A randomized controlled study of botulinum toxin A in the treatment of hemiplegic shoulder pain associated with spasticity. Intramuscular botulinum toxin-A reduces hemiplegic shoulder pain: a randomized, double-blind, comparative study versus intraarticular triamcinolone acetonide. Shoulder pain and external rotation in spastic hemiplegia do not improve by injection of botulinum toxin A into the subscapular muscle. Treatment of shoulder pain in spastic hemiplegia by reducing spasticity of the subscapular muscle: a randomised, double blind, placebo controlled study of botulinum toxin A. Intra-articular botulinum toxin A for refractory shoulder pain: a randomized, double-blinded, placebo-controlled trial. Efficacy and safety of a single botulinum type A toxin complex treatment (Dysport) for the relief of upper back myofascial pain syndrome: results from a randomized double-blind placebo-controlled multicentre study. Is botulinum toxin type A effective in the treatment of spastic shoulder pain in patients after stroke? A double-blind randomized clinical trial. Botulinum toxin A in the hemiplegic upper limb: a double-blind trial. A randomized controlled trial of strapping to prevent post-stroke shoulder pain.
To assess the effects of botulinum toxin A (BT-A) on hemiplegic shoulder pain associated with spasticity.
                Randomized, double-blind, placebo-controlled study.
                Outpatient clinic of a rehabilitation department.
                Patients, more than three months post stroke, with hemiplegic shoulder pain associated with shoulder adductor and elbow flexor spasticity, randomly assigned to BT-A or placebo.
                One-time injection of BT-A (500 units) into the pectoralis major and biceps brachii on the hemiplegic side.
                Visual analogue scale of shoulder pain (0 -10), shoulder adductor and elbow flexor tone using the Ashworth Scale and passive range of shoulder abduction. These were assessed at baseline, four weeks, eight weeks and 12 weeks post injection.
                Seventeen patients were enrolled, eight in the BT-A group and nine in the placebo group. At baseline, the median visual analogue scale score for shoulder pain was 6, the median Ashworth Scale shoulder adductor and elbow flexor spasticity score was 2 and the median range of shoulder abduction 76 degrees. Subjects who received BT-A showed significantly greater improvements in median shoulder adductor and elbow flexor Ashworth Scale scores than placebo at week 4 (P B / 0.01) but not at week 8 and 12. For shoulder pain and passive shoulder abduction range, all subjects showed postinjection improvements and no difference could be demonstrated between the two groups.
                Possible reasons for the negative finding in this study include the small sample size and the presence of causes of shoulder pain not related to spasticity which could have confounded outcome. Shoulder pain is frequent after stroke and interferes with the rehabilitative process and outcome. However, treatments used for hemiplegic shoulder pain are limited and largely ineffective. This prospective, randomized, double-blind controlled study was conducted to compare the efficacies of botulinum toxin type A (BoNT-A) and triamcinolone acetonide (TA) on hemiplegic shoulder pain and their effects on arm function in patients with stroke.
                Twenty-nine hemiplegic stroke patients with shoulder pain (duration <or=24 months, pain on numeric rating scale >or=6/10) were randomized into 2 groups. One group received intramuscular injections of BoNT-A (BOTOX 100 U total) during one session to the infraspinatus, pectoralis and subscapularis muscles in conjunction with an intraarticular injection of normal saline to painful shoulder joint, whereas the other group received an intraarticular injection of TA (40 mg) and an intramuscular injection of normal saline to the same muscles. Outcome measures were pain (measured using a numeric rating scale), physician's global rating scale, shoulder range of motion (ROM) in 4 directions, arm function measured using Fugl-Meyer score, and spasticity measured using the modified Ashworth scale. Measurements were made at baseline and 2, 6, and 12 weeks after injection.
                At 12 weeks after treatment mean decrease in pain was 4.2 in the BoNT-A-treated group versus 2.5 in the TA-treated group (P=0.051), and improvements in overall ROM were 82.9 degrees versus 51.8 degrees in these groups (P=0.059), showing a strong trend toward there being less pain and better ROM among those treated with BoNT-A than with TA. However, no significant differences were observed between the 2 groups in terms of improvement in physician global rating, Fugl-Meyer score or modified Ashworth scales. No adverse effect was observed in either group.
                Results from this study suggest that injection of BoNT-A into selected muscles of the shoulder girdle might provide more pain relief and ROM improvement than intraarticular steroid in patients with hemiplegic shoulder pain. A larger clinical trial needs to be undertaken to confirm the benefits of this approach. To study the effect of botulinum toxin A in the subscapular muscle on shoulder pain and humerus external rotation.
                22 stroke patients with spastic hemiplegia, substantial shoulder pain and reduced external rotation of the humerus participated in a randomised, double blind, placebo controlled effect study. Injections of either botulinum toxin A (Botox, 2x50 units) or placebo were applied to the subscapular muscle at two locations. Pain was scored on a 100 mm vertical Visual Analogue Scale; external rotation was recorded by means of electronic goniometry. Assessments were carried out at 0 (baseline), 6 and 12 weeks.
                21 patients completed the study. We observed no significant changes in pain or external rotation as a result of administration of botulinum toxin A. External rotation improved significantly (p = 0.001) for both the treatment group (20.4 degrees (16.6) to 32.1 degrees (14.0)) and the control group (10.3 degrees (19.5) to 23.7 degrees (20.7)) as a function of time.
                Application of botulinum toxin A into the subscapular muscle for reduction of shoulder pain and improvement of humeral external rotation in spastic hemiplegia does not appear to be clinically efficacious. This randomised, double blind, placebo controlled, two parallel group study was conducted to assess the beneficial effect of injection of botulinum toxin A (Dysport) into the subscapularis muscle on shoulder pain in stroke patients with spastic hemiplegia.
                A single dose of botulinum toxin A (500 Speywood units) or placebo was injected into the subcapularis muscle. Pain was assessed using a 10 point verbal scale. Subscapularis spasticity was assessed by the change in passive shoulder lateral rotation and abduction. Upper limb spasticity was assessed using the Modified Ashworth Scale for shoulder medial rotators, and elbow, wrist and finger flexors. Assessments were carried out at baseline and at weeks 1, 2 and 4.
                Twenty patients (10 patients per group), 11 with ischaemic stroke and 9 with haemorrhagic stroke, completed the study. Pain improvement with botulinum toxin A was observed from week 1; score difference from baseline at week 4 was 4 points versus 1 point with placebo (p = 0.025). Lateral rotation was also improved, with a statistically significant difference compared with placebo at week 2 (p = 0.05) and week 4 (p = 0.018). A general improvement in upper limb spasticity was observed; it was significant for finger flexors at week 4 (p = 0.025).
                Subscapularis injection of botulinum toxin A appears to be of value in the management of shoulder pain in spastic hemiplegic patients. The results confirm the role of spasticity in post-stroke shoulder pain. We compared the short-term efficacy and safety of intra-articular (IA) botulinum toxin A (BoNT/A) to IA-placebo in patients with chronic, refractory shoulder joint pain. Forty-three shoulder joints in patients with moderate-to-severe shoulder arthritis pain were randomized to receive (1) 100 units IA-BoNT/A + lidocaine or (2) IA-saline + lidocaine. The following outcomes were compared using analysis of covariance: (1) primary: change in pain severity on a visual analog scale at 1 month (VAS, 0 cm to 10 cm); (2) secondary: Shoulder Pain and Disability Index (SPADI) disability subscale, quality of life on short-form (SF)-36 subscales, percent of patients who achieved at least a 30% decrease or a 2-point reduction in VAS pain (clinically meaningful pain relief), and safety. Both BoNT/A (n = 21) and placebo (n = 22) groups were comparable at baseline. At 1 month post-injection, the VAS pain reduction was significantly more in the BoNT/A group versus the placebo group (-2.4 vs -0.8; P-value = 0.014). When comparing BoNT/A with the placebo group at 1 month, it was observed that 5 SF-36 subscale scores improved significantly (P </= 0.035), and the SPADI disability improved more with a trend toward significance (51.5 +/- 4.4 vs 64.9 +/- 3.9; P = 0.083). In addition, clinically meaningful pain relief occurred in 61% versus 36% patients (P = 0.22). The total number of adverse events was similar, which included 50 events in the BoNT/A group versus 46 events in the placebo group. A single injection of BoNT/A produced statistically significant and clinically meaningful pain relief and improvement in quality of life in patients with chronic refractory moderate/severe shoulder arthritis pain at 1 month. These data provide evidence to support the efficacy of this novel neurotoxin therapy that needs to be confirmed in a multicenter, randomized trial. Botulinum type A toxin (BoNT-A) has antinociceptive and muscle-relaxant properties and may help relieve the symptoms of myofascial pain syndrome. In this study we evaluated the efficacy and tolerability of BoNT-A (Dysport) in patients with myofascial pain syndrome of the upper back. We conducted a prospective, randomized, double-blind, placebo-controlled, 12-week, multicentre study. Patients with moderate-to-severe myofascial pain syndrome affecting cervical and/or shoulder muscles (10 trigger points, disease duration 6-24 months) were randomized to Dysport or saline. Injections were made into the 10 most tender trigger points (40 units per site). The primary outcome was the proportion of patients with mild or no pain at week 5. Secondary outcomes included changes in pain intensity and the number of pain-free days per week. Tolerability and safety were also assessed. At week 5, significantly more patients in the Dysport group reported mild or no pain (51%), compared with the patients in the placebo group (26%; p=0.002). Compared with placebo, Dysport resulted in a significantly greater change from baseline in pain intensity during weeks 5-8 (p<0.05), and significantly fewer days per week without pain between weeks 5 and 12 (p=0.036). Treatment was well tolerated, with most side effects resolving within 8 weeks. In conclusion, in patients with upper back myofascial pain syndrome, injections of 400 Ipsen units of Dysport at 10 individualised trigger points significantly improved pain levels 4-6 weeks after treatment. Injections were well tolerated. To determine the efficacy of botulinum toxin type A for the treatment of spastic shoulder pain in patients after stroke.
                Double-blind randomized clinical trial.
                Of 31 patients enrolled from an acute-care hospital in Spain, 2 cases dropped out (drop-out rate 6.5%). Fourteen subjects were treated with infiltration of 500 units of botulinum toxin type A in the pectoralis major muscle of the paretic side, and 15 with a placebo.
                After infiltration, both groups received transcutaneous electrical nerve stimulation for 6 weeks. Patients were assessed by the use of the Visual Analogue Scale for pain. A good result concerning pain was considered when the Visual Analogue Scale score was below 33.3 mm or less than half the initial score. The patients were followed-up for 6 months.
                The patients treated with botulinum toxin type A showed a significantly greater pain improvement from the first week post-infiltration. Persistent shoulder pain was observed more frequently in the placebo group, with relative risks in the range 0.32-0.41 during the follow-up period.
                Patients with spastic shoulder pain treated with a botulinum toxin type A infiltration in the pectoralis major muscle of the paretic side have a higher likelihood of pain relief (between 2.43- and 3.11-fold). In a randomised, double-blind study, the effects of intramuscular injection of botulinum toxin type A (BtA) into the upper limb were compared with those of normal saline solution in 14 patients with cerebral palsy; their mean age was 9 years. Range of movement and function were assessed before injection and at 2 and 12 weeks after injection. BtA injection significantly increased maximum active elbow and thumb extension and significantly reduced tone at wrist and elbow. The hand grasp-and-release score improved, representing a modest functional change, but fine motor function, assessed by the ability to pick up coins, did not improve and in some cases deteriorated temporarily. The most notable subjective change was the cosmetic benefit of reduced involuntary elbow flexion. The tone-reducing effect of BtA was clinically detectable in comparison with the placebo and patients and parents perceived the change as beneficial. The median of changes in the treatment group was small but the range was large, suggesting that BtA can be useful in selected patients. To determine whether strapping the shoulder in hemiplegic stroke patients: (1) prevents the development, or reduces the severity, of shoulder pain, (2) preserves range of movement in the shoulder, and (3) improves the functional outcomes for the arm and patient overall.
                A prospective, randomized, single-blind controlled trial of shoulder strapping versus no strapping.
                Care of the elderly wards in a teaching hospital, Christchurch, New Zealand.
                All patients admitted with an acute hemiplegic stroke, who had persisting weakness of shoulder abduction.
                The treatment group had their affected shoulder strapped for six weeks from randomization in addition to standard physiotherapy.
                All subjects were assessed at entry (week 0), at end of the treatment phase (week 6) and two months later (week 14). A visual analogue scale (VAS) was used to assess shoulder pain severity whereas shoulder range of movement to the point of pain (SROMP) assessed passive range of movement and pain. Functional Independence Measure (FIM), Motor Assessment Scale (MAS) and Rankin Disability Index measured functional outcomes.
                Ninety-eight subjects participated (49 strapped, 49 controls). Intention to treat analysis showed no significant difference in pain, range of movement or functional outcomes after the intervention phase or at the final assessment. However there were trends for less pain at six weeks (VAS, p = 0.11) and better final upper limb function (MAS, p = 0.16) in strapped patients. Skin reactions were uncommon (6.1%). The presence of neglect or sensory loss, but not subluxation, at baseline was independently associated with poor outcome. Range of movement was lost early (mean difference SROMP between hemiplegic and contralateral shoulders at baseline = 15.2 degrees (95% CI 10.9-19.5)) and continued throughout the study. Shoulder strapping did not alter the rate at which range of movement was lost.
                No significant benefit with shoulder strapping was demonstrated and reasons for this are discussed. Range of movement in the hemiplegic shoulder is lost very early and any preventive treatments need to begin within the first 1-2 days after a stroke.
The results should be interpreted with caution due to few studies with small sample sizes and high risk of bias. Botulinum toxin A injections seem to reduce pain severity and improve shoulder function and range of motion when compared with placebo in patients with shoulder pain due to spastic hemiplegia or arthritis. It is unclear if the benefit of pain relief in post-stroke shoulder pain at three to six months but not at one month is due to limitations of the evidence, which includes small sample sizes with imprecise estimates, or a delayed onset of action. More studies with safety data are needed.