Outcome measures in chronic migraine management: clinical use and potential cost savings: a case study

Outcome measures in chronic migraine management: clinical use and potential cost savings: a case study 

Nathan Hinkeldey, D.C.1,2 Kevin Percuoco, D.C.3 Michael Tunning DC, ATC, MS.4 Noelle Johnson, Pharm.D.,BCACP1 Laurie Hinrichs, PA-C5
Central Iowa VA Healthcare System,  Pain Management1
Adjunct Faculty, Palmer College of Chiropractic2
Palmer College of Chiropractic DoD/VA Clerkship3
Associate Professor, Palmer College4
Central Iowa VA Healthcare System, Primary Care5

Published:
Journal of the Academy of Chiropractic Orthopedists
December 2016, Volume 13, Issue 2

This article is available from: http://www.dcorthoacademy.com © 2016 Hinkeldey, Percuoco, Tunning, Johnson, Hinrichs and the Academy of Chiropractic Orthopedists. This is an Open Access article which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Introduction: Chronic migraine (CM) is a common primary headache. There are no gold standard prophylactic treatments for CM. OnabotulinumtoxinA is currently the only FDA approved prophylactic therapy for treatment of CM. Patients are seeking alternative treatments for headaches including spinal manipulative therapy (SMT). SMT has been indicated in two large systematic reviews reporting moderate evidence as a treatment for migraine headaches.

Clinical Features: A 44 year-old Caucasian male reported to the hospital-based chiropractic clinic with frequent debilitating headaches in a unilateral presentation, sensitivity to light and sound, nausea, and occasional emesis.

Interventions and Outcomes: He began quarterly OnabotulinumtoxinA injections. A new primary care provider initiated etodolac and consulted the chiropractic clinic. Following eight weekly chiropractic visits, the headache disability index was re-administered and scored at 32/100, a 20 point reduction from initial.

Conclusion: The use of outcome measures helped to identify effective changes in treatment for a patient undergoing pharmacologic and manual therapy interventions for chronic migraine. Utilization of consistent outcome measures across disciplines may assist providers in quantifying and comparing self-rated disability within and between different treatment modalities.

Introduction

Chronic migraine (CM) is a common primary headache disorder characterized by attacks lasting 4-72 hours, occurring 3 consecutive months for (>15) days/month, with features of migraine headache (e.g. aura, nausea, vomiting) on (≥8) days/month (1). CM is estimated to impact 1.4-2.2% of the adult population, resulting in significant disability and diminished quality of life. (2,3) As a result, $1 billion in medical expenditures and $16 billion in lost productivity each year is related to migraine. Currently, there are no gold standard prophylactic treatments for CM. Following the results of the PREEMPT trials, OnabotulinumtoxinA is currently the only FDA approved prophylactic therapy for treatment of CM. Despite concerns about the clinical efficacy of the PREEMPT clinical trials, statistically significant improvements were noted with regard to headache symptoms, function, and health-related quality of life (HR-QOL) outcomes in comparison to placebo. (5,9)

As described by Bronfort et al., increasing numbers of patients are seeking alternative treatments for headaches including spinal manipulative therapy (SMT)(10). Although there may exist more support for SMT in treating cervicogenic headaches, SMT has been indicated in two large systematic reviews reporting moderate evidence as a treatment for migraine headaches. (6,7) One possible mechanism is the onset of headache types through noxious stimulus. Painful tissues eliciting this stimulus may include joint capsules, muscles, and ligaments, all innervated by the cervical spine nerve roots. (10) The following case illustrates substantial benefit with respect to function, and potentially cost-savings, through the combination of OnabotulinumtoxinA and other treatment modalities.

Case Report

A 44 year-old Caucasian male reported to the hospital-based chiropractic clinic with frequent debilitating headaches in a unilateral presentation, sensitivity to light and sound, nausea, and occasional emesis. He was diagnosed with migraines at age 18. The migraines remained stable for 20 years but increased in intensity beginning November of 2010. He was consulted to Neurology at that time because he had trialed amitriptyline, zolmitriptan, and NSAIDs without benefit. In addition, he had been using SMT at a frequency of one treatment every 6-8 weeks for a year, resulting in 3-4 days without a migraine.

Throughout 2011, on the recommendation of neurology, the patient kept a headache journal which illustrated >15 migraines per month, substantiating the diagnosis of CM. He trialed propranolol, which reduced his daily tension headache to one every three days, and Sumatriptan, which provided abortive relief for his migraine attacks. In November 2011, he began quarterly OnabotulinumtoxinA injections which continued through August of 2014. His HIT-6 improved from 64 to 60 during the first 8 months of OnabotulinumtoxinA injections, but no follow up outcome measures were performed after this time period. He switched Primary Care Providers (PCP) on September 25, 2014. The new PCP initiated etodolac and consulted the chiropractic clinic.

He reported to the chiropractic clinic on October 10, 2014. At the initial evaluation, he scored 52/100 on the Headache Disability Index (HDI) and reported successful use of sumatriptan as an abortive therapy 2-3 times a week, but he was still missing work following its use. Following eight weekly chiropractic visits, the HDI was re-administered and scored at 32/100. He continued to experience migraines at a frequency of 5 per month; however, when they occurred, he was able to abort them with sumatriptan and continue working. The patient worked 60-70 hours per week as an emergency medical technician which may have contributed to headache triggers in the form of work-related stress and prolonged static postures. Based on the patient response to SMT as evidenced by a 20 point improvement in HDI and decrease in migraine frequency, the treatment plan was altered to no longer include OnabotulinumtoxinA injections.

Between December 2014 and February 2015, he reported weekly for additional treatment consisting of manual therapy and modifications to his home exercise program. Table 1 provides a summary of the care and treatment modalities provided to the patient during his time in the chiropractic clinic. His HDI improved to 16/100 in February 2015, and as a result, the frequency of treatment decreased to one visit every two weeks.

Over the next four months, he reported every other week for supportive care and exercise modification. His headache condition remained stable, suggesting an effective home exercise program. In May 2015, he was asked to follow up in one month. At the June visit, his presentation was mildly aggravated as a result of increased work frequency over the past month and non-compliance with his exercises; despite this, his HDI was recorded at 24/100.

Manipulation

Manual Therapy

Therapeutic Exercise

HDI

Education

C1,2; T2/4

Suboccipitals

Deep neck flexion

52

 

C1,2; T2/4

Suboccipitals

     

C1,2; T2/4

Suboccipitals

   

Posture education

C1,2; T2/4

Suboocipitals

   

Posture education

C1,2; T2/4

Suboccipitals

   

Posture education

C1,2; T2/4

Levator scapula

Added scapular triplanar matrix

 

Brugger posture breaks

C1,2; T2/4

Levator scapula

     

C1,2; T2/4

Levator scapula

     

C1,2; T2/4

Levator scapula

 

32

 

C1,2; T2/4

Levator Scapula

     

C1,2; T2/4

Levator scapula

Added self trigger point release

 

Tennis ball trigger-point self-release

C1,2; T2/4

Levator scapula

     

C1,2; T2/4

Levator scapula

     

C1,2; T2/4

Levator scapula

     
 

Posterior scalene

 

16

Patient concerned about not having treatment

T2/4

Posterior scalene

     

T2/4

Posterior scalene

Cat camel

   

T2/4

Posterior scalene

   

Reduced frequency to every 2 weeks in order to mitigate anxiety related to no treatment

T2/4

Posterior scalene

     

T2/4

Posterior scalene

Scapular depression and retraction 3 pt.

 

Ordered theracane

T2/4

Posterior scalene

     

T2/4

Posterior scalene

Diaphragmatic breathing

 

Educated about stress and paradoxical breathing

T2/4

Posterior scalene

     

T2/4

Posterior scalene

     

T2/4

Posterior scalene

   

Continued to do well without aggravation

T2/4

Posterior scalene

 

24

He stopped the HEP and worked 29 days in a row

Table 1: Summary of Care

Discussion

This case illustrates how outcome assessments can impact our care and clinical decision making. Prior to reporting to the chiropractic office, the patient employed sumatriptan, propranolol, and quarterly OnabotulinumtoxinA injections; however, he completed his first outcome assessment upon initiation of OnabotulinumtoxinA injections. Throughout healthcare, emphasis is often placed on self-reporting mechanisms of subjective improvement; however, the literature has provided us with outcome assessments that objectively quantify the impact of a disease state on a patient’s function (11-16).

Utilization of standardized outcome measures allows for healthcare providers to accurately compare the patient’s response between modalities. The literature provides many different options for measuring self-rated headache disability which have good reliability and utility (11-16). The Headache Disability Index (HDI), Headache Disability Questionnaire (HDQ), and Headache Impact Test-6 (HIT-6) are part of the headache outcome measures commonly used in research and practice (17-19). The HDI was chosen because it assesses performance of basic functions including daily routines, concentration, socialization, travel, reading and recreation.

The neurology clinic used the HIT-6 upon initiation of the OnabotulinumtoxinA injections and then again at 6 month follow up. A four point improvement was documented; however, a five point improvement is the threshold for clinical significance. Following the six month report, the use of the outcome measure was discontinued. During the PREEMPT trials, the HIT-6 illustrated significant improvement. At the start of the trial, 93.5% of the OnabotulinumtoxinA and 92.7% of the placebo groups reported scores of >60 on the HIT-6. During the trial, the patients completed the HIT-6 at 4 week intervals. Following the 24 week trial, 67.6% and 78.2% respectively illustrated scores >60 on the HIT-6 suggesting significant improvement and statistically significant difference between groups (p<.001) (20). Clinically, it would seem appropriate to employ this same approach in order to gauge monthly progress, regression, or plateauing with respect to the treatment plan. In our case, the HIT-6 was only administered twice; therefore, a conclusion of clinical significance cannot be established.

In addition to the considerations above, it would have been interesting to obtain and evaluate the outcome measure before and after medication changes. The patient could have completed an outcome assessment before and after the addition of propranolol, before and after the addition of sumatriptan, and before and after receiving each OnabotulinumtoxinA treatment. As a result, the patient and provider could track improvements, declines, and plateaus in self-rated disability associated with each specific intervention.

We were unaware that the patient had completed the HIT-6 outcome measure with neurology. If this had been known, it would have been appropriate to administer the same outcome measure at regular monthly intervals. In the chiropractic clinic, outcome assessments were issued; however, the periodization was inconsistent. The HDI did provide a standard for evaluation and additional evidence of self-rated functional improvement. Ideally, the HDI would be issued at defined intervals and at any point that the care plan changed. We could then assess the impact in the change of care.

The literature established OnabotulinumtoxinA as an approved mechanism for reducing acute medical use, physician visits, hospitalizations, and emergency department visits (21); however, cost comparison data has not been established comparing OnabotulinumtoxinA to other interventions. While we cannot draw any conclusion from a single case, it is interesting to consider potential savings with the substitution of chiropractic care for OnabotulinumtoxinA during a nine month treatment period.

The PREEMPT trials represent the largest studies in CM, and their results indicate efficacy in improving clinical and quality of life measures (20). Less clear are the impacts on outcomes such as migraine-related healthcare utilization and net cost associated with treatment (21). In 2013, the cost of OnabotulinumtoxinA treatment was estimated to be $1,225.51 per treatment session. Use of OnabotulinumtoxinA provided a decrease of emergency department visits by 55%, urgent care visits by 59%, and hospitalizations by 57% accounting for a mean reduction of $1,219.33 per patient over a six month time period (21). The case noted above resulted in 25 chiropractic visits and the codes 98940 and 97110 were billed in each instance. According to the Wellmark Blue Cross and Blue Shield of Iowa fee schedule, total expenditure for the chiropractic care would have been $1,525 over a nine month time period. Over the same time period, three OnabotulinumtoxinA cycles would have taken place costing $3,676.52. Using chiropractic care in lieu of OnabotulinumtoxinA would result in $2,151.52 ($3,676.52 – $1,525) of cost savings over a nine month period of time.

Following a thorough chart and medication review, the following are potential confounding factors: The American Academy of Neurology provides evidence based guidelines for the treatment and prevention of migraine headaches. These guidelines indicate that some non-steroidal anti-inflammatory drugs and selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and Tricyclic antidepressants have been established as Level B preventive therapies for chronic headaches (22). Etodolac was added September 2014 for comorbid knee arthralgia. Prior to the primary care appointment in September 2014, compliance with sertraline was suboptimal secondary to side effects, and was subsequently changed to fluoxetine. These pharmacologic changes may have contributed to migraine prophylaxis and as such would be confounding factors (23).

Conclusion

The use of outcome measures helped to identify effective changes in treatment for a patient undergoing pharmacologic and manual therapy interventions, as well BotulinumtoxinA injections for chronic migraine. Utilization of consistent outcome measures across disciplines may assist providers in quantifying and comparing self-rated disability within and between different treatment modalities. While this one case lacks the power of significance, it provides perspective for thought and further study. As healthcare resources become more costly and scarce, it makes sense that continued use of a modality should be substantiated by functional improvement of the patient’s condition.

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