Carpal Tunnel SyndromeEarly Phase 1IMPACTSNCT03616353
IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome
A Early Phase 1 study testing Perineural Hydrodissection and Corticosteroid Injection in people with Carpal Tunnel Syndrome, run by Leslie Witton at 1 site in Canada.
Trial summary
This is a multidisciplinary, single-blinded, three-arm randomized controlled trial, comparing perineural hydrodissection and steroid injection for the treatment of CTS. Patients are screened based on pre-established eligibility criteria and randomized to one of the three study groups. 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?
- Perineural Hydrodissection and Corticosteroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2018to 30 Jun 2020
- Phase
- Early Phase 1
- 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
Who may be able to join
- Adult men or women aged 18 years or greater.
- Clinical and electromyographic diagnosis of Carpal Tunnel Syndrome.
- Persistent symptoms from Carpal Tunnel Syndrome after at least three months of appropriate splinting.
- Ability to consent for study.
Who cannot join
- Acute symptom onset (less than 3 months).
- Bifid median nerve
- Anticoagulation with International Normalized Ratio (INR) > 1.4, or platelets <150.
- Anomalous muscles (eg. inverted palmaris longus).
- Patients requiring anti-platelet medication for the treatment of heart attack, stroke, or other medical condition.
- Previous surgery for Carpal Tunnel Syndrome.
- Previous local injections, including steroids within the past 6 months.
- Allergy to any of the injection agents.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 2x2
Meg Chiavaras, MD PhD, meg.chiavaras@gmail.com
Leslie Witton, MD, leslie.witton@medportal.ca
About this study
Official title: IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome (IMPACTS): A Single-Centre, Randomized Trial Comparing Perineural Hydrodissection of the Median Nerve Versus Steroid Injection in Patients With Carpal Tunnel Syndrome
This is a multidisciplinary, single-blinded, three-arm randomized controlled trial, comparing perineural hydrodissection and steroid injection for the treatment of CTS. Patients are screened based on pre-established eligibility criteria and randomized to one of the three study groups. Patients are followed at 6-week, 3-month, 6-month, and 12-month time points to assess the primary and secondary outcomes of the study, which include both patient-reported outcome measures and objective clinical assessments.
Read the detailed description
This study aims to examine the effect of perineural hydrodissection (PNH), a novel treatment for CTS. PNH is a minimally invasive, ultrasound-guided, percutaneous technique in which the median nerve is released by injecting fluid (local anesthetic and corticosteroid) circumferentially, using larger fluid volumes and higher pressure to target areas of adhesion between the median nerve and its surrounding structures. In chronic CTS, a rind of perineural fibrosis develops, tethering the median nerve to the overlying flexor retinaculum and to the adjacent flexor tendons. Theoretically, the removal of tethering to adjacent structures, via perineural hydrodissection, should allow circumferential bathing of the median nerve with the local anesthetic and corticosteroid, thus reducing inflammation and prolonging symptom relief.
The primary outcome is pain as measured by the Boston Carpal Tunnel Questionnaire (BCTQ). Secondary outcomes include health-related quality of life measures using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the Visual Analog Scale (VAS) for pain.
The selected questionnaires have been shown to correlate well with domains of the International Classification of Functioning, Disability, and Health (ICF) (3). Other secondary measures include the ultrasound appearance (cross-sectional index) of the median nerve, and electromyography (EMG) measurements (including sensory and motor conduction velocities, and amplitudes), before and after the injection.
The study hypothesis is that PNH will show greater benefits in terms of pain, function, and patient quality of life when compared to corticosteroid injection in patients with CTS. The null hypothesis is that there is no difference. The study is powered to address the primary outcome and will also be powered to identify minimally important differences in functional, sonographic, and electromyographic outcomes.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Perineural Hydrodissection, Corticosteroid Injection
- 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.
Perineural HydrodissectionProcedure or surgery
Also called PNH
The subcutaneous tissues of the ulnar aspect of the wrist at the level of the carpal tunnel will be infiltrated with 2 ml of lidocaine 1% for local anesthetic. Using ultrasound guidance and aseptic technique, the needle will then be angled deep to the median nerve within the carpal tunnel, and 5 ml of a 50%/50% mixture of lidocaine 1% and sensorcaine 0.5% will be injected under pressure. While continuing to use ultrasound guidance and aseptic technique, the needle will then be angled superficial to the median nerve within the carpal tunnel, and 5 ml of a 50%/50% mixture of lidocaine 1% and sensorcaine 0.5% will be injected under pressure. The needle will be returned to its original angle deep to the median nerve, and the syringe will be changed to inject 40 mg Depo-Medrol in 1ml of saline.
Corticosteroid InjectionProcedure or surgery
Also called Steroid
The subcutaneous soft tissues of the ulnar aspect of the wrist at the level of the carpal tunnel will be infiltrated with 2 ml of lidocaine 1% for local anesthetic. Using ultrasound guidance and aseptic technique, the needle will then be angled deep to the median nerve within the carpal tunnel, and 40 mg Depo-Medrol in 1ml of saline will be injected into the area deep to the median nerve.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Corticosteroid Injection | Experimental | Patients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices. Receives: Procedure: Corticosteroid Injection |
| Group 2: Perineural Hydrodissection | Experimental | Patients in this group will undergo a perineural hydrodissection plus an injection of corticosteroid into the carpal tunnel, as a novel technique. Receives: Procedure: Perineural Hydrodissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Boston Carpal Tunnel Questionnaire (BCTQ)
The BCTQ is a five-point rating scale with 19 items. The overall score is the average score across all items. The score will be recorded for each visit and change in score will be plotted over time.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes (6)
Change in Ultrasonographic Measurement
Cross-sectional index (CSI) of the median nerve as measured by ultrasound. The CSI will be recorded for each visit and change will be plotted over time.
Measured: Baseline, 6 weeks, 6 months, 1 year
Change in Electromyographic Measurement- Amplitude
Amplitudes will be recorded for each visit and change in these values will be plotted over time.
Measured: Baseline, 6 months, 1 year
Change in Electromyographic Measurement- Motor Conduction Velocity
Motor conduction velocities will be recordedfor each visit and change in these values will be plotted over time.
Measured: Baseline, 6 months, 1 year
Change in Electromyographic Measurement- Sensory Conduction Velocity
Sensory conduction velocities will be recordedfor each visit and change in these values will be plotted over time.
Measured: Baseline, 6 months, 1 year
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
The DASH is a 30-item measure using five-point Likert scales assessing aspects of physical functioning and symptoms, intended specifically to measure disability. Its overall score is between 0 and 100. The score will be recorded for each visit and change in score will be plotted over time.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Change in Visual Analog Scale (VAS) for Pain
The VAS is a commonly used, subjective scale in which the patient rates their pain on a scale ranging from 0 to 10 (0, no pain; 10, maximum pain possible). The score will be recorded for each visit and change will be plotted over time.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start15 Oct 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leslie Witton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leslie Witton, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616353
- Sponsor's protocol ID
- 1
- Acronym
- IMPACTS
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2017
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome (IMPACTS): A Single-Centre, Randomized Trial Comparing Perineural Hydrodissection of the Median Nerve Versus Steroid Injection in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03616353
- Acronym / sponsor ID
- IMPACTS / 1
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Leslie WittonUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 6 Aug 2018 (actual)
- 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 is a multidisciplinary, single-blinded, three-arm randomized controlled trial, comparing perineural hydrodissection and steroid injection for the treatment of CTS. Patients are screened based on pre-established eligibility criteria and randomized to one of the three study groups. Patients are followed at 6-week, 3-month, 6-month, and 12-month time points to assess the primary and secondary outcomes of the study, which include both patient-reported outcome measures and objective clinical assessments.
Detailed description
This study aims to examine the effect of perineural hydrodissection (PNH), a novel treatment for CTS. PNH is a minimally invasive, ultrasound-guided, percutaneous technique in which the median nerve is released by injecting fluid (local anesthetic and corticosteroid) circumferentially, using larger fluid volumes and higher pressure to target areas of adhesion between the median nerve and its surrounding structures. In chronic CTS, a rind of perineural fibrosis develops, tethering the median nerve to the overlying flexor retinaculum and to the adjacent flexor tendons. Theoretically, the removal of tethering to adjacent structures, via perineural hydrodissection, should allow circumferential bathing of the median nerve with the local anesthetic and corticosteroid, thus reducing inflammation and prolonging symptom relief.
The primary outcome is pain as measured by the Boston Carpal Tunnel Questionnaire (BCTQ). Secondary outcomes include health-related quality of life measures using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the Visual Analog Scale (VAS) for pain.
The selected questionnaires have been shown to correlate well with domains of the International Classification of Functioning, Disability, and Health (ICF) (3). Other secondary measures include the ultrasound appearance (cross-sectional index) of the median nerve, and electromyography (EMG) measurements (including sensory and motor conduction velocities, and amplitudes), before and after the injection.
The study hypothesis is that PNH will show greater benefits in terms of pain, function, and patient quality of life when compared to corticosteroid injection in patients with CTS. The null hypothesis is that there is no difference. The study is powered to address the primary outcome and will also be powered to identify minimally important differences in functional, sonographic, and electromyographic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Corticosteroid Injection | Experimental | Procedure: Corticosteroid InjectionPatients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices. |
| Group 2: Perineural Hydrodissection | Experimental | Procedure: Perineural HydrodissectionPatients in this group will undergo a perineural hydrodissection plus an injection of corticosteroid into the carpal tunnel, as a novel technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men or women aged 18 years or greater.
- Clinical and electromyographic diagnosis of Carpal Tunnel Syndrome.
- Persistent symptoms from Carpal Tunnel Syndrome after at least three months of appropriate splinting.
- Ability to consent for study.
Key exclusion criteria (8 listed)
- Acute symptom onset (less than 3 months).
- Bifid median nerve
- Anticoagulation with International Normalized Ratio (INR) > 1.4, or platelets <150.
- Anomalous muscles (eg. inverted palmaris longus).
- Patients requiring anti-platelet medication for the treatment of heart attack, stroke, or other medical condition.
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 |
|---|---|---|
| Perineural HydrodissectionAlso: PNHThe subcutaneous tissues of the ulnar aspect of the wrist at the level of the carpal tunnel will be infiltrated with 2 ml of lidocaine 1% for local anesthetic. Using ultrasound guidance and aseptic technique, the needle will then be angled deep to the median nerve within the carpal tunnel, and 5 ml of a 50%/50% mixture of lidocaine 1% and sensorcaine 0.5% will be injected under pressure. While continuing to use ultrasound guidance and aseptic technique, the needle will then be angled superficial to the median nerve within the carpal tunnel, and 5 ml of a 50%/50% mixture of lidocaine 1% and sensorcaine 0.5% will be injected under pressure. The needle will be returned to its original angle deep to the median nerve, and the syringe will be changed to inject 40 mg Depo-Medrol in 1ml of saline. | Procedure or surgery | Group 2: Perineural Hydrodissection |
| Corticosteroid InjectionAlso: SteroidThe subcutaneous soft tissues of the ulnar aspect of the wrist at the level of the carpal tunnel will be infiltrated with 2 ml of lidocaine 1% for local anesthetic. Using ultrasound guidance and aseptic technique, the needle will then be angled deep to the median nerve within the carpal tunnel, and 40 mg Depo-Medrol in 1ml of saline will be injected into the area deep to the median nerve. | Procedure or surgery | Group 1: Corticosteroid Injection |
Primary outcome
Change in Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
The BCTQ is a five-point rating scale with 19 items. The overall score is the average score across all items. The score will be recorded for each visit and change in score will be plotted over time.
6 secondary outcomes
Change in Ultrasonographic Measurement
Time frame: Baseline, 6 weeks, 6 months, 1 year
Change in Electromyographic Measurement- Amplitude
Time frame: Baseline, 6 months, 1 year
Change in Electromyographic Measurement- Motor Conduction Velocity
Time frame: Baseline, 6 months, 1 year
Change in Electromyographic Measurement- Sensory Conduction Velocity
Time frame: Baseline, 6 months, 1 year
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Change in Visual Analog Scale (VAS) for Pain
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Perineural Hydrodissection and Corticosteroid Injection in people with Carpal Tunnel Syndrome, run by Leslie Witton at 1 site in Canada.
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 4 inclusion and 8 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 9 Aug 2019. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Leslie A Witton, MD (905-521-2100 ext. 4750, leslie.witton@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Boston Carpal Tunnel Questionnaire (BCTQ) (time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year). 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 9 Aug 2019.