Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Latency of Antidromic median sensory nerve action potential |
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 µs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Latency will be registered with a specific software (Signal software, CED) and will be expressed in millisecond. |
Baseline at 0 minutes |
|
Primary |
Amplitude of Antidromic median sensory nerve action potential |
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 µs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts. |
Baseline at 0 minutes |
|
Primary |
Tactile Threshold |
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton |
Baseline at 0 minutes |
|
Primary |
Pressure Pain Threshold |
The PPT will be measured with an algometer and will be expressed in Newtons |
Baseline at 0 minutes |
|
Primary |
Muscle strength |
Muscle strength will be measured with a dynamometer and will be expressed in Kgs. |
Baseline at 0 minutes |
|
Primary |
Tactile Threshold |
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton |
During treatment at 15 minutes |
|
Primary |
Pressure Pain Threshold |
The PPT will be measured with an algometer and will be expressed in Newtons |
During treatment at 15 minutes |
|
Primary |
Latency Antidromic median sensory nerve action potential |
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 µs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Latency (NPL) will be registered with a specific software (Signal software, CED) and will be expressed in millisecond. |
Immediately after treatment at 20 minutes |
|
Primary |
Amplitude Antidromic median sensory nerve action potential |
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 µs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts. |
Immediately after treatment at 20 minutes |
|
Primary |
Tactile Threshold |
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton |
Immediately after treatment at 20 minutes |
|
Primary |
Pressure Pain Threshold |
The PPT will be measured with an algometer and will be expressed in Newtons |
Immediately after treatment at 20 minutes |
|
Primary |
Muscle strength |
Muscle strength will be measured with a dynamometer and will be expressed in Kgs. |
Immediately after treatment at 20 minutes |
|
Primary |
Latency Antidromic median sensory nerve action potential |
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 µs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Latency will be registered with a specific software (Signal software, CED) and will be expressed in millisecond. |
Immediately after treatment at 30 minutes |
|
Primary |
Amplitude Antidromic median sensory nerve action potential |
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 µs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts. |
Immediately after treatment at 30 minutes |
|
Primary |
Tactile Threshold |
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton |
Immediately after treatment at 30 minutes |
|
Primary |
Pressure Pain Threshold |
The PPT will be measured with an algometer and will be expressed in Newtons |
Immediately after treatment at 30 minutes |
|
Primary |
Muscle strength |
Muscle strength will be measured with a dynamometer and will be expressed in Kgs. |
Immediately after treatment at 30 minutes |
|
Secondary |
Baseline nerve temperature |
Nerve temperature will be measured using a termodoppler (Celsius degrees) |
Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes |
|
Secondary |
Numerical Discomfort Rate Score |
the possible discomfort caused by the interventions will be assess by a numerical rate score. The NRS consists of a scale from 0 (no discomfort) to 10 (worst possible discomfort) |
After the intervention at 35 minutes |
|
Secondary |
Numerical Pain Rate Score |
The NRS consists of a scale from 0 (no pain) to 10 (worst possible pain) |
After the intervention at 35 minutes |
|
Secondary |
Number of participants with intervention-related adverse effects |
The possible adverse effects caused by the interventions will be assess by a closed questionnaire, where the presence of any adverse effect would be qualified as 1 point and the negative presence of adverse effect as 0 point. |
After the intervention at 35 minutes |
|
Secondary |
Blinding success |
Blinding of subjects and researchers will be assessed using the Bang questionary. It will be the question after the intervention, "What type of treatment do you think you have received?" Will be asked, with 5 items: (1) "I firmly believe that I have received an experimental treatment"; (2) "I slightly believe that I have received an experimental treatment"; (3) "I strongly believe that I have received a placebo"; (4) "I slightly think I have received a placebo"; (5) "Don't know, don't answer.", Index where -1 is blinded and 1 is unblinded. |
After the intervention at 35 minutes |
|