Carpal Tunnel Syndrome
Conditions
Keywords
carpal tunnel syndrome, carpal tunnel, CTS, musculoskeletal disorder, peripheral neuropathy, repetitive stress injury, non-invasive device, non-significant risk, medical device, wrist pain
Brief summary
Sham-controlled, multi-center and remote patient-centered randomized controlled clinical trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.
Detailed description
It is hypothesized that daily wear of the study device will result in significant improvements in patient-reported symptom severity. It is also hypothesized that the effects from active study device treatment will be significantly greater than effects from sham treatment. In both cases, it is hypothesized that improvements will be sustained post-treatment. This study is designed as a randomized, double-blind, sham-controlled, two-arm trial consisting of an eight-week treatment period (active study device or sham), followed by one required follow-up four weeks later (at week 12). There are two study groups: the active device group receiving the active study device and the sham group receiving a non-active sham device. Subjects will be informed that they have a 50:50 chance of receiving treatment or a sham. They will also be informed that if they receive sham device, they will be offered the active device 4 weeks into the post-treatment period. However, all subjects will not know what treatment they are on until the conclusion of the trial.
Interventions
DEVICEStudy Device
Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks).
DEVICESham Device
Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). \*Note: participants in the sham group are given the real study device at the end of the Post-Treatment/Follow-up Phase.
Sponsors
The Cleveland Clinic
Mission Pain and Spine
Kaiser Permanente
Pressure Profile Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS) 2. CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 24 months OR at enrollment/baseline visit 1. CTS severity determined via AANEM criteria 13 2. Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the study wrist) 3. BCTQ SSS \> 2 4. Reliable access to and ability to use Internet, Wi-Fi, or mobile data through computers, mobile devices, laptops, and/or tablets 5. Willing to abstain from any other treatment or therapies for CTS throughout the study 6. Ability to read and write English, or has a reliable person to assist with reading and writing English
Exclusion criteria
1. Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies) 2. Double crush syndrome 3. Cervical stenosis 4. Brachial plexopathy 5. Wrist fractures or cysts 6. Prior wrist surgeries, especially carpal tunnel release surgery 7. Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months 8. Thyroid disease 9. Rheumatoid arthritis 10. Diabetes 11. Systemic diseases 12. Connective tissue diseases 13. Fibromyalgia or chronic pain syndrome 14. Diabetic neuropathy 15. BMI \> 40 16. Participation in other research studies or clinical trials currently or within the past 2 weeks. To assess eligibility, visit: carpaltunneltrial.com
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCTQ SSS at 8 Weeks vs Baseline | baseline and 8 weeks post-Baseline | The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCTQ SSS | 8-weeks post-Baseline and 12 weeks post-Baseline | The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Device Small, non-invasive, orthodontic arch with adhesive applied to the wrist
Study Device: Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). | 42 |
| Sham Device Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.
Sham Device: Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). \*Note: participants in the sham group were given the real study device at the end of the Post-Treatment/Follow-up Phase. | 38 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Study Device | Sham Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 37 Participants | 79 Participants |
| Age, Continuous | 48.6 years STANDARD_DEVIATION 11.7 | 48.6 years STANDARD_DEVIATION 9.9 | 48.6 years STANDARD_DEVIATION 10.8 |
| BCTQ Functional Severity Score (FSS) | 2.21 units on a 1-5 Likert scale STANDARD_DEVIATION 0.72 | 2.39 units on a 1-5 Likert scale STANDARD_DEVIATION 0.7 | 2.30 units on a 1-5 Likert scale STANDARD_DEVIATION 0.71 |
| Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Score (SSS) | 2.78 units on a 1-5 Likert scale STANDARD_DEVIATION 0.58 | 2.96 units on a 1-5 Likert scale STANDARD_DEVIATION 0.42 | 2.87 units on a 1-5 Likert scale STANDARD_DEVIATION 0.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 22 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 13 Participants | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 32 Participants | 30 Participants | 62 Participants |
| Sex/Gender, Customized Decline to Answer | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Female | 34 Participants | 27 Participants | 61 Participants |
| Sex/Gender, Customized Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 38 |
| other Total, other adverse events | 2 / 42 | 2 / 38 |
| serious Total, serious adverse events | 0 / 42 | 0 / 38 |
Outcome results
Primary
BCTQ SSS at 8 Weeks vs Baseline
The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms).
Time frame: baseline and 8 weeks post-Baseline
Population: Per-protocol population (patients that completed at least up to the first post-treatment follow-up (Week 12))
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Device | BCTQ SSS at 8 Weeks vs Baseline | Average SSS | 2.16 score on a scale | Standard Deviation 0.65 |
| Study Device | BCTQ SSS at 8 Weeks vs Baseline | Average Change in SSS | -0.62 score on a scale | Standard Deviation 0.69 |
| Sham Device | BCTQ SSS at 8 Weeks vs Baseline | Average SSS | 2.32 score on a scale | Standard Deviation 0.7 |
| Sham Device | BCTQ SSS at 8 Weeks vs Baseline | Average Change in SSS | -0.64 score on a scale | Standard Deviation 0.62 |
Secondary
BCTQ SSS
The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms).
Time frame: 8-weeks post-Baseline and 12 weeks post-Baseline
Population: Per-protocol population (patients that completed at least up to the first post-treatment follow-up (Week 12))
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Device | BCTQ SSS | Average SSS @12 weeks | 2.24 score on a scale | Standard Deviation 0.7 |
| Study Device | BCTQ SSS | Average Change in SSS between 12 and 8 weeks | 0.08 score on a scale | Standard Deviation 0.48 |
| Sham Device | BCTQ SSS | Average SSS @12 weeks | 2.44 score on a scale | Standard Deviation 0.68 |
| Sham Device | BCTQ SSS | Average Change in SSS between 12 and 8 weeks | 0.12 score on a scale | Standard Deviation 0.4 |