Carpal Tunnel SyndromePhase 2CTS/SMFNCT00521495
Carpal Tunnel Syndrome and Static Magnetic Field Therapy
A Phase 2 study testing neodymium permanent magnet, neodymium magnet and magnet in people with Carpal Tunnel Syndrome, run by National University of Natural Medicine at 1 site in United States.
Trial summary
The purpose of this Phase II study is to assess the feasibility of conducting a large scale trial which will evaluate the effectiveness of static magnetic field therapy as a treatment for Carpal Tunnel Syndrome. This preliminary study will determine which of three strength magnets to use in the future. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- neodymium permanent magnet, neodymium magnet and magnet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2009
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range (18-65 years) Both genders Hand or wrist pain with paresthesias or numbness in any or all fingers, predominating in a median nerve distribution, and especially occurring at night Symptoms present for at least 3 months No prior treatment with magnet therapy Baseline BCTQ >2.0 on SSS subscale Meet specific EDX inclusion/ exclusion criteria listed in Table 1 (below) Willing and able to provide informed consent Ability to read English fluently
Who cannot join
- Use of narcotic analgesia Corticosteroid injection into the carpal tunnel within previous 3 months Prior carpal tunnel surgery on affected side History of wrist or hand fracture on the symptomatic limb Skin rash or irritation on the wrist Participant (or bed partner) wearing a pacemaker or other electronic device Current pregnancy, less than 3 months postpartum, nursing, or planning a pregnancy Plans to move from area during the time frame of the study Inability to tolerate the baseline screening nerve conduction study Unable or unwilling to comply with the protocol Collecting workers' compensation or social-security disability benefits Involved in litigation regarding pain or disability Development of a rash or skin irritation to the tape applied to the wrist during a run-in baseline test period
- Concomitant medical conditions including:
- Insulin-dependent diabetes mellitus History of chronic renal failure or renal dialysis or forearm fistulae History of generalized peripheral neuropathy History of other neurologic disorders which may confuse the diagnosis of carpal tunnel syndrome, including but not limited to stroke, cervical radiculopathy, myelopathy, subdural hematoma, brain tumor Inflammatory articular disease or tendonitis of the involved hand or wrist Other disorders known to predispose to carpal tunnel syndrome including acromegaly, multiple myeloma, amyloidosis Cancer
- Table 1. Electrodiagnostic (EDX) Inclusion and Exclusion Criteria Inclusion Criteria
- Median nerve onset sensory latency > 3.5 ms at 13 cm
- Median-ulnar across palm latency difference ≥ 0.4 ms
Show all 10Show fewer
- Median-radial to thumb latency difference ≥ 0.7 ms
- Median-ulnar to ring finger latency difference ≥ 0.5ms ED Exclusion Criteria
- Absent sensory nerve action potential (SNAP)
- Median nerve distal motor latency > 6.0 ms
Trial locations and contacts
1 site in 1 country.
United States1 site
National College of Natural Medicine
Portland, Oregon, 97201
About this study
The purpose of this Phase II study is to assess the feasibility of conducting a large scale trial which will evaluate the effectiveness of static magnetic field therapy as a treatment for Carpal Tunnel Syndrome. This preliminary study will determine which of three strength magnets to use in the future.
Participants will be recruited from three primary sources. 1) Patients with a possible diagnosis of Carpal Tunnel Syndrome who have been referred to the Orthopaedic and Rehabilitation Clinics of OHSU for Nerve conduction studies. If after conducting these studies a potential participant shows evidence of mild to moderate Carpal Tunnel Syndrome s/he will be informed about the study and invited to participate in additional screening. B) Patients seen at the National College of Natural Medicine (NCNM) Clinics who have a clinical diagnosis of Carpal Tunnel Syndrome will be informed about the study and invited to enter the screening process for further eligibility. C) Participants will also be recruited from the general public including staff and students at OHSU and NCNM).
Read more
Eligibility will be determined through a stepwise process including telephone screening for general eligibility, Nerve Conduction screening for electrodiagnostic eligibility, and Boston Carpal Tunnel Questionnaire screening for symptom severity eligibility. Those potential participants who meet all eligibility requirements will be randomized to one of three magnetic field dosages. They will be provided with a ¾" diameter x 1/8" thick magnet which they will be required to apply for six weeks during the hours of sleep. Over the course of the study participants will have four visits to the General Clinical Research Center of OHSU and three visits to the Orthopaedic and Rehabilitation Clinics of OHSU for Nerve Conduction studies to be performed by either Dr. Nels Carlson or Dr. Hans Carlson.
Questionnaires to be completed during the course of the study include a general health information and demographics questionnaire, the Boston Carpal Tunnel Questionnaire, which will be completed on six occasions, a general symptoms checklist and a Post Treatment Participant satisfaction questionnaire.
Recruitment, retention, compliance and safety will be analyzed using descriptive statistics. Effectiveness of the three different strength magnets will be assessed by comparing participants' baseline scores on the Boston Carpal Tunnel Questionnaire with their scores after six weeks of magnet use.
Read the detailed description
See Brief Summary
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- neodymium permanent magnet, neodymium magnet, magnet
- Keywords
- static magnetic field, permanent magnet, carpal tunnel syndrome, median nerve
- 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.
neodymium permanent magnetDevice
3/4" diameter by 1/8" thick permanent magnet
neodymium magnetDevice
- 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target
magnetDevice
0 Gauss magnets are worn every night during hours of sleep for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Surface magnetic field strength at target 450 Gauss permanent magnet Receives: Device: neodymium permanent magnet; Device: neodymium magnet |
| B | Experimental | Surface field strength at target 150 Gauss permanent magnet Receives: Device: neodymium magnet |
| C | Active comparator | Not described Receives: Device: neodymium magnet; Device: magnet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire Symptom Severity Scale
Measured: Baseline, Wks 2, 4, 6, 18
Secondary outcomes (3)
1. Electrophysiological recovery of median nerve
Measured: Baseline, 6 weeks, 18 weeks
2. General symptom questionnaire
Measured: Baseline and on completion of intervention phase
3. Compliance with treatment
Measured: Baseline to study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startSep 2006
- Primary completionJun 2009 (estimated)
- Study completionAug 2009 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Oregon Health and Science University
- Investigators
- Agatha P Colbert, MD, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521495
- Sponsor's protocol ID
- R21AT003293
- Other IDs
- R21AT003293
- Acronym
- CTS/SMF
- Status last verified
- Nov 2009
- First submitted
- 24 Aug 2007
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Colbert AP, Markov MS, Carlson N, Gregory WL, Carlson H, Elmer PJ. Static magnetic field therapy for carpal tunnel syndrome: a feasibility study. Arch Phys Med Rehabil. 2010 Jul;91(7):1098-104. doi: 10.1016/j.apmr.2010.02.013.
PubMed 20599049
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Syndrome and Static Magnetic Field Therapy
- ClinicalTrials.gov ID
- NCT00521495
- Acronym / sponsor ID
- CTS/SMF / R21AT003293
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- static magnetic field, permanent magnet, carpal tunnel syndrome, median nerve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Oregon Health and Science University
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 28 Aug 2007 (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 this Phase II study is to assess the feasibility of conducting a large scale trial which will evaluate the effectiveness of static magnetic field therapy as a treatment for Carpal Tunnel Syndrome. This preliminary study will determine which of three strength magnets to use in the future.
Participants will be recruited from three primary sources. 1) Patients with a possible diagnosis of Carpal Tunnel Syndrome who have been referred to the Orthopaedic and Rehabilitation Clinics of OHSU for Nerve conduction studies. If after conducting these studies a potential participant shows evidence of mild to moderate Carpal Tunnel Syndrome s/he will be informed about the study and invited to participate in additional screening. B) Patients seen at the National College of Natural Medicine (NCNM) Clinics who have a clinical diagnosis of Carpal Tunnel Syndrome will be informed about the study and invited to enter the screening process for further eligibility. C) Participants will also be recruited from the general public including staff and students at OHSU and NCNM).
Eligibility will be determined through a stepwise process including telephone screening for general eligibility, Nerve Conduction screening for electrodiagnostic eligibility, and Boston Carpal Tunnel Questionnaire screening for symptom severity eligibility. Those potential participants who meet all eligibility requirements will be randomized to one of three magnetic field dosages. They will be provided with a ¾" diameter x 1/8" thick magnet which they will be required to apply for six weeks during the hours of sleep. Over the course of the study participants will have four visits to the General Clinical Research Center of OHSU and three visits to the Orthopaedic and Rehabilitation Clinics of OHSU for Nerve Conduction studies to be performed by either Dr. Nels Carlson or Dr. Hans Carlson.
Questionnaires to be completed during the course of the study include a general health information and demographics questionnaire, the Boston Carpal Tunnel Questionnaire, which will be completed on six occasions, a general symptoms checklist and a Post Treatment Participant satisfaction questionnaire.
Recruitment, retention, compliance and safety will be analyzed using descriptive statistics. Effectiveness of the three different strength magnets will be assessed by comparing participants' baseline scores on the Boston Carpal Tunnel Questionnaire with their scores after six weeks of magnet use.
Detailed description
See Brief Summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: neodymium permanent magnet, Device: neodymium magnetSurface magnetic field strength at target 450 Gauss permanent magnet |
| B | Experimental | Device: neodymium magnetSurface field strength at target 150 Gauss permanent magnet |
| C | Active comparator | Device: neodymium magnet, Device: magnet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age range (18-65 years) Both genders Hand or wrist pain with paresthesias or numbness in any or all fingers, predominating in a median nerve distribution, and especially occurring at night Symptoms present for at least 3 months No prior treatment with magnet therapy Baseline BCTQ >2.0 on SSS subscale Meet specific EDX inclusion/ exclusion criteria listed in Table 1 (below) Willing and able to provide informed consent Ability to read English fluently
Key exclusion criteria (10 listed)
- Use of narcotic analgesia Corticosteroid injection into the carpal tunnel within previous 3 months Prior carpal tunnel surgery on affected side History of wrist or hand fracture on the symptomatic limb Skin rash or irritation on the wrist Participant (or bed partner) wearing a pacemaker or other electronic device Current pregnancy, less than 3 months postpartum, nursing, or planning a pregnancy Plans to move from area during the time frame of the study Inability to tolerate the baseline screening nerve conduction study Unable or unwilling to comply with the protocol Collecting workers' compensation or social-security disability benefits Involved in litigation regarding pain or disability Development of a rash or skin irritation to the tape applied to the wrist during a run-in baseline test period
- Insulin-dependent diabetes mellitus History of chronic renal failure or renal dialysis or forearm fistulae History of generalized peripheral neuropathy History of other neurologic disorders which may confuse the diagnosis of carpal tunnel syndrome, including but not limited to stroke, cervical radiculopathy, myelopathy, subdural hematoma, brain tumor Inflammatory articular disease or tendonitis of the involved hand or wrist Other disorders known to predispose to carpal tunnel syndrome including acromegaly, multiple myeloma, amyloidosis Cancer
- Table 1. Electrodiagnostic (EDX) Inclusion and Exclusion Criteria Inclusion Criteria
- Median nerve onset sensory latency > 3.5 ms at 13 cm
- Median-ulnar across palm latency difference ≥ 0.4 ms
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 |
|---|---|---|
| neodymium permanent magnet3/4" diameter by 1/8" thick permanent magnet | Device | A |
| neodymium magnetA. 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target | Device | A, B, C |
| magnet0 Gauss magnets are worn every night during hours of sleep for 6 weeks. | Device | C |
Primary outcome
Boston Carpal Tunnel Questionnaire Symptom Severity Scale
Time frame: Baseline, Wks 2, 4, 6, 18
3 secondary outcomes
1. Electrophysiological recovery of median nerve
Time frame: Baseline, 6 weeks, 18 weeks
2. General symptom questionnaire
Time frame: Baseline and on completion of intervention phase
3. Compliance with treatment
Time frame: Baseline to study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
- Derived from this study: PubMed 20599049Colbert AP, Markov MS, Carlson N, Gregory WL, Carlson H, Elmer PJ. Static magnetic field therapy for carpal tunnel syndrome: a feasibility study. Arch Phys Med Rehabil. 2010 Jul;91(7):1098-104. doi: 10.1016/j.apmr.2010.02.013.
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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.
Agatha P Colbert, MD principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neodymium permanent magnet, neodymium magnet and magnet in people with Carpal Tunnel Syndrome, run by National University of Natural Medicine 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Nov 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (time frame: Baseline, Wks 2, 4, 6, 18). 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 NCT00521495, 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 25 Nov 2009.