Time-Varying Pulsed Electro-Magnetic Fields in Refractory Carpal Tunnel Syndrome (Cts): A Randomized, Placebo-Controlled Trial With Secondary Bayesian Modification
Pulsed electromagnetic fields (PEMF) have been approved by FDA and are utilized currently in treating non-union fractures, neurogenic bladder and musculoskeletal pains. Based on 2 prior pilot studies (open label) demonstrating reduction in neuropathic pain from carpal tunnel syndrome we decided to perform a placebo-controlled trial, randomized for 2 months utilizing a wrist PEMF device attached by Velcro for 4 hours/day.
Read the detailed description
INTRODUCTION:
Entrapment of the median nerve at the wrist is the most common cause of sensory and motor disturbance in the hands and can be progressively disabling.1,2 Complex mechanisms of compression and ischemia exist that adversely influence the large A myelinated fibers and small unmyelinated nociceptive C fibers. From a pathophysiological standpoint, neuropathic pain (numbness, tingling and burning, NP) is believed secondary to ectopic firing of nociceptive afferent unmyelinated C-fiber axons that are undergoing degeneration.3 Microneurography has confirmed that dysregulated expression of sodium and calcium channels, which accumulate at site of injury, are responsible for ectopic depolarization.3,4,53,54 When conventional therapy of splinting and pharmacotherapy fail, surgical decompression has been offered for moderate-severe cases. While usually successful, it is associated with significant complications, limitations and costs.5,6,7 Thus, the search for reliable and new therapeutic strategies is appealing.
Substantial evidence exists that time-varying magnetic fields produce biological effects by safely inducing extremely low-frequency (ELF) small electrical eddy currents within the tissues that can depolarize, repolarize and hyperpolarize neurons.8,9,10,11,12
Prior pilot data using static13 and pulsed magnetic fields (PEMF)14,15 directed to the carpal tunnel region significantly reduced NP. Since a new, novel device became commercially available that produced a combination of static and time-varying magnetic fields simultaneously, it was hypothesized that this energy could be directed into the wrists and potentially influence not only NP scores, but also modulate neuronal distal latencies (neurotransmission).
DEVICE:
DESCRIPTION: (FIGURE 1) This patented device (Biaxial Super Mini [Mx2R] by Nikken, Inc.) measures 2" in diameter and 1" in height and is worn with a Velcro strap similar to a wristwatch. It is noiseless and nonthermal. Its main component is a spherical permanent magnet, 1150G, 3/8" in diameter that rotates in two perpendicular directions simultaneously producing biaxial magnetic rotation (MX2R) and oscillating polarities up to 1,200 rpm-20 times per second. It is driven by a 2 V DC micro-motor which is shielded one inch away and produces a negligible back EMF. The device is powered by three ¼ AAA rechargeable NiMH (Nickel Metal Hydride) batteries
Randomized double blind placebo-controlled device with primary parameters of pain and sleep interupption scores, NPS scale and secondary parameters of neurological exam changes, nerve conduction latencies of median nerve, dynamometry, finger gauge pressures, CPT and PGIC were compared at baseline and end of two months. Patients were given a free "active" device gratis at end of study.
- Being tested
- reduction of pain scores by magnetic energy
- Keywords
- Carpal Tunnel Syndrome, Neuropathic Pain, Neuromodulation, PEMF, Magnetic Field Therapy, Magnetotherapy
- Medical subject headings
- Carpal Tunnel Syndrome, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduction of pain scores by magnetic energyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain scores 0-10 (leikert scale)
VAS Sleep interrupption 0-10
Neuropathic Pain scale (NPS)
Secondary outcomes (5)
Neurological Exam
Median nerve distal latencies (CMAP/SNAP)
Hand help Dynamometry and Finger gauge pressures
CPT (Neurometer)
PGIC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startJun 2004
- Study completionJul 2005
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 Refractory 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Weintraub, Michael I., MD, FACP, FAAN
- Collaborators
- Dr. Steven P. Cole, PhD. Statistician
- Investigators
- Steven P. Cole, PhD, Study chair, Statistician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277563
- Sponsor's protocol ID
- 1-Weintraub
- Status last verified
- Sep 2007
- First submitted
- 13 Jan 2006
- Last updated
- 21 Sep 2007
- Results posted
- No
Publications
Weintraub MI, Cole SP. A randomized controlled trial of the effects of a combination of static and dynamic magnetic fields on carpal tunnel syndrome. Pain Med. 2008 Jul-Aug;9(5):493-504. doi: 10.1111/j.1526-4637.2007.00324.x.
PubMed 18777606
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Exposure to Unique, Time-Varying Pulsed Electro-Magnetic Fields in Refractory Carpal Tunnel Syndrome (Cts): A Randomized, Placebo-Controlled Trial With Secondary Bayesian Modification
- ClinicalTrials.gov ID
- NCT00277563
- Acronym / sponsor ID
- 1-Weintraub
- Keywords
- Carpal Tunnel Syndrome, Neuropathic Pain, Neuromodulation, PEMF, Magnetic Field Therapy, Magnetotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Weintraub, Michael I., MD, FACP, FAAN
- Collaborators
- Dr. Steven P. Cole, PhD. Statistician
- Study start
- Jun 2004
- Study completion
- Jul 2005
- First posted
- 16 Jan 2006 (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.
Pulsed electromagnetic fields (PEMF) have been approved by FDA and are utilized currently in treating non-union fractures, neurogenic bladder and musculoskeletal pains. Based on 2 prior pilot studies (open label) demonstrating reduction in neuropathic pain from carpal tunnel syndrome we decided to perform a placebo-controlled trial, randomized for 2 months utilizing a wrist PEMF device attached by Velcro for 4 hours/day.
Detailed description
INTRODUCTION:
Entrapment of the median nerve at the wrist is the most common cause of sensory and motor disturbance in the hands and can be progressively disabling.1,2 Complex mechanisms of compression and ischemia exist that adversely influence the large A myelinated fibers and small unmyelinated nociceptive C fibers. From a pathophysiological standpoint, neuropathic pain (numbness, tingling and burning, NP) is believed secondary to ectopic firing of nociceptive afferent unmyelinated C-fiber axons that are undergoing degeneration.3 Microneurography has confirmed that dysregulated expression of sodium and calcium channels, which accumulate at site of injury, are responsible for ectopic depolarization.3,4,53,54 When conventional therapy of splinting and pharmacotherapy fail, surgical decompression has been offered for moderate-severe cases. While usually successful, it is associated with significant complications, limitations and costs.5,6,7 Thus, the search for reliable and new therapeutic strategies is appealing.
Substantial evidence exists that time-varying magnetic fields produce biological effects by safely inducing extremely low-frequency (ELF) small electrical eddy currents within the tissues that can depolarize, repolarize and hyperpolarize neurons.8,9,10,11,12
Prior pilot data using static13 and pulsed magnetic fields (PEMF)14,15 directed to the carpal tunnel region significantly reduced NP. Since a new, novel device became commercially available that produced a combination of static and time-varying magnetic fields simultaneously, it was hypothesized that this energy could be directed into the wrists and potentially influence not only NP scores, but also modulate neuronal distal latencies (neurotransmission).
DEVICE:
DESCRIPTION: (FIGURE 1) This patented device (Biaxial Super Mini [Mx2R] by Nikken, Inc.) measures 2" in diameter and 1" in height and is worn with a Velcro strap similar to a wristwatch. It is noiseless and nonthermal. Its main component is a spherical permanent magnet, 1150G, 3/8" in diameter that rotates in two perpendicular directions simultaneously producing biaxial magnetic rotation (MX2R) and oscillating polarities up to 1,200 rpm-20 times per second. It is driven by a 2 V DC micro-motor which is shielded one inch away and produces a negligible back EMF. The device is powered by three ¼ AAA rechargeable NiMH (Nickel Metal Hydride) batteries
Randomized double blind placebo-controlled device with primary parameters of pain and sleep interupption scores, NPS scale and secondary parameters of neurological exam changes, nerve conduction latencies of median nerve, dynamometry, finger gauge pressures, CPT and PGIC were compared at baseline and end of two months. Patients were given a free "active" device gratis at end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intractable neuropathic pain in median nerve innervated hand for at least 3 months;
- Abnormal neurological examination compatible with diagnosis of CTS
Key exclusion criteria (3 listed)
- Post-surgical failures,
- Pregnancy,
- Pts with pacemaker
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 |
|---|---|---|
| reduction of pain scores by magnetic energy | Device | – |
Primary outcome
VAS Pain scores 0-10 (leikert scale)
VAS Sleep interrupption 0-10
Neuropathic Pain scale (NPS)
5 secondary outcomes
Neurological Exam
Median nerve distal latencies (CMAP/SNAP)
Hand help Dynamometry and Finger gauge pressures
CPT (Neurometer)
PGIC
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 21 Sep 2007.
- Derived from this study: PubMed 18777606Weintraub MI, Cole SP. A randomized controlled trial of the effects of a combination of static and dynamic magnetic fields on carpal tunnel syndrome. Pain Med. 2008 Jul-Aug;9(5):493-504. doi: 10.1111/j.1526-4637.2007.00324.x.
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.
Steven P. Cole, PhD study chair
Statistician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing reduction of pain scores by magnetic energy in people with Refractory Carpal Tunnel Syndrome and Neurpathic Pain, run by Weintraub, Michael I., MD, FACP, FAAN at 1 site in United States.
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 2 inclusion and 3 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 21 Sep 2007. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
VAS Pain scores 0-10 (leikert scale). The study lists 3 primary outcomes in all. 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 NCT00277563, 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 21 Sep 2007.