Management of headache disorders: design of a randomised clinical trial screening for prognostic patient characteristics

Contains fulltext : 51576.pdf (publisher's version ) (Open Access)BACKGROUND: Treatment of headache disorders is not always optimal. Patients are treated in multiple ways, and the lack of scientific arguments for referral and the insufficient implementation of guidelines result in unclear treatment strategies. The coexistence of headache and neck pain can lead to the referral to a musculoskeletal physiotherapist. This treatment can only be successful if an underlying cervical segmental dysfunction is present. In such cases a physical treatment can be a valuable option that should be considered. The aim of this study is to identify prognostic therapeutic patient characteristics and to increase the number of correct physiotherapy referrals. METHODS/DESIGN: This trial is designed to identify patient characteristics which can influence the prognosis of the patient. Patients with recurrent headache and co-existent neck pain are recruited via a multicenter setup. After screening for eligibility, subjects are tested at baseline and randomly allocated to one of two treatment groups. Testing includes the administering of questionnaires (a Headache Diagnosis Questionnaire, Headache Inventory List and the Headache Impact Test (HIT-6)) and physical tests (Thermal Stimuli, Manual Cervical Spine Examination and Pressure Algometry). Treatment groups are a usual care group (UC) administered by the General Practitioner (GP) and a usual care plus musculoskeletal physiotherapy treatment group (UCMT). UC is based on the Dutch GP Guideline for Headache. UCMT consists of the UC plus a combination of exercises and spinal cervical mobilisations. Follow-up measurements consist of the completion of the Headache Inventory List, the HIT-6 and scoring of the global perceived effect (GPE). The latter allowing the distinction between responders (positive effect) and non-responders (no effect or worse). Logistic regression analysis will be used to identify the specific patient characteristics of the responders and the non-responders. The additional value of the musculoskeletal physiotherapy will be examined. Follow-up measurements up to 52 weeks are scheduled. DISCUSSION: This trial aims to identify prognostic patient characteristics, in order to supply a useful diagnostic tool for all health care workers, dealing with headache sufferers

Effect of TENS on pain in relation to central sensitization in patients with osteoarthritis of the knee: study protocol of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Central sensitization has recently been documented in patients with knee osteoarthritis (OAk). So far, the presence of central sensitization has not been considered as a confounding factor in studies assessing the pain inhibitory effect of tens on osteoarthritis of the knee. The purpose of this study is to explore the pain inhibitory effect of burst tens in OAk patients and to explore the prognostic value of central sensitization on the pain inhibitory effect of tens in OAk patients.</p> <p>Methods</p> <p>Patients with knee pain due to OAk will be recruited through advertisements in local media. Temporal summation, before and after a heterotopic noxious conditioning stimulation, will be measured. In addition, pain on a numeric rating score, WOMAC subscores for pain and function and global perceived effect will be assessed. Patients will be randomly allocated to one of two treatment groups (tens, sham tens). Follow-up measurements will be scheduled after a period of 6 and 12 weeks.</p> <p>Discussion</p> <p>Tens influences pain through the electrical stimulation of low-threshold A-beta cutaneous fibers. The responsiveness of central pain-signaling neurons of centrally sensitized OAk patients may be augmented to the input of these electrical stimuli. This would encompass an adverse therapy effect of tens. To increase treatment effectiveness it might be interesting to identify a subgroup of symptomatic OAk patients, i.e., non-sensitized patients, who are likely to benefit from burst tens.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01390285">NCT01390285</a></p