Carpal Tunnel SyndromeNCT02683343
The Use of Ultrasound to Quantify Muscle Overlying the Carpal Tunnel
An observational study of Carpal Tunnel Syndrome, run by Clalit Health Services.
Trial summary
Carpal tunnel syndrome (CTS) is a common condition that still lacks a reliable, objective screening test. Many anatomical aspects of the syndrome have been studied including the dimensions of the carpal tunnel and shape of the nerve within the tunnel. 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
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with the diagnosis of CTS and those without
Who may be able to join
- The diagnosis of CTS will include signs and symptoms of CTS: nighttime numbness and tingling or numbness and tingling in a median nerve distribution with a positive phalen or tinel or forearm compression test as well as a nerve conduction test and electromyography (NCT and EMG) that is positive for CTS.
- The normal subjects: individuals that do not have any signs and or symptoms of CTS.
Who cannot join
- Patients or individuals that have a known history of peripheral neuropathy or other condition in the hand including recent significant trauma.
- Patients with incomplete or unclear evaluation and tests.
- Individuals unwilling to sign a consent form to participate in the study.
About this study
Carpal tunnel syndrome (CTS) is a common condition that still lacks a reliable, objective screening test. Many anatomical aspects of the syndrome have been studied including the dimensions of the carpal tunnel and shape of the nerve within the tunnel. The investigators have observed varying amounts of muscle overlying the carpal tunnel in patients undergoing surgery for the condition. Assuming that this muscle may have a dynamic role in the development of the condition, the investigators attempted to quantify this muscle using ultrasound (US).
The purpose of this study was to devise a technique to evaluate the amount of muscle overlying the carpal tunnel.
The hypothesis is that patients with carpal tunnel syndrome will have significantly more muscle overlying the carpal tunnel than individuals without carpal tunnel syndrome.
Read the detailed description
Introduction:
The pathophysiology of carpal tunnel syndrome (CTS) is in all probability multifactorial including many parameters that ultimately increase the pressure within the carpal tunnel. It is likely that the increased pressure then causes injury to the median nerve and the signs and symptoms of CTS. The relationship between the size or dimensions of the hand and the occurrence of CTS has been evaluated and "square-shaped" hands have also been examined to determine if there is an increased tendency to develop CTS. The literature remains inconclusive at this time. Other static anatomical parameters that have been evaluated include the size of the carpal tunnel and the thickness and biomechanical properties of the transverse carpal ligament again without absolute consensus in the literature.
Additional studies have evaluated the role of the intrinsic musculature within and surrounding the carpal tunnel in the etiology of CTS. Most of these studies have evaluated the muscles as space occupying lesions that add to the pressure within the carpal tunnel. The investigators believe that some of the muscles described, specifically those that are found within the transverse carpal ligament and that cross the area of the carpal tunnel, actually have a dynamic role in the etiology of CTS, especially in manual laborers that use their hands in a forceful manner in a repetitive fashion. It is also possible that this anatomic variant (muscles crossing the area of the carpal tunnel) is related to the "square "hand configuration and that this dynamic contribution to the pressure within the carpal tunnel is the reason for the increased incidence of CTS in these patients. The purpose of this study is to quantify the amount of muscle crossing the area of the carpal tunnel in normal individuals and to compare it to the amount of muscle in the wrists of patients with CTS.
Hypothesis: Participants with CTS will have more muscle crossing the carpal tunnel that normal controls (without CTS).
Purpose: To compare the amount of muscle crossing the carpal tunnel in normal controls (without CTS) and in patients with CTS
Specific aims:
- To develop a system to quantify the amount of muscle crossing the carpal tunnel area using ultrasound of the wrist area.
- To compare this measurement in normal wrists and in wrists with CTS
- To compare the measurements in the CTS patients to intraoperative evaluation of the amount of muscle crossing the carpal tunnel area .
- To compare these measurements to the external measurements of the hand (palm width/palm length)
Methods:
Fifty participants will be recruited for the study. Twenty five participants with no CTS- and twenty five with CTS.
The CTS group inclusion criteria:
The diagnosis of CTS will include:
- Signs and symptoms of CTS: nighttime numbness and tingling or numbness and tingling in a median nerve distribution with a positive phalen or tinel or forearm compression test
- A nerve conduction test and electromyography (NCT and EMG) that is positive for CTS.
The participants without CTS inclusion criteria:
- Individuals that do not have any signs and or symptoms of CTS.
Exclusion criteria:
- Individuals that have a known history of peripheral neuropathy or other condition in the hand including recent significant trauma.
- Patients with incomplete or unclear evaluation and tests.
- Individuals unwilling to sign a consent form to participate in the study.
Patients that meet the inclusion criteria and that are sent for carpal tunnel release surgery will be consented and examined on the day of surgery. Their US results, external palmar measurements as well as the amount of overlying muscle will be recorded as well as demographic data. Demographic information, occupational history, history of hand diagnoses and procedures as well as history pertinent to CTS (nighttime numbness and tingling, pain, perceived pinch weakness, and duration of symptoms) will be collected. Results of nerve conduction testing (NCT) will be recorded.
Physical examination findings pertinent to CTS will be collected including pinch strength, grip strength, 2-point discrimination, and the hand measurements of palm width (PW), palm length (PL).
External measurements: PL is measured as the vertical length from the midline of the distal wrist crease to the proximal middle finger. PW is measured as the horizontal length from the base of the 1st metacarpophalangeal (MP) joint along the proximal palmar crease.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| carpal tunnel syndrome | No intervention | |
| normals | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount-depth of muscle overlying the carpal tunnel
As determined by ultrasound
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: PI is away, will hopefully perform the study at another institution.
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683343
- Sponsor's protocol ID
- Muscle mass
- Status last verified
- Jul 2015
- First submitted
- 16 Aug 2015
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
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
- The Use of Ultrasound to Quantify Muscle Overlying the Carpal Tunnel
- ClinicalTrials.gov ID
- NCT02683343
- Acronym / sponsor ID
- Muscle mass
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI is away, will hopefully perform the study at another institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 17 Feb 2016 (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 a common condition that still lacks a reliable, objective screening test. Many anatomical aspects of the syndrome have been studied including the dimensions of the carpal tunnel and shape of the nerve within the tunnel. The investigators have observed varying amounts of muscle overlying the carpal tunnel in patients undergoing surgery for the condition. Assuming that this muscle may have a dynamic role in the development of the condition, the investigators attempted to quantify this muscle using ultrasound (US).
The purpose of this study was to devise a technique to evaluate the amount of muscle overlying the carpal tunnel.
The hypothesis is that patients with carpal tunnel syndrome will have significantly more muscle overlying the carpal tunnel than individuals without carpal tunnel syndrome.
Detailed description
Introduction:
The pathophysiology of carpal tunnel syndrome (CTS) is in all probability multifactorial including many parameters that ultimately increase the pressure within the carpal tunnel. It is likely that the increased pressure then causes injury to the median nerve and the signs and symptoms of CTS. The relationship between the size or dimensions of the hand and the occurrence of CTS has been evaluated and "square-shaped" hands have also been examined to determine if there is an increased tendency to develop CTS. The literature remains inconclusive at this time. Other static anatomical parameters that have been evaluated include the size of the carpal tunnel and the thickness and biomechanical properties of the transverse carpal ligament again without absolute consensus in the literature.
Additional studies have evaluated the role of the intrinsic musculature within and surrounding the carpal tunnel in the etiology of CTS. Most of these studies have evaluated the muscles as space occupying lesions that add to the pressure within the carpal tunnel. The investigators believe that some of the muscles described, specifically those that are found within the transverse carpal ligament and that cross the area of the carpal tunnel, actually have a dynamic role in the etiology of CTS, especially in manual laborers that use their hands in a forceful manner in a repetitive fashion. It is also possible that this anatomic variant (muscles crossing the area of the carpal tunnel) is related to the "square "hand configuration and that this dynamic contribution to the pressure within the carpal tunnel is the reason for the increased incidence of CTS in these patients. The purpose of this study is to quantify the amount of muscle crossing the area of the carpal tunnel in normal individuals and to compare it to the amount of muscle in the wrists of patients with CTS.
Hypothesis: Participants with CTS will have more muscle crossing the carpal tunnel that normal controls (without CTS).
Purpose: To compare the amount of muscle crossing the carpal tunnel in normal controls (without CTS) and in patients with CTS
Specific aims:
- To develop a system to quantify the amount of muscle crossing the carpal tunnel area using ultrasound of the wrist area.
- To compare this measurement in normal wrists and in wrists with CTS
- To compare the measurements in the CTS patients to intraoperative evaluation of the amount of muscle crossing the carpal tunnel area .
- To compare these measurements to the external measurements of the hand (palm width/palm length)
Methods:
Fifty participants will be recruited for the study. Twenty five participants with no CTS- and twenty five with CTS.
The CTS group inclusion criteria:
The diagnosis of CTS will include:
- Signs and symptoms of CTS: nighttime numbness and tingling or numbness and tingling in a median nerve distribution with a positive phalen or tinel or forearm compression test
- A nerve conduction test and electromyography (NCT and EMG) that is positive for CTS.
The participants without CTS inclusion criteria:
- Individuals that do not have any signs and or symptoms of CTS.
Exclusion criteria:
- Individuals that have a known history of peripheral neuropathy or other condition in the hand including recent significant trauma.
- Patients with incomplete or unclear evaluation and tests.
- Individuals unwilling to sign a consent form to participate in the study.
Patients that meet the inclusion criteria and that are sent for carpal tunnel release surgery will be consented and examined on the day of surgery. Their US results, external palmar measurements as well as the amount of overlying muscle will be recorded as well as demographic data. Demographic information, occupational history, history of hand diagnoses and procedures as well as history pertinent to CTS (nighttime numbness and tingling, pain, perceived pinch weakness, and duration of symptoms) will be collected. Results of nerve conduction testing (NCT) will be recorded.
Physical examination findings pertinent to CTS will be collected including pinch strength, grip strength, 2-point discrimination, and the hand measurements of palm width (PW), palm length (PL).
External measurements: PL is measured as the vertical length from the midline of the distal wrist crease to the proximal middle finger. PW is measured as the horizontal length from the base of the 1st metacarpophalangeal (MP) joint along the proximal palmar crease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carpal tunnel syndrome | – | –No intervention |
| normals | – | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of CTS and those without
Key inclusion criteria (2 listed)
- The diagnosis of CTS will include signs and symptoms of CTS: nighttime numbness and tingling or numbness and tingling in a median nerve distribution with a positive phalen or tinel or forearm compression test as well as a nerve conduction test and electromyography (NCT and EMG) that is positive for CTS.
- The normal subjects: individuals that do not have any signs and or symptoms of CTS.
Key exclusion criteria (3 listed)
- Patients or individuals that have a known history of peripheral neuropathy or other condition in the hand including recent significant trauma.
- Patients with incomplete or unclear evaluation and tests.
- Individuals unwilling to sign a consent form to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
amount-depth of muscle overlying the carpal tunnel
Time frame: 2 years
As determined by ultrasound
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Clalit Health Services.
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 3 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: withdrawn, 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
amount-depth of muscle overlying the carpal tunnel (time frame: 2 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.