Carpal Tunnel SyndromeATTRACTNCT02609113
Static Magnetic Therapy for Carpal Tunnel Syndrome
A study testing Strong Magnetic Wristband and Weaker Magnetic Wristband in people with Carpal Tunnel Syndrome, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for 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?
- Strong Magnetic Wristband and Weaker Magnetic Wristband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 21 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
- ≥ 18 years
Who cannot join
- Current use of magnets as therapy for Carpal Tunnel Syndrome
- Known allergy to silicone
- Unwillingness to wear wristband for 6 weeks
- Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Strong Magnetic Wristband, Weaker Magnetic Wristband
- Keywords
- Carpal Tunnel Syndrome
- 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.
Strong Magnetic WristbandDevice
Weaker Magnetic WristbandDevice
| Study group | Role | What they receive |
|---|---|---|
| Strong Magnetic Wristband | Active comparator | Magnetic wristband of 1,795 Gauss strength Receives: Device: Strong Magnetic Wristband |
| Weaker Magnetic Wristband | Placebo comparator | Magnetic wristband of 5 Gauss strength. Receives: Device: Weaker Magnetic Wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.
Measured: Baseline and 6 weeks
Secondary outcomes (3)
Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks
Ultrasound to assess the anatomy of the median nerve
Measured: Baseline and 6 weeks
Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks
Ultrasound to assess the anatomy of the median nerve
Measured: Baseline and 6 weeks
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks
Ultrasound to assess the anatomy of the median nerve
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startAug 2015
- Primary completion21 Oct 2016
- Study completion21 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Baute, MD, Principal investigator, Wake ForestUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609113
- Sponsor's protocol ID
- CTS-MAG-22
- Acronym
- ATTRACT
- Status last verified
- Aug 2018
- First submitted
- 13 Nov 2015
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
- ClinicalTrials.gov ID
- NCT02609113
- Acronym / sponsor ID
- ATTRACT / CTS-MAG-22
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 21 Oct 2016 (actual)
- Study completion
- 21 Oct 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 16 Jan 2018
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 research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strong Magnetic Wristband | Active comparator | Device: Strong Magnetic WristbandMagnetic wristband of 1,795 Gauss strength |
| Weaker Magnetic Wristband | Placebo comparator | Device: Weaker Magnetic WristbandMagnetic wristband of 5 Gauss strength. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
- ≥ 18 years
Key exclusion criteria (4 listed)
- Current use of magnets as therapy for Carpal Tunnel Syndrome
- Known allergy to silicone
- Unwillingness to wear wristband for 6 weeks
- Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.
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 |
|---|---|---|
| Strong Magnetic Wristband | Device | Strong Magnetic Wristband |
| Weaker Magnetic Wristband | Device | Weaker Magnetic Wristband |
Primary outcome
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
Time frame: Baseline and 6 weeks
Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.
3 secondary outcomes
Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks
Time frame: Baseline and 6 weeks
Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks
Time frame: Baseline and 6 weeks
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vanessa Baute, MD principal investigator
Wake ForestUBMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strong Magnetic Wristband and Weaker Magnetic Wristband in people with Carpal Tunnel Syndrome, run by Wake Forest University Health Sciences 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 4 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 10 Sep 2018. 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. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks (time frame: Baseline and 6 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 10 Sep 2018.