Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial

Table 1 Schedule for treatment and outcome measurements

Period	S							T						P
Visit	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19
Week		1		2		3		4		5		6		7		8		9	17
Informed consent	●
Demographic characteristics	●
Inclusion/Exclusion criteria	●
Conformity assessment	●
Blood test	●
Vital signs	●	●	○	○	○	○	○	○	○	●	○	○	○	○	○	○	○	●	●
Medical history	●	●	○	○	○	○	○	○	○	●	○	○	○	○	○	○	○	●	●
Treatment expectancy questionnaire	●
Blinding test																	○
Random allocation		●
Treatment		○	○	○	○	○	○	○	○	○	○	○	○	○	○	○	○
PI-NRS	●	●								●								●	●
SF-MPQ		●								●								●	●
Sleep disturbance score		●								●								●	●
SF-36		●								●								●	●
Beck Depression Inventory		●								●								●	●
PGIC		●								●								●	●
Safety assessment		●	○	○	○	○	○	○	○	●	○	○	○	○	○	○	○	●	●

P post-treatment phase, PGIC Patient Global Impression of Change, PI-NRS 11-point Pain Intensity Numerical Rating Scale, S screening phase, SF-36 Short-Form 36v2 Health Survey, SF-MPQ Short-Form McGill Pain Questionnaire, T treatment phase, ● All groups, ○ Both the electroacupuncture and sham group.

ISSN: 1745-6215