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5.6 EXPERIMENTS AND RESULTS—STUDY PLOT 101

5.6.7.2 Secondary variables
The secondary variables considered in our study were: SF-36 Quality of Life—total, physical, and
mental scores.

5.6.8 ANALGESIC CONSUMPTION
These secondary variables are also termed as “secondary non headache measures” by the American
Headache Society Behavioral Clinical Trials Workgroup, 2005 [21].

5.6.9 ASSESSMENT OF OUTCOME VARIABLES
The demographic data in regards to age, gender, and chronicity of headache was collected from all the
subjects in the trial.

5.6.10 PAIN DIARY
As per the guidelines of the American Headache Society Behavioral Clinical Trials Workgroup, 2005
[21], a pain diary was given to all the subjects in which they were asked to note down the headache
episodes, duration, and intensity of headache they experienced in a week. At the end of the week, the
averages of the headaches in that week were calculated. The variables were recorded as:

(1) Average frequency of headache per week: number of headache episodes per week.
(2) Average duration of headache per week: total hours of all episodes of headache that week divided
by the number of episodes in that week.
(3) Average intensity of headache per week: average of the 10-point visual analogue score (VAS) per
headache that week.
The subjects were also requested to note down the use of analgesics during any of the pain episodes.
The secondary variables were assessed and a licensed SF-36 questionnaire was obtained from Qual-
ity Metric Incorporated, United States, in Hindi and English. It is a short-form health survey with 36
questions, which was multipurpose and yielded a psychometrically based physical and mental health
report calculated and a total score. The SF-36 was judged to be the most broadly calculated generic
patient assessed health outcome [25]. Its authenticity has been estimated using both internal consis-
tency and test-retest methods. Most of the published authentic statistics have exceeded 0.80. Validity
studies generally support the intended objective of high and low SF-36 scores as documented in the
original user’s manuals [26–28]. Analgesic consumption was recorded from the pain dairy of the sub-
jects as well as from the prescriptions for medications given to the subjects by their treating physicians.

5.6.11 DATA COLLECTION
All data was collected at the following time measures:
Baseline: scores of primary and secondary variables the week before the starting of the treatment.
Scores at 1, 3, 6months, and 1year. These were the scores of the last week of the corresponding month.