NCT03870451 · OUTCOME
Change in Motor Nerve Function (Tibial Amplitude) From Baseline to 8 Weeks
Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma · Source last updated 2026-10-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mV
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, 8 weeks
What was measured
Change in tibial motor response from baseline to 8 weeks will include tibial amplitude (mV)
Analysis population: The number in this outcome was determined by the number of participants completing both baseline and 8 week evaluations. Unable to collect amplitude for the ankle on one participant.
Groups in this outcome
Grade 2-3 Established Neuropathy
VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks.
VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
Grade 1-2 New-onset Neuropathy
VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks.
VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Reported measurements
Right Median Wrist
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in mV · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | -0.6 | 2.3 | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 1.0 | 1.9 | Not reported | Not reported | Not reported |
|---|
Left Median Wrist
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in mV · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | -0.2 | 2.6 | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | -0.5 | 2.1 | Not reported | Not reported | Not reported |
|---|
Right Median Elbow
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in mV · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | -0.8 | 2.0 | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 1.0 | 2.1 | Not reported | Not reported | Not reported |
|---|
Left Median Elbow
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in mV · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 0 | 2.0 | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | -0.1 | 1.6 | Not reported | Not reported | Not reported |
|---|
Right Tibial Ankle
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 5 |
|---|
Values in mV · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 0.4 | 1.4 | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | -1.0 | 1.7 | Not reported | Not reported | Not reported |
|---|
Left Tibial Ankle
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 5 |
|---|
Values in mV · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 0.8 | 1.0 | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | -0.3 | 2.1 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.3
- value
- -0.6
- group Id
- OG001
- spread
- 1.9
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Right Median Wrist
- categories
- measurements
- group Id
- OG000
- spread
- 2.6
- value
- -0.2
- group Id
- OG001
- spread
- 2.1
- value
- -0.5
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Left Median Wrist
- categories
- measurements
- group Id
- OG000
- spread
- 2.0
- value
- -0.8
- group Id
- OG001
- spread
- 2.1
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Right Median Elbow
- categories
- measurements
- group Id
- OG000
- spread
- 2.0
- value
- 0
- group Id
- OG001
- spread
- 1.6
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Left Median Elbow
- categories
- measurements
- group Id
- OG000
- spread
- 1.4
- value
- 0.4
- group Id
- OG001
- spread
- 1.7
- value
- -1.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Right Tibial Ankle
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- 0.8
- group Id
- OG001
- spread
- 2.1
- value
- -0.3
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Left Tibial Ankle
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Change in tibial motor response from baseline to 8 weeks will include tibial amplitude (mV)
- dispersion Type
- Standard Deviation
- groups
- description
- VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks.
VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
- id
- OG000
- title
- Grade 2-3 Established Neuropathy
- description
- VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks.
VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
- id
- OG001
- title
- Grade 1-2 New-onset Neuropathy
- param Type
- MEAN
- population Description
- The number in this outcome was determined by the number of participants completing both baseline and 8 week evaluations. Unable to collect amplitude for the ankle on one participant.
- reporting Status
- POSTED
- time Frame
- Baseline, 8 weeks
- title
- Change in Motor Nerve Function (Tibial Amplitude) From Baseline to 8 Weeks
- type
- SECONDARY
- unit Of Measure
- mV
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
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