Trial · NCT02070302
BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome
NCT02070302, Phase 2, Completed, Benjamin Sucher; results first posted 2017-09-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome. Trials, record NCT02070302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02070302
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome
- NCT number
- NCT02070302
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Benjamin Sucher
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Botulinum Toxin Type A, Placebo
- First posted
- 2014-02-25
- Last updated
- 2017-09-27
- Results first posted
- 2017-09-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Baseline-Week 18 | Patients with Levine score \< 4 were included in the study. The score for this assessment can range from 11-55. |
| Primary | Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. | Baseline-Week 18 | Patients with Levine score of \< 4 were included in the study. The score for this assessment can range from 8-40 |
| Primary | Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18. | Baseline to Week 18 | Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline. |
| Primary | Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18. | Baseline, week 6, week 12, and week 18. | Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline |
| Primary | Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18. | Baseline to Week 18 | Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds. |
| Primary | Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18. | Baseline-Week 18 | Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Baseline-Week 18 | Levine symptom severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. It ranges from 1 (no symptoms) to 5 (severe symptoms). This scale indicate how severe the CTS symptoms feel to the patient. Mean values (std deviation) are reported both Onabot and Placebo groups. | Scores on a scale | MEAN |
| PRIMARY | Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. | Baseline-Week 18 | Levine functional severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. This scale ranges from 1 (no symptoms) to 5 (severe symptoms). The function severity scale indicate interference of the symptoms on activities of daily living. Mean values reported for each group. | Scores on a scale | MEAN |
| PRIMARY | Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18. | Baseline to Week 18 | % change | MEAN | |
| PRIMARY | Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18. | Baseline, week 6, week 12, and week 18. | milliseconds | MEAN | |
| PRIMARY | Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18. | Baseline to Week 18 | milliseconds | MEAN | |
| PRIMARY | Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18. | Baseline-Week 18 | Pounds of Force (LBF) | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Botulinum Toxin Type A | Visit 2-Week 6 | 0.4 | Standard Deviation 6.8 | Scores on a scale |
| Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Placebo | Visit 2-Week 6 | -3.2 | Standard Deviation 6.8 | Scores on a scale |
| Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Botulinum Toxin Type A | Visit 3-Week 12 | -4.2 | Standard Deviation 5.1 | Scores on a scale |
| Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Placebo | Visit 3-Week 12 | -9.4 | Standard Deviation 8.3 | Scores on a scale |
| Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Botulinum Toxin Type A | Visit 4-Week 18 | -5.4 | Standard Deviation 8.7 | Scores on a scale |
| Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Placebo | Visit 4-Week 18 | -6.8 | Standard Deviation 6.8 | Scores on a scale |
| Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. | Botulinum Toxin Type A | Visit 2-Week 6 | -1.0 | Standard Deviation 9.3 | Scores on a scale |
| Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. | Placebo | Visit 2-Week 6 | -4.4 | Standard Deviation 11.9 | Scores on a scale |
| Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. | Botulinum Toxin Type A | Visit 3-Week 12 | -3.8 | Standard Deviation 4.8 | Scores on a scale |
| Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. | Placebo | Visit 3-Week 12 | -9.6 | Standard Deviation 9.3 | Scores on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botulinum Toxin Type A | 5 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A | 5 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Left Neck Pain | Musculoskeletal and connective tissue disorders | Botulinum Toxin Type A | 1 | 5 | 1 |
| other | Left Neck Pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 5 | 0 |
| other | Neck Stiffness | Musculoskeletal and connective tissue disorders | Botulinum Toxin Type A | 1 | 5 | 1 |
| other | Neck Stiffness | Musculoskeletal and connective tissue disorders | Placebo | 0 | 5 | 0 |
| other | Right Hand Weakness | Musculoskeletal and connective tissue disorders | Botulinum Toxin Type A | 1 | 5 | 1 |
| other | Right Hand Weakness | Musculoskeletal and connective tissue disorders | Placebo | 0 | 5 | 0 |
| other | Rash | Skin and subcutaneous tissue disorders | Botulinum Toxin Type A | 1 | 5 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 0 | 5 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Type A | 0 | 5 |
| Total, all-cause mortality | Placebo | 0 | 5 |
| Total, other adverse events | Botulinum Toxin Type A | 2 | 5 |
| Total, other adverse events | Placebo | 0 | 5 |
| Total, serious adverse events | Botulinum Toxin Type A | 0 | 5 |
| Total, serious adverse events | Placebo | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Botulinum Toxin Type A vs Placebo: deaths from any cause | Trial comparisons |
| Botulinum Toxin Type A vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02070302
GET https://conductscience.org/api/trials/v1/NCT02070302/results?page=2