Peripheral Neuropathy
Conditions
Keywords
QST (quantitative sensory testing), neuropathic pain, tapentadol pr, oxycodone
Brief summary
The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain signs and symptoms in comparison to oxycodone.
Interventions
DRUGtapentadol, oxycodone
tapentadol pr 100-500 mg oxycodone cr 20-120mg
Sponsors
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* thermal or mechanical hyperalgesia * chronic neuropathic pain (NRS =\> 6)
Exclusion criteria
* non-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Upon Numeric Rating Scale | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of pain upon Numeric Rating Scale (NRS; 0 = no pain at all; 10 = maximum pain imaginable) from V1 to V6 |
| Mechanical Pain Threshold (MPT) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Mechanical Pain Threshold from baseline to V6 The mechanical pain threshold (MPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. |
| Heat Pain Threshold (HPT) | day 0 (baseline) and day 78 (10 weeks) | Change of Heat Pain Threshold from V1 to V6 The was Heat Pain Threshold (HPT)measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. |
| Wind-Up Ratio (WUR) | day 0 (baseline) and day 78 (10 weeks) | Change of Wind-Up Ratio from V1 to V6 The Wind-Up Ratio (WUR) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. |
| Cold Pain Threshold (CPT) | day 0 (baseline) and day 78 (10 weeks) | Change of Cold Pain Threshold from baseline to V6 The Cold Pain Threshold (CPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. |
| Pressure Pain Threshold (PPT) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Pressure Pain Threshold from V1 to V6 The Pressure Pain Threshold (PPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. |
| Mechanical Pain Sensitivity (MPS) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Mechanical Pain Sensitivity from V1 to V6 The Mechanical Pain Sensitivity (MPS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. |
| Dynamic Mechanical Allodynia (DMA) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Dynamic Mechanical Allodynia from V1 to V6 The Dynamic Mechanical Allodynia (DMA) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). Subjects were asked to give a pain rating for each stimulus on a '0-100' numerical rating scale ('0' indicating no pain, and '100' indicating most intense pain imaginable). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. A lower score indicates an improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Warmth Detection Threshold (WDT) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Warmth Detection Threshold from V1 to V6 The Warmth Detection Threshold (WDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. |
| Thermal Sensory Limen (TSL) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Thermal Sensory Limen from V1 to V6 The Thermal Sensory Limen (TSL) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically trasnformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. |
| Mechanical Detection Threshold (MDT) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Mechanical Detection Threshold from V1 to V6 The Mechanical Detection Threshold (MDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. |
| Vibration Detection Threshold (VDT) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Vibration Detection Threshold from V1 to V6 The Vibration Detection Threshold (VDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. |
| Paradoxical Heat Sensations (PHS) | day 0 (baseline) and day 78 (V6; 10 weeks) | Change of Number of Paradoxical Heat Sensations from V1 to V6 The number of Paradoxical Heat Sensations (PHS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. An occurence of up to three paradoxical heat sensations was possible. The number was assessed. A lower number indicates an improvement. |
| Cold Detection Threshold (CDT) | day 0 (baseline) and day 78 (10 weeks) | Change of Cold Detection Threshold from V1 to V6 The Cold Detection Threshold (CDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxycodone tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg | 1 |
| Tapentadol tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Oxycodone | Tapentadol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 57 years | 52 years | 53.6 years |
| Race/Ethnicity, Customized caucasian/european | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment Germany | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 1 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Cold Pain Threshold (CPT)
Change of Cold Pain Threshold from baseline to V6 The Cold Pain Threshold (CPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (10 weeks)
Population: Due to low recruitement numbers only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Cold Pain Threshold (CPT) | V1 | 0.35 Z-score |
| Oxycodone | Cold Pain Threshold (CPT) | V6 | 0.35 Z-score |
| Tapentadol | Cold Pain Threshold (CPT) | V1 | -1.1 Z-score |
Primary
Dynamic Mechanical Allodynia (DMA)
Change of Dynamic Mechanical Allodynia from V1 to V6 The Dynamic Mechanical Allodynia (DMA) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). Subjects were asked to give a pain rating for each stimulus on a '0-100' numerical rating scale ('0' indicating no pain, and '100' indicating most intense pain imaginable). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. A lower score indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Dynamic Mechanical Allodynia (DMA) | V1 | 41 score on a scale |
| Oxycodone | Dynamic Mechanical Allodynia (DMA) | V6 | 2 score on a scale |
| Tapentadol | Dynamic Mechanical Allodynia (DMA) | V1 | 44 score on a scale |
| Tapentadol | Dynamic Mechanical Allodynia (DMA) | V6 | 5 score on a scale |
Primary
Heat Pain Threshold (HPT)
Change of Heat Pain Threshold from V1 to V6 The was Heat Pain Threshold (HPT)measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Heat Pain Threshold (HPT) | V6 | -1.4 Z-score |
| Oxycodone | Heat Pain Threshold (HPT) | V1 | -0.5 Z-score |
| Tapentadol | Heat Pain Threshold (HPT) | V1 | -0.2 Z-score |
Primary
Mechanical Pain Sensitivity (MPS)
Change of Mechanical Pain Sensitivity from V1 to V6 The Mechanical Pain Sensitivity (MPS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Mechanical Pain Sensitivity (MPS) | V1 | 2.2 Z-score |
| Oxycodone | Mechanical Pain Sensitivity (MPS) | V6 | -0.4 Z-score |
| Tapentadol | Mechanical Pain Sensitivity (MPS) | V1 | 2 Z-score |
| Tapentadol | Mechanical Pain Sensitivity (MPS) | V6 | 1.5 Z-score |
Primary
Mechanical Pain Threshold (MPT)
Change of Mechanical Pain Threshold from baseline to V6 The mechanical pain threshold (MPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Mechanical Pain Threshold (MPT) | V1 | 1.1 Z-score |
| Tapentadol | Mechanical Pain Threshold (MPT) | V1 | 2.6 Z-score |
| Tapentadol | Mechanical Pain Threshold (MPT) | V6 | 0.55 Z-score |
Primary
Pain Upon Numeric Rating Scale
Change of pain upon Numeric Rating Scale (NRS; 0 = no pain at all; 10 = maximum pain imaginable) from V1 to V6
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Pain Upon Numeric Rating Scale | V6 | 3 score on a scale |
| Oxycodone | Pain Upon Numeric Rating Scale | V1 | 6 score on a scale |
| Tapentadol | Pain Upon Numeric Rating Scale | V1 | 9.5 score on a scale |
| Tapentadol | Pain Upon Numeric Rating Scale | V6 | 5.5 score on a scale |
Primary
Pressure Pain Threshold (PPT)
Change of Pressure Pain Threshold from V1 to V6 The Pressure Pain Threshold (PPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Pressure Pain Threshold (PPT) | V1 | 0 Z-score |
| Tapentadol | Pressure Pain Threshold (PPT) | V1 | 1.65 Z-score |
| Tapentadol | Pressure Pain Threshold (PPT) | V6 | 0.9 Z-score |
Primary
Wind-Up Ratio (WUR)
Change of Wind-Up Ratio from V1 to V6 The Wind-Up Ratio (WUR) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Wind-Up Ratio (WUR) | V1 | -0.6 Z-score |
| Oxycodone | Wind-Up Ratio (WUR) | V6 | 0.75 Z-score |
| Tapentadol | Wind-Up Ratio (WUR) | V1 | -0.2 Z-score |
Secondary
Cold Detection Threshold (CDT)
Change of Cold Detection Threshold from V1 to V6 The Cold Detection Threshold (CDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (10 weeks)
Population: Due to low number of participants only descriptive data can be provided.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Cold Detection Threshold (CDT) | V1 | -1.2 Z-score |
| Oxycodone | Cold Detection Threshold (CDT) | V6 | -1.45 Z-score |
| Tapentadol | Cold Detection Threshold (CDT) | V1 | -2.3 Z-score |
Secondary
Mechanical Detection Threshold (MDT)
Change of Mechanical Detection Threshold from V1 to V6 The Mechanical Detection Threshold (MDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Mechanical Detection Threshold (MDT) | V1 | -2.2 Z-score |
| Tapentadol | Mechanical Detection Threshold (MDT) | V1 | -0.1 Z-score |
| Tapentadol | Mechanical Detection Threshold (MDT) | V6 | -1 Z-score |
Secondary
Paradoxical Heat Sensations (PHS)
Change of Number of Paradoxical Heat Sensations from V1 to V6 The number of Paradoxical Heat Sensations (PHS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. An occurence of up to three paradoxical heat sensations was possible. The number was assessed. A lower number indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Paradoxical Heat Sensations (PHS) | V1 | 0 sensations out of 3 |
| Tapentadol | Paradoxical Heat Sensations (PHS) | V1 | 0.5 sensations out of 3 |
| Tapentadol | Paradoxical Heat Sensations (PHS) | V6 | 0 sensations out of 3 |
Secondary
Thermal Sensory Limen (TSL)
Change of Thermal Sensory Limen from V1 to V6 The Thermal Sensory Limen (TSL) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Logarithmically trasnformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Thermal Sensory Limen (TSL) | V1 | -2.1 Z-score |
| Tapentadol | Thermal Sensory Limen (TSL) | V6 | -2.45 Z-score |
| Tapentadol | Thermal Sensory Limen (TSL) | V1 | -1.9 Z-score |
Secondary
Vibration Detection Threshold (VDT)
Change of Vibration Detection Threshold from V1 to V6 The Vibration Detection Threshold (VDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Vibration Detection Threshold (VDT) | V1 | -1.8 Z-score |
| Tapentadol | Vibration Detection Threshold (VDT) | V1 | -1.85 Z-score |
| Tapentadol | Vibration Detection Threshold (VDT) | V6 | -1.72 Z-score |
Secondary
Warmth Detection Threshold (WDT)
Change of Warmth Detection Threshold from V1 to V6 The Warmth Detection Threshold (WDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement.
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Population: Due to low number of participants only descriptive data is available
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone | Warmth Detection Threshold (WDT) | V1 | -2 Z-score |
| Tapentadol | Warmth Detection Threshold (WDT) | V1 | -1.05 Z-score |
| Tapentadol | Warmth Detection Threshold (WDT) | V6 | -2 Z-score |