<b>BACKGROUND: </b>Among all the causes of chronic low back pain, myofascial pain syndrome of the spinal stabilizer muscles is one of the most frequent, yet underconsidered sources of pain. The purpose of this prospective, randomized, double-blind, controlled trial was to evaluate the efficacy of type-A botulinum toxin (BTX-A) in relieving myofascial pain in patients experiencing mechanical low back pain due to bilateral myofascial pain syndrome involving the iliopsoas and/or the quadratus lumborum muscles.<b>METHODS: </b>Each of the 27 enrolled patients received a bilateral, fluoroscopically guided injection in the affected muscle(s) to randomly deliver BTX-A in one side of the low back and a control drug (randomly constituted by NaCl 0.9% or bupivacaine 0.25%) in the opposite side. To evaluate the effects of treatment on daily life activities and psychologic status, 5 different questionnaires were administered (Hospital Anxiety and Depression scale [HAD-A and HAD-D], Lattinen, Oswestry, and Spielberger State-Trait Anxiety Index).<b>RESULTS: </b>BTX-A injection did not significantly reduce visual analog scale scores more than treatment with NaCl or bupivacaine in the contralateral side; furthermore, the treatments administered did not result in a significant improvement of patients' daily life activities or psychologic status. Although a trend toward a decrease in postintervention visual analog scale scores could be recognized in all low back sides, this trend was significant only in the sides treated with BTX-A.<b>CONCLUSIONS: </b>BTX-A seems to provide significant postintervention pain relief. However, considering its high cost and the small differences compared with control treatments, its use should be reserved only for patients with pain refractory to other invasive treatments.
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.
OBJECTIVES: To investigate the effectiveness of botulinum toxin in preventing the development of chronic whiplash-associated disorder.DESIGN: Prospective, randomized, placebo-controlled double-blind study.SETTING: Regional Neurological Rehabilitation Centre with participants being at home.Subjects: Thirty-seven patients with whiplash-associated disorder who remained symptomatic two months after injury.INTERVENTIONS: Patients were randomized to receive either 250 units botulinum toxin type A (Dysport) or placebo (normal saline). Four trigger points were injected with 0.625 mL of injectant.Outcome measures: Tenderness to palpation scores, visual analogue pain scale, Vernon-Mior Neck Pain and Disability Index and cervical range of motion. Follow-up assessments were carried out at four weeks and three months after treatment.RESULTS: Twenty participants received botulinum toxin and 17 received placebo. Both groups showed a tendency towards improvement in pain scores, Vernon-Mior Index and range of motion at four weeks and three months, with the changes being more pronounced in the toxin group. The change in Vernon-Mior Index in the toxin group was both statistically and clinically significant (i.e. a change of score of >/=5 from baseline to follow-up). Group comparisons did not meet statistical significance.CONCLUSION: The improvements in outcome measures suggest that botulinum toxin type A may have a role to play in the management of whiplash-associated disorder but larger studies are required to clarify the situation.
<b>PURPOSE: </b>To evaluate the effects of botulinum toxin-A in the treatment of patients who have myofascial pain with or without functional disc displacement. <b>Patients and METHODS: </b>Twenty-four participants were randomly assigned to the study by using Research Diagnostic Criteria for Temporomandibular Disorders. All patients were informed about botulinum toxin-A, and were required to give informed consent. Before the injections, patients were asked to fill out a Biobehavioral Questionnaire to evaluate their pain and psychological status, and afterward, electromyography of the right and left masseter and anterior temporal muscles was recorded. Saline was injected into the masseter and anterior temporal muscles in the placebo group, and botulinum toxin-A was used in the study group. On days 14 and 28, patients were asked to fill out a Biobehavioral Questionnaire again, and electromyography of the right and left masseter and anterior temporal muscles was recorded again. <b>RESULTS: </b>The study group showed improvement in pain and psychological status. Although a decrease in the action potentials of the masseter muscles on day 14 was followed by an increase on day 28, the reduction of pain scores and improvement in psychological status continued on day 28. <b>CONCLUSIONS: </b>The injection of botulinum toxin-A decreases the muscle action potential in 14 days. The patients also show improvement in pain and psychological status.
The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed 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, randomized 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 mandibular 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 samples.
OBJECTIVES: Neck pain in chronic whiplash syndrome is a major burden for patients, healthcare providers and insurance companies. Randomized data on treatment of botulinum toxin in chronic whiplash syndrome are scarce. We conducted a randomized, placebo-controlled clinical trial to prove efficacy of botulinum toxin for neck pain in chronic whiplash syndrome.
METHODS: 40 patients with chronic whiplash syndrome (whiplash associated disorders grade 1 and 2) were randomly assigned to receive botulinum toxin (maximum 100 units) or placebo (saline) in muscles with increased tenderness.
RESULTS: After 12 weeks there was no significant difference between the two treatment groups in decrease of neck pain intensity on VAS (-7.0 mm, 95% confidence interval (CI) [-20.7 to +6.7]), mean number of neck pain days (-1%; 95% CI [-15% to +13%]), neck pain hours per day (-0.14; 95% CI [-3.0 to +2.7]), days on which symptomatic treatment was taken (-0.7%; 95% CI [-15% to +13%]) number of analgesics taken per day (-0.14; 95% CI [-0.6 to +0.4]) and total cervical range of motion (-11 degrees; 95% CI [-40 to +17]). There also was no significant difference in patient's assessment of improvement after week 4, 8 and 12.
CONCLUSIONS: Botulinum toxin was not proven effective in treatment of neck pain in chronic whiplash syndrome. Increased muscle tenderness alone might not be the major cause of neck pain in whiplash syndrome.
BACKGROUND: Radial epicondylitis (tennis elbow) is the most frequent type of myotendinosis. Patients can experience substantial loss of function, especially when this condition becomes chronic. A successful therapy has not yet been established. A preliminary study of injections of botulinum toxin A in patients with chronic epicondylitis has shown promising results.
METHODS: In the present prospective, controlled, double-blinded clinical trial, 130 patients were examined at sixteen study centers. A single injection of botulinum toxin A into the painful origin of the forearm extensor muscles was performed. Follow-up examinations were performed at two, six, twelve, and eighteen weeks. Clinical findings were documented with use of a new clinical pain score and with a visual analogue scale. A global assessment of the result of treatment was also provided by the patient and the attending doctor. Strength of extension of the third finger and the wrist was evaluated with use of the Brunner method, and grip strength (fist closure strength) was measured with a vigorimeter.
RESULTS: The group treated with botulinum toxin A was found to have a significant improvement in the clinical findings, compared with those in the placebo group, as early as the second week after injection (p = 0.003). Subjective general assessment also showed improvement in that group, compared with the placebo group, at six weeks (p = 0.001) and at the time of the final examination (at eighteen weeks) (p = 0.001). There was a consistent increase in fist closure strength in both the group treated with botulinum toxin A and the control group, but there was no significant difference between groups. As was expected as a side effect, extension of the third finger was observed to be significantly weakened at two weeks but this complication had completely resolved at eighteen weeks.
CONCLUSIONS: We concluded that local injection of botulinum toxin A is a beneficial treatment for radial epicondylitis (tennis elbow). The treatment can be performed in an outpatient setting and does not impair the patient's ability to work.
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. (PsycInfo Database Record (c) 2021 APA, all rights reserved)
Among all the causes of chronic low back pain, myofascial pain syndrome of the spinal stabilizer muscles is one of the most frequent, yet underconsidered sources of pain. The purpose of this prospective, randomized, double-blind, controlled trial was to evaluate the efficacy of type-A botulinum toxin (BTX-A) in relieving myofascial pain in patients experiencing mechanical low back pain due to bilateral myofascial pain syndrome involving the iliopsoas and/or the quadratus lumborum muscles.
METHODS:
Each of the 27 enrolled patients received a bilateral, fluoroscopically guided injection in the affected muscle(s) to randomly deliver BTX-A in one side of the low back and a control drug (randomly constituted by NaCl 0.9% or bupivacaine 0.25%) in the opposite side. To evaluate the effects of treatment on daily life activities and psychologic status, 5 different questionnaires were administered (Hospital Anxiety and Depression scale [HAD-A and HAD-D], Lattinen, Oswestry, and Spielberger State-Trait Anxiety Index).
RESULTS:
BTX-A injection did not significantly reduce visual analog scale scores more than treatment with NaCl or bupivacaine in the contralateral side; furthermore, the treatments administered did not result in a significant improvement of patients' daily life activities or psychologic status. Although a trend toward a decrease in postintervention visual analog scale scores could be recognized in all low back sides, this trend was significant only in the sides treated with BTX-A.
CONCLUSIONS:
BTX-A seems to provide significant postintervention pain relief. However, considering its high cost and the small differences compared with control treatments, its use should be reserved only for patients with pain refractory to other invasive treatments.
