ORIGINAL CONTRIBUTION
Blinding Protocols, Treatment Credibility, and Expectancy:
Methodologic Issues in Clinical Trials of Osteopathic Manipulative Treatment
John C. Licciardone, DO, MBA
David P. Russo, DO, MPH
Context: In testing an experimental new drug or therapy, the gold
standard in biomedical research for determining treatment effi-
cacy is the randomized controlled trial (RCT). In pharmaceu-
tical trials, inert placebos are an easily administered control that
facilitates blinded comparisons. In clinical trials that study the
effects of manual interventions, researchers must carefully con-
sider their use of treatment control models. Choosing credible con-
trols that will minimize bias in osteopathic manipulative treatment
(OMT) clinical trials poses unique challenges to researchers
because of heterogeneous OMT methods and practice.
Objective: To compare the treatment credibility of sham manip-
ulative treatment and untreated controls to active OMT.
Methods: Subjects recruited for an OMT clinical trial for chronic
low back pain completed a treatment-credibility rating scale
comparing two written descriptions of the study interventions
offered. The scale was administered to subjects before trial entry
and at 6-month follow-up. Scale scores were used to compute
credibility ratios for both intervention protocols (ie, OMT vs
sham manipulative treatment). Repeated measures analysis of
variance was used to assess changes in the credibility ratio over
time, including the measurement of study group and time main
effects, as well as study group ⫻ time interaction effects.
Results: Subjects (N=91) perceived OMT as a more credible
therapeutic option than sham manipulative treatment both
at trial entry and at 6-month follow-up (P⬍.05). Among sub-
jects completing the study protocol (n=66), there were no
changes in perceived credibility of the study interventions
over time. There were no significant differences in the credi-
bility ratio among study groups (P=.64) or over time (P=.79).
In addition, there were no significant study group ⫻ time inter-
actions (P=.59).
Conclusions: In clinical trials, OMT may be perceived by sub-
jects as a more credible treatment alternative than many con-
From the Osteopathic Research Center in Fort Worth, Tex, and the University
of North Texas Health Science Center at Fort Worth—Texas College of Osteo-
pathic Medicine (Licciardone) and the Comprehensive Pain Center at Oregon
Health & Science University (Russo) in Portland.
Address correspondence to David P. Russo, DO, Oregon Health & Sci-
ence University, Department of Anesthesiology and Peri-operative Medicine,
Comprehensive Pain Center, 3181 SW Sam Jackson Park Rd, Mailcode OP-26,
Portland, OR 97239-3011.
E-mail: russoda@ohsu.edu
Licciardone and Russo • Original Contribution
trol procedures. Treatment credibility can interact with subject
expectations and study design in complex ways. When ana-
lyzing the treatment effects of OMT, investigators must con-
sider the effects of these two subjective elements when com-
peting interventions are offered and subjects are asked to
self-report data. Study design should be optimized to equalize
these effects among interventions.
J Am Osteopath Assoc. 2006;106:457–463
I n testing an experimental new drug or therapy, the gold
standard in biomedical research for determining treat-
ment efficacy is the randomized controlled trial (RCT). In
RCTs, researchers and subjects are both blinded (or masked)
to comparisons between treatment outcomes, by which one
means that subjects and researchers are not able to deduce
group assignments (ie, treatment vs control). In pharmaceu-
tical trials, inert placebos are an easily administered control
that facilitates double-blinded comparisons.
In clinical trials that study the effects of manual inter-
ventions, however, such as osteopathic manipulative treat-
ment (OMT), researchers must carefully consider their use of
treatment control models. When the RCT double-blind study
model is applied to manual interventions, it quickly becomes
apparent that researchers in those fields will not be able to
adhere to a strict double-blind biomedical model in which
those administering the treatment are unaware of the proce-
dure taking place.1,2 For this reason, RCTs designed to evaluate
the efficacy of OMT are often, of necessity, single-blind, with
only the subjects unaware of their assignment to the study or
control group.3,4 In addition, isolating the specific treatment
effects (eg, the “active ingredient” in OMT) from other non-
specific treatment effects using single-blind protocols is also a
challenge to researchers interested in determining the efficacy
of manual techniques.5
The isolation of specific treatment effects is of central
importance in osteopathic medical research because osteo-
pathic physicians have long embraced an approach to patient
care that optimizes patient-physician rapport and focuses on
an array of psychosocial and individual health factors.6 There-
fore, studying the effects of OMT when it is removed from its
standard context of healthcare delivery raises questions
regarding treatment generalizability in clinical practice set-
JAOA • Vol 106 • No 8 • August 2006 • 457
ORIGINAL CONTRIBUTION

Differential dropout In medical trials, subjects sometimes drop out of the study before the completion of the study
rate protocols—or they are lost to follow-up. Because subjects are more likely to discontinue
participation if they feel their condition is not improving, investigators need to conduct an
analysis of dropout patterns between the treatment and control groups to determine if their
results might be influenced by attrition bias (also known as withdrawal bias). The differential
dropout rate must be addressed by researchers in their final analysis.
Unless dropout controls are retained in the data analysis, attrition bias can seriously affect
study outcomes. However, it may be appropriate in some studies to exclude dropout controls
from analysis if those subjects discontinued participation after the selection process but before
the study began (eg, nonblinded studies where subjects are not randomized to the study group
they prefer [ie, treatment vs control]).

Investigator bias
Subject assignments to study groups should not be left to the discretion of investigators.
Investigators should not, for example, be aware of the next group assignment when they are
screening patients for study eligibility. In addition, matters of scheduling for certain procedures or
diagnostic tests could be affected by this kind of bias in investigations studying certain somatic
dysfunctions or disease states.

Investigator-subject
relationship
In the course of treating musculoskeletal complaints, physicians often provide general patient
education and offer exercise and diet advice to patients. They may also evaluate the impact of
concomitant medical issues or treatments, making any necessary adjustments. When such routine
aspects of routine medical care are introduced to the clinical trial setting, they may improve
outcomes though they are not considered by researchers to be part of the treatment under
investigation. Thus, the “bedside manner” of the physician is an important part of the nonspecific
treatment effects inherent in the patient-physician relationship and should be monitored in the
clinical trial setting.
In addition to nonspecific treatment effects, the quality and strength of the relationship
between an individual physician and his or her patient—particularly with regard to the patient’s
perceptions of the physician’s status—can influence treatment outcomes (similar to attention bias
or the Hawthorne effect). In clinical trials where the same physician meets with the subject at all
follow-up visits, nonspecific treatment effects may be stronger compared with trials where a
research coordinator (or another member of the research team) meets with subjects. However,
study personnel should be careful not to appear cold or uncaring toward study participants as
these behaviors can negatively impact protocol adherence.
In reviewing protocol adherence rates in phase 3 clinical trials, sites where subjects perceived
study staff as more empathetic, as instilling a sense of purpose in subjects, and promoting less
formal interpersonal relationships with them had high rates of adherence to treatment
protocols.*
In order to diffuse nonspecific treatment effects away from any individual member of the
research team, investigators should have multiple clinicians administer both active and control
interventions, ensuring that contact time between clinicians and subjects in both arms of the
study is identical. (continued)

Figure. Sources of bias in clinical trials. More information on good clinical practice guidelines for clinical investigators can be found at the
US Food and Drug Administration Web site (http://www.fda.gov/oc/gcp/default.htm). *Mohr DC, Goodkin DE, Masuoka L, Dick LP, Russo D,
Eckhardt J, et al. Treatment adherence and patient retention in the first year of a Phase-III clinical trial for the treatment of multiple sclerosis.
Mult Scler. 1999;5:192–197.

tings.7 Furthermore, by offering OMT in addition to the full
armamentarium of state-of-the-art medical care to their
patients, osteopathic physicians—when their methods are
viewed through the rigorous lens of the RCT model—often
introduce potentially confounding treatments, including anal-
gesics, anti-inflammatory agents, muscle relaxants, and phys-
ical therapy.
Individual Psychosocial Factors in Treatment Outcomes
Although blinding protocols, treatment credibility, expectancy,
and nonspecific treatment effects are related concepts in clin-
ical research, investigators should carefully delineate in their
discussions which aspect of the RCT experience each term
describes (Figure).
It is widely accepted in a variety of research fields that an
individual’s beliefs and expectations about treatment efficacy
may have a significant effect on commonly measured out-
comes, including pain, function, and quality of life.8 Other
areas of nonpharmacologic research using RCT methods have
developed valid and reliable measures of treatment credibility
that may be helpful to OMT clinical investigators. Treatment
credibility, one component of patient belief, refers to the degree
to which subjects believe that the treatments offered in com-
peting arms of an RCT are believable, convincing, and a rational

458 • JAOA • Vol 106 • No 8 • August 2006 Licciardone and Russo • Original Contribution
 ORIGINAL CONTRIBUTION

Regression Chronic disorders such as back pain tend to vary in severity over time. Participants are more likely
to the mean to seek treatment, and to be enrolled in clinical trials, when their symptoms are severe. During the
study period, symptom severity may decrease simply as a result of the passage of time. In other
words, improvements to symptom severity are sometimes the result of the natural resolution of
the dysfunction rather than an accurate measure of treatment response.
Also called regression toward the mean.

Self-selection bias If subjects are given a choice between study groups, many will try to increase their chances of
getting assigned to the treatment group. Subjects who believe that they have been assigned to
the control group often have less motivation to remain compliant with study protocols as well as
lower expectations of improvement.
Some types of self-selection bias are less obvious and, therefore, more difficult to control.
See also temporal change in the subject pool, below. Participants who seek care from clinics or
physicians identified with certain treatment types may be less motivated to comply with study
protocols if they believe that they have been assigned to an alternative treatment group or the
control group.
Also called subject bias or volunteer bias.

Subject expectation Subjects’ preconceptions about the effectiveness of the study protocols in their assigned groups
can profoundly influence trial outcomes. For example, subjects may be inclined to evaluate their
outcomes more positively if they believe that they have been assigned to the treatment group
instead of the control group. In addition, they may be more motivated to remain compliant with
study protocols (eg, home stretching program) if they believe the treatment will be effective.

Temporal change Some clinical trials may extend over several years. During this time, the patient population at a
in the subject pool given clinic may change, especially if there is publicity about the trial or if new treatments become
available.
In addition, clinics or individual investigators may become well known for providing treatment
with a specific treatment modality. This particular kind of self-selection bias (see above) is known
as centripetal bias or referral bias.
To minimize the impact of changes in the pool of potential subjects over time, patients are
usually randomized in relatively small blocks to ensure that comparable numbers of subjects are
assigned to each study arm at each stage of the investigation.

Treatment credibility A cumulative rating of subjects’ assessments of the credibility of the competing treatment
options available within a study. Subjects may evaluate their outcomes more negatively if they
believe that a competing treatment is more appropriate or logical for their condition.

Figure (continued). Sources of bias in clinical trials. More information on good clinical practice guidelines for clinical investigators can be
found at the US Food and Drug Administration Web site (http://www.fda.gov/oc/gcp/default.htm).

solution to the chief complaint.9 A separate component,
expectancy, refers to the degree to which subjects believe that
improvements will occur as a result of the treatment pro-
vided.10 Nonspecific treatment effects is a term that describes a
broad category of idiosyncratic factors common to many med-
ical experiences such as suggestion, persuasion, patient-physi-
cian (or investigator-subject) rapport, and the subjects’ fre-
quently unconscious desire to please the investigator or be
“acceptable” to study personnel.8
Poor study design or methodologic flaws may result in
subjects or investigators becoming unblinded to random
assignment, thereby rendering interpretations of the data vul-
nerable to numerous sources of bias, including investigator bias
and withdrawal bias. Although randomized blinded assign-
ment protocols are well-accepted methodologic techniques
used to conceal treatment assignments and minimize the
impact of nonspecific treatment effects among study groups,
treatment credibility and expectancy are less understood sub-
ject-specific psychosocial variables that should also be carefully
measured in OMT clinical trials. By assessing potential study
subjects for the following five variables, osteopathic medical
researchers can strengthen the inference from observed out-
comes that measured improvements are the result of treat-
ment effects and not attributable to a source of bias:
▫ treatment history or knowledge of OMT
▫ treatment history or knowledge of other manual therapies
▫ perceptions of credibility for all competing interventions
▫ expectations for treatment
▫ perceptions of patient-physician (or investigator-subject)
rapport
Measures of subjects’ perceptions of treatment credibility
have been used to address issues involving placebo-controlled

Licciardone and Russo • Original Contribution JAOA • Vol 106 • No 8 • August 2006 • 459
ORIGINAL CONTRIBUTION
comparison in other areas of nonpharmacological research.11–13
Several years ago, the authors of the present study collaborated
with other researchers to conduct an RCT on the use of OMT
for chronic low back pain, using two control groups in the
study design: one that received sham manipulative treatment
and a second that received no intervention.15 This study design
allowed a direct comparison of the efficacy of OMT relative to
both control groups as well as an opportunity to further explore
how treatment credibility may affect trial completion and clin-
ical outcomes.
Methods
Methods and results for the chronic low back pain RCT have
been reported in detail elsewhere.15 All trial procedures were
approved by the institutional review board of the University
of North Texas Health Science Center at Fort Worth and verbal
and written informed consent were received from study par-
ticipants. As noted, the RCT was designed with two control
groups (sham manipulative treatment and no intervention)
for comparison with a single OMT group. Subjects, who were
masked to group assignments, were randomized evenly
among the control and treatment groups in a 1:1:2 ratio. All sub-
jects were allowed to continue their standard medical care for
low back pain (eg, over-the-counter medications, physical or
massage therapy, acupuncture, herbal therapies). However,
study exclusion criteria prohibited subjects from receiving
chiropractic spinal manipulation or additional sessions of
OMT. In addition to gathering basic demographic data, inves-
tigators at regular intervals (baseline and follow-up at 1-, 3-, and
6-months postintervention) recorded data on 14 primary out-
comes. Predoctoral osteopathic manipulative medicine fel-
lows performed clinical assessments and osteopathic struc-
tural examinations for all subjects and provided individualized
OMT to the study subjects in the OMT group and sham manip-
ulative treatment to subjects randomized to that control group.
The study’s final outcomes consisted of the five domains of
patient-based outcomes recommended by Bombardier16 as
essential for the evaluation of spinal disorders: general health
status, pain, back-specific function, work disability, and back-
specific patient satisfaction.
The present study focuses on subjects’ perceptions of
treatment credibility with regard to the OMT and sham manip-
ulative treatment protocols used in that January 2000 to
February 2001 trial. All subjects were asked to complete a brief
treatment credibility scale prior to randomized blinded assign-
ment and then again at 6-month follow-up. Previous versions
of the measure used for the present study have been used in
other nonpharmacologic RCTs, including psychotherapy,11,17
acupuncture,18 and biofeedback therapy.19,20 Subjects were
asked to rate their level of agreement with statements about
OMT and sham manipulative treatment. The statements were
designed to describe OMT and sham manipulative treatment
objectively, without explicitly labeling them. For this purpose,
the interventions were named Treatment 1 and Treatment 2,
460 • JAOA • Vol 106 • No 8 • August 2006
respectively. Furthermore, the descriptions of these treatments
were worded to minimize the likelihood that subjects would
subsequently discern their treatment allocation (ie, be at risk
of unblinding). The description of OMT was provided to all
study subjects as follows:
Treatment 1 uses a practitioner’s hands to find and treat
painful areas of the body and back. A practitioner will look
for areas of your body that hurt you and then apply manu-
ally guided forces in order to decrease pain and restore
proper alignment between bones, muscles, and connective
tissue that may have been altered by injury.
If you got assigned to this treatment, a practitioner would
meet with you for approximately 15–30 minutes and treat
areas on your body and back that hurt.
Sham manipulative treatment was described to all study sub-
jects as follows:
Treatment 2 involves light pressure applied to certain painful
areas of the body and back. A practitioner will look for areas
of your body that hurt, lay his hands on them, and apply light
pressure in order to decrease pain, improve communication
between your body’s nervous and endocrine systems that
may have been altered by injury, and help you relax.
If you got assigned to this treatment, a practitioner would
meet with you for approximately 15–30 minutes and treat
areas on your body and back that hurt.
The pertinent questionnaire item stem used to summarize
treatment credibility relative to each statement was, “I am
confident that this treatment can alleviate my complaint.” The
available Likert weighted-scale responses for both treatment
descriptions were as follows: 5, strongly agree; 4, agree; 3, unde-
cided; 2, disagree; and 1, strongly disagree. The primary out-
come measure was the credibility ratio (ie, the ratio of credi-
bility in OMT relative to sham manipulative treatment for
each subject, as computed by the relative weights for their
responses to the two treatment descriptions). A 95% confi-
dence interval was computed for each credibility ratio to assess
statistical significance.
Repeated measures analysis of variance was used to assess
the credibility ratio over time, including the measurement of
study group and time main effects, as well as study group
and time interaction effects. All data analyses were performed
with the SYSTAT software package (Version 7; SYSTAT Soft-
ware Inc, Richmond, Calif), using a .05 level of significance.
Results
A total of 91 (46%) of the 199 potential subjects who responded
to recruitment procedures were eligible for study participation
after screening and were randomly assigned to one of the
three study groups. The three groups were comparable with
regard to all baseline characteristics, including age, sex, race,
pain duration and intensity, self-reported functional assess-
ments (ie, MOS [Medical Outcomes Study] 36-Item Short-
Form Health Survey,21 Roland-Morris Low Back Pain and
Disability Questionnaire22), and the number of work or school
days lost in the past 4 weeks as a result of back pain.
Licciardone and Russo • Original Contribution

Attrition rates during the study protocols have been
reported elsewhere (1 mo, 9 [10%]; 3 mo, 20 [22%]).15 For the
subjects who completed the study (66 [73%]), there were no sig-
nificant differences in attrition over time among the three
study groups (P=.36). The present study analyzes treatment
credibility data gathered at trial entry and exit, as available from
the 91 subjects who entered the RCT and the 66 subjects who
completed the 6-month study.
For all subjects, the credibility ratio at baseline was 1.10
(1.03–1.16), indicating a small, but statistically significant, cred-
ibility differential favoring OMT over sham manipulative
treatment. Similarly, at 6-month follow-up, the credibility ratio
was 1.15 (1.06–1.23) in favor of OMT. Changes in the credibility
ratio over time were not significant (P=.36), however.
When subjects completing the trial are compared with
those who did not, the credibility ratios at baseline were 1.12
(1.03–1.21) and 1.03 (0.98–1.08), respectively (P=.18). The cred-
ibility ratios over time according to trial completion status
and study group are presented in the Table.
The results of the repeated measures analysis of vari-
ance—which included only those subjects who provided cred-
ibility data at baseline and at 6-month follow-up—indicated
that there were no significant differences in the credibility
ratio among study groups (P=.64) or over time (P=.79). In
addition, there were no significant study group ⫻ time interac-
tion effects (P=.59).
Comment
The present study is the first to empirically explore issues
related to treatment credibility, sham manipulative treatment,
and methodology in OMT research. Our results indicate that
subjects generally reported slightly elevated credibility ratios,
suggesting a small treatment credibility differential favoring
OMT over sham manipulative treatment. Although subjects
appeared to perceive the description of OMT at baseline and
Licciardone and Russo • Original Contribution
ORIGINAL CONTRIBUTION
at 6-month follow-up as a more credible therapeutic option
than sham manipulative treatment, this measurable differ-
ence did not appear to affect primary outcomes. It is also note-
worthy that there were no significant differences in the cred-
ibility ratio among the three study groups, over time, nor
when these two factors were combined. Furthermore, drop-out
rates could not be attributed to differences in perceived cred-
ibility of OMT and sham manipulative treatment, suggesting
that other factors were related to attrition. Thus, within the con-
text of this study, we can feel confident that the small, mea-
surable differences in treatment credibility were not a signif-
icant threat to the study’s internal validity.
Randomized controlled trials of OMT may combine the
use of that treatment modality with standard medical care for
the condition being studied. As illustrated by recent OMT
trials studying management of low back pain, control groups
may either include those who receive conventional medical care
and sham manipulative treatment15 or those who receive stan-
dard care alone.15,23 There are at least two important prob-
lems with designing a study that uses controls who receive no
manual intervention. First, the subjects may deduce that they
have been randomly assigned to the control group (ie,
unmasked), making them more likely to drop out of the trial
(ie, self-selection). Second, no-intervention control subjects
may receive less clinical care, either real or perceived, for their
condition—violating an ethical obligation to provide care. In
either case, monitoring and documenting subjects’ individual
beliefs about their treatment assignments as part of standard
study protocol would provide investigators with significant
insights into these issues and aid them in drawing valid con-
clusions about the cause-effect nature of their interventions.
Sham manipulative treatment is intended to overcome
the problems associated with using control subjects who
receive no manual intervention. In the process of providing
sham treatment, however, researchers must acknowledge that
JAOA • Vol 106 • No 8 • August 2006 • 461
ORIGINAL CONTRIBUTION
some therapeutic benefit may occur, thereby reducing the
comparative efficacy of OMT. Indeed, a 2001 review of placebo
effects found that, for conditions involving continuous mea-
sures of pain, there is a small, but statistically significant, ben-
eficial effect attributed to placebos when compared with no
treatment.24 This placebo effect has been estimated to be the
equivalent of one third of the effect of nonsteroidal anti-inflam-
matory drugs.25
The present study raises questions about OMT research
and the nature of treatment credibility and the placebo effect.
For some osteopathic medical investigators, the possibility of
natural (ie, regression to the mean) or placebo-related improve-
ment in patients’ musculoskeletal conditions and pain levels
dictates the use of rigorous control and masking procedures in
OMT study protocols. When RCTs focus on strict mechanis-
tically oriented questions,26–28 only sham-controlled, double-
blind trials can determine if beneficial outcomes are inher-
ently attributable to the manual techniques used. When
sham-controlled trials are not feasible, careful measures should
be taken to ensure that subject concealment, credibility, and
expectations are equivalent between treatment arms at base-
line and throughout the study period. Monitoring individual
subject’s beliefs about treatment and using independent eval-
uators to assess outcomes establishes the cornerstone of “dual-
blinding”—a promising modification of the traditional double-
blind RCT methodology that may be more appropriate for
evidence-based OMT research.29
If a study’s hypotheses about the effects of OMT are pre-
sumed to transcend a purely biomechanistic explanation, or if
resources are limited, other pragmatic study designs may be
considered. Under such conditions, OMT trials involving
non–placebo-controlled interventions can provide useful clin-
ical data—provided that subjects believe that all “treatments”
offered are of comparable credibility. And yet, without directly
addressing treatment mechanisms, investigators are able to
offer only limited conclusions about treatment efficacy. At
most, researchers can conclude that the hands-on treatment
under study contained some as-yet-unknown active ingre-
dient(s) that caused some degree of change (ie, beyond that
caused by factors common to all forms of human touch,30
physician-directed attention,31 placebo conditions, or chance).
Such conclusions are likely to have only limited influence in
persuading other clinical investigators, patients, policymakers,
and health insurance providers about the effectiveness of
OMT. A recent large, well-designed study of chiropractic
manipulation, physical therapy, and standard medical care
demonstrated that subjects’ initial confidence in the assigned
treatment correlated directly with outcome, but that the
strength of the effect depended on the quality of interaction
between the subject and the operator.32
Thus, along with subjective outcome measures, it is impor-
tant for OMT investigators to assess objective measures such
as changes in physiologic parameters or biomechanics because
these data are less susceptible to expectation bias and clearly
462 • JAOA • Vol 106 • No 8 • August 2006
demonstrate specific treatment effects. Objective measures of
physical functioning and hormonal or neurologic change may
be appropriate biomarkers for some studies of OMT and it is
relatively easy to protect blinded assessment with this method-
ologic design. The soundness, or validity, of future studies
would benefit from improved objective outcome measures
and blinded assessment.
When blinded assessment is used, it is essential that inves-
tigators regularly test the integrity of the study protocols by
assessing subjects and study personnel for their level of knowl-
edge regarding treatment allocation. When operator blinding
is not possible, the study design should control for investi-
gator bias (if only partially) using independent evaluators to
provide masked assessment. When subject blinding is not
possible, the study design should control for expectation bias
(if only partially) by regularly assessing the integrity of blinding
protocols, evaluating any changes in treatment credibility and
subject expectations, and ensuring adequate randomization.
The complex interaction of treatment credibility, subject
expectations, and the influence of nonspecific treatment effects
on clinical outcomes form the bridge that the osteopathic med-
ical profession must cross as we seek to further evaluate the effi-
cacy of OMT in an evidence-based paradigm. Careful con-
sideration of these three factors and their influence on clinical
outcomes are one of the hallmarks of a well-designed RCT in
osteopathic medicine.
References
1. Hoehler FK, Tobis JS, Buerger AA. Spinal manipulation for low back pain.
JAMA.1981;245:1835–1838.
2. MacDonald RS, Bell CM. An open controlled assessment of osteopathic
manipulation in nonspecific low-back pain [published correction appears in
Spine. 1991;16:104] Spine. 1990;15:364–370.
3. McReynolds TM, Sheridan BJ. Intramuscular ketorolac versus osteopathic
manipulative treatment in the management of acute neck pain in the emer-
gency department: a randomized clinical trial. J Am Osteopath Assoc.
2005;105:57–68. Available at: http://www.jaoa.org/cgi/content/full/105/2/57.
Accessed July 26, 2006.
4. Goldstein FJ, Jeck S, Nicholas AS, Berman MJ, Lerario M. Preoperative
intravenous morphine sulfate with postoperative osteopathic manipulative
treatment reduces patient analgesic use after total abdominal hysterectomy.
J Am Osteopath Assoc. 2005;105:273–279. Available at: http://www.jaoa
.org/cgi/content/full/105/6/273. Accessed July 26, 2006.
5. Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treat-
ment for low back pain: a systematic review and meta-analysis of randomized
controlled trials [review]. BMC Musculoskelet Disord. 2005;6:43. Available
at: http://www.biomedcentral.com/1471-2474/6/43. Accessed August 10, 2006.
6. Rogers FJ. Advancing a traditional view of osteopathic medicine through
clinical practice. J Am Osteopath Assoc. 2005;105(theme issue):255–259. Avail-
able at: http://www.jaoa.org/cgi/content/full/105/5/255. Accessed July 26,
2006.
7. Tessien RM. OMT’s effectiveness already proven [letter]. J Am Osteopath
Assoc. 2003;103:262. Available at: http://www.jaoa.org/cgi/reprint/103/6/262.
Accessed August 10, 2006.
Licciardone and Russo • Original Contribution

8. Shapiro AK. Placebo effects in medicine, psychotherapy, and psychoanal-
ysis. In Bergin AE, Garfield SL, eds. Handbook of Psychotherapy and Behavior
Change. New York, NY: John Wiley and Sons; 1971:439–473.
9. Kazdin AE. Nonspecific treatment factors in psychotherapy outcome
research. J Consult Clin Psychol. 1979;47:846–851.
10. Horvath P. Treatment expectancy as a function of the amount of infor-
mation presented in therapeutic rationales. J Clin Psychol. 1990;46:636–642.
11. Shapiro DA. Comparative credibility of treatment rationales: three tests
of expectancy theory. Br J Clin Psychol. 1981;20(pt 2):111–122.
12. Goossens ME, Vlaeyen JW, Hidding A, Kole-Snijders A, Evers SM. Treat-
ment expectancy affects the outcome of cognitive-behavioral interventions
in chronic pain. Clin J Pain. 2005;21:18–26.
13. Lewith GT, Prescott P, Davis CL. Can a standardized acupuncture technique
palliate disabling breathlessness: a single-blind, placebo-controlled crossover
study. Chest. 2004;125:1783–1790. Available at: http://www.chestjournal
.org/cgi/content/full/125/5/1783. Accessed August 10, 2006.
14. Hemme RW, Boor M. Role of expectancy set in the systematic desensiti-
zation of speech anxiety: an extension of prior research. J Clin Psychol.
1976;32:400–404.
15. Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, et al. Osteo-
pathic manipulative treatment for chronic low back pain: a randomized con-
trolled trial. Spine. 2003;28:1355–1362.
16. Bombardier C. Outcome assessments in the evaluation of treatment of
spinal disorders: summary and general recommendations [review]. Spine.
2000;25:3100–3103.
17. Thornett AM, Mynors-Wallis LM. Credibility of problem-solving theory and
medication for the treatment of depression among primary care patients. Med
Sci Monit. 2002;8:CR193–CR196. Available at: http://www.medscimonit
.com/pub/vol_8/no_3/2237.pdf. Accessed July 6, 2006.
18. Zaslawski C, Rogers C, Garvey M, Ryan D, Yang CX, Zhang SP. Strategies
to maintain the credibility of sham acupuncture used as a control treatment
in clinical trials. J Altern Complement Med. 1997;3:257–266.
19. Gauthier J, Lacroix R, Cote A, Doyon J, Drolet M. Biofeedback control of
migraine headaches: a comparison of two approaches. Biofeedback Self
Regul. 1985;10:139–159.
20. Scharff L, Marcus DA, Masek BJ. A controlled study of minimal-contact
thermal biofeedback treatment in children with migraine. J Pediatr Psychol.
2002;27:109–119.
Licciardone and Russo • Original Contribution
ORIGINAL CONTRIBUTION
21. Ware JE Jr, Snow KK, Kosinski M, Gandek B. The SF-36 Health Survey:
Manual and Interpretation Guide. Boston, Mass: The Health Institute, New
England Medical Center; 1993.
22. Roland M, Morris R. A study of the natural history of back pain. Part I:
development of a reliable and sensitive measure of disability in low-back
pain. Spine. 1983;8:141–144.
23. Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S.
A comparison of osteopathic spinal manipulation with standard care for
patients with low back pain [published correction appears in N Engl J Med.
2000;342:817]. N Engl J Med. 1999,341:1426–1431.
24. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? Update of a sys-
tematic review with 52 new randomized trials comparing placebo with no
treatment [review]. J Intern Med. 2004;256:91–100.
25. Gotzsche PC. Sensitivity of effect variables in rheumatoid arthritis: a
meta-analysis of 130 placebo controlled NSAID trials [published correction
appears in J Clin Epidemiol. 1991;44:613]. J Clin Epidemiol. 1990;43:1313–1318.
26. Plotkin BJ, Rodos JJ, Kappler R, Schrage M, Freydl K, Hasegawa S, et al.
Adjunctive osteopathic manipulative treatment in women with depression:
a pilot study. J Am Osteopath Assoc. 2001;101:517–523. Available at:
http://www.jaoa.org/cgi/reprint/101/9/517. Accessed August 10, 2006.
27. Bockenhauer SE, Julliard KN, Lo KS, Huang E, Sheth AM. Quantifiable
effects of osteopathic manipulative techniques on patients with chronic
asthma. J Am Osteopath Assoc. 2002;102:371–375. Available at:
http://www.jaoa.org/cgi/reprint/102/7/371. Accessed August 10, 2006.
28. McPartland JM, Giuffrida A, King J, Skinner E, Scotter J, Musty RE.
Cannabimimetic effects of osteopathic manipulative treatment. J Am
Osteopath Assoc. 2005;105:283–291. Available at: http://www.jaoa.org/cgi
/content/full/105/6/283. Accessed August 10, 2006.
29. Caspi O, Millen C, Sechrest L. Integrity and research: introducing the
concept of dual blindness. How blind are double-blind clinical trials in alter-
native medicine? [review] J Altern Complement Med. 2000;6:493–498.
30. Quinn JF. Therapeutic touch as energy exchange: testing the theory.
ANS Adv Nurs Sci. January 1984;6:42–49.
31. Jonas WB, Crawford C. Healing, Intention and Energy Medicine. London,
England: Churchill Livingstone; 2002.
32. Goldstein MS, Morgenstern H, Hurwitz EL, Yu F. The impact of treatment
confidence on pain and related disability among patients with low-back
pain: results from the University of California, Los Angeles, low-back pain study.
Spine J. 2002;2:391–399.
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