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

Abstract

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.

Psychological therapies (remotely delivered) for the management of chronic and recurrent pain in children and adolescents

“…Guidelines for trials of behavioural and pharmacological treatments for chronic and recurrent headache recommend reporting headache frequency as the primary outcome variable and pain intensity and duration as secondary outcome variables (Andrasik 2005; Penzien 2005; Tfelt-Hansen 2012). Therefore, we preferentially extracted data for children and adolescents who reported at least 50% reduction of headache frequency in both the treatment and control groups; this was possible in four studies (Connelly 2006; McGrath 1992; Rapoff 2014; Trautmann 2010).…”

“…Pain outcomes for headache and mixed pain conditions still vary. The International Headache Society and American Headache Society have published guidelines of preferred outcome measures in trials of behavioural and pharmacological interventions for individuals with recurrent and chronic headache (Andrasik 2005; Penzien 2005; Tfelt-Hansen 2012). Although these guidelines recommend reporting multiple measures of headache severity including pain intensity and duration, headache frequency is widely considered to be the primary outcome of interest in these trials.…”

Cognitive Behavioral Therapy Plus Amitriptyline for Chronic Migraine in Children and Adolescents

“…The headache education control demonstrates that improvements are not due solely to therapist support, education, or other nonspecific intervention effects. 18 …”

Disability in Bank Office Workers Due to Cervicogenic Headache.

“…Headache may arise from various structures of the cervical spine, containing the zygapophyseal joints (occiput-C1, C2, C3). (5,6) Key features of CGH usually are unilateral headache without side-shift combined with neck pain and decreased movement. (6) Up to about 70% of frequent intermittent headache are reported with associated neck pain making CGH difficult to diagnose.…”