Carpal Tunnel SyndromeNCT00558116
Treatment of Carpal Tunnel Syndrome With Dynamic Splinting
A study testing Dynamic splinting in people with Carpal Tunnel Syndrome, run by Advanced Centers for Orthopaedic Surgery and Sports Medicine at 1 site in United States.
Trial summary
The Purpose of this study is to examine the effect of using the Carpal Tunnel Dynasplint® System on patients diagnosed with CTS in a randomized, controlled, cross-over study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Dynamic splinting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must exhibit one of the following symptoms of CTS: numbness, tingling, or pain in the wrist or hand
- Patients will be ≥18 years old and of either gender
- Patients will agree and be able to sign a voluntary consent to participate form
- Nerve Conduction study results as follows:
- Sensory conduction latency to peak greater than 3.7ms when measured with ring pick up on the volar surface of the index finger measured 14cm from stimulation across the wrist at the median nerve Motor conduction latency to take off greater than 4.2ms when measured with disc pick up on the abductor pollicis brevis muscle measured 8 cm from stimulation across the wrist at the median nerve
- -
Who cannot join
- Patients that have thenar atrophy of the hand
- Patients that are currently undergoing manual, hand therapy
- Patients that have been previously diagnosed with cervical radiculopathy
- Patients whose examination shows evidence of a "Double Crush" syndrome
- Pregnancy
- Nerve Conduction study results as follows:
- Sensory conduction latency to peak less than 3.7ms when measured with ring pick up on the volar surface of the index finger measured 14cm from stimulation across the wrist at the median nerve Motor conduction latency to take off less than 4.2ms when measured with disc pick up on the abductor pollicis brevis muscle measured 8cm from stimulation across the wrist at the median nerve
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Advanced Centers for Orthopaedic Surgery and Sports Medicine
Owings Mills, Maryland, 21117
About this study
Official title: Treating Carpal Tunnel Syndrome With Dynamic Splinting: A Randomized, Controlled, Trial
The Purpose of this study is to examine the effect of using the Carpal Tunnel Dynasplint® System on patients diagnosed with CTS in a randomized, controlled, cross-over study.
Read the detailed description
This study will compare the efficacy of treating Carpal tunnel Syndrome with the Dynasplint® Systems device as compared to a non-treatment control group utilizing a randomized, controlled, cross-over study design. The dependant variables in this study are each patient's score on a Levine-Katz disability and pain scale test, and the change in nerve conduction of the median nerve that was tested upon diagnosis. The independent variables will include three different patient groups separated by randomization. The first group of subjects (selected randomly) will be fit with a therapeutic, functional Carpal Tunnel Dynasplint® versus the second, control patients will not be treated with dynamic splinting for the first sixty (60) days. After the initial sixty (60) days, the original control patients will be fit with a functional Carpal Tunnel Dynasplint® system and this will allow examiner to evaluate for further variance between subject groups, allowing the third group to be a Cross-Over group.
The METHODS for this multi-centered study include recruiting patients from multiple hand surgeons and neurologists and these patients will have been diagnosed with following the physicians' physical examination and a nerve conduction test of the median nerve. The subjects then will be briefed on this study and sign an informed consent as required by the IRB before participating. Subjects who do consent will then be given the Levine-Katz disability and pain scale test, and prior to being fit with the Carpal Tunnel Dynasplint® Subjects will be taught how to use a Carpal Tunnel Dynasplint® properly and after being fit with the Carpal Tunnel Dynasplint® each subject will be required to complete a weekly report showing compliance to the wearing and treatment schedule, and they must attend regular, monthly examinations by the referring physician. After the initial sixty (60) days in the study each subject will repeat the three lead conduction test of the median nerve.
Control subjects at this point will be fit with the Carpal Tunnel Dynasplint® systems becoming Cross-Over subjects and their final nerve conduction test will be administered after they have worn the Carpal Tunnel Dynasplint® system for sixty (60) days. Upon discharge from this study all subjects will also retake the Levine-Katz disability and pain scale test.
Eighty (80) SUBJECTS will be recruited following diagnosis of CTS (using nerve conduction testing of the median nerve for differential diagnosis) and group assignment will be determined through randomization following each patient's completion of the informed consent required by the IRB. All patients randomly selected to start in the experimental group will be fit with functional Carpal Tunnel Dynasplint® and the control group subjects will not be fit until after sixty (60) days. When they are ultimately fit, they will then be categorized as "Cross-Over" subjects to measure continued variance between all groups.
The DURATION for patients enrolled in this study will be sixty (60) days for the experimental subjects and the control subjects will spend their first sixty (60) days as a control role without treatment. However, following sixty days the initial control subjects but then they will be refit with a functional Carpal Tunnel Dynasplint® as a "Cross-Over" subject for an additional sixty (60) days, which makes the control subjects duration in this study 120 days.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Dynamic splinting
- Keywords
- Carpal Tunnel Syndrome, Dynamic Splinting, Nerve Conduction Studies, Splinting, Levine Katz Survey
- 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.
Dynamic splintingDevice
The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with Dynasplint device Receives: Device: Dynamic splinting |
| 2 | No intervention | Control group; does not receive conservative or surgical treatment. Receives: Device: Dynamic splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nerve Conduction Test results
Measured: 60 days
Secondary outcomes (1)
Change in score of Levine-Katz outcome survey
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2008 (estimated)
- Study completionDec 2008 (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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Centers for Orthopaedic Surgery and Sports Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dynasplint Systems, Inc.
- Investigators
- Stacey H Berner, MD, Principal investigator, Advanced Centers for Orthopaedic Surgery and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558116
- Sponsor's protocol ID
- 101010
- Status last verified
- May 2008
- First submitted
- 12 Nov 2007
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Carpal Tunnel Syndrome With Dynamic Splinting: A Randomized, Controlled, Trial
- ClinicalTrials.gov ID
- NCT00558116
- Acronym / sponsor ID
- 101010
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Dynamic Splinting, Nerve Conduction Studies, Splinting, Levine Katz Survey
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Advanced Centers for Orthopaedic Surgery and Sports MedicineUniversity, hospital or other
- Collaborators
- Dynasplint Systems, Inc.
- Study start
- May 2007
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 14 Nov 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 study is to examine the effect of using the Carpal Tunnel Dynasplint® System on patients diagnosed with CTS in a randomized, controlled, cross-over study.
Detailed description
This study will compare the efficacy of treating Carpal tunnel Syndrome with the Dynasplint® Systems device as compared to a non-treatment control group utilizing a randomized, controlled, cross-over study design. The dependant variables in this study are each patient's score on a Levine-Katz disability and pain scale test, and the change in nerve conduction of the median nerve that was tested upon diagnosis. The independent variables will include three different patient groups separated by randomization. The first group of subjects (selected randomly) will be fit with a therapeutic, functional Carpal Tunnel Dynasplint® versus the second, control patients will not be treated with dynamic splinting for the first sixty (60) days. After the initial sixty (60) days, the original control patients will be fit with a functional Carpal Tunnel Dynasplint® system and this will allow examiner to evaluate for further variance between subject groups, allowing the third group to be a Cross-Over group.
The METHODS for this multi-centered study include recruiting patients from multiple hand surgeons and neurologists and these patients will have been diagnosed with following the physicians' physical examination and a nerve conduction test of the median nerve. The subjects then will be briefed on this study and sign an informed consent as required by the IRB before participating. Subjects who do consent will then be given the Levine-Katz disability and pain scale test, and prior to being fit with the Carpal Tunnel Dynasplint® Subjects will be taught how to use a Carpal Tunnel Dynasplint® properly and after being fit with the Carpal Tunnel Dynasplint® each subject will be required to complete a weekly report showing compliance to the wearing and treatment schedule, and they must attend regular, monthly examinations by the referring physician. After the initial sixty (60) days in the study each subject will repeat the three lead conduction test of the median nerve.
Control subjects at this point will be fit with the Carpal Tunnel Dynasplint® systems becoming Cross-Over subjects and their final nerve conduction test will be administered after they have worn the Carpal Tunnel Dynasplint® system for sixty (60) days. Upon discharge from this study all subjects will also retake the Levine-Katz disability and pain scale test.
Eighty (80) SUBJECTS will be recruited following diagnosis of CTS (using nerve conduction testing of the median nerve for differential diagnosis) and group assignment will be determined through randomization following each patient's completion of the informed consent required by the IRB. All patients randomly selected to start in the experimental group will be fit with functional Carpal Tunnel Dynasplint® and the control group subjects will not be fit until after sixty (60) days. When they are ultimately fit, they will then be categorized as "Cross-Over" subjects to measure continued variance between all groups.
The DURATION for patients enrolled in this study will be sixty (60) days for the experimental subjects and the control subjects will spend their first sixty (60) days as a control role without treatment. However, following sixty days the initial control subjects but then they will be refit with a functional Carpal Tunnel Dynasplint® as a "Cross-Over" subject for an additional sixty (60) days, which makes the control subjects duration in this study 120 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Dynamic splintingTreatment with Dynasplint device |
| 2 | No intervention | Device: Dynamic splintingControl group; does not receive conservative or surgical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must exhibit one of the following symptoms of CTS: numbness, tingling, or pain in the wrist or hand
- Patients will be ≥18 years old and of either gender
- Patients will agree and be able to sign a voluntary consent to participate form
- Nerve Conduction study results as follows:
- Sensory conduction latency to peak greater than 3.7ms when measured with ring pick up on the volar surface of the index finger measured 14cm from stimulation across the wrist at the median nerve Motor conduction latency to take off greater than 4.2ms when measured with disc pick up on the abductor pollicis brevis muscle measured 8 cm from stimulation across the wrist at the median nerve
Key exclusion criteria (7 listed)
- Patients that have thenar atrophy of the hand
- Patients that are currently undergoing manual, hand therapy
- Patients that have been previously diagnosed with cervical radiculopathy
- Patients whose examination shows evidence of a "Double Crush" syndrome
- 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 |
|---|---|---|
| Dynamic splintingThe Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days. | Device | 1, 2 |
Primary outcome
Change in Nerve Conduction Test results
Time frame: 60 days
1 secondary outcome
Change in score of Levine-Katz outcome survey
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
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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.
Stacey H Berner, MD principal investigator
Advanced Centers for Orthopaedic Surgery and Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic splinting in people with Carpal Tunnel Syndrome, run by Advanced Centers for Orthopaedic Surgery and Sports 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 6 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: status not confirmed, as of the sponsor's last update on 13 May 2008. 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.
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 Stacey H Berner, MD (410-484-8088 ext. 1040, sberner@acossm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nerve Conduction Test results (time frame: 60 days). 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 13 May 2008.