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Summary: Following the AVMAa€™s lead on this subject, Complementary and Alternative Veterinary Medicine Considered thoroughly examines a variety of CAVM therapies and asks important questions regarding alternative treatments. Complementary and Alternative Veterinary Medicine Considered is a book that belongs in your veterinary library. In its 2001 Guidelines for Complementary and Alternative Medicine, the American Veterinary Medical Association (AVMA) recognizes the growing interest in CAVM, and encourages the critical examination of these therapies using the scientific method.
Complementary and Alternative Veterinary Medicine Considered will help practicing veterinarians to make informed decisions about specific CAVM therapies. The Diversified technique and the Gonstead method are the two most commonly used chiropractic manipulative treatment modalities in the profession, used by 91% and 59%, respectively, [21, 22] along with other manual and non-manual interventions, that is, soft tissue techniques, spinal and peripheral mobilisation, rehabilitation, postural corrections and exercises as well as general nutrition and dietetic advice. A few spinal manipulative therapy (SMT) randomised controlled trials (RCTs) using the Diversified technique have been conducted for migraine, suggesting an effect on migraine frequency, migraine duration, migraine intensity and medicine consumption. The objective of this study is to assess the efficacy of CSMT versus placebo (sham manipulation) and controls (continue usual pharmacological management without receiving manual intervention) for migraineurs in an RCT. This is a single-blinded placebo-controlled RCT with three parallel groups (CSMT, placebo and control).
Participants will be recruited in the period January to September 2013 through the Akershus University Hospital, through general practitioners and media advertisement, that is, posters with general information will be put up at general practitioners’ offices along with oral information in the Akershus and Oslo counties, Norway. Eligible participants are between 18 and 70 years of age and have at least one migraine attack per month. Exclusion criteria are contraindication to SMT, spinal radiculopathy, pregnancy, depression and CSMT within the previous 12 months. In response to initial contact, participants fulfilling the inclusion criteria will be invited to further assessment by the chiropractic investigator.
The participants will fill in a validated diagnostic paper headache diary 1 month prior to intervention which will be used as baseline data for all participants. Prepared sealed lots with the three interventions, that is, active treatment, placebo and the control group, will be subdivided into four subgroups by age and gender, that is, 18–39 and 40–70 years of age and men and women, respectively. Active treatment consists of CSMT using the Gonstead method, [21] that is, a specific contact, high-velocity, low-amplitude, short-lever spinal with no postadjustment recoil directed to spinal biomechanical dysfunction (full spine approach) as diagnosed by standard chiropractic tests.
The placebo intervention consists of sham manipulation, that is, a broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-intentional and non-therapeutic directional line. The control group will continue usual care, that is, pharmacological management without receiving manual intervention by the clinical investigator.
After each treatment session, the participants who receive active or placebo intervention will complete a de-blinding questionnaire administrated by an external trained independent party with no involvement from the clinical investigator, that is, providing a dichotomous ‘yes’ or ‘no’ answer as to whether active treatment was received.
Follow-up analysis will be conducted on the end points measured after the end of intervention and at 3, 6 and 12 months follow-up.
Change in primary and secondary end points from baseline to the end of intervention and to follow-up will be compared between the active and placebo groups and the active and control groups. Owing to the follow-up period, repeated recordings of primary and secondary end points will be available, and analyses of trend in primary and secondary end points will be of main interest.
Sample size calculations are based on the results in a recently published group comparison study on topiramate.
Current SMT RCTs on migraine suggest treatment efficacy regarding migraine frequency, duration and intensity.
The placebo response is furthermore high in pharmacological and assumed similarly high for non-pharmacological clinical studies; however, it might even be higher in manual therapy RCTs were attention and physical contact is involved. Conducting X-rays prior to the active and placebo interventions was found to be applicable in order to visualise posture, joint and disc integrity. Since we are unaware of the mechanisms of possible efficacy, and both spinal cord and central descending inhibitory pathways have been postulated, we see no reasons to exclude a full spine treatment approach for the intervention group. This RCT will highlight and validate the Gonstead CSMT for migraineurs, which has not previously been studied. Point 11–40 will be duplicate of point 1–10 above at 3, 6 and 12 months follow-up, respectively. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. A cross-sectional population-based survey of migraine and headache in 21,177 Norwegians: the Akershus sleep apnea project.
Magnetic resonance angiography of intracranial and extracranial arteries in patients with spontaneous migraine without aura: a cross-sectional study. Prevalence of primary chronic headache in a population-based sample of 30- to 44-year-old persons.
Prevalence of secondary chronic headaches in a population-based sample of 30–44-year-old persons. Dependence scores predict prognosis of medication overuse headache: a prospective cohort from the Akershus study of chronic headache.
Impact of headache on sickness absence and utilisation of medical services: a Danish population study. The effectiveness of chiropractic manipulation in the treatment of headache: an exploration in the literature.
Manual therapies for primary chronic headaches: a systematic review of randomized controlled trials. Central relationships of trigeminal and cervical primary afferents in the spinal cord and medulla. Specific manipulative therapy treatment for chronic lateral epicondylalgia produces uniquely characteristic hypoalgesia.
Immediate effects on electromyographic activity and pressure pain thresholds after a cervical manipulation in mechanical neck pain: a randomized controlled trial. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. A non-selective (amitriptyline), but not a selective (citalopram), serotonin reuptake inhibitor is effective in the prophylactic treatment of chronic tension-type headache. Differential Effectiveness of Placebo Treatments: A Systematic Review of Migraine Prophylaxis. International Chiropractic Assocoation Practicing Chiropractors’ Committee on Radiology Protocols (PCCRP) for biomechanical assessment of spinal subluxation in chiropractic clinical practice. Secondary International Chiropractic Assocoation Practicing Chiropractors’ Committee on Radiology Protocols (PCCRP) for biomechanical assessment of spinal subluxation in chiropractic clinical practice.
Organ dosimetry in spinal radiography: a comparison of 3-region sectional and full-spine techniques. Diagnostic radiology in Norway trends in examination frequency and collective effective dose. If you are a veterinarian wondering if you should incorporate complementary and alternative veterinary medicine (CAVM) into your practice, if you have recently hired an associate eager to try such things as acupuncture or homeopathy, or if you have clients asking you about chiropractic, herbal, or magnetic field therapy for their pets, youa€™ll want to understand the history, science and ethics behind such therapies.


Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management).
The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. On the recent Global Burden of Disease study, migraine was ranked as the third most common condition.
It is argued that migraine might originate from a complexity of nociceptive afferent responses involving the upper cervical spine (C1, C2 and C3), leading to a hypersensitivity state of the trigeminal pathway conveying sensory information for the face and much of the head. Participants will receive posted information about the project followed by a short telephone interview. Participants are diagnosed according to the diagnostic criteria of the International Classification of Headache Disorders (ICHD-II) by a neurologist at the Akershus University Hospital. Participants whom during the RCT receive any manual interventions by physiotherapists, chiropractors, osteopaths or other health professionals to treat musculoskeletal pain and disability, including massage therapy, joint mobilisation and manipulation, [44] changed their prophylactic headache medicine or pregnancy will be withdrawn from the study at that time and be regarded as dropouts. The assessment includes an interview and a physical examination with special emphasis on the whole spinal column. Time profile will be assessed from baseline to the end of follow-up for all end points (Figure 1). Participants will be equally allocated to the three groups by allowing the participant to draw one lot only. All the non-therapeutic contacts will be performed outside the spinal column with adequate joint slack and without soft tissue pretension so that no joint cavitations occur. This response was followed by a second question regarding how certain they were that active treatment was received on a 0–10 numeric rating scale (NRS), where 0 represents absolutely uncertain and 10 represents absolutely certainty. During this period, all participants will continue to fill in a diagnostic paper headache diary and return it on a monthly basis.
Baseline demographic and clinical characteristics will be tabulated as means and SDs for continuous variables and proportions and percentages for categorical variables. The null hypothesis states that there is no significant difference between the groups in average change, while the alternative hypothesis states that a difference of at least 25% exists. Intra-individual correlations (cluster effect) are likely to be present in data with repeated measurements.
All analyses will be performed by a statistician, blinded for group allocation and participants. However, a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings. Blinding is often difficult as there is no single validated standardised chiropractic sham intervention which can be used as a control group for this date. Since the trial duration is 17 months with a 12 month follow-up period, the risk for loss to follow-up is thus enhanced. However, we found that advantageous to multiple investigators, in order to provide similar information to participants in all three groups and manual intervention in the CSMT and the placebo groups. It has furthermore been postulated that pain in different spinal regions should not be regarded as separate disorders but rather as a single entity.
Results will be published in peer-reviewed international scientific journals in accordance with the CONSORT 2010 Statement.
The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The risk of medication overuse due to frequent migraine attacks represents a major health hazard with direct and indirect cost concerns.
If the CSMT treatment is effective, it will be offered to participants who received placebo or control after study completion, that is, after 12 months follow-up.
Those recruited from the general practitioners’ offices will have to contact the clinical investigator whose contact details have been provided on the posters in order to obtain extensive information about the study. They are allowed to continue and change their usual acute migraine medication throughout the trial. Oral and written information about the project will be provided in advance and oral and written consent will be obtained from all accepted participants during the interview and by the clinical investigator. X-rays will be taken in standing position in the anterioposterior and lateral planes of the entire spine. The block randomisation will be administrated by an external trained party with no involvement from the clinical investigator. In some sessions, the participant lay either prone on a Zenith 2010 HYLO bench with the investigator standing at the participant's right side with his left palm placed on the participant's right lateral scapular edge with the other hand reinforcing. In the case of unreturned diary or missing values in the diary, the participants will be contacted immediately on detection to minimise recall bias.
Cluster effect will thus be assessed by calculating intraclass correlation coefficient quantifying the proportion of total variation attributable to the intraindividual variations. It is, however, necessary to include a placebo group in order to produce a true net effect of the active intervention.
Co-occurrence of other manual intervention during the trial period is another possible risk, as those who receive manipulation or other manual physical treatments elsewhere during the trial period will be withdrawn from the study and regarded as dropouts at the time of violation.
Thus, we intend to eliminate inter-investigator variability which might be present if there are two or more investigators. Furthermore, the diagnosis of all participants is performed by experienced neurologists and not by questionnaires.
All data will be anonymised while participants must give oral and written informed consent. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT).
The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. The prevalence of medication overuse headache (MOH) is 1–2% in the general population, [13–15] that is, about half the population suffering chronic headache (15 headache days or more per month) have MOH. The study will adhere to the recommended clinical trial guidelines from the IHS, [32, 33] and the methodological CONSORT and SPIRIT guidelines.
In accordance with good clinical practice, all patients will be informed about the harms and benefits as well as possible adverse reactions of the intervention primarily including local tenderness and tiredness on the treatment day. In other sessions, the investigator will stand at the participant's left side and place his right palm over the participant's left scapular edge with the left hand reinforcing, delivering a non-intentional lateral push manoeuvre. On the basis of previous reviews on migraine, a 25% reduction is considered to be a conservative estimate.
Primary and secondary end points will be presented by suitable descriptive statistics in each group and for each time point. The trend in end points will be assessed by a linear regression model for longitudinal data (linear mixed model) to correctly account for the possible cluster effect. Participants who experience any sort of adverse effects during the trial period will be entitled to call the clinical investigator on the project cell phone.


Consensus about an appropriate placebo for a clinical trial of SMT among experts representing clinicians and academics has, however, not been reached. Although the Gonstead method is the second most commonly used technique among chiropractors, we do not see an issue of concern when it comes to generalisability and external validity.
Thus, it might strengthen the likelihood of successful blinding in the placebo group being achieved. Insurance is provided through “The Norwegian System of Compensation to Patients” (NPE), which is an independent national body set up to process compensation claims from patients who have suffered an injury as a result of treatment under the Norwegian health service. In addition, a written lay summary of the results will be available to study participants on request. AC prepared the initial draft and PJT commented on the final version of the research protocol.
Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Thus, considering the methodological shortcomings in previous RCTs, a clinical placebo-controlled RCT with improved methodological quality remains to be conducted for migraine. Alternatively, the participant lay in the same side posture position as the active treatment group with the bottom leg straight and the top leg flexed with the top leg's ankle resting on the bottom leg's knee fold, in preparation for a side posture push move, which will be delivered as a non-intentional push in the gluteal region. Normality of end points will be assessed graphically and transformation will be considered if necessary. The linear mixed model handles unbalanced data, enabling all available information from randomised patients to be included, as well as from dropouts.
Under the assumption of, on average, 10 migraine days per month at baseline in each group and no change in the placebo or control group during the study, 2.5 days reduction corresponds to a reduction by 25%. Despite the lack of consensus, the headache index has been recommended as an accepted standard secondary end point. Furthermore, the block randomisation procedure will provide a homogeneous sample across the three groups. In addition, all the placebo contacts will be performed outside the spinal column, thus minimising a possible spinal cord afferent input. The study also bridges cooperation between chiropractors and physicians, which is important in order to make healthcare more efficient.
A stopping rule was defined for withdrawing participants from this study in accordance with recommendations in the CONSORT extension for Better Reporting of Harms.
All authors should qualify for authorship according to the International Committee of Medical Journal Editors, 1997. Owing to two group comparisons, p values below 0.025 will be considered statistically significant.
The sham manipulation alternatives will be equally interchanged among the placebo participants according to protocol during the 12-week treatment period to strengthen the study validity.
A 50% reduction in medication consumption from baseline to the end of intervention and to follow-up is expected. Regression models with fixed effects for time component and group allocation as well as the interaction between the two will be estimated. Owing to two group comparisons in the primary end point, p values below 0.025 will be considered statistically significant. Since primary analysis includes two group comparisons, we set a significance level at 0.025. In addition, the internal validity is further strengthened by a concealed validated randomisation procedure. Finally, our method might be applied in future chiropractic and other manual therapy RCTs on headache.
Each author should have participated sufficiently in the work to take public responsibility for the content. AC, JSB, PJT and MBR were involved in the interpretation and assisted in the revision and preparation of the manuscript. And, just as importantly, what are the ethical and regulatory considerations concerning such therapies? The economic cost per migraineur was estimated to be $655 in USA and €579 in Europe per year. The active and the placebo groups will receive the same structural and motion assessment prior to and after each intervention.
The interaction will quantify possible differences between groups regarding time trend in the end points and serve as an omnibus test. A sample size of 20 patients is required in each group to detect a statistically significant average difference in reduction of 25% with 80% power. The final data set will be available to the clinical investigator (AC), the independent and blinded statistician (JSB) and Study Director (MBR). The final decision on the order of authorship will be decided when the project has been finalised. No additional cointerventions or advice will be given to participants during the trial period. Random effects for patients will be included to adjust the estimates for intraindividual correlations. The study design adheres to the recommendations for pharmacological RCTs as far as possible. Data will be stored in a locked cabinet at the Research Centre, Akershus University Hospital, Norway, for 5 years.
The skin is sensitive to all usual forms of pain stimuli, while temporal and neck muscles may especially be sources for pain and tenderness in migraine. Migraine costs more than neurological disorders such as dementia, multiple sclerosis, Parkinson's disease and stroke.
The treatment period will include 12 consultations, that is, twice per week in the first 3 weeks followed by once a week in the next 2 weeks and once every second week until 12 weeks are reached. RCTs that include a placebo group and a control group are advantageous to pragmatic RCTs that compare two active treatment arms. All interventions will be conducted at the Akershus University Hospital and administered by an experienced chiropractor (AC). The two pairwise comparisons will be performed by deriving individual time point contrasts within each group with the corresponding p values and 95% CIs.



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