Treatment of tension-type headache with botulinum toxin type A: a double-blind, placebo-controlled study

OBJECTIVE: To determine whether injections of botulinum toxin could be of therapeutic value in the treatment of tension-type headache. BACKGROUND: Botulinum toxin A is very effective at reducing muscle tenderness and pain in many diseases. Increased muscle tension may contribute to tension-type headache. METHODS: We performed a double-blind, placebo-controlled study with 21 patients fulfilling the International Headache Society criteria for tension-type headache. Participants were randomly assigned to treatment (pericranial injection of 10 x 20 mouse units botulinum toxin A) or placebo (injection of isotonic saline in the same manner). RESULTS: After 4, 8, and 12 weeks, no significant differences between placebo and treatment could be observed (with respect to visual analog scale, frequency and duration of headache attacks, consumption of analgesics, pressure pain threshold, total tenderness score, and quality-of-life parameters). CONCLUSIONS: The findings of our study strongly support the hypothesis that peripheral mechanisms, such as increased muscle tenderness, only play a minor role in the pathogenesis of tension-type headache.     

Botulinum toxin type A as an effective prophylactic treatment in primary headache disorders

OBJECTIVE: To measure the effect of botulinum toxin type A (Botox, Allergan, Inc, Irvine, CA) treatment in 271 patients diagnosed with headache in accordance with International Headache Society (IHS) criteria. BACKGROUND: Botulinum toxin type A has shown promise for the treatment of headache in several clinical trials, but uncertainty remains as to how botulinum toxin type A optimally should be used for treating headache and which patients are best suited for this treatment. METHODS: This was a retrospective chart review of all patients who received botulinum toxin type A for the treatment of headache from January 1999 to February 2002. Patients were injected with an average dose of 63.2 U (SD, 14.5) of botulinum toxin type A on 2 or more visits, with treatments involving a "fixed-site" or a "follow-the-pain" (or a combination of both) approach. In the fixed-site approach, botulinum toxin type A was injected into the procerus, corrugator, frontalis, and temporalis muscles. In the follow-the-pain approach, botulinum toxin type A was injected into a combination of the procerus, corrugator, frontalis, temporalis, occipitalis, trapezius, and/or semispinalis capitis muscles. The primary outcomes for the trial were the reduction in headache days per month or headache intensity (0 to 3 scale) (or both) from baseline. Patients were diagnosed according to IHS criteria and subsequently classified into the following categories: chronic daily headache (more than 15 headache days per month), episodic tension-type headache, episodic migraine, and "mixed" HA (less than 15 headache days per month, combination of migraine and tension-type headache). RESULTS: Treatment period was an average of 8.6 months (SD, 6.4); patients received an average of 3.4 doses (SD, 1.6) 3 months apart. Of the 271 patients, 29 (10.7%) had episodic migraine, 17 (6.3%) had episodic tension-type headache, 71 (26.2%) had mixed headache, and 154 (56.8%) had chronic daily headache. Two-hundred fifty-six patients had data for the number of headache days per month, 117 had data for headache intensity, and all 271 had data for headache days or headache intensity. Botulinum toxin type A treatment significantly reduced the number of headache days per month from 18.9 (SD, 10.3) to 8.3 (SD, 8.9) (n=256, P<.001)--a 56% reduction. Headache intensity decreased from 2.4 points (SD, 0.6) to 1.8 points (SD, 0.8) (n=117, P<.001)--a 25% reduction. Of 263 patients surveyed, 225 (85.6%) reported improvement in headache frequency and intensity. There was no correlation of effect/lack of effect with reason for treatment, duration/number of treatments, injection technique, mean/total dose, age, gender, or comorbidity. Approximately 95% of patients did not experience medication side effects. CONCLUSION: These results suggest that botulinum toxin type A may be an effective and safe prophylactic treatment for a variety of moderate to severe chronic headache types.     

Botulinum toxin injections for the treatment of frontal tension headache

Abstract We performed a randomized, double-blind, placebo-controlled trial to determine the efficacy of botulinum toxin type A (BOTOX; Allergan) in treating frontal tension-type headache (TTH). A total of 40 patients attending a headache treatment center were randomized to receive 50 U botulinum toxin type A or saline, injected at 10 sites of the forehead. Frequency and severity of headaches before and after injection were compared. The intensity of headaches in the botulinum toxin type A group, but not the placebo group, fell significantly from an average score of 5.19 to 4.65 (p<0.0001). Botulinum toxin type A patients and placebo patients experienced an average reduction in the number of headaches per month, but these reductions were not significantly different between groups. Botulinum toxin type A was well tolerated, with no significant adverse events. Botulinum toxin type A injections in the management of frontal TTH has been shown by this study to be both effective and well tolerated. It should be noted that the effect of botulinum toxin on intensity of headache, although statistically significant, was relatively small.     

Association Between Trapezius Muscle Tenderness and Tension-Type Headache in Female Office Workers: A Cross-sectional Study

Objective

The purpose of the study was to determine the association between trapezius muscle tenderness and tension-type headache among female office workers.

Improvement of tension-type headache when treating wrinkles with botulinum toxin A injections

Botulinum toxin A has been used to treat a spectrum of neuromuscular diseases. In recent years, it has become an accepted treatment for dynamic facial wrinkles. Following treatment of glabella and forehead wrinkles with botulinum toxin A, 9 of 134 patients coincidentally reported improvement of tension-type headache. We have retrospectively studied this group of patients in whom improvement of facial wrinkles closely paralleled improvement of tension-type headache. This observation suggests a role for muscle action in tension-type headache and a novel treatment.     

Treatment of chronic tension-type headache with botulinum toxin A: a randomized, double-blind, placebo-controlled multicenter study

A beneficial effect of botulinum toxin on tension-type headache was reported in open-label studies but scientifically rigorous clinical studies are lacking. Therefore we conducted a prospective, multicenter, randomized, double-blind, placebo-controlled trial. Multiple pericranial muscles of 112 patients with chronic tension-type headache were treated either with 500 mouse units of botulinum toxin (Dysport) or with placebo. The diagnoses were made strictly following the International Headache Society criteria. Co-existence of migraine was an exclusion criterion. Injections were made following a fixed scheme and not adjusted to the patient's symptoms. Patients kept a headache diary that was used to calculate the area under the headache curve of 6 weeks before and 12 weeks after the treatment as the main effect measure. Secondary effect measures were the number of days with headache, the number of days with intake of analgesics, the duration of the nocturnal sleep, and the Beck Depression Inventory score. There were no significant differences between the verum group and the placebo group in any of these variables. Seven patients of the verum group had transient weakness of the eyelids, the neck, or both, indicating that a higher dose than used in this study does not seem sensible for the treatment of headache. The statistical power of the study was high enough to warrant the conclusion that there is no clinically significant effect of botulinum toxin A on chronic tension-type headache.     

Single-site botulinum toxin type a injection for elimination of migraine trigger points

BACKGROUND: Botulinum toxin may be effective in suppressing migraine. Most injection regimens utilized have involved multiple sites. PURPOSE: To evaluate prospectively the effect of botulinum toxin type A injections into the corrugator supercilii muscles alone on the frequency and severity of migraine. METHODS: Twenty-nine patients (24 women, 5 men) with migraine were enrolled in the study. Average age was 45 years (range, 24 to 63). The frequency (number of migraines per month) and intensity (recorded on an analog scale of 1 to 10, 10 being most severe) of headache were recorded before and after treatment. Twenty-five units of botulinum toxin type A was injected into each corrugator supercilii muscle, for a total of 50 units. RESULTS: At 2 months, 24 (83%) of 29 patients reported a positive response to the injection of botulinum toxin type A (P <.001). Sixteen patients (55%) reported complete elimination of headache (P <.001), 8 (28%) experienced significant improvement (at least 50% reduction in frequency or intensity) (P <.04), and 5 (17%) did not notice a change in headache. The duration of efficacy of the botulinum toxin type A injections ranged from 6 to 12 weeks, with an average of 8 weeks. In patients who had improvement in migraine but not complete elimination, the headache frequency decreased from 6.4 to 2.1 per month on average (P <.04), and the intensity decreased from 8.6 to 6.1 (P <.04). CONCLUSION: These results support the hypothesis that focal injection of botulinum toxin type A may be an effective therapy for migraine.     

Effect of botulinum toxin A injections in the treatment of chronic tension-type headache: a double-blind, placebo-controlled trial

In addition to vascular and supraspinal influences, contraction of craniofacial muscles or central sensitization processes following continuous nociceptive input of craniofacial muscles may play an important role in the pathogenesis of tension-type headache. Chemodenervation induced by botulinum toxin injection is successfully used to decrease muscle tension. If muscle tension is important in this type of headache, then botulinum toxin could be helpful in its treatment. We conducted a randomized, placebo-controlled study to examine the effect of 20 U botulinum toxin injected into frontal and temporal muscles in patients with chronic tension-type headache. During a baseline of 4 weeks and a posttreatment period of 8 weeks, the effect was evaluated with daily records and the West Haven-Yale Multidimensional Pain Inventory. Some improvement in affective variables were demonstrated in the botulinum group, but important outcome variables, such as pain intensity, the number of pain-free days, and consumption of analgesics, were not statistically different between the groups. Reasons for these moderate effects may include the injection sites, dose of botulinum toxin, and duration of treatment.     

Botulinum toxin type A and EMG: a key to the understanding of chronic tension-type headaches?

BACKGROUND: The pathogenesis of chronic tension-type headache remains unclear, and the role of muscle tension is especially controversial. Botulinum toxin type A, a potent inhibitor of muscle tone, has been used to treat chronic tension-type headache. OBJECTIVE: To determine whether clinical response to treatment of chronic tension-type headache with Botox A parallels changes in resting muscle activity recorded through serial electromyography (EMG). METHODS: We randomly assigned eight patients with chronic tension-type headache to pericranial injection of 500 MU Botox A versus placebo (isotonic saline). RESULTS: At 6 and 12 weeks following treatment, there were no significant differences in clinical outcome between the placebo and the Botox A groups. This occurred despite EMG evidence of a reduction in resting muscle activity in the Botox A-treated patients. CONCLUSION: These results support the hypothesis that peripheral mechanisms such as increased muscle tone play, at most, a minor role in the pathophysiology of chronic tension-type headache.     

Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study

We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX); Allergan, Inc., Irvine, CA, USA) for the prophylaxis of chronic tension-type headache (CTTH). Three hundred patients (62.3% female; mean age 42.6 years) enrolled. For the primary endpoint, the mean change from baseline in the number of TTH-free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favouring placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headache-free days/month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had >or=50% decrease in tension headache days than did placebo (P 相似文献   

Effect of guided imagery on quality of life for patients with chronic tension-type headache

OBJECTIVE: To determine the effect of adjuvant guided imagery on patients with chronic tension-type headache. BACKGROUND: Management of chronic tension-type headache often requires a combination of pharmacological and nonpharmacological therapies. Guided imagery is a relaxation technique based on visualizing pleasant images and body awareness. METHODS: One hundred twenty-nine patients with chronic tension-type headache completed the Headache Disability Inventory and the Medical Outcomes Study Short Form (SF-36) at their initial visit to a specialty headache center and again 1 month after the visit. In addition to individualized headache therapy, patients listened to a guided imagery audiocassette tape daily for the month. One hundred thirty-one control subjects received individualized therapy without guided imagery. RESULTS: Controls and the patients who listened to the guided imagery tape improved in headache frequency, headache severity, patient global assessment, quality of life, and disability caused by headache. More guided imagery patients (21.7%) than controls (7.6%) reported that their headaches were much better (P = .004). The guided imagery patients had significantly more improvement than the controls in three of the SF-36 domains: bodily pain (95% CI; guided imagery patients 11.0, controls 0.2), vitality (95% CI; guided imagery patients 10.9, controls 1.7), and mental health (95% CI; guided imagery patients 7.8, controls 0.4). CONCLUSIONS: Guided imagery is an effective adjunct therapy for the management of chronic tension-type headache.     

Pathophysiological mechanisms of tension-type headache: a review of epidemiological and experimental studies

In this present thesis I have discussed the epidemiology and possible pathophysiological mechanisms of tension-type headache. A population-based study of 1000 subjects randomly selected from a general population, two clinical studies, and a method study of EMG recordings, were conducted. Tension-type headache was the most prevalent form of headache, with a life-time prevalence of 78% in a general adult population. Thirty percent were affected more than 14 days per year and 3% were chronically affected, i.e. had headache at least every other day. Females were more frequently affected than males, and young subjects more frequently affected than older subjects. Females were more sensitive to mechanical pressure pain and revealed more tenderness from pericranial muscles and tendon insertions than males, and young subjects were more pain-sensitive than older subjects. Significantly higher tenderness in pericranial muscles was found in subjects with tension-type headache compared to migraineurs and to subjects without any experience of headache. Tenderness increased significantly with increasing frequency of tension-type headache in both males and females, whereas no such relation was found for mechanical pain thresholds. The applied EMG methodology was fairly reliable and nonpainful, but due to intersubject variability paired studies should be preferred. Subjects with chronic tension-type headache had slightly increased EMG levels during resting conditions and decreased levels during maximal voluntary contraction compared with headache-free subjects, indicating insufficient relaxation at rest and impaired recruitment at maximal activity. In a subsequent clinical, controlled study, the effect of 30 min of sustained tooth clenching was studied. Within 24 h, 69% of patients and 17% of controls developed a tension-type headache. Shortly after clenching, tenderness was increased in the group who subsequently developed headache, whereas tenderness was stable in the group of patients who remained headache-free, indicating that tenderness might be a causative factor of the headache. Likewise, psychophysical and EMG parameters were studied in 28 patients with tension-type headache, both during and outside of a spontaneous episode of tension-type headache. It was concluded that a peripheral mechanism of tension-type headache is most likely in the episodic subform, whereas a secondary, segmental central sensitization and/or an impaired supraspinal modulation of incoming stimuli seems to be involved in subjects with chronic tension-type headache. Prolonged nociceptive stimuli from myofascial tissue may be of importance for the conversion of episodic into chronic tension-type headache. The author emphasizes that tension-type headache is a multifactorial disorder with several concurrent pathophysiological mechanisms, and that extracranial myofascial nociception may constitute only one of them. The present thesis supplements the understanding of the balance between peripheral and central components in tension-type headache, and thereby, hopefully, leads us to a better prevention and treatment of the most prevalent type of headache.     

Lifetime prevalence and characteristics of recurrent primary headaches in a population-based sample of Swedish twins

OBJECTIVE: To examine the lifetime prevalence and other characteristics of recurrent primary headaches in twins. BACKGROUND: The twin model may provide insights into the role of genetic and environmental influences in headache disorders. However, assumptions as to whether twins are representative of the general population, and whether monozygotic and dizygotic twins are similar have rarely been addressed. METHODS: The study population consisted of a random sample of 17- to 82-year-old twins from the Swedish Twin Registry (n = 1329). Structured interviews on the telephone by lay personnel and the International Headache Society criteria were used for assessment and diagnosis of recurrent primary headaches. Prevalence data of the general population for migraine and tension-type headache was obtained from various published reports. RESULTS: A total of 372 subjects (29%) had ever had recurrent headaches. In total, 241 recurrent headache sufferers fulfilled the criteria for migraine or tension-type headache, and the lifetime prevalence was 7.1% for migraine without aura, 1.4% for migraine always with aura, 1.9% for migraine occasionally with aura, 9.4% for episodic tension-type headache, and 1.3% for chronic tension-type headache. The lifetime prevalence of all migraine and all tension-type headache, including another 84 subjects fulfilling all but one of the criteria for migraine or tension-type headache, was 13.8% and 13.5%, respectively. The corresponding prevalence risk for women was 2.4 (95% confidence interval [CI] 1.7, 3.4) and 1.5 (95% CI 1.1, 2.1), respectively. Zygosity was not a significant predictor for migraine. In tension-type headache, the prevalence risk for dizygotic twins and unlike-sexed twins as compared with monozygotic twins was 1.9 (95% CI: 1.2, 3.1) and 1.8 (95% CI: 1.1, 2.9), respectively. CONCLUSION: There is no twin-singleton or monozygotic-dizygotic difference for the risk of migraine. In tension-type headache, twins seem to have a lower risk than singletons, and this is especially true for monozygotic twins.     

Muscle hardness in patients with chronic tension-type headache: relation to actual headache state

It has recently been reported that the pericranial muscles in patients with chronic tension-type headache are harder, i.e. have a higher consistency, than in controls. The primary aim of the present study was to investigate whether muscle hardness is influenced by the presence or absence of actual headache and whether hardness is correlated to tenderness. The secondary aim was to compare muscle hardness between patients and healthy controls. Hardness of the trapezius muscle was measured with a hardness meter in 20 patients with chronic tension-type headache and in 20 healthy controls. The patients were examined on 2 days, 1 day with headache and 1 day without headache. Pericranial myofascial tenderness was recorded with manual palpation. In addition, muscle hardness was measured in another five patients out-side headache and in 30 healthy controls. The muscle hardness recorded in patients (n = 20) on days with headache, 98 +/- 26 kPa/cm, did not differ significantly from the muscle hardness recorded on days without headache, 100 +/- 21 kPa/cm, (P = 0.62). The muscle hardness was positively correlated to the local tenderness score recorded from the trapezius muscle both on days with headache (R = 0.52, P = 0.02) and on days without headache (R = 0.53, P = 0.02). The total tenderness score (TTS) recorded in patients on days with headache, 23 +/- 10, was significantly higher than the TTS recorded on days without headache, 15 +/- 11, (P = 0.0001). There was a significant difference between the TTS recorded in patients without headache, 15 +/- 11, and in controls, 4 +/- 4, (P = 0.002). The muscle hardness was significantly higher in patients on days without headache (n = 25), 97 +/- 20 kPa/cm, than in controls (n = 30), 87 +/- 16 kPa/cm (P = 0.03). On basis of previous and present results, we suggest that muscle hardness and muscle tenderness are permanently altered in chronic tension-type headache and not only a consequence of actual pain. In addition, the positive correlation between muscle hardness and tenderness supports the common clinical observation that tender muscles are harder than normal muscles.     

A pilot methodological validation study for a population-based survey of the prevalences of migraine,tension-type headache and chronic daily headache in the country of Georgia

Abstract We report the methodology of an epidemiological survey of the prevalences of migraine, tension-type headache and chronic daily headache in Georgia. Medical residents visited adjacent households in Tbilisi to interview a pre-defined target of 100 biologically unrelated subjects. All respondents reporting headache in the previous year, as well as random 20 non-headache controls, were examined by a neurologist. The response rate was 70%. Of 156 respondents, 93 were biologically unrelated and 45 (48%) reported headache in the previous year. Eight subjects fulfilled all IHS criteria for migraine (1-year prevalence 8.6% [95% CI: 2.9–14.3%]), and 13 had probable migraine, meeting all but the criterion for duration. Nineteen had tension-type headache (20.4% [95% CI: 12.2–28.6%]) and five had chronic daily headache (5.4% [95% CI: 1–10.0%]). In comparisons of diagnoses by questionnaire and neurologist (considered the gold standard), sensitivities for the questionnaire of 89% for migraine and 67% for tension-type headache were calculated (overall kappa=0.74).     

Treating chronic tension-type headache not responding to amitriptyline hydrochloride with paroxetine hydrochloride: a pilot evaluation

CONTEXT: In some individuals, chronic tension-type headache fails to respond to tricyclic antidepressant medications that often serve as first-line therapy. OBJECTIVE: To evaluate the clinical efficacy of paroxetine hydrochloride for chronic tension-type headache not responding to amitriptyline hydrochloride. DESIGN AND SETTING: Open-label trial of paroxetine conducted at 2 outpatient sites in Ohio. PARTICIPANTS AND INTERVENTION: Thirty-one adults (mean age, 37 years; 20 women) with chronic tension-type headache (mean, 25 headache days per month) who had failed to respond (less than 30% improvement) to treatment with either amitriptyline (n = 13) or matched placebo (n = 18). All participants were treated with paroxetine (up to 40 mg per day) in a 9-month protocol. OUTCOME MEASURES: Monthly headache index calculated as the mean of pain ratings (0 to 10 scale) recorded by participants in a diary 4 times per day, number of days per month with at least moderate pain (pain rating of 5 or greater), and analgesic medication use. RESULTS: In patients who had not responded to amitriptyline, paroxetine failed to reduce chronic tension-type headaches or analgesic medication use. In patients who had not responded to placebo, paroxetine produced modest reductions in chronic tension-type headaches and analgesic use. CONCLUSIONS: We found no evidence that chronic tension-type headaches that failed to respond to tricyclic antidepressant therapy with amitriptyline improved when subsequently treated with paroxetine. More support was found for the efficacy of paroxetine in patients with chronic tension-type headaches who had failed to respond to placebo.     

Botulinum toxin type A in the management of headache: a review of the literature and personal experience

Abstract Botulinum toxin type A (BoNT-A) shows significant promise in the management of a variety of headache types including migraine, chronic daily headache, tension-type headache, and other head and neck pains. Confirmation of efficacy still awaits the report of well-controlled double-blind placebo-controlled trials; however, a mounting body of evidence suggests that BoNT-A is effective, well-tolerated and safe for the management of many headache disorders. In this paper, I review recent evidence on the efficacy of BoNT-A, and also report my personal experience with the treatment in over 600 headache patients.     

Botulinum toxin: could it be an effective treatment for chronic tension-type headache?

Several clinical trials suggest that botulinum toxin type-A (BTX-A) may be an effective treatment option for patients with chronic tension-type headache (CTTH); however, controversy remains as to how the botulinum toxin optimally should be used for treating headache and which patient's profile fits this treatment. The objective of this study was to evaluate the efficacy and tolerability of BTX-A for the prophylactic treatment of CCTH in Egyptian patients. This was a randomized, single-blind, placebo-controlled study of BTX-A for the treatment of patients aged 25–50 years old with CCTH. Following a 30-day screening, headache parameters and severity assessed by the standard visual analogue scale (VAS), and the 25-item Henry Ford Hospital Headache Disability Inventory (HDI) were recorded as a baseline. Then, injection was done with either BTX-A or with saline by a combination of two methods for detecting injection sites (the fixed-site approach and follow-the-pain approach). Our study showed significant improvement after 1 month of BTX-A injection regarding headache days/month, severity measured by VAS and HDI in headache severity. There was significant reduction of prophylactic medications, and there were minor complications, but these reversed spontaneously without further treatment. BTX-A was an effective and well-tolerated prophylactic treatment in Egyptian patients with CCTH.     

Pharmacoprophylaxis of tension-type headache

Although tension-type headache typically is not as disabling as migraine, its chronic form may significantly impair patients’ functional ability. The pathogenesis of tension-type headache remains largely unknown. Compared with migraine, tension-type headache is the object of much less research. For a number of years, research on headache therapy has vastly emphasized migraine. Even cluster headache, which is far less frequent than tension-type headache, has been subject to more therapeutic trials than tensiontype headache. Therefore, it is not surprising that since the advent of studies (as early as 1964) on amitriptyline, which remains a pivotal treatment choice, the number of emerging treatments for this condition remains scarce, even in 2005. This emphasizes the need for renewed interest in this field. However, alternate treatment approaches, such as botulinum toxin injections, albeit controversial, have renewed hopes lately. In addition, recent progress in the understanding of tension-type headache pathophysiology, such as the role of peripheral and central sensitization, has revived interest in the field. This is a review of available, proven, or suspected prophylactic therapies for tensiontype headache.     

Botulinum Toxin A, Adjunctive Therapy for Refractory Headaches Associated With Pericranial Muscle Tension

Pericranial muscle tension may contribute to the development of facial discomfort, chronic daily headache, and migraine-type headache. Elimination of pericranial muscle tension may reduce associated myalgia and counteract influences that can trigger secondary headaches which fall within the migraine continuum. Four patients with chronic, predominantly tension-type headaches and associated pericranial muscles tension failed prolonged conventional treatment and, therefore, symptomatic areas were treated with botulinum toxin A. This alleviated myalgia and reduced the severity and frequency of migraine-type headaches with a concomitant reduction in subsequent medical and physical therapy interventions. Judicious use of botulinum toxin A into defined areas of pericranial muscle tension may be useful for reducing primary myalgia and secondary headache.