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5.6 EXPERIMENTS AND RESULTS—STUDY PLOT 99

p1¼1.0 and p2¼0.75 were the mean differences of pre and post (baseline to 1year) average fre-
quency of headaches per month in the EMG biofeedback training group and pain management group
respectively from a study by Mullay et al.
p¼0.875 was calculated as (p1+p2)/2 and q¼0.125 was calculated as 1 p.
The sample size thus calculated was 26.6 per group. The size of the sample was chosen as 30 per
group in order to accommodate dropouts.

5.6.5 STUDY POPULATION
5.6.5.1 Inclusion criteria
Subjects included in the study were:
• subjects with headaches fulfilling the criteria for TTH determined by the International Headache
Society
• both males and females between 18 and 65years.

5.6.5.2 Exclusion criteria
Subjects excluded from the study were: those subjects who, in the previous 6months had consumed
complementary medicines; those who had drug addictions or used analgesic medicines and triptans
>10days/month; those suffering with severe psychiatric or somatic issues; those who were suffering
from more than one type of aches other than TTH or their headache started after 50years of age; those
suffering from ICHD-type 2 classification headache disorder in international standards.

5.6.6 INTERVENTION
After allocation of subjects to the seven groups, all subjects were informed about the treatment pro-
cedure in detail. Biofeedback (BF) training was provided in a separate room of DSVV, Hardwar of
Physiotherapy research laboratory, which had minimal lighting and minimal external noise, to facilitate
relaxation. All subjects underwent respective (EMG/GSR) BF training for 20min per session for seven
sessions.
Subjects underwent seven biofeedback sessions with one session per day. If the subject missed a
session, the biofeedback session was provided when the subject reported for therapy again, avoiding an
interval of more than 2days between the sessions to avoid unlearning and deconditioning. By the using
of EMG-IR Retrainer, the EMG BF was provided (Chattanooga Group Inc., United States) and using
the GSR biofeedback Biotrainer GPF-2000, the GSR BF was provided (Biotech, India).
The EMG BF provided auditory and visual feedback. Auditory feedback was in the form of clicks
that enhanced in frequency and became a continuous sound with an increase in frontalis muscle tension
and to no sound with relaxation of frontalis muscle. Visual feedback on the display monitor consisted of
glowing bars along with a displayed numerical that displayed the relative EMG activity of the frontalis
muscle in figures. The number of glowing bars was directly proportional to tension in the frontalis
muscle.
The GSR BF machine similarly provided visual and auditory feedback. Visual display was in the
form of glowing bars and displayed the numerical value of real time skin resistance in kilo-Ohms. An
increase in the number of red glowing bars depicted an increase in tension (fall in skin resistance) and a