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ADVOCATE FOR MASSAGE THERAPY AS A RECOGNIZED AND RESPECTED HEALTHCARE PROFESSION

Washington State Massage Therapy Association

www.mywsmta.org


Overview:

Health Technology Assessment

Chronic Migraine and Chronic Tension-type Headaches




Oct. 31, 2017

Dagmar Growe, LMT



Recently, Uniform Medical announced that starting January 1, 2018, massage therapy will no longer be covered for the treatment of chronic migraines and chronic tension-type headaches. This change is based on a decision by the Health Technology Clinical Committee on May 19, 2017.

All information in this report is from HTA documents except for some links relating to terminology. Find HTA documents here.


What is the HTCC (Health Technology Clinical Committee)?

The HTCC is part of the Washington State Health Care Authority’s Health Technology Assessment Program (HTA). The purpose of the HTA is to review health technologies and procedures for effectiveness and cost-efficiency. The HTCC decides which topics to evaluate, and reviews reports prepared by a contracted entity or HTA. Based on the report, the HTCC decides “whether and under what circumstances state agencies should pay for health technology based on whether the evidence shows it is safe, effective and has value.” The goal is to ensure that state health care funds are spent prudently. The HTCC’s decision is binding for PEBB, Medicaid and any other state funded medical programs.


Chronic migraine (CM) and chronic tension-type headache(CTTH) Assessment:

Key questions for the review were developed with public input between Oct. and December 2016. A draft report was published in March of 2017, followed by another public comment period. The final report was published April 20, 2017, and a decision was reached by the HTCC at their meeting on May 19, 2017.


Background:

Primary headaches (those that are not due to a discernible underlying pathology)  are the most common reason for patient visits in primary care and neurology settings. A 2015 study found that almost 19% of adults reported having had a migraine or severe headache in the past 12 months. Tension-type headaches account for 90% of all headaches. Chronic headaches are defined as those occurring 15 or more days each month for at least 3 months, or more than 180 days a year. There is no clear cause of tension-type headaches. Both types of headache are a leading cause of disability and diminished quality of life, the 4th most common reason for ER visits, and the 3rd highest cause of years of life lost to disability. Females are affected more than males. Many of the studies included in the review mentioned the fact that this group of patients tends to have a high percentage of medication overuse, which in itself can become cause for another type of chronic headache.

The review separately evaluated chronic migraines (CM), chronic tension-type headaches (CTTH) and chronic daily headaches (co-existent chronic migraine and tension-type headaches - CDH). It is important to note that the review specifically focused on long-term effects of preventing or diminishing headaches.


What types of treatment were reviewed?

Botulinum toxin (BonTA) injections, trigger point injections, transcranial magnetic stimulation, manipulation/manual therapy (defined as treatments done by a chiropractor or osteopath), acupuncture, and massage.


Key Questions:

  1. What is the evidence of the short (>6 months) and long-term (>12 months) efficacy and effectiveness of the interventions? (For clarification: “Efficacy determines whether an intervention produces the expected result under ideal circumstances, effectiveness measure the degree of beneficial effect in “real world” clinical settings). (www.ncbi.nlm.nih.gov/NBK44024).

  2. What is the evidence regarding short- and long-term harms and complications of the interventions?

  3. Is there evidence of differential efficacy, effectiveness, or safety? This would include considerations of age, sex, ethnicity, socioeconomic status and other)

  4. What is the evidence of cost-effectiveness?

Regarding all questions, the treatments are to be compared with standard alternative treatment options, placebo, sham (i.e. fake treatment), waitlist or no treatment.


Outcomes to be considered:

Primary/critical outcomes

  1. proportion of treatment responders

  2. complete cessation/prevention of headaches

  3. function/disability

  4. treatment related adverse events

  5. quality of life

Economic outcomes:

  1. cost-effectiveness (i.e. cost per improved outcome)

  2. cost-utility (e.g. cost per quality adjusted life year - QALY)

  3. incremental cost-effectiveness ratio - ICER


Inclusion Criteria:

Studies were included in the review if they met the following criteria:

  1. Population: Adults with CM, CTTH, or CDH at least 15 days each month for at least 3 months, or 180 days a year. If a study did not select their participants according to that definition, it would not qualify. Slight variations in an otherwise good study might be deemed acceptable.

  2. Interventions: Botulinum toxin (BonTA) injections, trigger point injections, transcranial magnetic stimulation, manipulation/manual therapy (defined as treatments done by a chiropractor or osteopath), acupuncture, and massage.

  3. Comparators: Standard alternative treatment options, placebo, sham (i.e. fake treatment), wait list or no treatment.

  4. Outcomes: Primary and economic outcomes listed above

  5. Studies: Must focus on at least one of the primary outcomes. Priority was given to studies with the least potential of bias (randomized controlled trials - RCTs) and reviews of RCTs.

  6. Timing: Focus on intermediate (>6 months) and long-term (>12 months) outcomes.


Public Involvement:

The HTA review process is open for public comments, both as part of the development of the key questions, and after the release of the draft report. Interestingly, there was very little participation. The Washington East Asian Medicine Association made comments regarding key question development. There were only 3 comments regarding the final report, 2 from peer reviewers, and an letter from Amgen, a biotech company. Amgen was being critical of the narrow view of economic costs - suggesting that looking at treatment costs is a narrow focus that does not take into account costs to the State of Washington due to worker absenteeism. The low level of participation suggests that HTA does not actively seek to engage outside parties in the process.


Final decision:

Chronic Migraines: OnabotulinumtoxinA will be a covered benefit under certain conditions, none of the other treatments will be covered.

Chronic tension-type headaches: None of the interventions will be covered.


Evidence presented in the report:

After a search of medical databases including PubMed, Cochrane and others, 27 studies were selected for inclusion. One Massage vs. sham study was included in the CDH review (this study involved Thai massage), no massage studies were included in the CM, CTTH and economic review. While the massage study was considered to be at low risk of bias (good quality RCT) it showed no statistically significant improvement in headache reductions. However, there was an acknowledgement that massage on cervical trigger points has been shown to improve ANS regulation and increase serotonin levels - and that ANS dysregulation and low serotonin levels have been implicated in CM.

Not surprisingly, the BoNTA studies were greatest in numbers and highest in quality ratings. There were a few acupuncture studies, and a couple of studies for the other modalities, all rated at moderately high risk of bias (poor quality RCTs). It is interesting to note that while acupuncture studies consistently showed improvement in long-term outcomes, the results were disregarded because either the study was deemed to be low quality or the improvement was deemed to be less than the required margin. Also, while there were documented side effects for BoNTA, the lack of side effect with manual therapy and acupuncture was disregarded due to small sample size.

A review of other reviews (mostly by health care agencies in other countries) mirrored the results of this one: There was not enough qualified research. However, this would be interpreted either as not enough evidence to recommend these treatments, or not enough evidence to make a recommendation for or against a treatment.


Review of Economic Impact:

There were 3 economic studies (looking at Botox and acupuncture), 2 were rated as poor to moderate quality, 1 as very poor quality. One statistic of interest was tracking PEBB/UMP data from 2012 to 2016. Between 2012 and 2016, the number of patients with chronic headaches more than doubled, the average number of treatments per patient declined from 5.5 to 4.4. The average cost per treatment increased from $403 to $ 550.

In 2012, Treatment for headaches was split between manual therapy (ca. 45%), acupuncture (ca. 30%), and massage (ca. 25%). Starting in 2013 and continuing to 2016, botox injection comprised around 80% of treatments, the rest being split between manual therapy, acupuncture and massage.


Questions to consider for us:

  • ICD10 Codes distinguish between “migraines”, “persistent migraines”, and “chronic migraines”. The codes for chronic migraines start with G437 (plus 2 additional digits).Tension-type headaches are separated into 3 categories - chronic (G44221 and G44229), episodic, and unspecified. Then there are codes for a myriad of other non-migraine or tension-type headaches, including chronic varieties. Our understanding at this time is that only the above codes will be affected by the HTCC decision.

  • Do RCT requirements create an inherent bias towards pharmaceuticals, and against CAM therapies?

  • Are there studies that are compatible with the inclusion criteria but were not included? Excluded studies are listed in Appendix C of the HTA documents with reason for exclusion.

  • While the review acknowledges the great cost of chronic headaches, both financially, and in terms of personal suffering, it makes no comments on pain management for those that are not helped by prevention strategies. It categorically eliminates interventions for both prevention/reduction and pain management.

  • CTTHs are defined by a lack of discernable cause. However, CAM therapists are trained to perform differential assessments of soft tissue, meridians, or subluxations. No competent CAM provider will treat all CTTHs in the same way.

  • Massage is not a technique, it is a field, similar to surgery being a field, in which many different types of technique are employed. This is why massage therapists frequently refer amongst each other. Depending on the dysfunction underlying the CTTH, some techniques or modalities will be more appropriate and effective than others. How can we develop studies that address the variety in some way?


See also Headache Fact Sheet in practice resources



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