Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03476486
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2018-03-17
Brief Title:
A Pilot Study to Evaluate the Effectiveness of Ultrasound Guided Looped Thread Carpal Tunnel Release
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
A Pilot Study to Evaluate the Effectiveness of Ultrasound Guided Looped Thread Carpal Tunnel Release
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Carpal tunnel syndrome occurs when a nerve gets pinched as it passes through a confined tunnel within the wrist and hand It is the most commonly pinched nerve and often results in disabling hand numbness tingling pain and weakness For moderate and severe cases an operation is often performed that cuts the ligament that presses on the nerve This surgery is generally very successful but involves a 2-5 cm long incision at the base of the palm Recovery from the surgery usually takes 3-8 weeks Ultrasound provides a clear noninvasive way of looking at the contents of the carpal tunnel A technique has been developed whereby a wire thread is looped around the ligament using a needle guided by ultrasound The ligament is cut by the wire below the surface of the skin This technique results in 2 needle puncture holes instead of the open incision of the traditional surgery The investigators have completed research on this technique in cadavers It was confirmed that complete or almost complete cutting of the ligament can be safely and predictably accomplished This research will look at the effectiveness of this looped thread technique of carpal tunnel release on patients who have carpal tunnel syndrome Specifically participants will be required to 1 rate the severity of their carpal tunnel syndrome symptoms and disability using a standard questionnaire 2 measure hand sensation 3 measure pinch and grip strength tests of their hands 4 undergo ultrasound measurements of the size of the pinched nerve at the carpal tunnel and 5 undergo electrical tests to measure the nerves ability to conduct impulses across the carpal tunnel These will be measured before the looped wire procedure and at 3 and 6 months following the procedure Recovery time will also be measured
Detailed Description:
Objectives to evaluate the effectiveness and safety of a minimally invasive ultrasound-guided looped thread technique of carpal tunnel release
Background Carpal tunnel syndrome CTS is the most common peripheral entrapment neuropathy having a prevalence of 37 CTS is the 2nd leading worktime loss condition Open surgical decompression of the carpal tunnel is an evidence-based and commonly performed treatment for moderate to severe cases predictably providing long-term symptom relief This surgical technique involves placing a 2-5 cm long longitudinal incision at the palm incising the skin subcutaneous tissue palmar fascia palmaris longus tendon if present and transverse carpal ligament under direct visualization After 3-8 weeks of recovery most patients experience excellent relief of symptoms and improvement in hand function On occasion the procedure is complicated by nerve damage scar or pillar pain A variety of strategies have been devised to minimize the invasive nature of carpal tunnel release in hopes to reduce post procedure pain weakness and recovery time In the late 1980s an endoscopic release technique was devised A recent meta-analysis of existing randomized control trials comparing open to endoscopic release found endoscopic release to provide better early recovery of grip and pinch strength less scar tenderness and earlier returned to work 9 days There was a similar risk of pillar pain and reoperation and a higher risk of nerve injury mostly transient neurapraxia The development of high-resolution ultrasound scanning allows detailed visualization of the carpal tunnel and its contents Hydrodissection the injection of fluid during ultrasound visualization adds to image clarity of both the contents of the carpal tunnel as well as the location of operative instruments A few minimally invasive ultrasound-guided percutaneous carpal tunnel release techniques have been described The cutting instruments have included needle tip knife saws blades and thread Initial results of these techniques suggest that they are feasible safe effective and are associated with short recovery times The most recently described minimally invasive technique involves percutaneously looping a cutting thread around the transverse carpal ligament using a needle under ultrasound guidance By reciprocally sliding the 2 ends of the thread back and forth like a Gigli saw the transverse carpal ligament is transected Only 2 needle puncture site are required The looped thread carpal tunnel release TCTR procedure was initially performed on a single cadaveric hand and dissection demonstrated complete transection of the transverse carpal ligament and no injury to other structures The authors then performed the same procedure on 34 hands of 20 patients The primary outcome measure was the Levine-Katz questionnaire completed 3 months postprocedure The questionnaire scores were compared to those reported in the literature for open and endoscopic release techniques and were found to be similar No post TCTR complications were reported Our research group has recently completed a cadaveric evaluation of this technique and found that ultrasound accurately defines the critical boundries and contents of the carpal tunnel in all cases complete or near-complete transection of the transverse carpal ligament was achieved and no trauma was sustained by any structure within the carpal tunnel other than the transverse carpal ligament
ProcedureMethods subjects with clinical and electrophysiologically confirmed CTS from the practice of the principal investigator will be invited to participate The 1st phase of this study will involve TCTR of 5 carpal tunnels Within a month prior to and at 3 and 6 months post procedure the following outcome measures will be collected subjective measure of symptom and functional limitation severity Boston Carpal Tunnel Questionnaire monofilament hand sensibility testing grip and pinch strength median nerve cross-sectional area measurement at the carpal tunnel inlet using ultrasound and electrophysiologic function of the median nerve across the carpal tunnel motor and sensory conduction velocities and amplitudes At weekly intervals for the 1st month each subject will also be contacted to report on their recovery return to everyday activities including work and any adverse effectscomplications The Boston Carpal Tunnel Questionnaire will also be completed at 1 month post TCTR Assuming no serious complications are encountered from the initial 5 procedures and upon approval from the supervising Data and Safety Monitoring Board 15 additional carpal tunnels will undergo TCTR and the same outcome measures will be recorded The outcome data will be analyzed using a repeated measures Analysis of Variance Boston Carpal Tunnel Questionnaire monofilament hand sensibilitygrip and pinch strength median nerve cross-sectional area median nerve motor and sensory conduction velocities and amplitudes and descriptive statistics recovery duration and adverse effectscomplications
Background Carpal tunnel syndrome CTS is the most common peripheral entrapment neuropathy having a prevalence of 37 CTS is the 2nd leading worktime loss condition Open surgical decompression of the carpal tunnel is an evidence-based and commonly performed treatment for moderate to severe cases predictably providing long-term symptom relief This surgical technique involves placing a 2-5 cm long longitudinal incision at the palm incising the skin subcutaneous tissue palmar fascia palmaris longus tendon if present and transverse carpal ligament under direct visualization After 3-8 weeks of recovery most patients experience excellent relief of symptoms and improvement in hand function On occasion the procedure is complicated by nerve damage scar or pillar pain A variety of strategies have been devised to minimize the invasive nature of carpal tunnel release in hopes to reduce post procedure pain weakness and recovery time In the late 1980s an endoscopic release technique was devised A recent meta-analysis of existing randomized control trials comparing open to endoscopic release found endoscopic release to provide better early recovery of grip and pinch strength less scar tenderness and earlier returned to work 9 days There was a similar risk of pillar pain and reoperation and a higher risk of nerve injury mostly transient neurapraxia The development of high-resolution ultrasound scanning allows detailed visualization of the carpal tunnel and its contents Hydrodissection the injection of fluid during ultrasound visualization adds to image clarity of both the contents of the carpal tunnel as well as the location of operative instruments A few minimally invasive ultrasound-guided percutaneous carpal tunnel release techniques have been described The cutting instruments have included needle tip knife saws blades and thread Initial results of these techniques suggest that they are feasible safe effective and are associated with short recovery times The most recently described minimally invasive technique involves percutaneously looping a cutting thread around the transverse carpal ligament using a needle under ultrasound guidance By reciprocally sliding the 2 ends of the thread back and forth like a Gigli saw the transverse carpal ligament is transected Only 2 needle puncture site are required The looped thread carpal tunnel release TCTR procedure was initially performed on a single cadaveric hand and dissection demonstrated complete transection of the transverse carpal ligament and no injury to other structures The authors then performed the same procedure on 34 hands of 20 patients The primary outcome measure was the Levine-Katz questionnaire completed 3 months postprocedure The questionnaire scores were compared to those reported in the literature for open and endoscopic release techniques and were found to be similar No post TCTR complications were reported Our research group has recently completed a cadaveric evaluation of this technique and found that ultrasound accurately defines the critical boundries and contents of the carpal tunnel in all cases complete or near-complete transection of the transverse carpal ligament was achieved and no trauma was sustained by any structure within the carpal tunnel other than the transverse carpal ligament
ProcedureMethods subjects with clinical and electrophysiologically confirmed CTS from the practice of the principal investigator will be invited to participate The 1st phase of this study will involve TCTR of 5 carpal tunnels Within a month prior to and at 3 and 6 months post procedure the following outcome measures will be collected subjective measure of symptom and functional limitation severity Boston Carpal Tunnel Questionnaire monofilament hand sensibility testing grip and pinch strength median nerve cross-sectional area measurement at the carpal tunnel inlet using ultrasound and electrophysiologic function of the median nerve across the carpal tunnel motor and sensory conduction velocities and amplitudes At weekly intervals for the 1st month each subject will also be contacted to report on their recovery return to everyday activities including work and any adverse effectscomplications The Boston Carpal Tunnel Questionnaire will also be completed at 1 month post TCTR Assuming no serious complications are encountered from the initial 5 procedures and upon approval from the supervising Data and Safety Monitoring Board 15 additional carpal tunnels will undergo TCTR and the same outcome measures will be recorded The outcome data will be analyzed using a repeated measures Analysis of Variance Boston Carpal Tunnel Questionnaire monofilament hand sensibilitygrip and pinch strength median nerve cross-sectional area median nerve motor and sensory conduction velocities and amplitudes and descriptive statistics recovery duration and adverse effectscomplications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None