Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .
Treatment of Pain Attributed to Plantar Fasciitis with Botulinum Toxin A: A Short-Term, Randomized, Placebo-Controlled, Double-Blind Study
Babcock MS , Foster L , Pasquina P , Jabbari B : Treatment of pain attributed to plantar fasciitis with botulinum toxin A : A short-term , r and omized , placebo-controlled , double-blind study . Am J Phys Med Rebabil 2005;84:649–654 . Objective : To investigate the effect of botulinum toxin A on associated pain and functional impairment of refractory plantar fasciitis . Design : This is a r and omized , double-blind , placebo-controlled study of 27 patients ( 43 feet ) with plantar fasciitis . Block r and omization was performed using computer software . In patients with bilateral symptoms of comparable severity , botulinum toxin A was injected in one foot and saline in the other foot . The treatment group received a total of 70 units of botulinum toxin A divided into two sites per foot . One of the two sites was the tender area in the medial aspect of the heel close to the calcaneal tuberosity ( 40 units ) , and the other was in the arch of the foot between an inch anterior to the heel and middle of the foot ( 30 units ) . The placebo group received the same volume of normal saline . Main outcome measures included : Pain Visual Analog Scale , Maryl and Foot Score , Pain Relief Visual Analog Scale , and pressure algometry response . Patients were assessed before injection , at 3 wks , and at 8 wks . Results : The study revealed statistically significant changes in the treatment group . Compared with placebo injections , the botulinum toxin A group improved in all measures : Pain Visual Analog Scale ( P < 0.005 ) , Maryl and Foot Score ( P = 0.001 ) , Pain Relief Visual Analog Scale ( P < 0.0005 ) , and pressure algometry response ( P = 0.003 ) . No side effects were noted . Conclusions : Botulinum toxin A injection for plantar fasciitis yields significant improvements in pain relief and overall foot function at both 3 and 8 wks after treatment
Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .