Compliance with Ethical Standards
This study was approved by the PeaceHealth Institutional Review Board (Lane County, OR).
Subject recruitment
Subjects were recruited primarily from family medicine practices in the Eugene-Springfield and Portland areas of Oregon.
Study Design
To minimize variables in this pilot exploratory study, we focused on females between the ages of 18 and 50 years, the most common demographic group afflicted by chronic migraine [21]. Study inclusion criteria were as follows; female subjects aged 18 to 50 years, with a clinical history of migraine headaches (with or without aura) for at least one year prior to study onset; a minimum migraine frequency of 4 migraines/month; the ability to provide written informed consent; and commitment to participate in periodic written self-assessments. Exclusion criteria included the following: females younger than 18 years or older than 50 years of age; males; individuals diagnosed with analgesic overuse headache or painful cervical nerve compression syndrome; and inability to provide written informed consent. Other exclusion criteria included ongoing use of antipsychotic or antidepressant medications, daily use of benzodiazepines or narcotic medications, drug or alcohol abuse, pregnancy, or plans to become pregnant during the study.
Data collection
Subjects completed a weekly online diary, in which the number of discrete migraines (defined as severe headache with phonophobia, photophobia, and nausea) was self-reported. Migraines that lasted for more than 1 day were tallied as a single event, while migraines that occurred after subjects had been migraine-free for 24 hours were tallied as separate events. Of note is that the duration and intensity of migraines were not quantified in this study. Subjects also completed a validated migraine-specific QoL survey at the onset of the study and at monthly intervals throughout the treatment period (Migraine-Specific Quality of Life Survey questionnaire; MSQLS, 14-question version [22, 23]. Study subjects recorded the number of migraine medications used each week, independent of dosage. Medications were grouped as follows; 1) over-the-counter analgesics, 2) narcotics, 3) triptans, and 4) preventive migraine medications. Subjects collected 4 weeks of baseline data prior to their first Kiatsu therapy session, thereby serving as their own historical controls. After this baseline period, subjects underwent four weekly Kiatsu therapy sessions during the first month, followed by additional sessions of Kiatsu once a month for five months; the overall duration of the study was six months.
Ki Training and Kiatsu Therapy
The initial study visit (session 1) lasted 1 hour, while subsequent sessions were 30 minutes. During session 1, subjects were taught a technique referred to as ‘Keeping One Point’ [24]. This technique involves a precise method for training individuals to sit and stand with good posture while focusing one’s mind on center of balance, with the purpose of improving postural habits and reducing stress. Once learned, this technique can be performed in 3-5 seconds. All subjects readily mastered the technique during their first session, as assessed using physical tests for balance and stability administered by a skilled practitioner (90% of the time provided by CT, 10% of the time by TC). Once trained, subjects were instructed to practice these techniques at least 100 times per day, as a strategy to reinforce their understanding of the process.
Subjects then received Kiatsu[17] from an advanced practitioner (90% of the time provided by CT, 10% of the time by TC). During each session, the practitioner applied light/moderate pressure with their hands to different areas of the head, neck, upper back, and shoulder blades. This process was continued until tight muscles in the neck and back began to relax. Although the duration of each Kiatsu session varied depending on each subject’s responsiveness, they typically lasted an average of ~15 minutes.
Subjects were also taught a simple meditation exercise called ‘Ki meditation’[24]. For this method, subjects were instructed to sit comfortably and practice keeping one point (as described above), with the goal of ensuring that they maintained good posture while focusing on their center of balance. To initiate Ki meditation, subjects were then instructed to visualize energy moving infinitely in all directions, using a simple sequence of guided imagery. In addition, subjects were taught a gentle deep breathing technique called ‘Ki breathing’ [25, 26], involving repeated cycles of long, relaxed exhalations (through the mouth) followed by gentle inhalations (through the nose) while being coached to maintain relaxed posture. After learning these techniques, subjects were instructed to practice Ki meditation for 1−2 minutes followed by Ki breathing for 2−5 minutes before bedtime daily. The goal of this combined exercise was to improve sleep quality [20].
Subjects returned weekly during the first month for a total of four sessions. Instruction in how to correct posture and mental focus (‘keeping one point’), practice Ki meditation, and perform Ki breathing was repeated at the beginning of each of these sessions. Kiatsu was also provided during each session, as described above. Subsequently, subjects received additional sessions of Kiatsu once a month for the following 4-5 months (depending on their individual schedules). Subjects documented the number of migraines and medication usage on a weekly basis; most subjects also recorded QoL assessments throughout the study (Table 1).
Table 1
Summary of study data included in analysis
Number of Migraines | Quality of Life |
---|
Subject # | Data available; months (n) | Subject # | Data available; months (n) |
2 | 7 | 6 | 7 |
4 | 7 | 9 | 7 |
6 | 7 | 17 | 7 |
7 | 7 | 4 | 6 |
8 | 7 | 7 | 6 |
9 | 7 | 8 | 6 |
13 | 7 | 13 | 6 |
15 | 7 | 15 | 6 |
16 | 7 | 16 | 6 |
17 | 7 | 19 | 6 |
19 | 7 | 20 | 6 |
20 | 7 | 28 | 6 |
21 | 7 | 31 | 6 |
22 | 7 | 2 | 5 |
23 | 7 | 22 | 5 |
28 | 7 | 30 | 5 |
30 | 7 | 21 | 4 |
31 | 7 | 26 | 4 |
32 | 7 | 32 | 4 |
1 | 6 | |
18 | 6 |
Total (n) | 21 | 19 |
Number of Migraines ≥ 6 months of data (n = 21) |
Quality of Life ≥ 4 months (n = 19) |
Statistical Analysis
Data were analyzed using Microsoft Excel. Categorical variables (number of migraines per month, QoL and medication usage) were assessed for significance using a single factor ANOVA test with an alpha value of 0.02 for complete data sets. Significance of variations for each month compared to baseline month was assessed using a two-sample Student’s t-Test assuming equal variances. Data sets with a p-value of < 0.02 for t_stat ≤ t_criticial were considered to not meet the null hypothesis (i.e. significant variations were observed). In most cases p-values were < 0.001.