Manual therapists frequently employ soft tissue
mobilization interventions such as massage or myofascial
release to reduce symptoms of pain, muscle spasm and trigger
points in their clients. There is substantial evidence to
support the use of such interventions. In this age of
rapidly changing health care policies and managed care
limitations on therapy reimbursement, it is critical to
provide supportive documentation for the use of therapeutic
interventions. Using a case study format, I will discuss the
research which provides support for manual therapy as an
effective intervention for headaches.
History of the Case: “Melinda Jones” is a 47 year old female
with a medical diagnosis of cervicogenic headache
post-whiplash injury to her neck, sustained in a MVA on
3/1/09. In the accident, Melinda was driving her car at
65mph in highway traffic when she reportedly stopped
suddenly to avoid the car ahead, spun and struck a cement
wall on the driver’s side of her car. She struck the left
side of her head on the window, but did not lose
consciousness. Since the accident, she has suffered from
neck pain, limited cervical range of motion and intermittent
headaches, which become disabling about once per week. She
is taking Naprosyn 500mg 2x/day and Flexiril prn at night,
to control her headache. She has no other medical problems.
She has had prior whiplash type injuries over the years, but
none which caused persistent headaches. Melinda works
full-time as a science teacher. She has not been able to
participate in her usual recreational activities tennis,
running, and aerobic dance since the accident. She has tried
the usual course of physical therapy with hot packs,
electrotherapy, and stretching exercise with minimal
temporary relief of the neck pain and headaches. Symptoms
return when she is physically active, lifting over 5 pounds,
pushing or pulling over 25 pounds, and after attempting to
run, dance, or play tennis for over 15 mins. She has missed
several days from work due to the severity of her headaches.
She said that massage therapy provides the greatest relief,
to allow her to work, but the symptoms return if she exerts
herself by lifting over 50 pounds, or if she inverts her
head for greater than a minute or two. She had x-rays, neck
and brain MRI, which showed DJD of the cervical spine. No
further medical testing was performed. She reports her
general health is excellent.
To determine if the research evidence is applicable to this
patient, I reviewed studies about manual treatments for
headache relief. Some of the evidence indicates that manual
therapy or massage may be beneficial for patients with
headache. Most articles do not specify what type of headache
they review, some group different headache types into a
single study. Some studies incorporate several interventions
to note the effect on headache, which does not allow us to
isolate the effect of a particular intervention. Studies use
a variety of different treatment frequencies, durations, and
follow-up times. It is difficult to compare evidence when a
variety of factors are not homogenous. I recommend future
studies review the effect of a single or selected group of
interventions on a specific type of headache: migraine,
tension, or cluster headache. Future studies must look at
the differences between varying frequencies, durations and
long term effects of the interventions in homogenous subject
groups. The original studies I located could not be found in
full text articles. The library provided only two full text
articles from a loan request. My impression of the available
full text studies, which are systematic reviews, follows.
A systematic review was conducted by Bronfort, et al,
entitled “Noninvasive Physical Treatments for
Chronic/Recurrent Headache” in Cochrane Database of
Systematic Reviews (1). The authors reviewed 21 randomized and
one quasi-randomized controlled trials of 2628 patients with
headaches, to quantify and compare the effects of the
physical treatments on headaches. The trials were scored for
methodological quality, with 100 being the highest score.
Ten studies scored at least 50. The review indicated
variable results for different types of headaches. One study
reported that a combination of auto-massage, stretching, and
electrotherapy showed weaker evidence than spinal
manipulation for tension headache relief (2). Manipulation was
more effective as prophylaxis than massage for short-term
relief of cervicogenic headache. Few adverse effects were
reported for physical treatments for headaches. The
reviewers determined that additional studies of a more
homogenous nature are needed to determine which types of
physical treatments are effective for reducing headaches.
The studies considered several types of headaches including
cervicogenic, migraine, cluster, tension and, posttraumatic,
and mixed headaches. The authors determined that none of the
evidence was conclusive due to the heterogeneity of the
samples reviewed.
The treatments reviewed compared the physical treatment to
placebo or another intervention or no intervention. Outcome
measures included pain level, patient satisfaction,
activities of daily living/functional level, medication use,
duration and frequency of headache, and level of
improvement. Bronfort’s review included a descriptions of
the methods of review. Studies were analyzed by two separate
reviewers who extracted specific data from each article
using a checklist. The reviewers were not blinded, they
standardized the effect size scores and outcomes data using
percentage points. The quality of individual studies was
reported on a scale of zero to 100; studies scored at least
a 50 or more were considered to be of high quality.
Reviewers classified twenty methodological items as
“informativeness” items or “internal validity” items. Some
of the items were: randomization, inclusion/exclusion
criteria, comparability of variables for groups studied,
reliability/validity, blinding, bias, post intervention
follow-up periods, description of interventions, comparison
to other interventions, study objective or hypothesis,
analysis consistency with the design of the study,
statistical power, confidence intervals, dropout impact,
random data allocation, intention to treat analysis,
adjustments made to the number statistical tests, and
validity of main conclusions (3).
Researchers classified the quality levels for each study
into five levels from strong, moderate, limited,
preliminary, or conflicting evidence, based on validity
scores. Trial results were pooled if the interventions,
outcomes or patient population were homogenous. One primary
outcome measure was headache index or pain intensity. Based
on the exhaustive nature of the quantitative analysis of
trial results and the level of evidence used to evaluate the
reviewed studies, it appears that the conclusions generated
were substantive.
The valid results of this review are important for many
reasons. Manual therapy practitioners often use a range of
individual physical treatments or a combination of
interventions to manage headaches. The reviews included
comparing a wide range of individual interventions to
combination package interventions and also to controls or
placebos. Several of the studies assessed massage as one of
the interventions. It appears that the heterogeneity of the
interventions used make it difficult to draw conclusions. Of
the 22 trials reviewed, only one directly addressed the
effect of massage on cervicogenic headache (4). The studies
were very different in the number of interventions performed
(1-12 over 1-6 weeks). More research is needed to determine
the optimal number of interventions and duration of
treatment to perform to achieve the desired outcome of
headache reduction.
In studies that included massage in combination with other
physical treatments such as heat, ultrasound or acupuncture,
one cannot decide whether any individual intervention or the
combination most influenced the outcome measures. Since
massage was not tested as the only variable, no direct
conclusion can be drawn about the benefit of massage alone.
The Bronfort review discussed limitations of the study,
including publication bias. The authors noted that three of
the studies reviewed were ones in which at least one of the
authors participated (5). The review included only published
research, which is more likely to have positive outcomes
than unpublished research (6). The authors also mentioned that
clinical trials done in languages other than English may
have been missed. The authors used two methodological
scoring systems in order to minimize bias. Overall, the
review was very comprehensive, with few limitations. The
authors made an excellent summary point, stating, “Authors
too often draw inappropriate conclusions when they declare
treatment effectiveness based solely on presence or absence
of statistical differences between a test treatment and a
control. To inform decisions about management of individual
patients, it may be much more appropriate to think in terms
of available treatment options which have shown a meaningful
clinical effect, rather than choosing or discarding specific
therapies based on mean group differences of undefined
clinical importance (7).”
The authors concluded that, “No single approach to
interpreting findings from RCTs and systematic reviews is
perfect. To inform decisions about the management of
individual patients, it may be more appropriate to think in
terms of available treatment options that have shown a
meaningful clinical effect, rather than choosing or
discarding specific therapies solely based on mean group
differences of undefined clinical importance (8).” Their
conclusion is reasonable in consideration of the fact that
therapists select from a wide variety of interventions to
treat headaches, and the outcome of primary importance is
the response of the individual patient to a given
intervention. This systematic review provided some evidence
to indicate that manual therapies, including massage and
spinal manipulation, may help to reduce headaches, with
little adverse effects. More studies must be done using
specific headache classifications, subject homogeneity, and
specific outcome criteria, in order to identify the types of
therapies effective in reducing headache pain. The results
of this review are applicable to this case study. In
treating this patient’s headache, I utilized a combination
of massage therapy, joint mobilization, (manipulation)
therapeutic exercise, and relaxation training. The evidence
from the review provides moderate support for the use of the
manipulation, and minimal support for the use of massage,
exercise and relaxation training. Overall, there are few
side effects of these interventions, and if the patient
shows improvement with any of them, I will choose to
continue the treatment. Based on the outcomes of the review,
I may focus more time on manipulation to reduce headaches,
and measure the outcome for my individual patient. If the
outcome is favorable, I will continue the treatment.
Another systematic review of the effect of manual therapies
on headache reduction was undertaken by Fernandez de las
Penas, et al. (9). The authors reviewed the computerized
databases Medline, Pubmed, Ovid, Cochrane, AMED, MANTIS,
CINAHL, EMBASE, and PEDro. They selected controlled clinical
trials and reviews to determine the effect of manual therapy
on tension type headaches. To authors reviewed publications
based on specific inclusion criteria using a standardized
format for data extraction. The author stated that they
agreed on the items in the form, and verified “observer
reliability” using coefficient (K= 0.79) (10). Studies selected
included open uncontrolled studies and randomized controlled
trials, which included manual therapy treatment for tension
headaches. The studies were limited to English language
publications post-1994. The PEDro quality scoring method was
used to determine methodological quality on a scale of 0 to
10, with a score greater than five considered high quality
and a score less than five low quality. Authors used either
effect size (ES) or an outcome quality score of P<0.05 to
determine the level of scientific evidence for the trials,
ranging from strong, moderate, limited, or inconclusive
evidence. The primary outcome measure included headache
frequency, intensity, or duration. Fifty-five articles were
cited, however, only six total articles met their
eligibility criteria for final selection (11). The total number
of subjects across all studies was 405.
The manual therapies evaluated in the studies included
“spinal manipulation, classic massage, connective tissue
manipulation, soft tissue massage, Dr. Cyriax’s vertebral
mobilization, manual traction, and CV-4 craniosacral
technique (12). The studies varied widely in the duration of
intervention, from a single session to 6 weeks of therapy.
“(mean=3.6+/- 1.9 weeks)…sessions ranged from 1 to 20 (mean
= 11.6+/- 7.3) (13). Four of the six studies assessed a single
intervention, the others used a combination of techniques.
As a result of the mix of interventions, a meta-analysis
could not be done. Different controls were used in each
study, with variable follow-up periods ranging from
immediately post-treatment to 6 months post- treatment. Some
used medication groups as controls, others compared
manipulation alone to a combination of manipulation with
traction or massage or placebo laser, to neck exercises or
to no treatment at all. Because so many types of treatments
were considered, it is difficult to draw conclusions about
any one type of intervention. The interventions are too heterogenous to draw a final conclusion about any one
intervention.
The methodological quality of the studies reviewed was
determined by use of PEDro scores, which ranged from 2-8
points (mean=5.8+/-2.1) (14). Four of the six trials reviewed
scored from 6-8 points, and were therefore considered to be
of high quality. The effect size (ES) could only be
calculated in two trials. Effect sizes were reported as
(0.3) on headache frequency and intensity values (0.49) on
pressure pain threshold, and (0.1) on range of cervical
motion for the Cyriax mobilization group (15). The craniosacral
group has the largest ES (0.84) on pain outcomes relative to
the control and exercise groups (16). The authors determined
that the level of evidence for the value of spinal
manipulation was inconclusive, based on the outcome of two
high quality studies and one poor quality study, which had
differing results. They found limited evidence for
connective tissue massage and craniosacral therapy, since
each had only one trial study performed. The authors
concluded that due to the limited number of high quality
studies on manual therapies, (RCTs) and the heterogeneity of
the samples and techniques used, there is little evidence to
support the use of manual therapy for tension headaches.
The authors determined that the reviewed studies were
inconclusive in regard to the efficacy of manual therapies
on headache for several reasons. The studies used different
outcome measures, different manual techniques, and
inconsistency in the design of the clinical trails. (Some
assessors were not blinded, or did not use an
intention-to-treat analysis) They suggest using other
standard outcome measures such as the Pressure Pain
Threshold, McGill Pain Questionnaire, or Neck Disability
Index, to make the outcomes measures more homogenous (17).
Publication bias may be evident in this review, since only
published English studies were considered, and mostly
positive outcomes may be represented. The authors
recommended that future studies of higher quality design
with more homogenous subjects and interventions would better
represent the outcomes of manual therapies for tension
headaches.
I could use the results of Fernandez de las Penas’ review to
consider the type of manual therapy I may use with this case
study patient. They did remark that there if limited
evidence for effectiveness of soft tissue manipulation for
reducing headaches, and inconclusive findings for the use of
manipulation. I utilize both treatments in my plan for
headache reduction for my patient, with good results in pain
reduction and lower duration of pain, and in the improved
scores on the Neck Disability Index. Since the soft tissue
intervention has low risk of side effects, (compared to
medication or vertebral manipulation) I will continue to use
it. I always use outcome measures in my practice, including
those recommended by the authors, such as range of motion,
Neck Disability Index, and the SF-36 questionnaires. When I
note positive outcomes based on these objective measures, I
continue to apply the manual therapy to get favorable
results. Simply finding a lack of evidence in the literature
to support manual therapy does not preclude its use in my
practice. I find that using objective measures such as the
Neck Disability Index and other standard outcome measures to
assess the results of my interventions is superior to using
literature review, because I can see the immediate and long
term results with my patients on a one-to-one basis. I will
use the literature as a guide to determine which
interventions may be efficacious for a given problem, such
as headaches (18-20). When I do not generate positive results
within two to three visits, I will return to the literature
to find alternative interventions. Since the research is
constantly updated, I obtain the latest information directly
in my e-mail from Medline. I recommend manual therapists
learn know how to perform a literature review to locate
recent studies which may prove beneficial in improving
practice outcomes. By reviewing the research regularly,
practitioners will find more high-quality evidence to use in
clinical practice, in a reasonable period of time. Based on
the studies reviewed here, more research is needed with
better methodology to determine the optimal interventions
for a given problem.
Last revised: January 31, 2011
by Theresa A. Schmidt, DPT, MS, OCS, LMT, CEAS, CHYDD
REFERENCES
1. Bronfort, G, Nilsson, N, Haas, M, Evans, R, Goldsmith, CH, Assendelft,
WJJ, and Bouter, LM. Noninvasive Physical Treatments for Chronic/Recurrent
Headache. [Reviews]. Cochrane Database of Systematic Reviews, 2007;3: 1-47.
Available at http://0-gateway.tx.ovid.com.lilac.une.edu/gwl/ovidweb.cgi,
Accessed November 2, 2007. Footnote 1-16
2. Bronfort, p. 2.
3. Bronfort, p. 11-12
4. Bronfort, p.15.
5. Bronfort, p.33.
6. Bronfort, p.30
7. Bronfort, p. 31.
8. Bronfort, p. 33.
9. Fernandez de las Penas, C, Alonso-Blanco, C, Luz Cuadrado, M, Miangolarra,
JC, Barriga, FJ, and Pareja, JA, Are Manual Therapies Effective in Reducing
Pain from Tension Type Headache? A Systematic Review. Clinical Journal of
Pain March/April 2006; 22:(3): 278-285.
(Footnote 9-17)
10. Fernandez de las Penas, p. 279.
11. Fernandez de las Penas, p. 280.
12. Fernandez de las Penas, p. 280.
13. Fernandez de las Penas, p. 282.
14. Fernandez de las Penas, p. 282.
15. Fernandez de las Penas, p. 283.
16. Fernandez de las Penas, p. 283.
17. Fernandez de las Penas, p. 284.
18. Haraldsson, BG, Gross, AR, Myers, CD, Ezzo, JM, Morien, a, Goldsmith, C,
Peloso, PM, Bronfort, G. Massage for Mechanical Neck Disorders. Cochrane
Database of Systematic Reviews. 3:2007.
19. Tsao, JC, Effectiveness of Massage Therapy for Chronic Nonmalignant
Pain: a Review. Evidence-based Complementary and Alternative Medicine. 2007
June; 4(2): 165-179. Epub 2007 Feb 5. Available at:http://www.ncbi.
nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=show... Accessed November 2, 2007.
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