Carpal Tunnel SyndromeNCT01277003
To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome
A study testing Aculife Magnetic Wave Therapist and TENS in people with Carpal Tunnel Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Carpal tunnel syndrome (CTS) is the most common compressive focal mononeuropathy seen in clinical practice. Patients commonly experience a constellation of symptom complex brought on by compression of the median nerve as it traverse through the carpal tunnel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Aculife Magnetic Wave Therapist and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2010to Feb 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- electrodiagnostic study confirmed with carpal tunnel syndrome
- clinical symptom related to carpal tunnel syndrome
Who cannot join
- hypothyroidism, gout, systemic lupus erythematosus, rheumatoid arthritis, diabetes mellitus, chronic renal failure, acromegaly, polyneuropathy, brachial plexopathy, proximal median nerve entrapment, deficiency neuropathy (vitamine 2, B12, ect.), drug usage that may cause neuropathy, any surgery for peripheral nerve in the upper limb such as carpal tunnel surgical release, history of trauma in the upper limb such as wrist fracture, or having pregnancy.
Trial locations and contacts
1 site in 1 country.
Sui Foon Lo contact
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University
Taichung, Taiwan, 404
Sui Foon Lo, d4659@mail.cmuh.org.tw
About this study
Carpal tunnel syndrome (CTS) is the most common compressive focal mononeuropathy seen in clinical practice. Patients commonly experience a constellation of symptom complex brought on by compression of the median nerve as it traverse through the carpal tunnel. When compression of the nerve occurs, ischemia and mechanical disruption of nerve function may result. Pathological analysis shows a constellation of nerve injuries. Until now, no satisfactory conservative treatment method. Local steroid injections or oral steroids may result in initial relief, but relapses are frequent and have much side effects, which preclude their routine use for CTS. Full time wrist splints are claimed effective, but compromise hand function and daily activities. There are reasonable studies showing relief of pain with acupuncture on diverse pain conditions. However the therapeutic efficacy of acupuncture in CTS was less convincing in the past. Until recent decade, some case reports and few prospective studies reported the therapeutic effect of acupuncture in CTS. Other study also reported that low-level laser and microamperes transcutaneous electrical nerve stimulation (TENS) are effective in improvement of clinical outcome of patients with CTS. Another report suggested that TENS should be considered for the treatment of painful diabetic peripheral neuropathy. Therefore, the investigators perform this study to evaluate the effect of Aculife Magnetic Wave Therapist (a battery operated device with a probe electrode which contains magnetic elements that transform the oscillating current into an electromagnetic wave to stimulate the acupuncture points, simulate the effect of electroacupuncture ) on CTS and compared with that of Transcutaneous Electrical Nerve Stimulation(TENS). After at least 4 weeks treatment ( at least 16 treatment sessions) the therapeutic effects will be evaluated by comparison of symptom severity score, electrophysiological study, sonographic morphology study or magnetic resonance imaging study, before and after treatment, and between the different groups.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Aculife Magnetic Wave Therapist, TENS
- 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.
Aculife Magnetic Wave TherapistDevice
two therapeutic points, each for 15 minutes
TENSDevice
tow therapeutic points, each for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Aculife Magnetic Wave Therapist | Experimental | patients with carpal tunnel syndrome treated with Aculife Receives: Device: Aculife Magnetic Wave Therapist |
| TENS | Active comparator | patients with carpal tunnel syndrome treated by TENS Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
nerve conduction study
Measured: after at least four weeks treatment (at least 16 treatment sesstions)
Secondary outcomes (1)
questionnaire
Measured: after at least four weeks treatment ( at least 16 treatment sesstions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2011 (estimated)
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 China Medical University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277003
- Sponsor's protocol ID
- 0994266G
- Status last verified
- Nov 2010
- First submitted
- 13 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT01277003
- Acronym / sponsor ID
- 0994266G
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (estimated)
- First posted
- 14 Jan 2011 (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.
Carpal tunnel syndrome (CTS) is the most common compressive focal mononeuropathy seen in clinical practice. Patients commonly experience a constellation of symptom complex brought on by compression of the median nerve as it traverse through the carpal tunnel. When compression of the nerve occurs, ischemia and mechanical disruption of nerve function may result. Pathological analysis shows a constellation of nerve injuries. Until now, no satisfactory conservative treatment method. Local steroid injections or oral steroids may result in initial relief, but relapses are frequent and have much side effects, which preclude their routine use for CTS. Full time wrist splints are claimed effective, but compromise hand function and daily activities. There are reasonable studies showing relief of pain with acupuncture on diverse pain conditions. However the therapeutic efficacy of acupuncture in CTS was less convincing in the past. Until recent decade, some case reports and few prospective studies reported the therapeutic effect of acupuncture in CTS. Other study also reported that low-level laser and microamperes transcutaneous electrical nerve stimulation (TENS) are effective in improvement of clinical outcome of patients with CTS. Another report suggested that TENS should be considered for the treatment of painful diabetic peripheral neuropathy. Therefore, the investigators perform this study to evaluate the effect of Aculife Magnetic Wave Therapist (a battery operated device with a probe electrode which contains magnetic elements that transform the oscillating current into an electromagnetic wave to stimulate the acupuncture points, simulate the effect of electroacupuncture ) on CTS and compared with that of Transcutaneous Electrical Nerve Stimulation(TENS). After at least 4 weeks treatment ( at least 16 treatment sessions) the therapeutic effects will be evaluated by comparison of symptom severity score, electrophysiological study, sonographic morphology study or magnetic resonance imaging study, before and after treatment, and between the different groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aculife Magnetic Wave Therapist | Experimental | Device: Aculife Magnetic Wave Therapistpatients with carpal tunnel syndrome treated with Aculife |
| TENS | Active comparator | Device: TENSpatients with carpal tunnel syndrome treated by TENS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- electrodiagnostic study confirmed with carpal tunnel syndrome
- clinical symptom related to carpal tunnel syndrome
Key exclusion criteria (1 listed)
- hypothyroidism, gout, systemic lupus erythematosus, rheumatoid arthritis, diabetes mellitus, chronic renal failure, acromegaly, polyneuropathy, brachial plexopathy, proximal median nerve entrapment, deficiency neuropathy (vitamine 2, B12, ect.), drug usage that may cause neuropathy, any surgery for peripheral nerve in the upper limb such as carpal tunnel surgical release, history of trauma in the upper limb such as wrist fracture, or having pregnancy.
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 |
|---|---|---|
| Aculife Magnetic Wave Therapisttwo therapeutic points, each for 15 minutes | Device | Aculife Magnetic Wave Therapist |
| TENStow therapeutic points, each for 15 minutes | Device | TENS |
Primary outcome
nerve conduction study
Time frame: after at least four weeks treatment (at least 16 treatment sesstions)
1 secondary outcome
questionnaire
Time frame: after at least four weeks treatment ( at least 16 treatment sesstions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
Related trials for Carpal Tunnel Syndrome
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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.
Sui Foon Lo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aculife Magnetic Wave Therapist and TENS in people with Carpal Tunnel Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
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 1 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 19 Jan 2011. 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 Taiwan. 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.
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?
Contact Sui Foon Lo (d4659@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nerve conduction study (time frame: after at least four weeks treatment (at least 16 treatment sesstions)). 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 19 Jan 2011.