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| ID | Type | Description | Link |
|---|---|---|---|
| 85700 | Other Grant/Funding Number | Allergan Sales. LLC |
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study will be a prospective double blind controlled randomized trial of ten patients diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of medical practices in Arizona. Patients who meet inclusion criteria will be randomly distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned individuals.
This is a pilot study, to assist with determining appropriate BOTOX® (onabotulinumtoxin A) dosing and injection locations in patients suffering from CTS.
Outcome measures will be obtained at follow-up at 6, 12, and 18 weeks post BOTOX® (onabotulinumtoxin A) injection and post saline injection using the same scales and instruments at baseline, namely Levine scale, JAMAR pinch dynamometer, EDX/NCS and NMUS. These measurements will be used to identify the effectiveness of BOTOX® (onabotulinumtoxin A) in decreasing thenar muscle strength, appropriate BOTOX® (onabotulinumtoxin A) injection dosing, and ability to decrease the inflammation, median nerve dysfunction, edema, symptoms of pain, numbness, and tingling often with associated with CTS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin Type A | Active Comparator | After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB) |
|
| Placebo | Placebo Comparator | .4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55. | Baseline-Week 18 |
| Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. | Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40 | Baseline-Week 18 |
| Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18. | Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline. | Baseline to Week 18 |
| Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at 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 | Baseline, week 6, week 12, and week 18. |
| Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18. | Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds. | Baseline to Week 18 |
| Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18. | Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Sucher, DO | Arizona Arthritis & Rheumatology Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology | Phoenix | Arizona | 85032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB) Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each |
| FG001 | Placebo | .4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB) Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
10 patients with bilateral CTS, diagnosed by nerve conduction studies and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing), divided into control and Onabot groups. Non-dominant hands were injected under ultrasound guidance with 40 units (0.4 cc) of Onabot or normal saline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A (Onabot) | A prospective, randomized, double blind pilot study of patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). For 5 out of 10 subjects, non-dominant hands were injected under ultrasound guidance with 40 units of Onabot (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. | Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline-Week 18 |
|
18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin Type A | At 18 weeks, mean distal motor latency changes of -0.6 ms (P-value = 0.078) in the Onabot group were noted; and distal sensory latency changes of -0.3ms in the Onabot group; less slowing. Decreased mean cross-sectional area of -2.2 mm2 (P-value =0.040) in Onabot group were noted; less nerve edema. Decreased percent compression of the median nerve during stress testing was -12.6% in Onabot group. Three subjects injected with Onabot demonstrated decreases in median distal motor latencies that were nearly significant (p-value<.1, >.05), Two had decreases in median distal sensory latencies, and some had decreases in cross-sectional area on NMUS that were nearly significant. One Onabot subject did not show improvement or changes in median distal latencies but remained stable while the non-injected hand worsened with increasing median distal latencies. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Santimaw | Arizona Arthritis & Rheumatology Research, PLLC | 4806266653 | amanda.santimaw@azarthritis.com |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo | Drug | Placebo (Normal Saline) divided into 2 injections of .4cc each |
|
|
| Baseline-Week 18 |
| BG001 | Placebo | A prospective, randomized, double blind pilot study of 10 patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). Non-dominant hands were injected under ultrasound guidance with 40 units of 40 units of normal saline (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | .4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB) Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each |
|
|
| Primary | Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. | Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40 | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline-Week 18 |
|
|
|
| Primary | Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18. | Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline. | Posted | Mean | Standard Deviation | % change | Baseline to Week 18 |
|
|
|
| Primary | Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at 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 | Posted | Mean | Standard Deviation | milliseconds | Baseline, week 6, week 12, and week 18. |
|
|
|
| Primary | Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18. | Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Week 18 |
|
|
|
| Primary | Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18. | Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges. | Posted | Mean | Standard Deviation | Pounds of Force (LBF) | Baseline-Week 18 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Placebo | .4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB) Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each | 0 | 5 | 0 | 5 | 0 | 5 |
|
| Neck Stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to the study |
|
| Right Hand Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Related to the study. |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash on Left Groin Area. Not related to the study. |
|
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Visit 4-Week 18 |
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| Visit 4-Week 18 |
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| Visit 4-Week 18 |
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| Visit 4-Week 18 |
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| Visit 4-Week 18 |
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