Research Protocol
April 3, 2014
The effectiveness of acupuncture for the symptomatic relief of chronic frontal tension-type headache:
A randomized controlled trial of adult patients seen at the PGH outpatient department
Main Investigator: Dr. Emille May Almeda, MD
(resident, Department of Family and Community Medicine, Philippine General Hospital)
Co-Investigator: Dr. Philip Niño Tan-Gatue, MD
(consultant, Department of Family and Community Medicine, Philippine General Hospital)
Abstract:
Background
Tension-type headache is one of the common complaints in primary care clinics. However,
with increasing frequency of episodes, use of pain medications alone may be insufficient.
This study aims determine if acupuncture can be a valuable option for these patients.
Objectives
This study aims to determine the effectiveness and safety of acupuncture as an adjunct to
use of pain medications for the symptomatic relief of patients with chronic tension type
headache
Study Design
This is a six week randomized open-label study
Setting
The study will be conducted at the Traditional Medicine Clinic located at the Philippine
General Hospital Outpatient Department (PGH OPD).
Patients
Patients assessed to have chronic frontal tension-type headache will be screened for study
1
eligibility within a week prior to the start of trial. A minimum of 14 participants will be
randomized in a 1:1 ratio to either be part of the treatment or control group.
Interventions During the six week study, patients may receive either 5 sessions of acupuncture plus pain
medications (treatment group) or pain medications alone (control group). Pain medications
will initially be taken as prescribed by their primary physicians and titrated accordingly.
Main
Outcome
Measures
To compare the proportion of patients achieving clinically significant headache intensity
(measured by at least 2 points decrease in VAS from baseline) and the proportion of patients
achieving clinically significant decrease in symptom frequency (at least 50 % decrease
frequency from baseline) after six weeks of the clinical trial.
Adverse side effects of groups to both acupuncture and pain medication therapy will also be
documented per study visit.
Data Analysis
Sample size was computed from previous literature on patients presenting with tensiontype headache, regardless of frequency. As it is estimated that 1 – 3 % of the general
population presents with chronic tension-type headache and that frontal location of
headaches occurs approximately 30.4 % of the time, the minimum sample size to be studied
per subgroup would be 7.
Demographic and baseline characteristics will be compared between the two study groups
using the t-test (continuous variables) or chi-square test (categorical variables). Test for
means will be done using ANCOVA.
Conclusion
It is hypothesized that patients with chronic frontal tension-type headache treated with
acupuncture in addition to pain medications will have a statistically and clinically significant
difference in terms of improvement of symptoms in comparison to the control group.
2
INTRODUCTION
I. Background of the Study
Epidemiological studies indicate that tension-type headaches are widely prevalent and account
for one of the main reasons for primary care consultation. It is the most common type of primary
headache.
The International Headache Society (2004) describes tension-type headache as pain that is
typically mild to moderate in intensity, occurs bilaterally and is pressing or tightening in quality. They
may occur with either photophobia or phonophobia. Nausea, vomiting and worsening with physical
activity are not characteristic features of this condition.
Further subdivisions of tension-type headache fall into three categories, based on frequency of
headache attacks. Infrequent episodic tension-type headache occurs less than 1 day per month on
average. Frequent episodic tension-type headache occurs from 1 to less than 15 days per month for
more than 3 months. Lastly, there is chronic tension-type headache.
Chronic tension-type headache occurs on 15 or more days of the month on average for more
than 3 months, or more than 180 days per year. Patients with chronic tension headache have symptoms
which may last hours or are continuous. Estimates report that chronic tension-type headache affects 1 –
3 % of adults (WHO, 2012).
The European Federation of the Neurological Societies (EFNS) recommends that simple
analgesics such as paracetamol or aspirin and non-steroidal anti-inflammatory drugs are effective for the
treatment of sudden attacks of tension-type headache. However, this same guideline noted decreasing
efficacy of these pain medications associated with increasing frequency of headaches.
With this, the EFNS cautions the overuse of pain medications and states that the use of nondrug treatment, such as acupuncture, may be a valuable option for patients with tension-type headache
3
even though the scientific basis is limited. The WHO also notes that large clinical trials failed to
distinguish between acupuncture and sham procedures (WHO, 2007).
Acupuncture involves the insertion of thin needles through the skin at strategic points on the
body (Mayo Clinic, 2012).
In traditional Eastern practice, pain is thought to result from blockage or stagnation of the
normal movement of energy or “qi” in a particular area. Acupuncture stimulates the underlying points
and channels to correct and maintain smooth flow of the qi along the body.
In comparison, for Western practices, it is believed that acupuncture causes the release of
neurochemical messenger molecules from the brain and spinal cord. These molecules which include
endorphins, adenosine, neuropeptide Y and serotonin, change how stress is perceived and reduces pain
sensitivity (Kelly, 2009).
Acupuncture is generally well tolerated in clinical settings with few adverse effects. Mild adverse
effects include tiredness, local pain and temporary exacerbation of symptoms. More significant effects
include nausea, fainting, severe or prolonged exacerbation of symptoms and strong emotional reactions.
There have also been reports of pneumothorax or serious infection as a result of acupuncture, but these
are rare events (Kelly, 2009).
Various studies have attempted to establish that acupuncture therapy does indeed alleviate
symptoms of tension-type headache (Bovey, 2013) (Endres, 2007) (Granato et al, 2010) (Kelly, 2009)
(Linde et al, 2011), (Melchart, 2005), (Sun and Gan, 2008) (Vickers et al, 2010) (Vickers, 2004).
Control groups include use of medication therapy alone and use of other non-drug management
like physiotherapy and neuromuscular stimulation. Sham acupuncture also has been used as a control
option and includes non-penetration to superficial needle insertion, insertion at non-acupuncture points
and insertion at points not indicated for the condition under study (Vickers, 2004).
4
Yet, despite the number of studies conducted regarding acupuncture for the treatment of
tension-type headache, consensus has been divided.
A systematic review (Sun, 2008) showed a trend in favor of acupuncture versus sham
procedures. This review also indicated that acupuncture was superior to medication therapy for
headache intensity, frequency, physical function and response rate.
More support for acupuncture therapy includes a Cochrane Database system review (Linde,
2011) on eleven trials. Results for this review found statistically significant short-term benefits (within 3
months) of acupuncture over medication control. Benefits included treatment response, number of
headache days and pain intensity. Long-term benefits of acupuncture lasting beyond three months of
treatment were not investigated. This review also noted small, but still statistically significant, benefits of
acupuncture over sham therapy.
Another randomized controlled trial (Vickers, 2004) used 12 sessions of acupuncture therapy
over a course of three months. This was compared to a control intervention offering standard care.
Results indicated that headache scoring was lower in the acupuncture group and also used 15% less
medication, made 25% fewer visits to their general practitioners and took 15% fewer days off sick.
Other studies, meanwhile, do not make as much of a generalization in terms of the benefits of
acupuncture therapy for tension-type headache.
A randomized trial by Endres (2007) reported that although tension-type headache does indeed
improve with acupuncture therapy, sham acupuncture also produces comparable results.
Another randomized study by Melchart (2005) also noted that acupuncture had a significant and
clinically relevant effect over no treatment but that minimal acupuncture (superficial needling distant
from traditional acupuncture points) also had a similar effect.
5
To stress this further, a meta-analysis indicated that compared to acute treatment only or
pharmacological prophylaxis, acupuncture may reduce headache frequency but that there was no
significant difference in comparison with a sham intervention (Linde, 2009).
Variance in trial outputs has been attributed to several factors. One of the more common
problems encountered with assessment of acupuncture studies is the standardization of treatment.
Systematic reviews of randomized controlled trials of acupuncture for headache indicate that
most Chinese studies have used a fixed treatment protocol whereas those in the West have tended to be
semi-standardized. With these scenarios, external validity to treatment response may have been
compromised (Bovey, 2013). Acupoints tend to vary per patient according to what was deemed fit by the
acupuncture specialists.
Duration of treatment provided has also been debated. The systematic review conducted by
Sun and Gan (2008) included studies averaging 10 sessions (range of 6 – 16 sessions) during a mean of 8
weeks (range of 4 – 24 weeks). A study conducted by Ahn et al (2011) noted pain alleviation to be
significantly different after the fifth and sixth acupuncture sessions for patients with headache.
Other common problems encountered include lack of adequate blinding strategies as well as
poorly defined outcomes and duration of observation of studies (Sun, 2008).
The studies on acupuncture and tension-type headache also included patients with different
duration and frequency of symptoms. There is no definite consensus of the role of acupuncture for
patients with chronic tension-type headache.
With these disagreements on the effectiveness of acupuncture therapy for tension-type
headache, medical literature has recommended the need for additional research using adequate
strategies, controls and tools to further address the issue. By doing so, a more stable recommendation
can be made to aid physicians in caring for their patients with chronic tension-type headache.
6
II. Statement of the Problem
The use of analgesics has been the standard of care for patients diagnosed with tension-type
headache. However, the increased frequency of attacks in chronic tension-type headache can be
debilitating and less responsive to use of pain medications. Management for this condition, therefore,
may entail a high economic burden and affect quality of life.
Previous clinical trials have considered acupuncture as one of the strategies aimed at addressing
this therapeutic dilemma. However, disagreements arise regarding actual effectiveness and
standardization of treatment and as such, a clear-cut recommendation for the use of acupuncture
therapy in management of tension-type headache is still at large.
III. Research Question
“Among adult patients with chronic frontal tension-type headache, will acupuncture as an
adjunct to pain medication intake provide significant symptom relief (measured by decreased frequency
of symptoms and VAS) in comparison to pain medications alone in a randomized control trial?”
This question is based on the hypothesis that the addition of acupuncture to standard medical
care will increase the chances for symptomatic relief.
The frontal portion of the head was chosen to be able to standardize specific acupoints. It is also
the most commonly involved region for headaches with an estimate of 30.4% (Tahir et al, undated).
7
III. Research Objectives
1. General Objective
To determine the effectiveness and safety of acupuncture as an adjunct to use of pain
medications for the symptomatic relief of patients with chronic tension type headache
2. Specific Objectives
a) To compare patients’ subjective report of frequency of symptomatic headache days after six
weeks of acupuncture therapy adjunct to pain medications versus frequency of symptoms in
patients using pain medications alone
b) To compare the patients’ subjective report of severity of headache episodes (measured by VAS)
after six weeks of acupuncture therapy adjunct to pain medications versus severity of headache
in patients using pain medications alone
c) To document the side effects reported by patients after acupuncture therapy adjunct to pain
medications and the side effects reported by patients using pain medications alone
8
RESEARCH FRAMEWORK
I. Conceptual Framework
Management of chronic tension-type headache tends to be challenging because of an
altered perception to pain. There is note of hypersensitivity of neurons, which is then translated as pain
in the cerebral cortex. This neuronal hypersensitivity is believed to be aggravated by various physiologic
and psychogenic stressors such as muscle tension, fatigue and anxiety.
Acupuncture therapy promotes release of molecules such as endorphins, adenosine,
neuropeptide Y and monoamines, which are associated with decreased pain sensitivity. It is in line with
this concept that this model (Fig 1) was constructed.
Physiologic Factors
- Muscle tension
- Sleep deprivation
- Fatigue
- Postural habits
- Hunger
Psychogenic Factors
- Emotional Stressors
- Anxiety
- Depression
Aggravates
Aggravates
Molecular Release
- Endorphins
- Adenosine
- Serotonin
- Neuropeptide Y
- Monoamines
- Emotional
stressors
- Anxiety
- Depression
Acupuncture
Neuron Hypersensitivity
Alters
Heightened Pain Perception
Acupuncture
Chronic tension-type headache
Figure 1. Conceptual Framework
9
RESEARCH METHODOLOGY
I. Design of the Study
This is a 6-week randomized open-label study to be conducted at the Philippine General Hospital
Outpatient Department (OPD).
Patients seen at the OPD will be assessed for study eligibility prior to the start of trial. Eligible
participants will then be randomized in a 1:1 ratio to receive either 5 sessions of acupuncture plus pain
medications (treatment group) or pain medications alone (control group).
All participants will be instructed to take their pain medications as prescribed by their primary
care physicians and may include, but are not limited to; Paracetamol, NSAIDs and weak opioids. Titration
of dosage and frequency for use of pain medications will be conducted as seen fit and reported
accordingly.
Should any participant in the control group prefer to be in the treatment group, they will be
offered the respective acupuncture sessions without charge after the study duration has been
completed.
Adult patients with chronic tension-type headache
N=
Inclusion/Exclusion Criteria
Excluded
N=
Treatment Group
N=
Control Group
N=
5 sessions of acupuncture
+ pain medications taken
on a PRN basis
Pain medications taken on
a PRN basis
10
Figure 2. Study Design
II. Settings of the Study
Recruitment of participants will be conducted at the Philippine General Hospital Outpatient
Department (PGH-OPD). Screening and (if found eligible) subsequent follow-up for evaluations and
acupuncture sessions will be held at the Traditional Medicine Clinic, which is also located at the PGHOPD.
IV. Study Flow
This trial will be conducted over a course of six weeks at the Traditional Medicine Clinic. During
this period, patients are expected to follow-up for six sessions. Intention-to-treat analysis will be
conducted on participants who are not able to complete the allotted treatment duration.
At visit 1 (week 0), participants of both treatment and control groups will answer a baseline case
report form that will aid to determine the initial status of their headache (severity and attack frequency).
Patients within the treatment group will then be offered the first acupuncture session during this visit.
Five acupuncture sessions in total will be conducted for the treatment group (week 0 – week 5).
A maximum of 2 acupuncture sessions may be conducted in any given week. During each follow-up,
participants of both groups will be answering report forms that will assess study outcomes.
During the 6th visit (week 6), participants will then answer the final case report form.
Place the figure above in this space.
III. Study Population and Sampling Procedures
11
a. Inclusion Criteria
The study will include adult patients ages 19 years and above presenting at the Outpatient
Department of the Philippine General Hospital. They should be assessed to have chronic tension-type
headache by fulfilling the criteria specified by the International Headache Society (IHS) 2004, as follows:
A. Headache occurring on > 15 days per month on average for > 3 months (> 180 days per year)
and fulfilling criteria B – D
B. Headache lasts hours or may be continuous
C. Headache has at least 2 of the following characteristics:
1. Bilateral location
2. Pressing/tightening (non-pulsating) quality
3. Mild or moderate intensity
4. Not aggravated by routine physical activity such as walking or climbing stairs
D. Both of the following:
1. No more than one of photophobia, phonophobia or mild nausea
2. Neither moderate or severe nausea nor vomiting
E. Not attributed to another disorder
Moreover, pain should be located along the frontal portion of the head.
b. Exclusion Criteria
Patients are to be excluded if they are < 18 years old, pregnant and/or are unable to provide
informed consent. Exclusion criteria also includes those with acute to episodic frequency of headache
(non-chronic) and other types of headache (ex: migraine, cluster type, secondary headaches). Patients
12
who also have a history of acupuncture therapy for the same condition as the study or who have known
adverse reactions to acupuncture will also be excluded.
c. Insert paragraph for getting informed consent, randomization and concealment of allocation
d. insert paragraph to discuss the two interventions arms
Acupoints are standardized for all patients in the treatment group. These points were chosen
from literature indicating relief for headache symptoms. Insertion of stainless steel needles will be
performed by an acupuncture specialist. Perpendicular insertions will be done at a 90° angle, oblique
insertion at 45° and transverse insertion at a 10 - 20° angle.
There will be five acupoints per patient, done bilaterally. Acupoints include the following:
Acupoint
Location
Insertion
Large Intestine 4
Along the depression of the flesh between the 1st and 2nd metacarpal bone.
0.5 – 0.8 inch
(LI 4)
perpendicular
Stomach 36
Three body inches below the knee and roughly 1 inch lateral to the crest of
0.5 – 1.5 inch
(ST 36)
the tibia
perpendicular
M-HN-3
Along the glabella, between the medial ends of the eyebrows
0.2 – 0.5 inch
(Yin Tang)
transverse
M-HN-9
In the depression about 1 inch posterior to the midpoint between the
0.3 – 0.4
(Taiyang)
lateral end of the eyebrow and outer cantus
backward
oblique
Du Mai 20
On the midline of the head, 5 body inches above the midpoint of the
0.3 – 0.5 inch
(DU 20)
anterior hairline. Approximately on the midpoint of the line connecting the
perpendicular
apexes of both ears
e. Insert paragraph on how to measure the outcomes
13
The objectives of this study are to compare the proportion of patients achieving clinically significant
headache intensity (measured by at least 2 points decrease in VAS from baseline) and the proportion of
patients achieving clinically significant decrease in symptom frequency (at least 50 % decrease frequency
from baseline) after six weeks of the clinical trial.
Adverse side effects of groups to both acupuncture and pain medication therapy will also be
documented per study visit. In addition, vital signs with physical examination and adjustment of pain
medications as needed, will be conducted and documented on all study participants at each clinic visit.
f. Sample Size and statistical analysis
We are planning a study of independent experimental cases (medicines plus acupuncture) and
controls (medicines only) with 1 control per experimental case. We assume that the failure rate for pain
control among medicines only is 50%. If the true failure rate for experimental subjects will be lower by
15% i.e. 35%, we will need to study 169 experimental subjects and 169 control subjects to be able to
reject the null hypothesis that the failure rates for experimental and control subjects are equal with
probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is
0.05. We will use an uncorrected chi-squared statistic to evaluate this null hypothesis.
Insert a paragraph on how data management and analysis will be done.
14
References
Acupuncture: Definition. (2012). Mayo Clinic.
Acupuncture: Review and analysis of reports on controlled clinical trials. (undated). World Health
Organization.
Acupuncture and Headache. (July 2011). Headache. British Acupuncture Council.
Ahn, et al. (2011). Journal of Acupuncture and Meridian Studies. Vol 4 (1): p 29 – 43.
Bendtsen, L. et al. (2010). EFNS guideline on the treatment of tension-type headache – Report of an EFNS
task force. European Journal of Neurology.
Bovey, M. (February 2013). Acupuncture for Headache. ACNR. Vol 1 (6).
Ellis, A. et al. (1991). Fundamentals of Chinese Acupuncture. Massachusetts, U.S.A.
15
Endres, H.G. (2007). Acupuncture for tension-type headache: a multicentre, sham-controlled, patientand observer-blinded, randomised trial. Journal of Headache Pain. Vol 8: p 306 – 314.
Granato, A. et al. (June 23, 2010). Acupuncture in tension-type headache. Neuroepidemiology. 35: p 160
– 162.
Informed Consent Form Template for Clinical Studies. (undated). World Health Organization.
Kelly, R.B. (September 1, 2009). Acupuncture for pain. American Family Physician. Vol 80 (5), p 481 – 484.
Linde, K. et al. (May 23, 2011). Acupuncture for tension-type headache. Cochrane Database System
Review.
Melchart, D. et al. (July 29, 2005). Acupuncture in patients with tension-type headache: randomised
controlled trial. BMJ.
Migraine and Tension Headache Diagnosis and Treatment Guideline. (May 2011). Group Health
Cooperative
NIH Consensus Development Conference on Acupuncture. (November 1997). Bethesda, Maryland.
Sun, Y., and Gan, T.J. (2008). Acupuncture for the management of chronic headache: A systematic
review. International Anesthesia Research Society. Vol 107 (6) p 2038 – 2047.
Tahir, M.U. et al. (undated). Headache Prevalence, Patterns and Symptoms Amongst Medical Students at
Fatima Memorial College, Lahore.
The International Classification of Headache Disorders. 2nd edition. (2004). International Headache
Society.
Vickers, A.J. et al. (2010). Individual patient data meta-analysis of acupuncture for chronic pain: protocol
of the Acupuncture Trialists’ Collaboration.
Vickers, A.J. et al. (November 2004). Acupuncture of chronic headache disorders in primary care:
randomised controlled trial and economic analysis. Health Technology Assessment. Vol 8 (48).
16
Woolhouse, M. (August 2005). Migraine and tension headache: A complementary and alternative
medicine approach. Australian Family Physician. Vol 34 (8).
World Health Organization. (October 2012). Headache Disorders. Fact Sheet.
World Health Organization and European Headache Federation. (2007). Lifting the Burden: The Global
Campaign to Reduce the Burden of Headache Worldwide. Journal of Headache Pain 8:S2.
V. Study Time Line
2013
TASK
Jn - A
O-D
2014
J
F
M A
M
J
J
2015
A
S
O
N
D
J
F
M
A
M
J
J
A
S
O
Writing of
Proposal
Technical
Review
Proposal
Defense to
Panel
Editing of
Proposal
Submission &
Approval by
EHRO
Data
Collection
Data Analysis
Writing of
Final Paper
Presentation
of results to
Panel
Submission
for
Publication
17
N
D
VI. Expected Outcomes
VII. Budgetary Requirement
Operating and maintenance costs
7,000
Materials and supplies
2,000
Final paper handling
1,000
TOTAL
P 10,000
18
Acupuncture and Chronic Frontal Tension-Type Headache RCT
CASE REPORT FORM
Part I. (Screening)
The effectiveness of acupuncture for the symptomatic relief of chronic frontal tension-type headache:
A randomized controlled trial of adult patients seen at the PGH outpatient department
DATE:
CASE NO.
PROTOCOL ID NO.
NAME:
AGE:
SEX:
 Male
 Female
CONTACT NO.
INCLUSION CRITERIA:
PLACE OF RESIDENCE:
YES
NO
1. Adult patients age 19 years old and above
2. Pain is localized along the frontal portion of the head only
3. Diagnosed with chronic tension-type headache
19

Headache occurring on > 15 days per month on average for > 3
months (> 180 days per year)

Headache lasts hours or may be continuous

Headache has at least 2 of the following characteristics:
a)
Bilateral location
b)
Pressing/tightening (non-pulsating) quality
c)
Mild or moderate intensity
d)
Not aggravated by routine physical activity such as
walking or climbing stairs

Both of the following:
a)
No more than one of photophobia, phonophobia or
mild nausea
b)
Neither moderate or severe nausea nor vomiting
If any of the inclusion is ticked NO, the patient is not eligible for the study
EXCLUSION CRITERIA:
YES
NO
1. Pregnant
2. Headaches attributed to another disorder
3. Acute to episodic frequency of headache
4. Previously underwent acupuncture therapy for the same
headache complaint
5. Unable to provide informed consent
20
6. Known adverse event to acupuncture therapy
If any of the exclusion is ticked YES, the patient is not eligible for the study
If all the inclusion were fulfilled and none of the exclusion criteria, please proceed to part II
Part II. (Baseline Case Report)
CIVIL STATUS:
EDUCATION LEVEL:
EMPLOYMENT:
 Single
 None
 Vocational
 None
 Married
 Elementary
 College
 Employed
 Separated
 High School
Post-graduate
 Self-employed
 Widow/er
CO-MORBIDITIES:
 Hypertension
 Diabetes
CURRENT PAIN MEDICATIONS:
 Allergies (please specify)
(please indicate drug, dose and current frequency of use)
___________________
 Bronchial Asthma
1. _____________________________
 Tuberculosis
 Operations (specify)
 Dyslipidemia
____________________
2. _____________________________
 Stroke
 Others:
3. _____________________________
_________________________________
Place an X-mark on the line to indicate the current headache severity
(Markahan ng X ang linya kung saan tumutugma ang kasalukuyang tindi ng sakit ng ulo)
21
Calculated VAS score =
How often do you experience headaches in a week?
(Gaano kadalas kayo nakararamdam ng pananakit ng ulo sa isang linngo?)
Part III. (Case Report Form Per Follow-Up Session)
DATE:
NUMBER OF VISITS:
VITAL SIGNS:
CURRENT PAIN MEDICATIONS:
BP
_____
(please indicate drug, dose and current frequency of use)
HR
_____
1. _____________________________
RR
_____
2. _____________________________
Temp _____
3. _____________________________
Place an X-mark on the line to indicate the current headache severity
(Markahan ng X ang linya kung saan tumutugma ang kasalukuyang tindi ng sakit ng ulo)
22
Calculated VAS score =
How often do you experience headaches in a week?
(Gaano kadalas kayo nakararamdam ng pananakit ng ulo sa isang linngo?)
Please indicate any side effects associated with acupuncture therapy
(Pakisulat ang mga pangalawang epekto ng acupuncture na naidulot sa inyo)
CONSENT FORM
Magandang umaga!
Ako si Dra. Emille May Almeda, residente ng Departamento ng Family and Community Medicine
ng Philippine General Hospital (PGH). Kasalukuyan kaming gumagawa ng pag-aaral na pinamagatang,
“Acupuncture as an adjunct to pain medication for the symptomatic relief of chronic frontal tension-type
headache: A randomized controlled trial of adult patients seen at the PGH outpatient department”.
Bibigyan ko kayo ng impormasyon at imbitasyon na makilahok sa proyektong ito. Hindi ninyo
kailangang mag-desisyon sa araw na ito kung kayo ay papayag na makilahok. Sakaling may mga
katanungan kayo ukol sa pag-aaral, ipagbigay alam ninyo para ating talakayin.
Ukol sa Pag-aaral
Ang tension-type headache ang pinaka-karaniwang dahilan kung bakit sumasakit ang ulo ng
isang tao. Kadalasan, natutugunan ito sa paggamit ng mga gamot para sa kirot o pain relievers. Subalit
napagalaman na hindi na masyadong tumatalab ang pain relievers sa mga pasyenteng paulit-ulit at
matagal nang nakakaramdam ng ganitong sakit. Sa ganitong paraan, nais naming alamin kung ang
acupuncture ay isang posibleng solusyon para sa ganitong karamdaman.
23
Ang pagsali niyo sa pag-aaral na ito ay kusang-loob. Sakaling hindi kayo pumayag na makilahok,
pwede pa rin kayong makinabang sa lahat ng serbisyo ng hospital. Maaari ding magbago ang isip niyo na
sumali sa pag-aaral kahit nakapag-bigay na ng paunang kasunduan.
Mayroong dalawang grupo dito sa pag-aaral; isang grupo ng mga pasyenteng bibigyan ng pain
relievers (control group) at isang grupo na dadanas ng acupuncture karagdagan sa pag-inom ng pain
relievers (treatment group). Random ang pagsali sa mga grupo, ibig sabihin ay walang makakapagpili
kung saang grupo maisasama. Sakaling napunta ka sa control group at nais mong makaranas ng
acupuncture, maari mong maranasan ito ng libre pagkatapos ng pag-aaral.
Ang pag-aaral ay magtatagal ng 6 na linggo at gaganapin sa Traditional Medicine Clinic ng PGHOPD. Nilalayon ng pag-aaral na ito na ihambing ang 2 grupo base sa paggaling ng kanilang
nararamdamang sakit.
Ang 2 grupo ay papayuhang uminom ng pain relievers tuwing sasakit ang ulo. Maaari ding
dagdagan o baguhin ang mga gamot para mas matugunan ang kasalukuyang nararamdaman.
Maaaring makaramdam ng sakit at kaunting pagdurugo sa acupuncture. Maaari ding makadanas
ng ibang epekto buhat ng acupuncture. Pinapangako namin na susundan namin ang kalagayan niyno.
Kung kinakailangan, tatalakayin natin kung nararapat ipagpatuloy o ihinto ninyo ang acupuncture.
Ang lahat ng personal na impormasyong matitipon ay mananatiling kompidensyal. Ipagbibigay
alam din sa inyo ang kalalabasan ng pag-aaral.
If mayroon pa kayong karagdagang katanungan, ipagbigay alam sa sumusunod:
Dra. Emille May Almeda
Departmento ng Family and Community Medicine, Philippine General Hospital
09326159997
24
Sertipiko ng Pagsang-ayon
Nabasa ko ang mga impormasyon ukol sa pag-aaral o di kaya’y mayroong nagbasa para sa akin.
Naipaliwanag sa akin ang pag-aaral at nabigyan ako ng oportunidad na makapagtanong. Pumapayag ako
na maging kalahok ng pag-aaral na ito.
Pangalan ng Kalahok __________________
Lagda ng Kalahok
___________________
Petsa ___________________________
Pahayag ng Tagapagpananaliksik
Ipinabasa ko o binasa ko ng tama sa potensyal na kalahok ang impormasyon ukol sa pag-aaral na
ito. Ako ay nagbibigay patunay na nagkaroon ng oportunidad ang kalahok para makapagtanong at
tinugunan ko ang mga katanungang ito sa abot ng aking kaalamanan. Ako rin ay nagbibigay patunay na
kusang-loob ang pakikilahok ng pasyente sa pag-aaral at walang sinu man ang pumilit sa kanya.
Isang kopya nitong consent form ay nilaan para sa kalahok.
______________________________
25
Dra. Emille May Almeda
Petsa ___________________________
26