Guidelines for Trials of Behavioral Treatments for Recurrent Headache, First Edition: American Headache Society Behavioral Clinical Trials Workgroup

Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.     

Botulinum toxin and neuromotor rehabilitation: An integrated approach to idiopathic cervical dystonia.

Currently, the best treatment option for idiopathic cervical dystonia (ICD) is injection of botulinum toxin (BTX) into the affected muscles, whereas rehabilitative approaches have given disappointing results. We evaluated whether the association of an ad hoc rehabilitative program may improve the clinical efficacy of BTX treatment in a single-center, cross-over, controlled study. Forty patients with ICD were randomly assigned to two different treatment groups: (1) BTX type A (BTX-A) plus a specific program of physical therapy (BTX-PT) or (2) BTX-A alone (BTX-0). Patients in the BTX-PT group showed a longer duration of the clinical benefit (118.8 vs. 99.1 days) and needed a lower dose of BTX at reinjection (284.5 vs. 325.5 units). In addition, they showed more marked reductions in their disability in activities of daily living (-9.7 vs. -4.85 points) and subjective pain (-13.35 vs. 6.95 points) scores. Association of BTX-A therapy with a specific program of physical therapy may improve ICD treatment outcome.     

An effective treatment for functional urinary incoordination

Twenty women diagnosed with functional urinary incoordination were randomly assigned to one of two treatment groups: biofeedback or progressive muscle relaxation. Ten subjects who were placed on a waiting list prior to treatment allocation served as a comparison group. The biofeedback intervention focused specifically on retraining of pelvic floor musculature (PFM). Patients were assessed pretreatment, posttreatment, and at 2-month follow-up. Outcome measures included self-reported symptomatology, psychological functioning, psychophysiological assessment of the PFM, and urologist ratings of problem severity and treatment efficacy. Both treatment approaches proved effective in improving symptomatology and psychological state. Subjects on the waiting list demonstrated no change in urological difficulties. No differences were found between the two treatment groups on any of the outcome measures. Theoretical and practical implications of the results are discussed.     

Effect of EMG Biofeedback and Progressive Muscle Relaxation Training on Awareness of Frontalis Muscle Tension

Awareness of muscle tension, as estimated by a modification of the Kinsman et al. (1975) procedure for determining probability of correct estimation (P(c)) of absolute differences in muscle tension between adjacent trials, was examined before and after volunteer subjects underwent 4 sessions of either: 1) EMG biofeedback (BF) training, 2) progressive muscle relaxation (PMR) training, or 3) a placebo-control (MC) procedure which involved listening to music as an alleged guide for relaxation. The subjects were 30 females (mean age = 28.3 yrs) responding to an offering of experimental treatment for anxiety and tension. Measurements of frontalis muscle tension (EMG) and P(c) were made before and after training. The results showed that EMG was significantly reduced by BF and PMR training but not by the MC procedure. Increases in P(c) after training were significantly greater for BF than for PMR or MC training. There were no group differences for subjective report of tension. Correlations between pre- to post-training EMG and P(c) change scores were significant only for the BF group and the combined group of BF and PMR subjects. These results suggest that: 1) both BF and PMR training were effective in producing frontalis EMG reductions, 2) the following relationship may exist among training groups in terms of relative influence upon awareness of tension—BF training > PMR training > MC training, and 3) awareness of tension appears to be related to the ability to reduce EMG although the exact nature of this relationship remains unclear.     

Comparison of Frontal EMG Biofeedback and Several Types of Relaxation Instructions in Reducing Multiple Indices of Arousal

During the training phase, 96 subjects were given one of four types of relaxation instructions (single instructions, repeated instructions, relaxation training, no instructions) and in addition either did or did not receive frontal EMG biofeedback training. Results indicated that each of the instructions and biofeedback procedures were equally effective in reducing frontal EMG, but that none of these procedures had any effect on subjective anxiety or autonomic indices of arousal (pulse rate, skin temperature, and finger pulse volume). During the generalization/stress phase, subjects were threatened with electric shock and were told to apply the relaxation techniques they learned during the training phase even though no additional instructions and/ or biofeedback training would be provided. To assess the effectiveness of the shock manipulation, a no-threat control group was included. Results indicated that: a) the shock manipulation was effective in increasing arousal, b) previous instructions and/or biofeedback were equally effective in reducing frontal EMG levels, but that c) only relaxation training was consistently effective in reducing subjective and autonomic indices of arousal. These findings: a) suggest that in stressful situations, relaxation training may be more effective than either EMG biofeedback or simple relaxation instructions in producing a general relaxation effect as opposed to a specific EMG effect; and b) indicate the importance of assessing the effectiveness of relaxation procedures during stressful situations during which subjects’ levels of arousal are elevated above resting baseline levels.     

Effects of a second bout of maximal eccentric exercise on muscle damage and electromyographic activity

This study examined whether a second bout of maximal eccentric exercise performed 3 days after the first exercise bout would produce further changes in muscle damage and electromyographic activity (EMG). Male students (n=26) were randomly assigned to experimental 70 (EX70; n=9), experimental 30 (EX30; n=8), and control (CON; n=9) groups. The initial exercise was 30 maximal voluntary isokinetic eccentric contractions (MAX1) on non-dominant elbow flexors at 60° s⁻¹ (1.05 rad s^-1). The EX70 and EX30 groups performed a second bout of 70 and 30 eccentric contractions (MAX2), respectively, 3 days after MAX1. Upper arm circumference , range of motion , strength, integrated EMG (IEMG), and mean power frequency (MPF) were measured before, immediately after, and once a day for 9 days after MAX1. Plasma creatine kinase (CK) activity and muscle soreness were assessed before and for 9 days after MAX1. Total work, work per contraction, IEMG, and MPF were also recorded during MAX1 and MAX2. All indicators of muscle damage changed following MAX1 for each group (P<0.05), but no indicators of additional damage (P>0.05) were apparent after MAX2 for either the EX70 or EX30 groups. IEMG (P=0.03) and MPF (P=0.04) were lower for MAX2 compared with MAX1 for both the EX30 and EX70 groups. It is concluded that performing a second bout of eccentric exercise with damaged muscles 3 days after the initial bout does not produce further damage or retard recovery, even when the second bout of exercise is more strenuous. EMG findings were consistent with reduced activation of fast-twitch motor units during the second eccentric bout. These results may be interpreted as evidence of a neural protective mechanism. Electronic Publication     

Biomechanical assessment with electromyography of post-stroke ankle plantar flexor spasticity

Spasticity has been defined as a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex (muscle tone). Muscle tone consists of mechanical-elastic characteristics, reflex muscle contraction and other elements. The aims of this study were to determine whether to assess spasticity quantitatively, and to characterize biomechanical and electromyographic spasticity assessment parameters. These assessment parameters were described by investigating the correlation between clinical measures and the response to passive sinusoidal movement with consecutive velocity increments. Twenty post-stroke hemiplegic patients and twenty normal healthy volunteers were included in the study. Five consecutive sinusoidal passive movements of the ankle were performed at specific velocities (60, 120, 180, and 240 degrees/ sec). We recorded the peak torque, work, and threshold angle using a computerized isokinetic dynamometer, and simultaneously measured the rectified integrated electromyographic activity. We compared these parameters both between groups and between different velocities. The peak torque, threshold angle, work, and rectified integrated electromyographic activity were significantly higher in the post-stroke spastic group at all angular velocities than in the normal control group. The threshold angle and integrated electromyographic activity increased significantly and linearly as angular velocity increased, but the peak torque and work were not increased in the post-stroke spastic group. Peak torque, work, and threshold angle were significantly correlated to the Modified Ashworth scale, but the integrated electromyographic activity was not. The biomechanical and electromyographic approach may be useful to quantitatively assess spasticity. However, it may also be very important to consider the different characteristics of each biomechanical parameter.     

EMG Biofeedback as a Tool for Simulating the Effects of Specific Leg Muscle Weakness on a Lifting Task

This study investigated the use of EMG biofeedback to simulate weakened rectus femorii and gastrocnemii muscles during the performance of a lifting task. Eight healthy women performed 15 kg free-style lifts from floor level. Three conditions were tested: unconstrained lifting, lifting with rectus femorii activity volitionally limited bilaterally through EMG biofeedback to less than 45% of maximal EMG activity, and lifting with the gastrocnemii limited to a similar level. Limiting leg muscle activity through biofeedback led to an alteration of lifting strategy, with resulting performance variables (joint angles and torques, angular velocities, center of pressure excursion, and segment coordination) comparing favorably with those from lifting trials performed by six women with moderate leg muscle weaknesses. The data indicate that EMG biofeedback can be used to simulate the effects of leg muscle weakness during these lifts, providing a new tool to study the biomechanics of muscle weakness.     

A psychophysiological evaluation of female urethral syndrome: Evidence for a muscular abnormality

This is a preliminary investigation into a recently defined urological disorder occurring in a subgroup of women with urethral syndrome suggestive of pelvic floor muscular (PFM) dysfunction. Symptoms include straining to void, urgency, frequency, hesitation, incontinence and/or retention, and subpubic pain. Finding neither bladder nor urological abnormalities, urologists may consider these women emotionally unstable without organic cause for their symptoms. However, their distress may be a consequence rather than a cause of their voiding problems. Sixteen female urological patients were matched with 16 asymptomatic controls to investigate PFM functioning, psychological status, and symptomatology. Results showed heterogeneity of symptomatology and little elevation of depression or anxiety when comparing patients with controls. Hypotheses of muscular abnormality were confirmed. Patients evidenced poor control over tensing and relaxing PFM, elevations of PFM activity under various conditions, and chronic pain as a prominent symptom. Treatment approaches specifically designed to address PFM dysfunction are discussed.     

复方茵陈蒿汤对兔奥狄氏括约肌肌电活动及胆总管压力的影响

目的:揭示奥狄氏括约肌肌电活动与机械收缩的关系和复方茵陈蒿汤治疗胆石症的作用机制。方法:采用同步记录技术,动态观察灌胃前后兔奥狄氏括约肌肌电活动及胆总管压力的变化。结果:胆总管压力波动与括约肌肌电发放在时程上一致,药后30～75min,括约肌肌电脉冲频数明显增加,其增值明显高于相应时间的给予等量水灌胃的对照组(P<0.05,60min,P<0.01),胆总管压力无相应的升高。结论:奥狄氏括约肌肌电活动与机械收缩相藕联,复方茵陈蒿汤通过兴奋括约肌肌电活动,增强括约肌的节律性舒缩,促进胆汁排放。