TriangleNCT01541644 · OUTCOME
To Determine the Response Rate (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale (1 - 100)
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and 10 weeks
What was measured
The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians \& the TNSc in our trial was performed by a research nurse. The reliability \& validity of research nurse's TNSc not established pre-trial. For the scale range, the higher the score the worse the symptoms and function. No subscales were used.
Groups in this outcome
Acupuncture
All participants will receive acupuncture treatments over a total of 10 weeks. Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.
| Group | Source count |
|---|---|
| Acupuncture | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Acupuncture | 13.3 | 6.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 6.5
- value
- 13.3
- denoms
- counts
- group Id
- OG000
- value
- 27
- units
- Participants
- description
- The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians \& the TNSc in our trial was performed by a research nurse. The reliability \& validity of research nurse's TNSc not established pre-trial. For the scale range, the higher the score the worse the symptoms and function. No subscales were used.
- dispersion Type
- Standard Deviation
- groups
- description
- All participants will receive acupuncture treatments over a total of 10 weeks. Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.
- id
- OG000
- title
- Acupuncture
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline and 10 weeks
- title
- To Determine the Response Rate (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN)
- type
- PRIMARY
- unit Of Measure
- units on a scale (1 - 100)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice