RUNNING HEAD: Qigong intervention for trigeminal neuralgia 1

Qigong intervention for trigeminal neuralgia: mindfulness, pain, and stress

Miquella A. Young

Arizona State University

QIGONG INTERVENTION FOR TRIGEMINAL NEURALGIA 2

Abstract

This intervention aims to examine feasibility, acceptability and preliminary efficacy of a

weekly medical qigong practice for patients with trigeminal neuralgia (TN). The only treatment

options available for TN are seizure medications and surgery, both of which are often ineffective

(Carlson, 2007). In search of less symptomatic and invasive treatment options, a daily medical

qigong practice may aid patients in tolerating the chronic pain of this debilitating condition.

Qigong is an ancient Chinese healing art that integrates elements of breathwork, gentle

movement patterns, meditation and the concept that our bodies function using the essential

element of “qi”, or energy (Lee, Pittler, & Ernst, 2009).

Thirty participants who suffer from TN will be recruited for this three-month study

through social media and physician recommendation. To evaluate the preliminary efficacy,

participants will be evaluated monthly using measures of perceived stress, mindful awareness,

general health, and pain. The participants will practice qigong for one hour each week in a group,

one their own, or in a one-on-one session with a medical qigong practitioner. The acceptability

and feasibility of this study is exploratory. However, it is hypothesized that participants will

experience lower levels and less frequent bouts of stress and orofacial pain associated with TN;

participants will experience increases in mindfulness and quality of life scores.

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Qigong intervention for trigeminal neuralgia: mindfulness, pain, and stress

With the opioid overdose crisis in full swing, it is natural to finally turn our heads away

from pharmaceutical drugs. The reality is that 43% of adults experience pain daily (CDC, 2016).

Evidence only supports short-term efficacy of opioids for reducing this chronic discomfort

(CDC, 2016). At the height of those who experience chronic pain are patients who suffer from

trigeminal neuralgia (TN). Trigeminal neuralgia is a degenerative nerve disorder causing extreme

unilateral orofacial pain (Zakrzewska, 2001). Their use of opioids among other symptomatic

medications, like carbamazepine and gabapentin, and surgery are their only treatment options

(Zakrzewska, 2001). Current treatments for the “suicide disease” leave patients without a cure or

consistent relief from their symptoms and may even add more to their list (Carlson, 2007).

The nervous system cannot regenerate (Zakrzewska, 2001). In trigeminal neuralgia (TN),

the break down of myelin around the trigeminal nerve causes unpredictable shooting pain attacks

that can last up to three minutes (Dworkin, 1998). Pain is a result of vascular compression, but

the etiology is otherwise unknown. According to cognitive behavioral therapy, pain is both a

sensory and emotional experience, "treatments that fail to take into account the behavioral and

psychological factors that are associated with orofacial pains likely will not work reliably"

(Carlson, 2007).

Although the pain cannot be eliminated, pain sensitivity can be reduced by building

confidence, self-efficacy, assurance, distraction, relaxation, and positive emotional states

(Carlson, 2007). Qigong is a practice that uses meditation to train the mind and raise these

qualities to new awareness levels. Patients suffering from trigeminal neuralgia don’t know what

the best form of treatment is, and they’re looking for answers (Zakrzewska, 2001). For some,

Qigong may be a new area of explorative healing.

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Unprecedented in TN care, qigong is an integrative approach to healing which involves

gentle movement patterns, breathwork, and a meditative mind (Jerath, 2016). Qigong stems from

the Han Dynasty in 206 B.C. and is based in the healing principles of the traditional Chinese

medicine system; it remains the primary system of practice in many eastern countries today. This

study explores how one branch of the practice, medical qigong, may be useful in mitigating the

pain experience on the physical level of neural-impulse modulation and in the cognitive space of

psycho-social engagement (Sancier & Holman, 2004). Pain, anger, and fear are processed in the

same part of the brain that are responsible for processing trigeminal pain (Carlson, 2007). By

inducing and holding the parasympathetic relaxation response, medical qigong may mitigate

trigeminal pain altogether or transmute the experience into something more tolerable.

This study will identify change for each participant in areas of stress, mindfulness,

general health, and the subjective pain experience. The transtheoretical model describes a

person's motivation and readiness to change, or in this case, willingly participate in the qigong

intervention (Raingruber & Haffer, 2001). This is both an intervention and behavioral model that

will be used to look at how each participant will either grow or remain stagnant while practicing

qigong to manage TN. It will aid in assessment of self-efficacy, change process, and decision

criteria for each participant (Raingruber & Haffer, 2001). Participant engagement in the five-step

process of precontemplation, contemplation, preparation, action, and maintenance will determine

the acceptability and feasibility of qigong for patients with TN.

The salutogenic model encompasses additional emotional and social factors and focuses

on health-enhancing behaviors and holistic perspective (Raingruber & Haffer, 2001). The

continuum spans ease to dis-ease instead of health to disease. TN fits on this continuum where

remission is a potential possibility with the intervention, but complete eradication of TN is not.
QIGONG INTERVENTION FOR TRIGEMINAL NEURALGIA 5

Thus, complete health is no longer restorable where ease may be. The salutogenic model is based

on creating a sense of coherence (SOC) where individuals and groups utilize their abilities,

resources, capacities, strengths and forces to perceive life as manageable, comprehensible, and

meaningful (Raingruber & Haffer, 2001). Generalized resistance (GRR) are another factor of this

model that will assist in overcoming hypothesized barriers to practicing medical qigong

(Raingruber & Haffer, 2001). GRR’s are internal and external tools for managing life and

increasing SOC. In the qigong intervention, participants will be given the chance to discover

some of these ancient tools for managing their mind and ultimately their stress and pain. If

nothing else, salutogenesis will help the team understand cognitive, behavioral, and motivational

factors determined by the participant's consistency of life experiences, overload-underload

balance, participation in decision making, social standing, family structure, work type, gender

and genetics as they relate to TN (Raingruber & Haffer, 2001).

This research is just one step in the collective movement towards integrative medicine.

There is no longer singular focus on reductionism or neglect of those practices which simply

have not received funding for research in the United States. Qigong has been practiced in eastern

cultures for centuries, healing perceivably incurable anomalies like cancer (Lefevere, 2007).

Conversely, the rarity of trigeminal neuralgia can only be explained utilizing imaging and

diagnostic tools of modern medicine (Bantick, et al.. 2002). Qigong for trigeminal neuralgia

brings best practices from both eastern and western ideologies into synchronicity. After three

months of consistent practice, patients with TN who have completed the weekly qigong exercise

at least 80% of the time will experience an increase in quality of life and mindfulness and

decrease in perceived stress and pain measures according to the Perceived Stress Scale (PSS),
QIGONG INTERVENTION FOR TRIGEMINAL NEURALGIA 6

Mindful Attention and Awareness Scale (MAAS), West-Haven Yale Multi-dimensional Pain

Inventory (WHYMPI), and the Short Form Health Survey (SFHS).

Methods

The study will be framed as an integrative approach to managing TN pain and

prescription-related symptoms and will not intended as an alternative form of treatment. Data

will be collected in a single-group, non-randomized, pre-post design to generate preliminary data

on the efficacy of medical qigong for patients with TN. The design will be used to attain

quantitative measures of pain, stress, mindfulness, and general health areas once a month for

three months, for four total assessments including the baseline.

All procedures involving human subjects will be approved by respective Institutional

Review Boards of participating institutions. Written informed consent will be obtained from all

participants.

Participants

Participants will be organized into a single, non-randomized group. The sample size of

thirty individuals was determined by instance of TN as a rare disease, with only 108,000 total

cases in the United States (Facial Pain Association, 2017). Participants will be recruited directly

through snowball sampling, physician referrals, and social networks. This may look like posting

messages on Facebook support groups for patients struggling with TN.

To meet eligibility criteria, participants must have medical records stating their diagnosis

of trigeminal neuralgia. Participants must have lived with the condition for at least six months

prior to the intervention start date. Persons are excluded if there is no prescribed medication in

use to treat TN as this may signal a misdiagnosis or underdeveloped form of the condition.

Medications included in this list are Tegretol (carbamazepine), Trileptal, Carbatrol, Dilantin,
QIGONG INTERVENTION FOR TRIGEMINAL NEURALGIA 7

Lamictal, Keppra, Topamax, Neurontin, Klonopin, and Lyrica. Those who take prescription

medications for other pre-existing conditions are eligible for the study upon reporting their use

and documenting any changes. Persons may participant in this study regardless of preliminary

stress and pain levels.

Qigong instructors must be certified by the state of Arizona and have at least ten years of

experience teaching qigong. To lead group classes, practitioners must have some experience with

medical qigong, but it does not have to be their main branch of qigong practice. For those

leading private subject-practitioner sessions, medical qigong must be the main branch of qigong

practice.

Intervention

The intervention will consist of an hour-long qigong practice, once a week for three months:

a group session on the first Sunday morning of each month, an at home video practice on the

second and fourth Wednesday of each month, which may be completed at any time of day, and

an evening subject-practitioner practice the third Friday of each month. Restroom breaks are

discouraged during the hour-long qigong session, but water breaks are encouraged. Each

participant will be required to sign in with the research team prior to beginning the session and

sign out when leaving. Each sign-in will require input of name, current ranking of stress, pain,

and happiness. Participants will receive qigong instruction in the same two movement patterns to

develop comfortability with the practice: healing qigong parts one and two.

Transportation to and from the group and individual meeting sites will not be provided.

Reminder messages will be sent to participants the day before and an hour before the Sunday and

Friday sessions that require participants to attend the intervention sites. Sunday group sessions

will be held at 10am at the Walter Art Gallery, home of Hug the Moon Qigong studio located at
QIGONG INTERVENTION FOR TRIGEMINAL NEURALGIA 8

6425 E. Thomas Rd., Scottsdale, AZ 85251. Friday sessions will be scheduled in accordance

with the participant schedules between 4-7pm. and held at Papago Park: 625 N. Galvin Parkway,

Phoenix AZ 85008.

Home Practice. The at home video will require access to a computer or a smart phone,

and Wi-fi or internet connection. The participant will receive the sequence, “healing qigong part

two” via e-mail and complete the same video session each week of the program. Each participant

must send a confirmation e-mail or text message to the primary researcher upon completion of

the at-home practice. The at-home practice may be completed at any time during the Wednesday

of that week. It may also be completed the preceding Tuesday or following Thursday if there are

personal scheduling conflicts.

For ten minutes participants will begin standing and stretching with attention to breathing

rhythms to relax the body. Breathing will be deep: inhaling for four counts, holding for four

counts, and exhaling for eight counts. The next thirty minutes will be spent in guided movement

patterns with easy-to-follow visual and auditory direction. The next five minutes will be spent in

breathing exercises that will energize the body. An example of this is called bellow’s breath: the

arms reach straight up as you inhale fully, the arms come straight down to land with your elbows

by your hips, and your hands in closed fists next to your shoulders while you forcefully exhale.

This will be done for twenty breaths following thirty-second resting periods. The twenty-breath

series is repeated three times. The last fifteen minutes will be spent in silent meditation, as

guided by the words of the instructor, with the eyes closed in a comfortable seated position. It is

up to participant’s discretion as to what to wear. Lose, comfortable clothing and an open, outdoor

space are strong recommendations.

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Group Practice. The group practice will follow the same pattern as above, but a slightly

different movement routine. “Healing qigong part one” will be guided by a live instructor.

Comfortable walking shoes that allow flexibility at the ankle joint are also strongly encouraged

in this outdoor setting. Modifications and seating will be provided for those in need of a lower

intensity practice. The group members are advised to intermingle with the other participants

before and after the session. Qigong practitioners and lead researchers will always be available

20 minutes before and after group sessions to tend to any questions and concerns the participants

may have.

Subject-Practitioner Practice. These meetings will begin with ten minutes of deep-

breathing exercises. For the next forty minutes the participant is guided through movement,

imagery and meditation in a sitting or lying position, depending on the preference of each

participant. This time will be divided up as the practitioner sees fits the participant’s unique

needs and recommendations. The remaining ten minutes are utilized for questions and other

conversation with the qigong practitioner about the practice. These may include discussion of

barriers or discomforts the participant may experience or the at-home and group experiences

with qigong.

These practices are standardized by the International College of Medical Qigong which

specializes in the Chinese Energetic Medicine through certification and practice requirements.

Participants may choose to stop practicing at any point if they feel they can no longer continue

with the exercises. This intervention will total twelve hours of participation in qigong practices,

approximately three hours in data recording, and varying intervals of travel time to and from

qigong sites twice per month.

Data Collection
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Using the WHYMPI, PSS, MAAS, and the SFHS, quantitative data will be taken at four

points in the study: before the intervention, one month, two months, and at the end of the three-

month intervention period.

West-Haven Yale Multi-Dimensional Pain Inventory (WHYMPI). WHYMPI measures

several important dimensions of the chronic pain experience. It examines the impact of pain on

the patients' lives, the responses of others to the patients' communications of pain, and the extent

to which patients participate in common daily activities through 2 pre-evaluation questions and

three short sections that containing 20 questions or less (Kerns, Terk, & Rudy, 1985).

Participants will be asked to rate pain and other factors on a 0-6 scale. Questions like, “how

sensitive is your spouse/caregiver to your pain problem?” are included in the scale.

Perceived Stress Scale (PSS). PSS is a psychological assessment that measures the

subjective or personal experience of stress (Cohen, Kamarck, & Mermelstein, 1983). It includes

general questions about levels of experienced stress through responses to thoughts and feelings

from the past month. Participants will be asked items such as, “In the past month, how often have

you been upset because of something that happened unexpectedly?” which are answered using a

0-4 (never to very often) scale. Participants will receive total a score from 0-40 points.

Mindful Attention Awareness Scale (MAAS). MAAS is a fifteen-item scale used to

describe levels of mindfulness, which is the sensitive awareness and observation of what is

taking place in the present moment (Brown & Ryan, 2003). It asks for a rating of day to day

experiences on a scale of 1-6, ranging from “almost always” to “almost never.” Scale items are

short statements like, “I find it difficult to stay focused on what’s happening in the present.”

Sensitive items from the scale may be, “I break or spill things because of carelessness, not
QIGONG INTERVENTION FOR TRIGEMINAL NEURALGIA 11

paying attention, or thinking about something else.” The scale takes about five minutes to

complete and participants will receive a score from 15-90 points.

Short Form Health Survey (SFHS). SFHS asks 11 questions about general health in the

past 4 weeks. It is a generic indicator of health status, with a focus on chronic medical and

psychological conditions (Ware & Sherbourne, 1992). It will take about fifteen minutes to

complete. Each question has 5-8 sub-sections and the response selections vary for each question.

Sensitive questions may ask about limitations in performing activities like walking up one flight

of stairs, requiring a response of, “a lot,” “a little,” or “not at all.” Other personal questions ask

how true or false a following statement is, such as, “I seem to get sick a little easier than other

people.” The participant will receive a score of 0-100 on physical functioning, role limitations

due to physical health, role limitations due to emotional problems, energy/fatigue, emotional

well-being, social functioning, pain, and general health which will be summarized into a physical

composite score and a cognitive composite score.

Analysis

Analysis will be performed using SPSS statistics program, version 24.0. SPSS is the

world’s leading statistics software, using ad-hoc analysis, hypothesis testing, and predictive

analysis (IBM Corp, 2016). This system will be used to make sense of overall stress,

mindfulness, pain, and general health levels as recorded from the SFHS, MAAS, PSS, and

WHYMPI. Data will be analyzed using these measures along with medical records and self-

reported medical-intake records. The analysis will be framed to primarily determine the

feasibility that patients with TN participate in each of the three forms of qigong practices. As

participation in each session holds weight in the analysis of practicality in this intervention, a
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trusting and personal relationship is encouraged between each participant, qigong instructor and

researcher involved.
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