Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in dermatomal somatosensory evoked potentials |
In all dermatomes, 2 complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at < 5 k Cutaneous areas of L3,L4,L5, S1 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject. |
baseline (pre-treatment) , 2 weeks ,through study completion, an average of 1 week |
|
Secondary |
Change in Skin Sympathetic response |
For measurement of the Skin Sympathetic response, electromyography equipment will be used. The skin temperature will be maintained at 32° )by making the stability of room temperature around 26° C, asking subjects to stay in the room for 20 minutes with that temperature before the examination and prevent local warm-up for extremities) . Active surface electrodes will be attached on the palmar side, and the references will be placed on the dorsum of the hand. The stimulus will be given at the wrist contralateral to the recording side. The latency and peak to peak amplitude will be determined. Sympathetic skin response will be considered absent if there is no response after ten stimuli. |
baseline (pre-treatment) , 2 weeks ,through study completion, an average of 1 week |
|
Secondary |
Change in Pressure pain threshold |
An algometer will be used to measure Pressure pain threshold at both the thenar eminence and the proximal third of the right ventral forearm. . Before measurements on these points will be taken, Pressure pain threshold measurement will be demonstrated in the opposite upper limb to familiarize the patient with the procedure. Participants will be instructed to say "stop" when the sensation changed from pressure to pain. The Pressure pain threshold will be measured with the patient's hand and forearm in supination and supported on a table. Three measurements will be taken at each point. The mean value was used for between groups comparisons. A 30-second resting period will be allowed between each measurement. The pressure will be applied at a rate of 3 N/s up to a maximum of 60 N, which was not exceeded because of the risk of tissue damage. |
baseline (pre-treatment) , 2 weeks of treatment and at 1 week following the end of treatment |
|