Botulinum toxin type A for the treatment of trigeminal neuralgia: results from a randomized, double-blind, placebo-controlled trial Botulinum toxin-type A: could it be an effective treatment option in intractable trigeminal neuralgia? Botulinum Toxin A in Postherpetic Neuralgia: A Parallel, Randomized, Double-Blind, Single-Dose, Placebo-controlled Trial Botulinum toxin type-A (BOTOX) in the treatment of occipital neuralgia: a pilot study. Subcutaneous injection of botulinum toxin a is beneficial in postherpetic neuralgia. Two doses of botulinum toxin type A for the treatment of trigeminal neuralgia: observation of therapeutic effect from a randomized, double-blind, placebo-controlled trial Acute Treatment of Trigeminal Neuralgia With Onabotulinum Toxin A The safety and efficacy of botulinum toxin type B in the treatment of patients with cervical dystonia: summary of three controlled clinical trials. Clinico-immunologic aspects of botulinum toxin type B treatment of cervical dystonia Efficacy of botulinum toxin type A for treatment of persistent myofascial TMD pain: A randomized, controlled, double-blind multicenter study Distant effects of locally injected botulinum toxin: a double-blind study of single fiber EMG changes. Kinematic Aiming Task: Measuring Functional Changes in Hand and Arm Movements After Botulinum Toxin-A Injections in Children with Spastic Hemiplegia Efficacy of Botulinum Toxin in Treating Myofascial Pain in Bruxers: A Controlled Placebo Pilot Study Comparing botulinum toxin A with casting for treatment of dynamic equinus in children with cerebral palsy. Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. Repetitive transcranial magnetic stimulation versus botulinum toxin injection in chronic migraine prophylaxis: a pilot randomized trial EUS-Guided Intragastric Injection of Botulinum Toxin A in the Preoperative Treatment of Super-Obese Patients: a Randomized Clinical Trial A Comparison of Botulinum Toxin A and Intralesional Steroids for the Treatment of Plantar Fasciitis Botulinum Toxin Type A in Prophylactic Treatment of Migraine The Role of Kinesiotaping Combined With Botulinum Toxin to Reduce Plantar Flexors Spasticity After Stroke A pilot study of botulinum toxin A for male chronic pelvic pain syndrome Safety and Efficacy of Botulinum Toxin A in Children Undergoing Lower Limb Lengthening and Deformity Correction: Results of a Double-blind, Multicenter, Randomized Controlled Trial Functional outcomes of intramuscular botulinum toxin type a and occupational therapy in the upper limbs of children with cerebral palsy: a randomized controlled trial.
Aim : To investigate the efficacy , safety and tolerability of intradermal and /or submucosal administration of botulinum toxin type A ( BTX-A ) for patients with trigeminal neuralgia ( TN ) . Methods : In this r and omized , double-blind , placebo-controlled study , 42 TN patients were r and omly allocated into two groups , namely , intradermal and /or submucosal injection of BTX-A ( 75 U/1.5 mL ; n = 22 ) or saline ( 1.5 mL ; n = 20 ) in the skin and /or mucosa where pain was experienced . The primary endpoints were pain severity ( assessed by the visual analogue scale ) and pain attack frequency per day . The secondary endpoint was the patient ’s overall response to treatment , assessed using the Patient Global Impression of Change scale . Patients with ≥ 50 % reduction in mean pain score at week 12 were defined as responders . Results : A total of 40 patients completed the study .  BTX-A significantly reduced pain intensity at week 2 and pain attack frequency at week 1 . The efficacy was maintained throughout the course of the study . More BTX-A treated patients reported that pain had improved by the end of the study . Significantly more responders were present in the BTX-A group ( 68.18 % ) than in the placebo group ( 15.00 % ) . BTX-A was well tolerated , with few treatment-related adverse events . Conclusions : BTX-A may be an efficient , safe and novel strategy for TN treatment Background Botulinum toxin type A ( BTX-A ) has been reported to have analgesic effects independent of its action on muscle tone , mostly by acting on neurogenic inflammatory mediators and controlling the neurotransmitter release of sensory and autonomic nerve terminals that are involved in many chronic painful conditions as chronic intractable trigeminal neuralgia (TN).The aim of our work was evaluating the efficacy , safety , and tolerability of BTX-A for the treatment of intractable idiopathic TN . Methods This was a r and omized , single-blinded , placebo-control study carried out on 20 Egyptian patients with intractable TN . Patients received a one-time subcutaneous administration of BTX-A using “ follow the pain ” method . The primary efficacy measure was reduction in pain severity on the 10-cm VAS score as well as in paroxysms frequency from the baseline to week 12 ( endpoint last observation carried forward [ LOCF ] ) . Secondary efficacy measures included QoL assessment and number of acute medications received from baseline to the endpoint . Results Pain reduction at the 12-week endpoint was significant in BTX-A group ( p<0.0001 ) ; VAS scores at endpoint LOCF relative to baseline for BTX-A group showed a decrease of 6.5 compared with a decrease of 0.3 for placebo , also there was a significant decrease in the number of acute medications and an increase in QoL functioning scale . Conclusion These results indicate that BTX-A has a direct analgesic effect in patients with TN and can represent a therapeutic option for intractable cases Objectives : Cumulative evidence support a beneficial effect of botulinum toxin A ( BTX-A ) in postherpetic neuralgia ( PHN ) . We aim ed to assess efficacy , safety , and tolerability of BTX-A in the management of PHN , performing a r and omized , double-blind , single-dose , placebo-controlled trial . Methods : Thirty adults with PHN were r and omized either to BTX-A or placebo .  Severity of pain was evaluated by patients using a visual analogue scale ( VAS ) and quality of sleep was assessed using a 5-item question naire . Primary outcome was reduction in VAS score , with a greater than 50 % reduction being considered clinical ly significant . Secondary outcomes were reduction in sleep score and maintenance of VAS score after treatment , with over 50 % maintenance considered clinical ly meaningful . Results : Thirteen patients from the experimental arm achieved an at least 50 % reduction in VAS score , compared with none of the placebo patients ( NNT=1.2 , 95 % CI , 2 - 1 ; ARR=0.87 , 95 % CI , 055 - 096 ; P<0.001 ) . BTX-A patients showed significant reduction in VAS pain scores between baseline and week 2 , which persisted for a median period of 16 weeks . BTX-A patients showed significant reduction in sleep scores between baseline and week 2 , which remained unchanged until 16th week ( P<0.001 ) . Treatment was well tolerated . Discussion : Data confirm that BTX-A is effective and well tolerated in the treatment of PHN OBJECTIVE To determine the efficacy of occipital nerve blocks using reconstituted botulinum toxin type-A ( BTX-A ) in providing significant and prolonged pain relief in chronic occipital neuralgia . BACKGROUND Occipital neuralgia is a unilateral or bilateral radiating pain with paresthesias commonly manifesting as paroxysmal episodes and involving the occipital and parietal regions . Common causes of occipital neuralgia include irritation or injury to the divisions of the occipital nerve , myofascial spasm , and focal entrapment of the occipital nerve . Treatment options include medication therapy , occipital nerve blocks , and surgical techniques . BTX-A , which has shown promise in relief of other headache types , may prove a viable therapeutic option for occipital neuralgia pain . METHODS Botulinum toxin type-A ( reconstituted in 3 cc of saline ) was injected into regions traversed by the greater and lesser occipital nerve in 6 subjects diagnosed with occipital neuralgia . Subjects were instructed to report their daily pain level ( on a visual analog pain scale ) , their ability to perform daily activities ( on several quality of life instruments ) and their daily pain medication usage ( based on a self-reported log ) , 2 weeks prior to the injection therapy and 12 weeks following injection therapy . Data were analyzed for significant variation from baseline values . RESULTS The dull/aching and pin/needles types of pain reported by the subjects did not show a statistically significant improvement during the trial period . The sharp/shooting type of pain , however , showed improvement during most of the trial period except weeks 3 - 4 and 5 - 6 . The quality of life measures exhibited some improvement . The headache-specific quality of life measure showed significant improvement by 6 weeks which continued through week 12 . The general health- and depression-related measures showed no statistical improvement . No significant reduction in pain medication usage was demonstrated . CONCLUSIONS Our results indicate that BTX-A improved the sharp/shooting type of pain most commonly known to be associated with occipital neuralgia . Additionally , the quality of life measures assessing burden and long-term impact of the headaches , further corroborated improvement seen in daily head pain OBJECTIVE To assess the benefits of subcutaneous injection of botulinum toxin A ( BTX-A ) for the treatment of postherpetic neuralgia ( PHN ) . DESIGN We investigated the therapeutic benefits of BTX-A in subjects with PHN in a r and omized , double-blind , placebo-controlled study . Sixty subjects with PHN were r and omly and evenly distributed into BTX-A , lidocaine , and placebo groups . MEASURES After r and omization , one of the following solutions was injected subcutaneously in the affected dermatome : 5u/mL BTX-A , 0.5 % lidocaine , or 0.9 % saline ( placebo ) .  Visual analog scale ( VAS ) pain and sleeping time ( hours ) were evaluated at the time of pretreatment , day 1 , day 7 , and 3 months posttreatment . Opioid usage was calculated at day 7 and 3 months posttreatment . RESULTS Compared with pretreatment , VAS pain scores decreased at day 7 and 3 months posttreatment in all three groups ( P<0.01 ) . However , the VAS pain scores of the BTX-A group decreased more significantly compared with lidocaine and placebo groups at day 7 and 3 months posttreatment ( P<0.01 ) . Sleep time ( hours ) had improved at day 7 and at 3 months compared with pretreatment in all three groups , but the BTX-A group improved more significantly compared with lidocaine and placebo groups ( P<0.01 ) . The percent of subjects using opioids posttreatment in the BTX-A group was the lowest ( 21.1 % ) compared with the lidocaine ( 52.6 % ) and placebo ( 66.7 % ) groups ( P<0.01 ) . CONCLUSIONS Subcutaneous administration of BTX-A significantly decreased pain in PHN and reduced opioid use compared with lidocaine and placebo at day 7 and 3 months post-treatment . It also increased subjects ' sleep times Background In the majority of cases , trigeminal neuralgia ( TN ) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve . Although prophylactic pharmacological treatment is first choise , considering of insufficient effect or unacceptable side effects , neurosurgical treatment or lesion treatment should be considered . In addition to all these procedures mentioned above , one approach has been based on local intradermal and /or submucosal injections of Botulinum Toxin Type A ( BTX-A ) . Methods We conducted a r and omized , double-blind , placebo-controlled since November 2012 , and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A. Eighty four patients were r and omized into following groups : placebo ( n = 28 ) ; BTX-A 25U  ( n = 27 ) ; BTX-A 75U ( n = 29 ) . Follow-up visits were conducted every week after the injection , and the overall duration of the study for each patient were 8 weeks to observe the pain severity , efficacy and adverse reactions at endpoint . Results The visual analogue scale ( VAS ) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1 , and sustained until week 8 throughout the study . There was no significant difference in VAS between 25U and 75U groups throughout the study . The response rates of 25U group ( 70.4 % ) and 75U group ( 86.2 % ) were significantly higher than placebo group ( 32.1 % ) at week 8 , and there was no significant difference between 25U and 75U groups . Evaluation of the Patient Global Impression of Change ( PGIC ) demonstrated that 66.7 % ( 25U group ) and 75.9 % ( 75U group ) of the patients reported that their pain symptoms were ‘ much improved ’ or ‘ very much improved ’ versus 32.1 % of the placebo group , and there was also no significant difference between 25U and 75U groups . All adverse reactions were grade d as mild or moderate . Conclusions BTX-A injection in TN is safe and efficient . It is a useful treatment for refractory TN . Lower dose ( 25U ) and high dose ( 75U ) were similar in efficacy in short-term Abstract A double-blind , r and omized , placebo-controlled study of patients with essential trigeminal neuralgia and treatment with a single injection of onabotulinum toxin A ( BTX )  was carried out . The efficacy , safety , and tolerability of either 1 mL 0.9 % saline plus 50 U of BTX or only 1 mL of 0.9 % saline injected subcutaneously in the affected area were evaluated . Cases with involvement of the third branch of the trigeminal nerve also received intramuscularly either 10 U of BTX or matching placebo in the masseter muscle , ipsilateral to the pain location . Pain was assessed with the visual analog scale ( VAS ) . Twenty subjects were administered BTX , and 16 subjects received placebo .  Two months after the intervention , a trend to statistical significance was observed for the VAS mean values in subjects treated with BTX and those who received placebo ( VAS 4.9 vs 6.63 , t test , P = 0.07 ) . Three months after the injection , significant differences were observed in the average VAS score for subjects treated with BTX and those treated with placebo ( VAS 4.75 vs 6.94 , respectively ; t test , P = 0.01 ) . Onabotulinum toxin A was well tolerated and seems to be a safe and useful therapy for patients with essential trigeminal neuralgia Cervical dystonia ( CD ) is characterized by abnormal , involuntary contractions of the cervical and /or shoulder muscles . Direct injection of Botulinum toxin type A ( BTX-A ) into the affected muscles has been used successfully to treat this condition . However , clinical resistance to BTX-A therapy develops in a limited number of patients . Moreover , an unknown proportion of treated patients have a suboptimal response to their present therapy . BTX-B is antigenically distinct from BTX-A and possesses a different mechanism of action . Three r and omized , double-blind , placebo-controlled clinical trials evaluated the safety and efficacy of BTX-B ( Elan 's BTX-B evaluated as NeuroBloc ) as a treatment for patients with CD . Patients received a single dose of BTX-B ranging from 2,500 to 10,000 U. The primary efficacy evaluation for each of these studies used the Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) total score . Additional efficacy measures included the TWSTRS severity , disability , and pain subscale scores , as well as the Patient Analog Pain Assessment and Patient 's and Physician 's Global Assessment s of Change . In all three studies , groups receiving BTX-B displayed statistically significant improvements in TWSTRS total score and other efficacy end points compared with those who received placebo treatment . The clinical benefits after BTX-B treatment lasted 12 to 16 weeks and were observed in both BTX-A-responsive and BTX-A-resistant patients . In general , treatment with BTX-B was well tolerated and most of the reported adverse events were of short duration , mild to moderate in severity , and anticipated . The results from the three controlled clinical trials demonstrate the safety and efficacy of BTX-B in the treatment of patients with CD , including those who are resistant to BTX-A treatment In this multicenter study of 100 patients with cervical dystonia , we examined the immunogenicity of botulinum toxin type B ( BTX-B ) and correlated the clinical response with the presence of blocking antibodies ( Abs ) using a novel mouse protection assay . One-third of the patients who were negative for BTX-B Abs at baseline became positive for BTX-B Abs at last visit . Thus , the high antigenicity of BTX-B limits its long-term efficacy & NA ; Evidence of an effect by botulinum toxins is still lacking for most pain conditions . In the present r and omized , placebo‐controlled , crossover multicenter study , the efficacy of botulinum toxin type A ( BTX‐A ) was investigated in patients with persistent myofascial temporom and ibular disorders ( TMD ) . Twenty‐one patients with myofascial TMD without adequate pain relief after conventional treatment participated . A total of 50 U of BTX‐A or isotonic saline ( control ) was r and omly injected into 3 st and ardized sites of the painful masseter muscles . Follow‐up was performed after 1 and 3 months , followed by a 1‐month washout period , after which crossover occurred . Pain intensity at rest was the primary outcome measure , while physical and emotional function , global improvement , side effects , and clinical measures were additional outcome measures . There was no main difference between drugs ( ANOVA ; P = .163 ) , but there was a significant time effect ( P < .001 ) , so BTX‐A reduced mean ( SD ) percent change of pain intensity by 30 ( 33 % ) after 1 month and by 23 ( 30 % ) after 3 months compared to 11 ( 40 % ) and 4 ( 33 % ) for saline . The number of patients who received a 30 % pain reduction was not significantly larger for BTX‐A than after saline at any follow‐up visit . The number needed to treat was 11 after 1 month and 7 after 3 months . There were no significant changes after treatment in any other outcome measures , with the exception of pain on palpation , which decreased 3 months after saline injection ( P < .05 ) . These results do not indicate a clinical relevant effect of BTX‐A in patients with persistent myofascial TMD pain . Botulinum toxin type A is not an effective adjunct to conventional treatment in persistent myofascial temporom and ibular disorders We used single fiber electromyography ( SFEMG ) to study 42 patients who had enrolled in a double-blind , placebo-controlled trial undertaken to assess the efficacy of botulinum toxin ( BTX ) injection of neck muscles to treat torticollis . SFEMG in a limb muscle was performed before treatment , 2 , and 12 weeks after injection of placebo or BTX . Before treatment , the mean jitter was 26.8 microsec in patients who were to receive BTX , and 25.7 microsec in the placebo group . Two weeks after injection , mean jitter in the group receiving BTX was 43.6 microsec . In the placebo group , it was 26.5 microsec ( P = less than .05 ) . Twelve weeks after injection , mean jitter in the BTX group was 35.5 ; for the placebo group it was 24.5 . Fiber density did not change in any patient during the study . There were no remote clinical effects of BTX . Injection of BTX into muscles affected with focal dystonia is a promising and safe treatment , but there are sub clinical effects on uninjected muscles Rameckers EAA , Speth LAWM , Duysens J , Vles JSH , Smits-Engelsman BCM : Kinematic aim ing task : measuring functional changes in h and and arm movements after botulinum toxin-a injections in children with spastic hemiplegia . Am J Phys Med Rehabil 2007;86:538–547 . Objective : To describe different aspects of a kinematic aim ing task ( KAT ) as a quantitative way to assess changes in arm movements within 2 wks after botulinum toxin-A ( BTX-A ) injections in children with spastic hemiplegia . Design : Intervention study r and omized clinical trial ; follow-up within 4 wks after baseline measurement . Results : The KAT gave a high intraclass correlation on movement time , spread of end points ( END ) , and index of performance effective ( IP-E ) . After BTX-A , a significant increase of END and IP-E was shown if precision dem and in the KAT was high , whereas the inverse occurred when speed was more important . These functional changes coincided with a significant decrease of the maximum voluntary contraction of the flexor muscles of the forearm . Muscle tone measured with the Ashworth scale did show a nonsignificant decrease of muscle tone , as did the stretch restricted angle and the active and passive ranges of motion of the elbow and wrist . Conclusions : Muscle force decreased immediately after BTX-A , showing the direct effect of BTX-A. The KAT is an adequate , reproducible way to quantify functional changes after BTX-A in the upper limb . BTX-A has an inverse effect in the precision task when accuracy is important , and it has a positive effect when speed prevails Abstract The present investigation is a preliminary double-blind , controlled placebo , r and omized clinical trial with a six month follow-up period . The study aim ed to assess the efficacy of type A botulinum toxin ( Botox , Allergan , Inc. Irvine , CA ) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers . Twenty patients ( ten males , ten females ; age range 25 - 45 ) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind , controlled placebo , r and omized clinical trial , with a treatment group ( ten subjects treated with botulinum toxin injections- BTX-A ) and a control group ( ten subjects treated with saline placebo injections ) . A number of objective and subjective clinical parameters ( pain at rest and during chewing ; mastication efficiency ; maximum nonassisted and assisted mouth opening , protrusive and laterotrusive movements ; functional limitation during usual jaw movements ; subjective efficacy of the treatment ; tolerance of the treatment ) were assessed at baseline time and at one week , one month , and six months follow-up appointments . Descriptive analysis showed that improvements in both objective ( range of m and ibular movements ) and subjective ( pain at rest ; pain during chewing ) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects . Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects . Differences were not significant in some cases due to the small sample size . Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers , and provided pilot data which need to be confirmed by further research using larger sample The purpose of this study was to compare the cumulative efficacy ( three treatment sessions ) of botulinum toxin A ( BTX-A ) alone , casting alone , and the combination of BTX-A and casting in the management of dynamic equinus in ambulatory children with spastic cerebral palsy ( CP ) . Thirty-nine children with spastic CP ( mean age 5y 10mo , range 3 to 9y ) were enrolled in the study . A multicenter , r and omized , double blind , placebo-controlled prospect i ve study was used . Children were r and omly assigned to one of three treatment groups : BTX-A only ( B ) , placebo injection plus casting ( C ) , or BTX-A plus casting ( B+C ) . The dosage for the BTX-A injections was 4U/kg per extremity . Assessment s were performed at baseline , 3 , 6 , 7.5 , and 12 months with a total of three treatments administered after the evaluations at baseline , 3 , and 6 months . Primary outcome measures were ankle kinematics , velocity , and stride length . Secondary outcome measures were ankle spasticity , strength , range of motion , and ankle kinetics . Group B made no significant change in any variable at any time . Groups C and B+C demonstrated significant improvements in ankle kinematics , spasticity , passive range of motion , and dorsiflexor strength . Results of this 1-year study indicate that BTX-A alone provided no improvement in the parameters measured in this study , while casting and BTX-A/casting were effective in the short- and long-term management of dynamic equinus in children with spastic CP PURPOSE We determined the safety and efficacy of each of 2 doses of botulinum toxin type A ( BTX-A ) ( 200 or 300 U BOTOX ) injected into the detrusor for urinary incontinence caused by neurogenic detrusor overactivity of predominantly spinal cord origin . MATERIAL S AND METHODS A total of 59 patients with urinary incontinence caused by neurogenic detrusor overactivity ( due to spinal cord injury in 53 and multiple sclerosis in 6 ) requiring clean intermittent self-catheterization were r and omized to receive a single dose into the detrusor of BTX-A ( 200 U or 300 U ) or placebo . Changes in daily frequency of urinary incontinence episodes were monitored via a patient bladder diary during 24 weeks . Key urodynamic assessment s ( maximum cystometric capacity , reflex detrusor volume and maximum detrusor pressure during bladder contraction ) were used to provide objective measures of the treatment effect on bladder function . The impact of treatment on quality of life was assessed using the Incontinence Quality of Life question naire . RESULTS There were significant posttreatment decreases in incontinence episodes from baseline in the 2 BTX-A groups ( p < /=0.05 ) but not in the placebo group . In addition , more patients who received BTX-A reported no incontinence episodes during at least 1 posttreatment evaluation period . Positive treatment effects were also reflected by significant improvements in bladder function in the BTX-A groups , as assessed by urodynamics and in patient quality of life . Benefits were observed from the first evaluation at week 2 to the end of the 24-week study . No safety concerns were raised . CONCLUSIONS Intramuscular injections of BTX-A into the detrusor can provide rapid , well tolerated , clinical ly significant decreases in the signs and symptoms of urinary incontinence caused by neurogenic detrusor overactivity during a 24-week study period Background Chronic migraine is a prevalent disabling disease , with major health-related burden and poor quality of life . Long-term use of preventive medications carries risk of side effects . Objectives The aim of this study was to compare repetitive transcranial magnetic stimulation ( rTMS ) to botulinum toxin-A ( BTX-A ) injection as preventive therapies for chronic migraine . Methods A pilot , r and omized study was conducted on a small-scale sample of 29 Egyptian patients with chronic migraine , recruited from Kasr Al-Aini teaching hospital outpatient clinic and diagnosed according to ICHD-III ( beta version ) . Patients were r and omly assigned into two groups ; 15 patients received BTX-A injection following the Phase III Research Evaluating Migraine Prophylaxis Therapy injection paradigm and 14 patients were subjected to 12 rTMS sessions delivered at high frequency ( 10 Hz ) over the left motor cortex ( MC , M1 ) . All the patients were requested to have their 1-month headache calendar , and they were subjected to a baseline 25-item ( beta version ) Henry Ford Hospital Headache Disability Inventory ( HDI ) , Headache Impact Test ( HIT-6 ) , and visual analogue scale assessment of headache intensity . The primary efficacy measures were headache frequency and severity ; secondary measures were 25-item HDI , HIT-6 , and number of acute medications . Follow-up visits were scheduled at weeks 4 , 6 , 8 , 10 , and 12 after baseline visit . Results A reduction in all outcome measures was achieved in both the groups . However , this improvement was more sustained in the BTX-A group , and both the therapies were well tolerated . Conclusion BTX-A injection and rTMS have favorable efficacy and safety profiles in chronic migraineurs . rTMS is of comparable efficacy to BTX-A injection in chronic migraine therapy , but with less sustained effect Background Obesity is a disease that is highly prevalent in Brazil , and the associated comorbidities represent a major global public health challenge . Botulinum toxin type A ( BTX-A ) is a potent neurotoxin and inhibitor of gastric smooth muscle activity . In theory , BTX-A administration should promote early satiety and weight loss because it delays gastric emptying by inhibiting acetylcholine-mediated peristalsis , which is primarily responsible for gastric motility . Because results in the literature are discrepant , the efficacy of intragastric injections of BTX-A as a primary treatment for obesity remains unknown . The objective of this prospect i ve , double-blind , single-center r and omized study was to evaluate the effects of endoscopic ultrasound-guided intragastric BTX-A injections , as a bridge to bariatric surgery , in super-obese patients . Methods Thirty-two super-obese patients were r and omized to one of two groups : BTX-A , in which 200 units of BTX-A were injected into the gastric antrum and body ; and control , in which the same injections were performed with 0.9 % saline .  Weight , body mass index ( BMI ) , and loss of excess weight were measured monthly over a 6-month period . Gastric emptying scintigraphy was performed before and after the procedure . Results The patients in both groups showed significant weight loss over the course of the study ( p < 0.001 ) . There were no statistically significant differences between the groups regarding weight loss , excess weight , total loss of excess weight , total weight loss , or change in BMI . Conclusions Intragastric injection of BTX-A does not appear to be an effective method of achieving preoperative weight loss in super-obese patients Background : The objective of this study was to compare intramuscularly applied botulinum toxin A ( BTX-A ) in the gastroc-soleus complex with intralesional steroids for the treatment of plantar fasciitis . Methods : The patients were r and omly divided into 2 groups according to the treatment received . The patients were evaluated over 6 months . The evaluation scores included the Visual Analog Scale ( VAS ) , Maryl and Foot and Ankle , Foot and Ankle Disability Index ( FADI ) , and American Orthopaedic Foot and Ankle Society ( AOFAS ) score . Moreover , patients were instructed to perform plantar fascia stretching exercises over the course of the study . The final number of patients was 36 , of whom 19 received BTX-A ( 10 men and 9 women ) and 17 ( 6 men and 11 women ) received steroids .  Results : When compared to patients who received steroids , the patients who received BTX-A exhibited more rapid and sustained improvement over the duration of the study . Conclusion : A combination of BTX-A and plantar fascia stretching exercises yielded better results for the treatment of plantar fasciitis than intralesional steroids . Level of Evidence : Level I , therapeutic studies Current migraine preventive therapies are often unsatisfactory because of their limited efficacy , adverse effects , and drug interactions . An open-label , noncontrolled study of botulinum toxin type A ( BTX-A ) suggested some benefits for patients with migraine . To assess the efficacy and safety of BTX-A , a r and omized , double-blind , vehicle-controlled , parallel group study was conducted in 32 patients with a history of 2 to 8 migraine attacks per month , with or without aura . The patients were r and omized to receive single administrations of 50-U BTX-A or vehicle injected into multiple sites of pericranial muscles at the same visit . Patients kept daily diaries in which they recorded outcome measures like migraine frequency , migraine severity , and the occurrence of migraine-associated symptoms . Patients grade d symptoms on a 4-point scale ranging from grade s 0 to 3 before and up to 3-months after treatment . The assessment s were made at 0 , 1 , and 3 months . The primary efficacy parameters included number of headaches resolved ( grade 3/2 to grade 0 ) and alleviation of other accompanying symptoms of migraine . The supplementary end point included improvement in quality of life ( QOL ) . About 75 % of patients reported complete relief to mild headache ( grade 0–1 ) by BTX-A and none by placebo group . Patient ' QOL parameters like energy/vitality and feelings and concerns about the treatment had shown considerable improvement . However , normal day-to-day work functioning and social interactions deteriorated . No adverse effects were reported in any of the patients in either of the groups during the study . It is evident from the study that pericranial injection of 50-U BTX-A showed good efficacy and tolerability as a prophylactic agent . However , this therapy will be expensive to the patients , but it is far superior in providing relief to the patients compared with existing therapies Abstract Purpose : To evaluate the effect of kinesiotaping as an adjuvant therapy to botulinum toxin A ( BTX-A ) injection in lower extremity spasticity . Methods : This is a single-center , r and omized , and double-blind study . Twenty hemiplegic patients with spastic equinus foot were enrolled into the study and r and omized into 2 groups . The first group ( n=10 ) received BTX-A injection and kinesiotaping , and the second group ( n=10 ) received BTX-A injection and sham-taping . Clinical assessment was done before injection and at 2 weeks and 1 , 3 , and 6 months . Outcome measures were modified Ashworth scale ( MAS ) , passive ankle dorsiflexion , gait velocity , and step length . Results : Improvement was recorded in both kinesiotaping and sham groups for all outcome variables . No significant difference was found between groups other than passive range of motion ( ROM ) , which was found to have increased more in the kinesiotaping group at 2 weeks . Conclusion : There is no clear benefit in adjuvant kinesiotaping application with botulinum toxin for correction of spastic equinus in stroke Abstract Objective . Male chronic pelvic pain syndrome ( CPPS ) has been the subject of numerous clinical trials , but so far , no uniformly effective treatment has been identified . A commonly reported tender spot in men with CPPS is the bulbospongiosus muscle . A r and omized placebo controlled pilot trial of botulinum toxin A ( BTX-A ) injection into the perineal skeletal musculature for the treatment CPPS was conducted . Material and methods . Twenty-nine men with CPPS were identified from a urology clinic . Symptom evaluation was performed using a Global Response Assessment ( GRA ) and the Chronic Prostatitis Symptom Index ( CPSI ) .  All subjects were r and omized to receive either BTX-A 100 U or normal saline injected into the perineal body and bulbospongiosus muscle . Results . BTX-A  injection was administered in 13 men . At the 1 month follow-up there was a 30 % response rate for BTX-A treatment compared with 13 % for placebo ( p = 0.0002 ) , based on GRA results . Total CPSI score did not reach significance in the BTX-A-treated group , compared with controls . The CPSI pain subdomain score reached statistical significance in the BTX-A patients compared with controls ( p = 0.05 ) . The injections were well tolerated . There were no complications from the injections and no patients reported side-effects . Conclusions . BTX-A injection into the perineal body and bulbospongiosus muscle results in a modest response rate on the GRA compared with placebo for overall symptoms associated with CPPS . The treatment is well tolerated and safe . BTX-A use may enhance polytherapeutic pain management Background : Lengthening of the lower limb is a complex procedure in which pain management and complications such as pin-site infections and muscle contractures impact the family and affect the child ’s quality of life . As a result , the paralytic and antinociceptive actions of neurotoxins may be indicated in managing these complications ; however , few studies have explored ways to improve outcomes after lengthenings . The objective of this study was to evaluate the safety and efficacy of botulinum toxin A ( BTX-A ) in children undergoing lower limb lengthenings and deformity correction . Methods : Participants with a congenital or acquired deformity of the lower extremity requiring surgery to one limb were r and omized to receiving either BTX-A as a single dose of 10 units per kilogram body weight , or an equivalent volume of saline solution .  Pain , medication , quality of life , and physical function were assessed at different time-points . Adverse events were recorded in all participants . T test and & khgr;2 tests were used to compare potential differences across both groups . Results : Mean age of the 125 participants was 12.5 years ( range , 5 to 21 y ) , and lengthenings averaged 4.2 cm . Maximum pain scores on day 1 postoperatively were lower in the BTX-A group ( P=0.03 ) than in the placebo group , and remained significant favoring botox when stratifying by location of lengthening ( femur vs. tibia ) . Clinical benefits for BTX-A were found for 3 quality of life domains at mid-distraction and end-distraction . When stratifying according to location of lengthening , there were significantly fewer pin-site infections in the tibia favoring botox ( P=0.03 ) . The amount of adverse events and bone healing indices were no different in both groups . Conclusions : The clinical differences in quality of life , the lower pain on the first postoperative day , and the lower number of pin-site infections in the tibia favoring BTX-A support its use as an adjunctive treatment to the lengthening process . The detailed analyses of pain patterns help inform families on the pain expectations during lower limb lengthenings . The amount of adverse events were no different in both groups , and bone healing rates were similar , indicating that the use of BTX-A in children undergoing limb lengthening and deformity correction is safe . Level of Evidence : Level OBJECTIVE To investigate the functional outcomes of botulinum toxin type A ( BTX-A ) injections to the upper limb in combination with occupational therapy ( OT ) in children with cerebral palsy ( CP ) . DESIGN R and omized controlled trial with follow-up at 2 weeks , 3 months , and 6 months . SETTING Specialist outpatient physical disabilities clinic within a public pediatric teaching hospital . PARTICIPANTS Eighty children with spastic quadriplegic , triplegic , or hemiplegic CP from these clinics were r and omly assigned to BTX-A plus OT , BTX-A alone , OT alone , or a no-treatment control group . INTERVENTIONS Single set of BTX-A ( Botox ) injections and 12 weeks of OT . MAIN OUTCOME MEASURES Canadian Occupational Performance Measure ( COPM ) and Goal Attainment Scale ( GAS ) . RESULTS The combination of BTX-A and OT result ed in accelerated attainment of functional goals measured by the COPM and GAS . There were no differences between groups on the Melbourne Assessment of Unilateral Upper Limb Function , Quality of Upper Extremity Skills Test , Pediatric Evaluation of Disability Inventory , Child Health Question naire , or active and passive range of motion . As expected , there was a significant reduction in muscle tone at follow-up 2 weeks after injection , which returned to baseline level by 6 months . CONCLUSIONS OT enhanced individualized functional outcomes following BTX-A injections in the upper limbs of children with CP
Conclusion Based on the current evidence , BTX-A may be an effective and safe option for the treatment of neuralgia .
Aim This meta- analysis was performed to evaluate the efficacy and safety of botulinum toxin-A ( BTX-A ) for the treatment of neuralgia .