Carpal Tunnel SyndromeNCT04271319
Avazzia HVPC Bio-Electrical Stimulation Technology (BEST™) Microcurrent CTS RCT
A study testing BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device in people with Carpal Tunnel Syndrome, run by Avazzia, Inc at 1 site in United States.
Trial summary
A clinical study at Activated Family Chiropractic \& Wellness, is being proposed to test the efficacy of a novel electrical stimulation platform named the Pro-Sport Ultra® designed by AVAZZIA to relieve pain and improve mobility in patients with Carpal Tunnel Syndrome (CTS). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 31 Aug 2021
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a prior diagnosis (Dx) of CTS and have had a trial of conservative treatment for a minimum of 4 weeks without successful results due to continuing symptoms that interfere with normal function.
- Confirmation of this Dx shall include at least three findings as defined below:
- Muscle atrophy, severe weakness of thenar muscles
- 2-point discrimination test >6mm
- Flick sign (shaking hand)
- Phalen's sign
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- Tinel's sign
- Reverse Phalen's sign
- Abnormal Katz hand diagram scores
- Positive NCV testing
- Age >18 - <70 years old
- Males/Females of all ethnicities
- Post-surgical failures >6 months post op
- Ability to understand the informed consent document before signing it
Who cannot join
- Systemic disease that would affect treatment outcome such as inflammatory joint diseases (i.e., rheumatoid arthritis, systemic lupus); malignancies undergoing treatment or any malignancies (in remission or not) with involvement of the musculoskeletal system.
- Co-morbidities, thoracic outlet nerve impingement, neuropathy, etc. should be identified and, if significant, the candidate should be excluded from the study.
- Cubital tunnel syndrome, anterior and posterior interosseous nerve syndrome, lateral and medial epicondylitis, handlebar palsy, De Quervain's disease, trigger finger, and Intersection syndrome should be differentiated from CTS and not included in this study.
- Uncontrolled mood disorders, such as depression, anxiety.
- Drug or substance abuse within past 90 days.
- Any hand pathology requiring surgical intervention.
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- Active litigation, workers compensation
- Any participant with an electrically implanted device such as a pacemaker, neural stimulator, etc.
- Participant is currently pregnant, nursing, or may become pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Activated Family Chiropractic and Wellness
Dallas, Texas, 75240
About this study
Official title: Efficacy of a High Voltage Pulsed Current in the Non-Invasive Treatment of Carpal Tunnel Syndrome
A clinical study at Activated Family Chiropractic \& Wellness, is being proposed to test the efficacy of a novel electrical stimulation platform named the Pro-Sport Ultra® designed by AVAZZIA to relieve pain and improve mobility in patients with Carpal Tunnel Syndrome (CTS).
Read the detailed description
This study will recruit patients with a prior diagnosis (Dx) of CTS and have had a trial of conservative treatment for a minimum of 4 weeks without successful results due to continuing symptoms that interfere with normal function.
The primary objective of this study is to compare the changes obtained in CTS that have not successfully responded to non-surgical management by incorporating PRO-Sport Ultra® as opposed to an inactive device. This study aims to compare improvement obtained in CTS using the new therapy.
All participants will be randomized into two treatment groups and receive treatment with both active and inactive devices during the study. During the first 2 weeks, one group will receive treatment with the active device and the other group will receive treatment with the inactive device. At the end of week 3 (no treatment week), participants will return to the clinic and will be crossed over for the next 2 weeks of treatment.
The Avazzia PRO-Sport Ultra® and BEST-RSI® devices are non-invasive, hand-held, battery operated microcurrent devices that are FDA-cleared for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device, Sham PRO-SPORT Ultra® Device
- Keywords
- musculoskeletal disorder, median nerve, carpal tunnel, hand numbness, electric stimulation, microcurrent
- Medical subject headings
- Carpal Tunnel Syndrome, Musculoskeletal Diseases, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® DeviceDevice
Participants will receive treatment with an active electrical stimulation device for 7 in-clinic treatments over 2 weeks.
Active Avazzia PRO-Sport Ultra® medical device, BEST™ HVPC microcurrent electrical stimulation, FDA cleared for pain relief
Sham PRO-SPORT Ultra® DeviceDevice
Participants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks.
Sham PRO-SPORT Ultra® device will be used. The built in electrodes and the accessory port for connecting the lead wire to the electrode pads will be disconnected internal to the device. The device will power on with the same sounds and indications.
| Study group | Role | What they receive |
|---|---|---|
| BEST™ Pro-Sport Ultra® microcurrent device | Experimental | Participants will receive treatment with an active electrical stimulation device for 7 in-clinic treatments over 2 weeks. Receives: Device: BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device |
| Electrical Stimulation - Sham Comparator | Sham comparator | Participants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks. Receives: Device: Sham PRO-SPORT Ultra® Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level Assessment
Change in pain associated with CTS during visit #1, 7, 8 ,14, and visit 15 [Time Frame: baseline to 5 weeks] Pain will be assessed with VAS (Visual Analog Scale pain score) from 0 to 10 where 10 is the worst pain ever.
Measured: 5 weeks
Motor Function Examination
Change in the score of motor function examination during visit #1, 7, 8 ,14, and visit 15 [Time Frame: baseline to 5 weeks] Change will be assessed using the motor function score from 0 to 5 where 5 is full range of motion.
Measured: 5 weeks
Nerve Conduction Velocity
Nerve conduction velocity during visit #1, 7, 8 ,14, and visit 15 [Time Frame: baseline to 5 weeks] Change in nerve conduction velocity will be assessed from the score obtained from testing done by the Mediracer Carpal Tunnel Syndrome Sensory exam from normal to severe.
Measured: 5 weeks
Secondary outcomes (3)
Healthy Related Quality of Life Changes
Change in health Related Quality of Life during visit #1, 7, 8 ,14, and visit 15 [Time Frame: baseline to 5 weeks] Change will be assessed with QuickDash score from 0 to 100 where 100 is most severe disability.
Measured: 5 weeks
Sensory ability changes
Change in sensory ability during visit #1 and 15 [Time Frame: baseline to 5 weeks] Change will be assessed with Katz Hand Diagram.
Measured: 5 weeks
Dosage/Frequency of Analgesics changes
Change in frequency and dosage of analgesics during visit #1, 7, 8 ,14, and visit 15 [Time Frame: baseline to 5 weeks] Change will be assessed with comparison of frequency and analgesics from visit to visit.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start14 Sep 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (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
- Model description
- Device: Avazzia Pro-Sport Ultra® device High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avazzia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joseph Surace, D.C.
- Responsible party
- Sponsor
- Investigators
- Joseph Surace, D.C., Principal investigator, Activated Family Chiropractic & Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271319
- Sponsor's protocol ID
- RA-190930-CTS-01
- Status last verified
- Jul 2021
- First submitted
- 22 Jan 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a High Voltage Pulsed Current in the Non-Invasive Treatment of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04271319
- Acronym / sponsor ID
- RA-190930-CTS-01
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- musculoskeletal disorder, median nerve, carpal tunnel, hand numbness, electric stimulation, microcurrent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Avazzia, IncIndustry (pharma, biotech, devices)
- Collaborators
- Joseph Surace, D.C.
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 17 Feb 2020 (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.
A clinical study at Activated Family Chiropractic \& Wellness, is being proposed to test the efficacy of a novel electrical stimulation platform named the Pro-Sport Ultra® designed by AVAZZIA to relieve pain and improve mobility in patients with Carpal Tunnel Syndrome (CTS).
Detailed description
This study will recruit patients with a prior diagnosis (Dx) of CTS and have had a trial of conservative treatment for a minimum of 4 weeks without successful results due to continuing symptoms that interfere with normal function.
The primary objective of this study is to compare the changes obtained in CTS that have not successfully responded to non-surgical management by incorporating PRO-Sport Ultra® as opposed to an inactive device. This study aims to compare improvement obtained in CTS using the new therapy.
All participants will be randomized into two treatment groups and receive treatment with both active and inactive devices during the study. During the first 2 weeks, one group will receive treatment with the active device and the other group will receive treatment with the inactive device. At the end of week 3 (no treatment week), participants will return to the clinic and will be crossed over for the next 2 weeks of treatment.
The Avazzia PRO-Sport Ultra® and BEST-RSI® devices are non-invasive, hand-held, battery operated microcurrent devices that are FDA-cleared for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Device: Avazzia Pro-Sport Ultra® device High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.
| Arm | Type | Receives |
|---|---|---|
| BEST™ Pro-Sport Ultra® microcurrent device | Experimental | Device: BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® DeviceParticipants will receive treatment with an active electrical stimulation device for 7 in-clinic treatments over 2 weeks. |
| Electrical Stimulation - Sham Comparator | Sham comparator | Device: Sham PRO-SPORT Ultra® DeviceParticipants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a prior diagnosis (Dx) of CTS and have had a trial of conservative treatment for a minimum of 4 weeks without successful results due to continuing symptoms that interfere with normal function.
- Confirmation of this Dx shall include at least three findings as defined below:
- Age >18 - <70 years old
- Males/Females of all ethnicities
- Post-surgical failures >6 months post op
Key exclusion criteria (9 listed)
- Systemic disease that would affect treatment outcome such as inflammatory joint diseases (i.e., rheumatoid arthritis, systemic lupus); malignancies undergoing treatment or any malignancies (in remission or not) with involvement of the musculoskeletal system.
- Co-morbidities, thoracic outlet nerve impingement, neuropathy, etc. should be identified and, if significant, the candidate should be excluded from the study.
- Cubital tunnel syndrome, anterior and posterior interosseous nerve syndrome, lateral and medial epicondylitis, handlebar palsy, De Quervain's disease, trigger finger, and Intersection syndrome should be differentiated from CTS and not included in this study.
- Uncontrolled mood disorders, such as depression, anxiety.
- Drug or substance abuse within past 90 days.
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 |
|---|---|---|
| BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® DeviceParticipants will receive treatment with an active electrical stimulation device for 7 in-clinic treatments over 2 weeks. Active Avazzia PRO-Sport Ultra® medical device, BEST™ HVPC microcurrent electrical stimulation, FDA cleared for pain relief | Device | BEST™ Pro-Sport Ultra® microcurrent device |
| Sham PRO-SPORT Ultra® DeviceParticipants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks. Sham PRO-SPORT Ultra® device will be used. The built in electrodes and the accessory port for connecting the lead wire to the electrode pads will be disconnected internal to the device. The device will power on with the same sounds and indications. | Device | Electrical Stimulation - Sham Comparator |
Primary outcome
Pain Level Assessment
Time frame: 5 weeks
Change in pain associated with CTS during visit #1, 7, 8 ,14, and visit 15 [Time Frame: baseline to 5 weeks] Pain will be assessed with VAS (Visual Analog Scale pain score) from 0 to 10 where 10 is the worst pain ever.
Motor Function Examination
Time frame: 5 weeks
Change in the score of motor function examination during visit #1, 7, 8 ,14, and visit 15 [Time Frame: baseline to 5 weeks] Change will be assessed using the motor function score from 0 to 5 where 5 is full range of motion.
Nerve Conduction Velocity
Time frame: 5 weeks
Nerve conduction velocity during visit #1, 7, 8 ,14, and visit 15 [Time Frame: baseline to 5 weeks] Change in nerve conduction velocity will be assessed from the score obtained from testing done by the Mediracer Carpal Tunnel Syndrome Sensory exam from normal to severe.
3 secondary outcomes
Healthy Related Quality of Life Changes
Time frame: 5 weeks
Sensory ability changes
Time frame: 5 weeks
Dosage/Frequency of Analgesics changes
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Joseph Surace, D.C. principal investigator
Activated Family Chiropractic & Wellness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device in people with Carpal Tunnel Syndrome, run by Avazzia, Inc 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 14 inclusion and 9 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 27 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
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?
Pain Level Assessment (time frame: 5 weeks). The study lists 3 primary outcomes in all. 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 27 Jul 2021.