Carpal Tunnel SyndromeNCT01897272
Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study
An observational study of Carpal Tunnel Syndrome, run by Christine M. Kleinert Institute for Hand and Microsurgery at 2 sites in United States.
Trial summary
This research study is for patients who are schedule to have carpal tunnel release surgery. The investigators have developed this study in order to determine if post-operative splinting is effective in improvement of patient outcomes after this surgical procedure. 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?
- Splinting
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Sep 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: We are looking for patients who are old enough to give informed consent who are preparing to have nerve decompression with short incision for their carpal tunnel syndrome.
Who may be able to join
- Patients who were diagnosed with carpal tunnel syndrome and are going to receive nerve decompression with short incision
- The Criteria of CTS
- Numbness, tingling, pain and night symptoms in median nerve distribution
- Positive Tinel signs over the median nerve at the Carpal Tunnel
- Negative Tinel signs at the Supraclavicular and Infraclavicular areas
- Positive Carpal Tunnel Tests
Show all 9Show fewer
- Electrophysiological changes (confirmed with NCT)
- Over the age of 18
- Ability to give informed consent to participate in a research study
Who cannot join
- Patients with peripheral neuropathy of the median nerve secondary to trauma, external compressions (tumours, bone malunion) or other non-compressive causes.
- Patients with the presence of Thoracic Outlet Syndrome (Tinel must be negative at the Supraclavicular and Infraclavicular areas)
- Patients with the presence of Cervical Disc disease
- Patients with another site of compression (such as pronator teres compression)
- Patients who have had previous carpal tunnel release on the same hand
- Patients under the age of 18
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Christine M. Kleinert Institute for Hand and Microsurgery
Louisville, Kentucky, 40202
Millicent Horn, BS, 502-562-0307, mhorn@cmki.org
Huey Tien, MD
- Recruiting
Kleinert, Kutz & Associates
Louisville, Kentucky, 40202
Ross Gibson, BA, 502-562-0307, rgibson@cmki.org
Huey Tien, MD
About this study
Official title: Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective, Randomized Study
This research study is for patients who are schedule to have carpal tunnel release surgery. The investigators have developed this study in order to determine if post-operative splinting is effective in improvement of patient outcomes after this surgical procedure. The study is being conducted under the direction of Huey Tien, MD. The purpose of this study is to determine if post-operative splinting is effective in improving patient outcomes after having short-incision carpal tunnel release. The investigators will randomize each patient into group 1, splinting after surgery or group 2 no splinting after surgery. Each group will have the same outcome measurements done to determine the best outcome of the two groups.
Read the detailed description
Your participation in this study will last for five office visits of approximately 30 minutes each. If you decide to participate in this study, we would first have you come to clinic where you would undergo some standard measurements. This includes measuring grip and key pinch strength and completing a patient questionnaire. During your visits we will scan the cross-sectional area of the median nerve at the pisiform bone level to determine the level of CTS with the Ultrasound Biomiscroscopy machine (Vevo 2100). This is a new technique with a machine similar to a regular ultrasound machine. The primary difference is that the frequency of soundwaves is higher than a standard ultrasound machine. There are no known significant risks associated with the use of this machine. At this time the machine is experimental, and is not currently approved by the FDA for clinical use. However, this device is not considered to pose significant risk. Candidates for this study must have been diagnosed with single carpal tunnel syndrome and are going to receive nerve decompression with short incision, over the age of 18, and able to give informed consent to participate in a research study.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Splinting
- Keywords
- carpal tunnel syndrome, splinting, nerve decompression
- 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.
SplintingBehavioural
One group will have their wrist splinted after their carpal tunnel release surgery.
| Study group | Role | What they receive |
|---|---|---|
| Splinting After Surgery | This group will be fitted for a splint and given instructions on wearing their splint after their short-incision Carpal Tunnel Release Receives: Behavioral: Splinting | |
| No Splinting After Surgery | This group will not be splinted after the short-incision carpal tunnel release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level
This is a high resolution ultrasound used to determine the distance between the surface and the median nerve. This device is a research device not approved for clinical use, but is considered a non-significant risk (NSR) device. This machine is just like a regular ultrasound machine. The primary difference is that the frequence of the soundwaves is higher than a standard ultrasound machine. At this time, the machine is experimental, and it is not currently approved by the FDA for clinical use. However, this same technology is used in similar devices by opthamologists to image retinas. It has been used on hudnreds of humans for research studies.
Measured: Up to two years
Secondary outcomes (3)
Key Pinch Strength
Measured: Up to two years
Grip Strength
Measured: Up to two years
DASH questionnaire
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huey Tien, MD, Principal investigator, Christine M. Kleinert Institute for Hand and MicrosurgeryMillicent L Horn, BS, Study chair, Christine M. Kleinert Institute for Hand and Microsurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897272
- Sponsor's protocol ID
- 12.0416
- Status last verified
- Jan 2018
- First submitted
- 13 Jun 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT01897272
- Acronym / sponsor ID
- 12.0416
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, splinting, nerve decompression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Christine M. Kleinert Institute for Hand and MicrosurgeryUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Jul 2013 (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.
This research study is for patients who are schedule to have carpal tunnel release surgery. The investigators have developed this study in order to determine if post-operative splinting is effective in improvement of patient outcomes after this surgical procedure. The study is being conducted under the direction of Huey Tien, MD. The purpose of this study is to determine if post-operative splinting is effective in improving patient outcomes after having short-incision carpal tunnel release. The investigators will randomize each patient into group 1, splinting after surgery or group 2 no splinting after surgery. Each group will have the same outcome measurements done to determine the best outcome of the two groups.
Detailed description
Your participation in this study will last for five office visits of approximately 30 minutes each. If you decide to participate in this study, we would first have you come to clinic where you would undergo some standard measurements. This includes measuring grip and key pinch strength and completing a patient questionnaire. During your visits we will scan the cross-sectional area of the median nerve at the pisiform bone level to determine the level of CTS with the Ultrasound Biomiscroscopy machine (Vevo 2100). This is a new technique with a machine similar to a regular ultrasound machine. The primary difference is that the frequency of soundwaves is higher than a standard ultrasound machine. There are no known significant risks associated with the use of this machine. At this time the machine is experimental, and is not currently approved by the FDA for clinical use. However, this device is not considered to pose significant risk. Candidates for this study must have been diagnosed with single carpal tunnel syndrome and are going to receive nerve decompression with short incision, over the age of 18, and able to give informed consent to participate in a research study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splinting After Surgery | – | Behavioral: SplintingThis group will be fitted for a splint and given instructions on wearing their splint after their short-incision Carpal Tunnel Release |
| No Splinting After Surgery | – | –This group will not be splinted after the short-incision carpal tunnel release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We are looking for patients who are old enough to give informed consent who are preparing to have nerve decompression with short incision for their carpal tunnel syndrome.
Key inclusion criteria (9 listed)
- Patients who were diagnosed with carpal tunnel syndrome and are going to receive nerve decompression with short incision
- The Criteria of CTS
- Numbness, tingling, pain and night symptoms in median nerve distribution
- Positive Tinel signs over the median nerve at the Carpal Tunnel
- Negative Tinel signs at the Supraclavicular and Infraclavicular areas
Key exclusion criteria (6 listed)
- Patients with peripheral neuropathy of the median nerve secondary to trauma, external compressions (tumours, bone malunion) or other non-compressive causes.
- Patients with the presence of Thoracic Outlet Syndrome (Tinel must be negative at the Supraclavicular and Infraclavicular areas)
- Patients with the presence of Cervical Disc disease
- Patients with another site of compression (such as pronator teres compression)
- Patients who have had previous carpal tunnel release on the same hand
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 |
|---|---|---|
| SplintingOne group will have their wrist splinted after their carpal tunnel release surgery. | Behavioural | Splinting After Surgery |
Primary outcome
Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level
Time frame: Up to two years
This is a high resolution ultrasound used to determine the distance between the surface and the median nerve. This device is a research device not approved for clinical use, but is considered a non-significant risk (NSR) device. This machine is just like a regular ultrasound machine. The primary difference is that the frequence of the soundwaves is higher than a standard ultrasound machine. At this time, the machine is experimental, and it is not currently approved by the FDA for clinical use. However, this same technology is used in similar devices by opthamologists to image retinas. It has been used on hudnreds of humans for research studies.
3 secondary outcomes
Key Pinch Strength
Time frame: Up to two years
Grip Strength
Time frame: Up to two years
DASH questionnaire
Time frame: Up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Christine M. Kleinert Institute for Hand and Microsurgery
Louisville, United States
Huey Tien, MD principal investigator
Christine M. Kleinert Institute for Hand and Microsurgery
Millicent L Horn, BS study chair
Christine M. Kleinert Institute for Hand and Microsurgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Christine M. Kleinert Institute for Hand and Microsurgery at 2 sites 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 9 inclusion and 6 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level (time frame: Up to two years). 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 25 Jan 2018.