Effectiveness of Individualised Homoeopathic Medicine in Management of Tension Type Headache among Adults An Experimental Non Controlled Study

INTRODUCTION

Tension
Type Headache is a primary and highly prevalent headache disorder, in

|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 DESIGNAn Experimental Non-Controlled Study

2. STUDY SETTINGCases of Tension Type Headache will be recruited from outpatient department of the institute

3. STUDY POPULATIONClinically diagnosed cases of Tension Type Headache except Probable Tension Type Headache

4.  DURATION OF STUDY18 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 CRITERIANot Applicable

 7. SPECIFICATION OF INSTRUMENTS AND RELATED MEASUREMENTS

Standardized Homoeopathic Case Taking format

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

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

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:

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.

Posology will be selected as per the requirement of the case

 4. STUDY INSTRUMENT/ DATA COLLECTION TOOLS:-

Informed written consent will be taken.

Complete Homoeopathic Case taking proforma.

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.

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:

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.

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.

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.