Carpal Tunnel Syndrome
Conditions
Brief summary
A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).
Detailed description
A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical function in subjects previously diagnosed with mild to severe carpal tunnel syndrome.
Interventions
DEVICECarpal Tunnel Tissue Manipulation Device (CTMD)
This piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece for a duration of 2-14 hours.
Sponsors
Pressure Profile Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. male or female, ages 21-65 and in good general health; 2. subject diagnosed with mild to severe carpal tunnel syndrome (CTS) (AANEM criteria for CTS) * mild CTS: prolonged distal sensory latency with ± decreased sensory amplitude * moderate CTS: abnormal median sensory latency with prolongation of the distal motor latency * severe CTS: prolonged motor and sensory distal peak latencies either with a low or absent SNAP or CMAP 3. bilateral CTS accepted (either mild, moderate or severe CTS bilaterally), however, more involved wrist (via NCS) used as study wrist; 4. Boston Carpal Tunnel Questionnaire (BCTQ) Symptoms Score ≥ 2; 5. women of childbearing potential must be willing to practice effective contraception for the duration of the study (i.e., abstinence, condoms or diaphragm with spermicide, IUD, or birth control pills \[BCP\]); NOTE: Females on birth control pills (BCP) must be stable on the same type and dose of pill for at least three months prior to entering the study and must not change the type of BCP or dosing regimen during the study. Those who have discontinued using BCPs in favor of another form of contraception must have discontinued BCP usage at least 3 months prior to the start of the study. 6. women of child bearing potential must have a negative urine pregnancy test at the Baseline Visit (Visit 1, Day 0) and must not be lactating; and 7. willingness to follow protocol requirements, including signing an informed consent and health information release forms, attending routine follow-up visits and completing questionnaires.
Exclusion criteria
1. known sensitivity to adhesives or glue; 2. history of diabetes mellitus; 3. history of thyroid disease; 4. history of prior wrist fractures; 5. known to be easily bruised (hematoma); 6. concurrent use of blood thinners; 7. history of connective tissue disease; 8. diagnosed with superimposed peripheral neuropathy; 9. history of cervical radiculopathy; 10. diagnosed with purely ulnar paresthesias; 11. history of ulnar neuropathy; 12. history of brachial plexopathy; 13. diagnosed with pronator teres syndrome; 14. history of polyneuropathy; 15. uncontrolled systemic disease; 16. history of any mass, tumor, severe trauma or deformity of the hand or wrist; 17. previous surgery of the hand or wrist; 18. history of prior carpal tunnel release; 19. current use of any splinting or bracing medical device for CTS; 20. currently taking any medication therapy that could cause a focal or generalized neuropathy (e.g., antiepileptics, statins, chemotherapeutic or antiarrhythmic); 21. history of any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; 22. concomitant use of systemic medication(s) or therapy that may have a substantial effect on CTS condition, unless such medication(s) or therapy has/have been used for a minimum of 3 months prior to study enrollment, is/are expected to remain constant throughout the course of the study and is/are considered necessary for a subjects' welfare; 23. females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception; 24. inability to give informed consent; and 25. concurrent participation or prior participation in any investigation drug or device study within the last 30 days prior to the Baseline Visit (Visit 1).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SSS of the BCTQ at 28 Days vs Baseline | 28 days | The primary efficacy variable is the decrease in Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The SSS is a patient-reported measure of the severity of the patient's symptoms caused by carpal tunnel syndrome, on a scale of 1 (no symptoms) to 5 (worst symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline | 2 months | The secondary efficacy variable is the decrease in Symptoms Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ) obtained 2 months after the 28-day CTMD treatment period compared to the Baseline SSS score. |
Countries
United States
Participant flow
Pre-assignment details
Participants were only enrolled if a nerve conduction study (NCS) was performed at the enrollment visit or within the past 6 months, electrodiagnostically confirming the presence of mild to severe CTS.
Participants by arm
| Arm | Count |
|---|---|
| Carpal Tunnel Medical Device (CTMD) The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period.
If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Carpal Tunnel Medical Device (CTMD) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 51.4 years STANDARD_DEVIATION 11.1 |
| Bilaterality Bilateral CTS | 4 Participants |
| Bilaterality Unilateral CTS | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Severity Mild | 3 Participants |
| Severity Moderate | 4 Participants |
| Severity Severe | 4 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 7 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Change in SSS of the BCTQ at 28 Days vs Baseline
The primary efficacy variable is the decrease in Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The SSS is a patient-reported measure of the severity of the patient's symptoms caused by carpal tunnel syndrome, on a scale of 1 (no symptoms) to 5 (worst symptoms).
Time frame: 28 days
Population: Primary outcome measures were analyzed for unilateral and bilateral subjects combined, but measures were analyzed for unilateral and bilateral subjects separately as well.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral+Bilateral | Change in SSS of the BCTQ at 28 Days vs Baseline | 0.59 point decrease in SSS | Standard Deviation 0.68 |
| Unilateral Only | Change in SSS of the BCTQ at 28 Days vs Baseline | 0.93 point decrease in SSS | Standard Deviation 0.52 |
| Bilateral Only | Change in SSS of the BCTQ at 28 Days vs Baseline | .00 point decrease in SSS | Standard Deviation 0.5 |
Secondary
Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline
The secondary efficacy variable is the decrease in Symptoms Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ) obtained 2 months after the 28-day CTMD treatment period compared to the Baseline SSS score.
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral+Bilateral | Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline | 0.79 point decrease in SSS | Standard Deviation 0.74 |
| Unilateral Only | Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline | 1.20 point decrease in SSS | Standard Deviation 0.53 |
| Bilateral Only | Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline | 0.09 point decrease in SSS | Standard Deviation 0.41 |