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CLINICAL METHODS
a
Myofascial Therapy and Research Foundation, India
b
School of Physiotherapy, AIMST University, 08100 Bedong, Kedah, Malaysia
Received 27 July 2010; received in revised form 18 January 2011; accepted 18 January 2011
KEYWORDS Summary Background: Tension-type headache (TTH) is essentially defined as bilateral head-
Myofascial release; ache of a pressing or tightening quality without a known medical cause. Myofascial release (MFR)
Myofascial trigger is currently being applied for patients with TTH but its efficacy has not been evaluated formally.
points; Objective: To investigate whether direct technique myofascial release (DT-MFR) reduces the
Tension headache frequency of headache more effectively than the indirect technique myofascial release (IDT-
MFR) in comparison to a Control Group receiving slow soft stroking.
Design: Randomized, controlled, single blinded trial.
Setting: The clinical wing of Myofascial Therapy and Research Foundation, Kerala, India.
Participants: 63 patients with episodic or chronic tension-type headache.
Interventions: DT-MFR, IDT-MFR or Control. The techniques were administered by certified myo-
fascial release practitioners and consisted of 24 sessions per patient over 12 weeks.
Main outcome measure: Difference in numbers of days with headache between Weeks 1e4 (i.e.
4 weeks prior to start of Intervention) and Weeks 17e20, following 12 weeks of Intervention
between Weeks 5e16 as recorded by participants in headache diaries.
Results: The number of days with headache per 4 weeks decreased by 7.1 (2.6) [mean (SD)] days
in the DT-MFR group compared with 6.7 (1.8) days in the IDT-MFR group and 1.6 (0.5) days in the
control group, (P < 0.001). Patients in the DT-MFR Group, IDT-MFR Group and Control Group re-
ported a 59.2%, 54% and 13.3% reduction in their headache frequency in Weeks 17e20 compared
to that in Weeks 1e4.
Conclusions: This study provides evidence that Direct Technique or Indirect Technique Myofas-
cial Release is more effective than the Control Intervention for tension headache.
2011 Elsevier Ltd. All rights reserved.
* Tel.: 60124362154.
E-mail address: ajimshaw.ms@gmail.com.
1360-8592/$ - see front matter 2011 Elsevier Ltd. All rights reserved.
doi:10.1016/j.jbmt.2011.01.021
432 M.S. Ajimsha
V. Stretch of face muscles (10 min). DT-MFR and two participants in the IDT-MFR groups did not
VI. Gross stretch of the Sternocleidomastoid (10 min). maintain headache diaries as advised and their data were
excluded from the results presented below.
Within the study period, no serious adverse events
Control intervention
occurred in any of three Groups. Three patients from the
DT-MFR group and one from the IDT-MFR group reported
Patients in the Control Group received slow soft stroking
headaches in the first week following initiation of treat-
with finger pads all over the head in the same areas as the
ment, and this was reported to have subsided within a week
application of Myofascial Release (in the other Groups) for
without any medication.
the same duration (1 h per treatment session), twice
There were no statistically significant differences
a week for 12 weeks. After the completion of the study,
between the groups for any of the baseline characteristics
patients in the Control arm were provided MFR therapy, as
(Table 1).
advised by the Ethics Committee.
From Weeks 1e4 to Weeks 17e20, the number of days with
Patients in all groups filled in headache diaries the
headache per 4 weeks decreased by 7.1 (SD 2.6) days in the
month before randomization (Weeks 1e4), and following
DT-MFR group compared with 6.7 (SD 1.8) days in the IDT-MFR
treatment (Weeks 9e20). All study participants were
group and 1.6 (SD 0.5) days in the Control Group (difference:
advised to take medication for headache exacerbations as
DT-MFR vs IDT-MFR, 0.6 days, 95% confidence interval 2.4 to
required, but were required to record them in their head-
1.2 days, P Z 0.51; DT-MFR vs Control Group, 5.8 days, 7.6
ache diaries. Practitioners who provided MFR therapy in this
to 4.0 days, P < 0.001, IDT-MFR vs Control Group, 5.4 days,
study had been trained in the techniques for at least 100 h
7.2 to 3.7 days, P < 0.001) (Table 2).
and had a median experience of 10 months with the tech-
The proportion of responders, defined as participants who
nique. The DT-MFR, IDT-MFR, and Control Treatments con-
had at least 50% reduction in headache days between Weeks
sisted of 24 sessions, each lasting an hour, given over 12
1e4 and Weeks 17e20, was 81.8% in the DT-MFR Group, 86.4%
weeks in 2 sessions per week with a minimum of 2 days gap
in the IDT-MFR Group, and 0% in the Control Group. Patients
between sessions. The primary outcome measure was the
in the DT-MFR group reported a 59.2% reduction in their
difference in number of days with headache between
headache frequency; IDT-MFR group reported 54% reduction
Weeks 1e4 and Weeks 17e20.
whereas Control Group reported 13.3% reduction in their
pain frequency per 4 weeks in the Weeks 17e20. However,
Statistics differences in headache frequency between the DT-MFR and
the IDT-MFR Groups were statistically insignificant.
The three groups at baseline were compared using one-way
analysis of variance. Then, in accordance with the primary Discussion
objective of the study, we compared the number of days with
headache in the DT-MFR and IDT-MFR groups as compared to
The principal finding of this proof of the concept study is
Control Group using unpaired t-test. A two-tailed P value less
that both of the Myofascial Release interventions tested in
than 0.05 was accepted as statistically significant.
this study were significantly more effective than slow
stroking for decreasing the frequency of tension-type
Results headache. The principal difference between the Direct and
Indirect Techniques of Myofascial Release used in this study
Of the 63 individuals recruited into this study, 56 partici- is that the pressure applied was of the order of kilograms
pants (22 in DT-MFR Group; 22 in IDT-MFR Group and 12 in and for a shorter duration in the Direct Technique, whereas
Control Group) completed the study protocol. Two partic- in the Indirect Technique the amount of pressure is of the
ipants in the DT-MFR and one participant each from the order of a few grams but sustained longer. One limitation of
remaining 2 Groups dropped out of the study without this trial was that practitioners could not be blinded.
providing any specific reason for it. One participant in the Another limitation was the absence of long-term follow up
Table 2 Headache diary readings (17e20 weeks) following completion of 3 months Intervention. Data are the means (SD).
Headache Diary Reading DT-MFR IDT-MFR Control Group
Headache Frequency (Weeks 1e4) 12 (2.8) 12.4 (2.8) 12 (2.5)
Frequency of Headache (Weeks 17e20) 4.9 (1.7) 5.7 (1.3) 10.4 (2.7)
Mean (SD) of difference in days with headache 7.1 (2.6) 6.7 (1.8) 1.6 (0.5)
between Weeks 1e4 and Weeks 17e20
Comparison of headache frequency scores DT-MFR vs IDT-MFR DT-MFR vs Control group IDT-MFR vs Control Group
of the DT-MFR, IDT-MFR and the Control 0.6 (2.4 to 1.2) 5.8 (7.6 to 4.0) 5.4 (7.2 to 3.7)
Groups of the Weeks 17e20.
(95% Confidence Interval)
P value by unpaired t-test 0.51 <0.001 <0.001
of study participants. A slight improvement over time manipulations and delivering quality hands on care for
occurred in the Control Group; this could be due to those in need.
a meaning response (Moerman and Jonas, 2002).
Myofascial Release has been reported to reduce pain and
improve quality of life in idiopathic scoliosis (LeBauer et al.,
2008), Raynauds phenomenon (Walton, 2008) and in
Acknowledgment
systemic sclerosis (Martin, 2009). A recent study has shown
that treatment with Myofascial Release following repetitive We thank all the practitioners and professionals of MFTRF,
strain injury resulted in normalization in apoptotic rate, cell India and the physicians who participated in the consensus
morphology changes, and reorientation of fibroblasts process and analysis to establish the trial interventions. We
(Meltzer et al., 2010). Active myofascial trigger points in the are expressing our special gratitude to Dr. E. S. Prakash,
cervical and suboccipital musculature have been identified Associate Professor, School of Medicine, AIMST University,
in 65% of individuals with chronic tension-type headache (De- Malaysia for his expertise editing of the manuscript.
Las-Penas et al., 2006; Couppe et al., 2007). According to
Schleip (2003), under normal conditions, fascia tends to References
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