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most cases episodic. Attacks of highly variable frequency and
duration are characterized by mild-to-moderate headache without associated
symptoms, although pericranial tenderness may be present. In a minority of
cases the disorder evolves, with increasingly frequent headache and sometimes
loss of episodicity .According to who, globally, headache disorders affect
approximately 40 percent of the population in 2021, and are more common in
females compared to males. Tension type headache and other headaches can affect people’s
ability to work, through decreased productivity, and interpersonal relationships.
Headache-related productivity loss may affect people’s careers and/or
security, financial situation, relationships, and mental health. The current
line of treatment is with Non-steroidal anti-inflammatory drugs are the
primary treatment options for aborting TTH episodes. Various
interventions have been reviewed, addressing the effectiveness and safety of
nondrug treatments such as acupuncture and cognitive behavioral therapy being
used alongside drug therapies anticonvulsants, noradrenergic and specific
serotonergic antidepressants, NSAIDs, opioid analgesics, serotonin reuptake
inhibitor antidepressants, and tricyclic antidepressants adverse effects appear, which commonly
include dry mouth, drowsiness, urinary retention, cardiac arrhythmias, and
glaucoma. Homoeopathy
with its scientific holistic approach helps understanding the individual who
is suffering from Tension Type Headache & not just the disease. Thus,
offering relief in most gentle and comprehensive way. The
psychobiological determinants of our emotions were recognized by Dr.
Hahnemann long before the modern science proved it through Observations and
various experiments. He insisted that in all illness, the physician must
study the mind and the body and study how each interacts with the other
AIMS AND
OBJECTIVES
Primary
Objective
To
assess the effectiveness of Individualised Homoeopathic Medicine in
management of Tension Type Headache among adults
Secondary
Objective 1
To
compare the patient pre-treatment and post treatment score for Tension Type
Headache on HIT 6 Questionnaire & VAS Scale
Secondary
Objective 2
To
arrive at a group of remedies (Homoeopathic medicines) indicated in the
management of Tension Type Headache among adults
MATERIALS
AND METHODOLOGY
1. STUDY
DESIGN An
Experimental Non-Controlled Study
2. STUDY SETTING Cases of
Tension Type Headache will be recruited from outpatient department of the
institute
3. STUDY POPULATION Clinically
diagnosed cases of Tension Type Headache except Probable Tension Type
Headache
4. DURATION OF STUDY 18 months.
5. METHODS
OF SELECTION OF STUDY SUBJECT
INCLUSION
CRITERIA:
a.
Patients above the age of 18 yrs
b.
Patients clinically diagnosed with Infrequent Episodic Tension Type Headache,
Frequent Episodic Tension Type Headache, Chronic Tension Type Headache as per
ICHD-3 diagnostic criteria
c.
Patients of all sexes
d.
Patients willing to give informed written consent
EXCLUSION
CRITERIA
a.
All types of headache according to ICHD-3 beta version except Tension Type
Headache
b.
Probable Tension Type Headache
c.
Suspected Immunocompromised patients
d.
Pregnant and lactating woman
e. Patient
taking any other mode of treatment
SUBJECT WITHDRAWAL
CRITERIA
a.
Patient who does not wish to continue the treatment.
b.
Patients not coming for follow up regularly
c.
Patients who withdraw their consent to continue the homoeopathic treatment
further
d.
Patients who are not taking their prescribed medications timely
e.
Patient taking complementary or alternative medicine or any other treatment
modalities for TTH
6.
METHOD OF SELECTION OF COMPARISON OR CONTROL GROUP AND MATCHING CRITERIA Not Applicable
7.
SPECIFICATION OF INSTRUMENTS AND RELATED MEASUREMENTS
1.
Standardized Homoeopathic Case Taking format
2.
Outcome Assessment Tool
Pre-validated
Visual Analogue Scale (VAS) A common method to assess pain intensity is
using a Visual Analogue Scale (VAS), a 10-point scale where 0 represents no
pain and 10 represent the worst possible pain.
Pain
Intensity Categories
o Mild: Scores of 1-3.
o Moderate: Scores of 4-7
o Severe: Scores of 8-10
Pre-validated
Headache Impact Test-6 (HIT-6) Score:
The Headache Impact Test-6 (HIT-6) was developed to measure a
wide spectrum of the factors contributing to the burden of headache, and it
has demonstrated utility for generating quantitative and pertinent
information on the impact of headache.
The HIT-6 consists of six items: pain, social functioning,
role functioning, vitality, cognitive functioning, and psychological
distress.
The patient answers each of the six related questions using
one of the following five responses: "never", "rarely",
"sometimes", "very often", or "always".
These responses are summed to produce a total HIT-6 score that
ranges from 36 to 78, where a higher score indicates a greater impact of
headache on the daily life of the respondent. Scores can be interpreted using
four groupings that indicate the severity of headache impact on the patient’s
life.
Outcome assessment criteria:
A sum score is calculated (range: 36-78) & severity level
is categorized as
1.
Little-to-no impact HIT 6 score- 36-49
2.Moderate
Impact HIT 6 score- 50-55
3.Substantial
Impact HIT 6 score- 56-59
4.Severe
Impact HIT 6 score-60-78
IMPROVED
A
Score of less than 49 is considered to be improved.
NOT
IMPROVED
A
Score of more than is considered to be not improved.
Outcome
will be assessed in terms of
1.
Improved
2.Not
Improved
These
criteria will be assessed as per the score of HIT-6 Score
Patients
Characteristic state with respect to Mental, Physical Generals and Physical Particulars
will be considered for the Outcome Assessment as improved or not improved
along with HIT-6 Score
1. SAMPLE SIZE calculated is 35
2. SAMPLING
TECHNIQUE: Non Probability Purposive Sampling Technique
3. METHODS OF DATA COLLECTION RELEVANT TO
OBJECTIVE:
1.
Non Probability Purposive sampling will be done.
2. Informed
written consent of 35 patients diagnosed with Tension Type headache will be
recruited from outpatient department of the institute and their cases will be
recorded.
3. Detailed
Homoeopathic case taking will be done as per the Proforma for collecting and
analyzing data prepared to arrive at Individualised Homoeopathic Medicine.
4. Depending
on the clinical presentation of the patient and totality erected, the patient
will be administered indicated Individualised Homoeopathic Medicine.
5.
Posology will be selected as per the requirement of the case
4. STUDY
INSTRUMENT/ DATA COLLECTION TOOLS:-
1.
Informed written consent will be taken.
2.
Complete Homoeopathic Case taking proforma.
3.
Visual Analogue Scale (VAS) & HIT 6 Questionnaire translated to mother
language & retranslated will be used to assess the severity of symptoms
before and after the treatment.
4. Appropriate
reference books like Homoeopathic Materia Medica, Medicine books, Organon
books, Pathology books, different homoeopathic journals and research papers
will be considered.
5. Appropriate Software will be used for repertorization of
case.
5. DATA MANAGEMENT AND ANALYSIS PROCEDURE:
1. Framing of totality of symptoms will be done as per
principles of Homoeopathy.
2 .Selection of remedy: Individualised Homoeopathic Medicine
will be given according to Totality of Symptoms after referring Materia
medica.
3. The Posology: Appropriate potency for each case will be
selected based on the susceptibility of each patient. Potency will be
modified as and when required.
4.
Duration of Study
a. Duration
of study : 18 months
b. Duration of each case : Each case will be
studied for 8 months or till relief of symptoms
c. Duration
of follow up: Each case will be followed up after 15 day or as and when required
d. Clinical
Outcome Assessment will be done at baseline, 1 month, 3 month, 6 month and at
termination of treatment.
6.
DATA ANALYSIS PLAN AND METHODS:
1.
Data collected will be compiled on MS Office Excel Sheet and will be
subjected to statistical analysis using an appropriate software like
SPSS(Statistical Package for Social Sciences). Descriptive statistics like
frequency (n) & percentage (%) of categorical data, mean & standard
deviation of numerical data in each time interval depicted.
2.
Normality of numerical data will be checked using Shapiro– Wilk test or
Kolmogorov-Smirnov test. Depending on the normality of data, statistical
tests will be determined.
3.Intra
group comparisons for a numerical continuous data following a normal
distribution will be done using paired t test (for 2 observations) else a non
parametric substitute like Wilcoxon signed rank test (for 2 observations)
will be used.
4.
Keeping alpha error (Type I error) at 5% and Beta error (Type II error) at
20%, power at 80%, p<0.05 will be considered statistically significant.
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