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Development of A Clinical Prediction Rule To Identify Patients With Neck Pain Likely To Benefit From Thrust Joint Manipulation To The Cervical Spine
Development of A Clinical Prediction Rule To Identify Patients With Neck Pain Likely To Benefit From Thrust Joint Manipulation To The Cervical Spine
EMILIO J. PUENTEDURA, PT, DPT, PhD1 • JOSHUA A. CLELAND, PT, DPT, PhD2 • MERRILL R. LANDERS, PT, DPT, PhD3
PAUL MINTKEN, PT, DPT4 • ADRIAAN LOUW, PT, MSc5 • CÉSAR FERNÁNDEZ-DE-LAS-PEÑAS, PT, MSc, PhD6
N
eck pain is
TTSTUDY DESIGN: Prospective cohort/predictive used to determine the most parsimonious set of
a common
validity study. variables for prediction of treatment success. Vari-
complaint
TTOBJECTIVE: To determine the predictive valid-
ables retained in the regression model were used to
SUPPLEMENTAL
develop a multivariate clinical prediction rule. in the adult VIDEO ONLINE
Copyright © 2012 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
1
Assistant Professor, Department of Physical Therapy, School of Allied Health Sciences, University of Nevada, Las Vegas, Las Vegas, NV. 2Professor, Department of Physical
Therapy, Franklin Pierce University, Concord, NH. 3Associate Professor, Department of Physical Therapy, School of Allied Health Sciences, University of Nevada, Las Vegas, Las
Vegas, NV. 4Associate Professor, Physical Medicine and Rehabilitation, Physical Therapy Program, School of Medicine, University of Colorado, Aurora, CO. 5Senior Instructor,
International Spine and Pain Institute, Story City, IA. 6Professor, Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey
Juan Carlos, Alcorcón, Madrid, Spain. The study was approved by the University of Nevada, Las Vegas Office for Research Integrity - Human Subjects. This clinical study received
funding from the American Academy of Orthopaedic Manual Physical Therapists, 2008 Cardon Research Grant. Address correspondence to Dr Emilio J. Puentedura, Assistant
Professor, University of Nevada, Las Vegas, School of Allied Health Sciences, Department of Physical Therapy, 4505 Maryland Parkway, Box 453029, Las Vegas, NV 89154-3029.
E-mail: louie.puentedura@unlv.edu t Copyright ©2012 Journal of Orthopaedic & Sports Physical Therapy
journal of orthopaedic & sports physical therapy | volume 42 | number 7 | july 2012 | 577
These risks are well documented, and, A clinical prediction rule for patients and not the number that can be entered
as a result, premanipulative screening with neck pain who responded favorably into the logistic regression model. For
tools have primarily focused on identi- to cervical TJM was developed in 2006 these reasons, it was determined that a
fying patients who may experience ver- by Tseng et al67; however, the study only sufficient number of patients had to be
tebrobasilar insufficiency or may have addressed immediate (within-session) recruited to enable sufficient statistical
cervical arterial dysfunction.6,40 The use results, and the threshold for “success” assessment of a broad-enough number
of these screening tools to rule out risk might have been too low, as the pretest of predictors.
of arterial dissection associated with TJM probability of success was 60%. With a The recruitment strategy was a
is controversial.57,64 The lack of evidence pretest probability of success of 60%, sample of convenience using a prospec-
for premanipulative screening has caused and a positive likelihood ratio (+LR) of tive cohort of patients with mechanical
some authors to suggest that identifying 5.33 (95% confidence interval [CI]: 1.72, neck pain. To get an appropriate num-
patients for whom there may be risks as- 16.54) for at least 4 of 6 predictors pres- ber of patients, consecutive patients
sociated with TJM in the cervical spine ent, the authors arrived at an 89% post- with a primary complaint of neck pain
is virtually impossible and that perhaps test probability of success. A +LR of 5.33 were screened for eligibility criteria at
Copyright © 2012 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
the potential benefits may not outweigh represents only a small to moderate shift outpatient physical therapy clinics in 4
the inherent risks.16,23,24 This may explain in probability,36 and the wide CI also different locations (Las Vegas, NV; Au-
why physical therapists will report uti- detracts from the clinical utility of the rora, CO; Overland Park, KS; and Ma-
lizing TJM in the thoracic spine more rule. In addition, by only assessing for an drid, Spain). For patients to be eligible
frequently than in the cervical spine in immediate response, the study failed to to participate, they had to be between
patients with neck pain,1 despite evidence provide information on longer-term out- 18 and 60 years of age, have a primary
that many of these potential negative out- comes that would have been more indica- report of neck pain with or without uni-
comes may be prevented through careful tive of a true change in condition. lateral upper extremity symptoms, and
examination.56 The purpose of this study was to de- have a baseline Neck Disability Index
Journal of Orthopaedic & Sports Physical Therapy®
Recent evidence suggests that TJM to velop a clinical prediction rule using a (NDI) score of 10 points (out of 50) or
the thoracic spine may improve pain and more rigorous design (ie, higher thresh- greater. Exclusion criteria were as fol-
disability in patients with neck pain.13 old for success, longer-term outcome) to lows: any medical red flags suggesting
Treating the thoracic spine in these pa- identify patients with neck pain likely to that the etiology of symptoms might be
tients has demonstrated benefits and benefit from TJM to their cervical spine, nonmusculoskeletal; diagnosis of cervi-
involves arguably less risk but may not based on a reference standard of patient- cal spinal stenosis (as identified in the
completely address the patient’s present- reported improvement. Developing this patient's medical intake form); bilateral
ing symptoms and mobility impairments. clinical prediction rule should be seen upper extremity symptoms; evidence of
Our experience and recent evidence54 as only the first step in creating a tool to central nervous system involvement; his-
suggest that the addition of TJM to the guide the use of TJM to the cervical spine tory of whiplash injury within 6 weeks of
cervical spine to a comprehensive man- in patients with mechanical neck pain. the examination; pending legal action re-
agement package improves clinical out- garding the neck pain; 2 or more positive
comes. Puentedura et al54 completed a METHODS neurologic signs consistent with nerve
randomized controlled trial comparing root compression (changes in sensation,
T
TJM to the cervical spine versus the tho- here are many rules of thumb in myotomal weakness, or decreased deep
racic spine in patients with neck pain the statistical literature regarding tendon reflexes); or any history of cervi-
who met the criteria for a proposed clini- adequate sample sizes for logis- cal spine surgery, rheumatoid arthritis,
cal prediction rule intended to identify tic regression.17,51,52 Most suggest that a osteoporosis, osteopenia, or ankylosing
individuals with neck pain who would minimum of 10 cases of data should be spondylitis. The study was approved
benefit from TJM to the thoracic spine.12 collected for each predictor in the model; by the University of Nevada, Las Vegas
Both groups received the same exercise others suggest 15 cases of data per pre- Office for Research Integrity - Human
program, and the results indicated that dictor.17,51,52 These suggested sample sizes Subjects, and all study participants pro-
patients with acute neck pain (less than are thought to oversimplify the issue vided informed consent prior to their
30 days in duration) who received TJM considerably,17 as the required sample participation.
578 | july 2012 | volume 42 | number 7 | journal of orthopaedic & sports physical therapy
journal of orthopaedic & sports physical therapy | volume 42 | number 7 | july 2012 | 579
Follow-up 48 h
Dropouts, n = 0 of the patient’s treating therapist. A flow
later, n = 82
diagram showing subject recruitment,
including reasons for ineligibility and
dropout, is provided in FIGURE 3.
Successful outcome
Yes, n = 20
on visit 2
Adverse Events
No All patients were asked to report any ad-
Total in success group, verse events or treatment side effects at
Underwent second
n = 32 each follow-up. We defined an adverse
treatment, n = 62
Journal of Orthopaedic & Sports Physical Therapy®
patients were instructed in gentle active deal worse), 0 (about the same), and +7 Data Analysis
ROM exercise (10 repetitions performed (a very great deal better). It was deter- Patients participating in the study were
3-4 times daily) (FIGURE 2) and advised to mined a priori that patients who rated dichotomized as having experienced or
maintain usual activity within the limits their perceived recovery on the GROC as not experienced a successful outcome
of pain. The patient was scheduled for a +7 (a very great deal better), +6 (a great based on the previously described cut-
follow-up visit 2 to 4 days after the base- deal better), or +5 or higher (quite a bit off for the GROC. Mean NDI and NPRS
line exam. better) at the second session would be change scores and 95% CIs were calculat-
The global rating of change (GROC) categorized as a success and their partici- ed for both groups and analyzed using an
was used as the reference criterion for pation in the study would be complete. independent t test to ascertain difference
establishing a successful outcome follow- This high threshold for determining a between the groups. The success group
ing treatment. The GROC is a 15-point successful outcome was based on previ- and the nonsuccess group were then
scale with the anchors at –7 (a very great ous similar studies,12,13 with the intent to compared on each of the variables from
580 | july 2012 | volume 42 | number 7 | journal of orthopaedic & sports physical therapy
that was nearest the upper left corner Symptoms aggravated by:
represented the value with the best di- Turning right, n (%) 46 (56%) 20 (63%) 26 (52%) .186‡
agnostic accuracy, and this point was Turning left, n (%) 43 (52%) 18 (56%) 25 (50%) .010‡
selected as the cutoff defining a positive Looking up, n (%) 39 (48%) 20 (63%) 19 (38%) .021‡
test within this study. If 2 points were Looking down, n (%) 39 (48%) 16 (50%) 23 (46%) .049‡
equidistant, then the point at which the Driving, n (%) 56 (68%) 23 (72%) 33 (66%) .577‡
Computer use, n (%) 63 (77%) 29 (91%) 34 (68%) .018‡
curve made a marked turn after the steep
initial section was determined to be the Abbreviations: FABQPA, Fear-Avoidance Beliefs Questionnaire physical activity subscale; FABQW,
Fear-Avoidance Beliefs Questionnaire work subscale; NDI, Neck Disability Index; NPRS, numeric
cut-point. pain rating scale; TSK-11, Tampa Scale of Kinesiophobia.
Journal of Orthopaedic & Sports Physical Therapy®
Using these ROC curve–generated *Data are mean SD unless otherwise indicated.
cutoff points, each score was dichoto-
†
Independent-samples t tests.
‡
Chi-square tests.
mized as above or below the cut-point
and the following were calculated: sensi-
tivity, specificity, and positive and nega- essentially the same information and did flexion ROM,” it made clinical sense to
tive LRs. These dichotomized potential not have a statistically significant impact remove “side-to-side difference in lateral
predictor variables were then entered on predicting the dependent variable. flexion ROM” and to keep “side-to-side
into a backward (LR) stepwise logistic Individual R2 value and variance infla- difference in rotation ROM,” cervical
regression model to determine the most tion factor were assessed for each of the rotation differences being easier for cli-
parsimonious set of variables for pre- variables. Variables that exhibited high R2 nicians to assess using the clinical predic-
diction of treatment success. Backward and variance inflation factor values were tion rule.
entry was used because it is generally determined to be collinear and would, After combining or eliminating cor-
considered the preferred method for ex- therefore, affect model fit by multicol- related variables, 9 variables were left to
ploratory analyses.17 Variables retained linearity. This issue was resolved by either consider for entry into logistic regression.
in the regression model were then used combining a pair of correlated variables Although logistic regression is capable of
to develop a multivariate clinical predic- or removing 1 of the 2 correlated vari- handling both continuous and categori-
tion rule for classifying patients likely to ables. As an example, “cervical rotation cal data, the remaining 9 variables were
benefit from cervical TJM for this study range to the right” was highly correlated converted to dichotomous (yes/no and
sample. with “cervical rotation range to the left.” present/not present) attributes. This was
Variables that demonstrated a signifi- Therefore, a new variable named “side- done on the basis that the clinical predic-
cant (P<.05) univariate relationship with to-side difference in rotation ROM” was tion rule would be easier to administer
the GROC reference criterion were then created. Because “side-to-side difference clinically if therapists simply had to de-
assessed for multicollinearity. Variables in rotation ROM” was highly correlated termine whether the predictor attribute
that were highly correlated contributed with “side-to-side difference in lateral was present (positive) in a particular
journal of orthopaedic & sports physical therapy | volume 42 | number 7 | july 2012 | 581
pain rating of greater than 5, side-to-side Cervical flexion, deg† 54.6 10.6 53.8 12.0 55.2 9.7 .549
difference in cervical rotation ROM of Cervical extension, deg† 50.9 15.1 46.7 16.5 53.6 13.7 .044
10° or greater, and deep neck flexor en- Cervical lateral flexion right, deg† 38.4 9.3 36.3 9.6 39.8 8.9 .101
durance of less than 18 seconds. These 4 Cervical lateral flexion left, deg† 37.8 9.1 35.7 10.7 39.2 7.7 .087
dichotomized attributes were then com- Side-to-side difference in lateral 7.2 8.0 13.3 9.3 3.3 3.5 <.001
bined with 5 additional attributes (con- flexion, deg†
taining nominal data) that exhibited a Cervical rotation right, deg‡ 69.0 12.1 65.8 13.1 71.0 11.0 .053
significance level less than .05, resulting Cervical rotation left, deg‡ 68.0 15.4 63.8 16.9 70.8 13.9 .042
in 9 potential predictor attributes (inde- Side-to-side difference in rotation, deg‡ 10.8 11.7 19.2 12.1 5.4 7.6 <.001
pendent variables) to be entered into the Deep neck flexor endurance, s 20.0 8.6 16.4 6.6 22.3 9.0 .002
*Data are mean SD.
logistic regression. †
Indicates measurement with gravity inclinometer.
‡
Indicates measurement with standard dual-arm goniometer.
RESULTS
Copyright © 2012 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
B
etween October 2009 and May
Categorical Variables From the History
2011, 82 patients were recruited TABLE 3
Portion of the Baseline Clinical Examination
for the study. All patients enrolled
in the study completed all requirements
All Subjects Success Nonsuccess
(there were no dropouts). Subject demo- Variable (n = 82) (n = 32) (n = 50) P Value (χ2)
graphics and initial baseline variables Neck pain is bothersome (yes), n 71 31 40 .029
from the patient history and self-report Headache is bothersome (yes), n 35 16 19 .284
measures for patients, as well as the suc- Arm and hand pain is bothersome (yes), n 17 3 14 .042
cess and nonsuccess groups, are in TABLE Numbness tingling is bothersome (yes), n 17 3 14 .042
Journal of Orthopaedic & Sports Physical Therapy®
1. From the baseline clinical examina- Weakness arm/hand is bothersome (yes), n 7 3 4 .828
tion variables for all patients and both Positive expectation that:
groups, continuous data are in TABLE 2 Medications will help (yes), n 47 16 31 .284
and categorical data in TABLES 3 through Rest will help (yes), n 54 21 33 .972
6. Thirty-two patients (39%) were cat- Surgery will help (yes), n 22 5 17 .067
egorized as having achieved a successful Modalities will help (yes), n 69 25 44 .232
outcome and 50 (61%) as a nonsuccessful Massage will help (yes), n 73 27 46 .281
one. Twenty of the 32 patients (62.5%) Manipulation will help (yes), n 52 29 23 <.001
reported success after the initial treat- Traction will help (yes), n 68 27 41 .780
ment, and the remaining 12 after 2 ses- Aerobic exercise will help (yes), n 71 29 42 .391
sions. The mean SD number of days Range-of-motion exercise will help (yes), n 73 30 43 .273
between visits 1 and 2 was 2.8 0.8 and Strengthening exercise will help (yes), n 69 28 41 .506
2.7 0.9 (P = .27) for the success and
nonsuccess groups, respectively. The
mean SD number of days between vis- (FIGURE 4) and significantly greater im- such as increased neck pain, headache,
its 1 and 3 was 5.7 0.9 and 5.3 1.0 provements (P<.001) in disability (NDI and fatigue. The presence of these in-
(P = .60) for the success and nonsuccess change score, 9.6; 95% CI: 8.2, 11.0) over creased symptoms led them to report
groups, respectively. Analysis of NPRS the nonsuccess group (NDI change score, worsening (negative scores) on the GROC
and NDI change scores revealed that the 5.4; 95% CI: 4.2, 6.7) (FIGURE 5). (FIGURE 6). However, by the final session,
success group experienced significantly No patients experienced an adverse only 5 patients reported continued wors-
greater improvements (P<.001) in pain event that required them to withdraw ening on the GROC (FIGURE 7).
(NPRS change score, 3.5; 95% CI: 3.0, from further participation in the study. The accuracy statistics and 95% CIs
4.1) compared to the nonsuccess group After the first treatment session, 10 pa- for all 9 potential predictor attributes
(NPRS change score, 1.1; 95% CI: 0.7, 1.5) tients reported treatment side effects entered into the regression are in TABLE
582 | july 2012 | volume 42 | number 7 | journal of orthopaedic & sports physical therapy
A
*Continuity correction secondary to cells having expected count less than 5. s previous clinical prediction
rule derivation studies12,18,26,48 have
done, the present study focused on
Categorical Variables From the the +LR to identify patients with neck
Copyright © 2012 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Cervical rotation to the left, n 31 15 16 .007 might respond rapidly and positively to a
Cervical lateral flexion to the right, n 30 16 14 .022 TJM technique applied to the midcervi-
Cervical lateral flexion to the left, n 30 14 16 .004 cal region. Based on our results, a patient
Cervical quadrant* to the right, n 25 14 11 .098 with neck pain who exhibited at least 3
Cervical quadrant* to the left, n 24 12 12 .184 of 4 criteria and was treated with TJM
*Quadrant is the combined extension, sidebending, and rotation to 1 side. to the cervical spine showed an increase
from a pretest probability of success of
7. The +LR ranged from 1.75 to 6.77, with efit from cervical TJM. All 16 patients 39% to a posttest probability of success
the strongest predictor being “side-to- who met all 4 criteria were in the success of 90%. This represents a significant shift
side difference in cervical rotation ROM group. Twenty-six of the 29 patients who in probability and a potentially powerful
of 10° or greater.” Of the 9 predictor at- were positive on at least 3 of the criteria tool to guide clinical decision making in
tributes entered into the regression, the were in the success group. Of the 53 pa- the use of cervical TJM for treating pa-
following 4 attributes were retained in tients who exhibited 2 or fewer of the 4 tients with nonradiating neck pain.
the final model: symptom duration less criteria, 47 were in the nonsuccess group Due to concerns regarding the poten-
than 38 days, a positive expectation that (TABLE 8). Accuracy statistics were calcu- tial risks associated with cervical TJM,
manipulation will help, side-to-side dif- lated for each level of the clinical predic- adverse events were monitored during
ference in cervical rotation ROM of 10° tion rule (TABLE 9). The pretest probability the course of the study. There were no se-
or greater, and pain with posteroanterior for the likelihood of success with TJM for rious adverse events encountered during
spring testing of the middle cervical spine this study was 39%. That is, 39% of the the study that required the withdrawal of
(χ2 = 71.6, df = 4, P<.001, Nagelkerke R2 patients exhibited treatment success re- patients from the study. A small percent-
= 0.790). A combination of these 4 at- gardless of their clinical profile. However, age of patients (12%) reported worsening
tributes was considered to be the most taking into account the model of their of their symptoms after the first treat-
accurate predictor to identify those pa- clinical profile, if the patient exhibited at ment session (FIGURE 6), and 1 patient re-
tients with neck pain who will likely ben- least 3 of 4 attributes, the +LR was 13.5 ported feeling “a very great deal worse”
journal of orthopaedic & sports physical therapy | volume 42 | number 7 | july 2012 | 583
3 2.57
1.24
Variable (n = 82) (n = 32) (n = 50) P Value (χ2) 1
Presence of muscle tightness in: 0
Latissimus dorsi, n 39 12 27 .144 Pre Post
Success Nonsuccess
Journal of Orthopaedic & Sports Physical Therapy®
(GROC, –7). Despite this, all 10 patients absence of a combination of these attri-
underwent a repeat cervical TJM dur- butes, therapists should carefully weigh FIGURE 5. Baseline and final scores for the NDI for
ing their second session, of whom only 5 the benefit-risk ratio in deciding whether the success and nonsuccess groups. The change
(6%) continued to report worsening on to include cervical TJM as a part of the score (9.6 4.0) for the success group was
the GROC at the third visit (FIGURE 7). It is treatment for such patients and perhaps significantly greater (P<.001) than the change score
(5.4 4.4) for the nonsuccess group. Abbreviation:
important to remember that all patients consider more appropriate treatment
NDI, Neck Disability Index.
participating in this study were screened options.
for contraindications and precautions The success rate of 39% for the en-
for TJM to the cervical spine and were tire heterogeneous group of patients in tion system for patients with neck pain
excluded from participation if they ex- this study was lower than the previously proposed by Childs et al,10 examining case
hibited any such contraindications. This reported rate of successful outcomes data for 274 consecutive patients receiv-
underscores the importance and value of for manipulating the thoracic spine in ing physical therapy. They found that the
the thorough history and physical exami- patients with neck pain (54%).12 It was most common classification subgroup
nation prior to intervention. also lower than the values obtained for was centralization (34.7%), followed
The absence of the combination of the percentage of successful outcomes closely by the exercise-and-conditioning
predictor attributes derived from this of manipulating the lumbopelvic region subgroup (32.8%). The mobility sub-
study may also be helpful in identifying in patients with mechanical low back group (those presumed to respond more
patients with neck pain who should re- pain (45%).18 This may be explained by favorably to cervical TJM and exercise)
ceive forms of treatment other than TJM. the possibility that patients with neck represented only 17.5% of the patients.
All 27 patients in the study who exhibited pain who are more likely to benefit from The remaining subgroups of headache
only 1 of the predictor attributes and all cervical TJM represent a small subset of and pain control accounted for 15% of the
8 patients who had none of the attributes the heterogeneous group of patients with 274 patients. The 39% who were found to
failed to achieve success. Given the lower neck pain. Fritz and Brennan20 conducted have successful outcomes from the TJM
likelihood of success associated with the a preliminary examination of a classifica- in our study, which is considerably larger
584 | july 2012 | volume 42 | number 7 | journal of orthopaedic & sports physical therapy
Number of Patients
10
10
9
Attributes Identified in the Clinical
8
Prediction Rule 7
Worse, 10 6 6
From the broad list of potential vari- 6
ables for inclusion in our clinical predic-
4
tion rule for patients with nonradicular 3
neck pain, only 4 predictor attributes 2 2 2
2
1 1
were selected for the final model: symp- 0 0
tom duration less than 38 days, a posi- 0
with posteroanterior spring testing of the FIGURE 6. Frequency of the GROC scores at the second session. Blue bars represent patients who were classified
middle cervical spine. Because these 4 as having experienced success with the cervical spine thrust joint manipulation. All other colors represent
attributes represent an important aspect nonsuccess, with green bars representing perceived worsening, the black bar representing no perceived change,
of clinical decision for success in cervical and orange bars representing some perceived improvement but not to the predetermined cutoff for success.
Abbreviation: GROC, global rating of change.
TJM, we will discuss each in turn.
Duration of Symptoms
Success, 32
In previous studies, shorter duration of 22
symptoms was the predictor with the
Journal of Orthopaedic & Sports Physical Therapy®
20 19
highest +LR (6.4) in identifying patients
with neck pain who were likely to have 18
12
11
to benefit from lumbar spine manipula-
tion (4.39).18 Furthermore, several stud- 10
journal of orthopaedic & sports physical therapy | volume 42 | number 7 | july 2012 | 585
Symptom duration <38 d 0.72 (0.53, 0.86) 0.88 (0.75, 0.95) 6.0 (2.7, 13.1) 79% (64%, 89%)
Positive expectation that manipulation will help 0.91 (0.74, 0.98) 0.54 (0.39, 0.68) 2.0 (1.4, 2.7) 56% (48%, 63%)
Current pain rating (NPRS, 0-10) >5 0.50 (0.32, 0.68) 0.82 (0.68, 0.91) 2.8 (1.4, 5.5) 64% (47%, 78%)
No symptoms beyond point of shoulder 0.71 (0.53, 0.86) 0.62 (0.47, 0.75) 1.9 (1.3, 2.9) 54% (44%, 64%)
Postural rotation to 1 side 0.66 (0.47, 0.81) 0.86 (0.73, 0.94) 4.7 (2.3, 9.7) 75% (59%, 86%)
Worse with cervical extension 0.59 (0.41, 0.78) 0.70 (0.55, 0.82) 2.0 (1.2, 3.3) 56% (43%, 68%)
Side-to-side difference in cervical rotation ROM at least 10° 0.81 (0.63, 0.92) 0.88 (0.75, 0.95) 6.8 (3.1, 14.6) 81% (67%, 91%)
Deep neck flexor endurance <18 s 0.69 (0.50, 0.83) 0.72 (0.57, 0.83) 2.5 (1.5, 4.1) 61% (49%, 72%)
Pain with spring (PA) testing of the middle cervical spine 0.88 (0.70, 0.96) 0.50 (0.36, 0.64) 1.8 (1.3, 2.4) 53% (45%, 60%)
Abbreviations: NPRS, numeric pain rating scale; PA, posteroanterior; ROM, range of motion.
*Pretest probability of success, 39%.
TABLE 8 Prediction Rule and the Number of the cervical spine have been thoroughly
Patients in Each Group at Each Level* researched over many years and appear
to be well accepted.14,21,37 Lateral flexion
Number of Predictor Attributes Present Success Group Nonsuccess Group Percent Success and rotation are coupled motions in the
4 16 0 16/16 = 100 cervical spine. In the upper cervical seg-
3 10 3 10/13 = 76.9 ments (0-C1 and C1-C2), lateral flexion
2 6 12 6/18 = 33.3 is coupled with contralateral rotation
1 0 27 0/27 = 0 and rotation is coupled with contralat-
0 0 8 0/8 = 0 eral lateral flexion.33,34,44 The opposite
Journal of Orthopaedic & Sports Physical Therapy®
*Attributes in the CPR: symptom duration of less than 38 days, positive expectation that manipula- has been observed in the lower cervical
tion will help, side-to-side difference in cervical rotation range of motion of 10° or greater, pain with
spring (posteroanterior) testing of the middle cervical spine.
spine (C3-C7), where coupling motions
are ipsilateral.3,53 Furthermore, Bogduk
and Mercer3 and Mercer and Bogduk46
have suggested that the notion of lateral
Combination of Predictor
flexion and rotation in the cervical spine
TABLE 9 Attributes and Associated Accuracy
might be an artificial construct, arguing
Statistics (95% Confidence Intervals)
that this movement should be viewed as
a gliding that occurs in the plane of the
Number of Predictor Positive Probability
Attributes Present Sensitivity Specificity Likelihood Ratio of Success, %*
facet joints.
4 0.50 (0.31, 0.68) 1.00 (0.91, 1.00) Infinite (3.2, infinite) 100% (67%, 100%)
In our study, patients who exhibited
3+ 0.81 (0.63, 0.92) 0.94 (0.82, 0.98) 13.5 (4.5, 41.1) 90% (74%, 96%)
decreased ROM in rotation to 1 side also
2+ 1.00 (0.87, 1.00) 0.70 (0.55, 0.82) 3.3 (2.1, 4.9) 68% (58%, 76%)
demonstrated decreased ROM in lat-
1+ 1.00 (0.87, 1.00) 0.16 (0.08, 0.30) 1.2 (1.0, 1.4) 43% (40%, 46%)
eral flexion to the same side. We found
a side-to-side difference in cervical rota-
*The probability of success is calculated using the positive likelihood ratios and assumes a pretest
probability of 39%. Predictor attributes included: symptom duration of less than 38 days, a positive tion ROM to be highly correlated with a
expectation that manipulation will help, side-to-side difference in cervical rotation range of motion of side-to-side difference in cervical lateral
10° or greater, pain with spring (posteroanterior) testing of the middle cervical spine.
flexion ROM (r = 0.80, P<.001), and,
therefore, eliminated 1 or the other when
We found that a side-to-side difference in used a rotation (upslope) cervical TJM finalizing the test variables to enter into
cervical rotation ROM of 10° or greater technique, which is purported to have our prediction model. We chose cervi-
(FIGURE 8, ONLINE VIDEO) was the predic- a biomechanical effect of “opening” or cal rotation ROM difference over lateral
tor that demonstrated the highest +LR distracting the articular surfaces of the flexion ROM difference on the clinical
(6.8). Of interest is that in this study we particular zygapophyseal (facet) joint grounds that it is arguably easier for
586 | july 2012 | volume 42 | number 7 | journal of orthopaedic & sports physical therapy
cutoff points for the ROC curve favored pain.69 Several studies report the pres- pain. Patients with chronic pain or cen-
rotation (10° difference or greater), as it ence of synovial folds,32,68,76 meniscoids,19 tral sensitization have been shown to
exceeded the standard error of measure- and fat pads65 within facet joints that may report widespread pain and difficulty
ment of 5.5°, whereas lateral flexion (4.5° become entrapped during aberrant mo- accurately locating their pain.59,61,78 In
difference or greater) did not exceed the tions of the cervical spine and lead to the cases in which a patient’s experience of
standard error of measurement of 7°.11 onset of neck pain. It seems plausible that neck pain has extended beyond a local
We found that patients with neck pain if such entrapment did occur, motions mechanism (eg, facet joint arthropathy),
who exhibited a difference in cervical ro- that would require the affected joints to it would be reasonable to conclude that a
tation ROM to either side were limited close down against the entrapped tissues local treatment technique, such as cervi-
Journal of Orthopaedic & Sports Physical Therapy®
toward the painful side or, in the case would provoke symptoms. The possibil- cal TJM, would not be as likely to provide
of patients with bilateral neck pain, to- ity of nociceptive tissues being entrapped immediate benefit.
ward the more painful side. It could be within facet joints in patients with acute
argued that rotation toward the painful neck pain would lend support to the idea Positive Expectation That Manipulation
side may cause the facet joints on that that a cervical TJM technique may allow Will Help
side to close down (articular surfaces for release of the impinged nociceptive Unlike the other attributes discussed so
would approximate) due to the coupled tissues with a subsequent amelioration far, which are theoretically and logically
same-side lateral flexion. Rotation away of pain. classified as treatment-effect mediators
from the painful side may cause the facet (factors that change as a consequence
joints on the painful side to open (articu- Pain With Posteroanterior Spring Testing of the treatment and thereby influence
lar surfaces would be distracted) due to of the Middle Cervical Spine outcome), a positive expectation of ma-
the coupled same-side lateral flexion. The Although the reliability of manual palpa- nipulation is classified as a treatment
therapists who participated in this study tion of the cervical spine has been called moderator because it is a baseline char-
were instructed to apply the rotation into question,60,70 palpation for spinal acteristic that may influence the outcome
(upslope) cervical TJM technique in the tenderness has been shown to be highly of treatment.50 The finding that a positive
nonpainful (or least painful) direction reliable.29 It seems reasonable that a test expectation for manipulation was predic-
first, then to apply the same technique to assessing the presence of local symptoms tive of success is consistent with the fact
the opposite side. It is biomechanically (pain) in the cervical spinal segments to that expectation of benefit (placebo) has
plausible that the cervical TJM technique receive a cervical TJM technique would been shown to have a robust effect on
might have provided an opening (distrac- be identified as a predictor of success pain.71,72 These nonspecific effects need
tion) force to facet joints that were pain- (FIGURE 9, ONLINE VIDEO). In contrast, the to be considered more carefully in all fu-
ful with closing down. A recent review population of patients with neck pain ture research of treatment interventions.
article concluded that more than 50% of who do not report pain with palpation We sought to ensure that the interven-
patients presenting to a pain clinic with in spinal segments may be a different tion (TJM) was delivered in a standard-
journal of orthopaedic & sports physical therapy | volume 42 | number 7 | july 2012 | 587
tive about the cervical TJM intervention may be more appropriate to use than the study was that the cervical TJM tech-
to be used and limited their discussion perceived level of disability remaining. In nique used might not have been spe-
to the information provided in the in- studies that follow patients over a longer cific to the targeted vertebral segments.
formed-consent form. The questionnaire period (eg, 4 weeks, 6 months), perceived Evidence suggests that both thrust and
used in this study to assess for treatment disability may be more appropriate.54 nonthrust manipulation techniques may
expectations is provided in the APPENDIX. Jaeschke et al36 have proposed that not be joint specific4,58; however, this was
a score of +4 on the GROC provides in- adequately addressed by not claiming
Perceived Recovery Versus Perceived creased confidence that improvement or that the cervical TJM technique used in
Disability recovery has occurred. Similar to a pre- this study was specific to any segment. It
As in a previous clinical prediction rule vious clinical prediction rule derivation could also be argued that the results of
derivation study involving patients with study,12 we chose to use a higher thresh- this study could not be specifically cor-
neck pain,12 we chose to use perceived old for defining success (+5 through +7) related with the cervical TJM technique,
recovery using the GROC to determine to provide a greater degree of distinction as gentle cervical ROM exercises were
success rather than a perceived level of between patients who improved dramati- also incorporated in the intervention.
Copyright © 2012 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
disability using the NDI. This was based cally and those who might have improved The cervical ROM exercises were includ-
on the fact that the GROC is considered over time due to the natural history of ed to more closely approximate clinical
to be a valid reference standard for iden- their disorder. In this study, we identi- practice, where therapists are likely to
tifying clinically important change.5,30 We fied potential predictor attributes of pa- use more than a single intervention. Ad-
also chose to use perceived recovery as tients with neck pain who might respond ditionally, the incorporation of a basic
the reference criterion, because the NDI rapidly to cervical TJM; however, this is ROM exercise was consistent with other
has been criticized for not adequately only the first in a 3-step process for de- studies that developed18 and validated9 a
capturing low levels of disability and for veloping and testing a clinical prediction clinical prediction rule for patients with
not being responsive to small but clini- rule,45 and future studies are necessary to low back pain, and developed12 but failed
Journal of Orthopaedic & Sports Physical Therapy®
cally important changes in patients with examine the validity of our results. to validate13 a clinical prediction rule for
low levels of initial disability.28 The mean patients with neck pain who would im-
change score for the NDI in patients who Limitations prove with thoracic manipulation.
reported success was 8.7 (lower-bound Cointerventions such as medication and Finally, as with other clinical predic-
estimate of 95% CI, 4.0) and in patients self-directed exercise are potentially con- tion rule derivation studies, this was a
who reported nonsuccess was 6.2 (lower- founding variables. We sought to control single-arm design, and without a con-
bound estimate of 95% CI, 1.7), meaning for these confounding variables by direct- trol group it is not possible to determine
that both change scores exceeded the rec- ing patients in the study to continue with whether the clinical prediction rule iden-
ommended minimal detectable change of their present medication and activities, tifies prognosis (regardless of treatment)
5 points, but only the success group ex- while not initiating the use of any new or response to the specific treatment.2,25,49
ceeded the minimal clinically important medication or activity while they were Without a control group, we cannot know
difference of 7 points.43 However, with participating in the study. We collected whether improvement after the clinical
standard deviations of 4.71 and 4.46, re- data on medication usage and found no prediction rule treatment was actually
spectively, there were some patients in statistical difference in medication usage due to the treatment. This is considered a
the success group who failed to exceed (over the counter or prescription) be- significant limitation of the single-group
the minimal detectable change and mini- tween the 2 groups. design, in that an initially hypothesized
mal clinically important difference, and, Although data for this study were col- clinical prediction rule does not have pre-
equally, some patients in the nonsuccess lected from 4 geographic locations, there scriptive validity.49 Patients in our single-
group who did exceed the minimal de- was an unequal distribution of patients group study who improved might have
tectable change and minimal clinically among the 4 sites. Data were collected had a more favorable natural history, and,
important difference for the NDI. Ad- from 42 patients (51%) in Madrid, Spain, consequently, patients who were positive
ditionally, measures of success ratings 26 patients (32%) in Las Vegas, NV, 9 pa- on our initially hypothesized clinical pre-
based on the patient’s perceived recovery tients (11%) in Aurora, CO, and, finally, diction rule might have done just as well
have previously been used in clinical trials 5 patients (6%) in Overland Park, KS. with no cervical TJM intervention.25 This
588 | july 2012 | volume 42 | number 7 | journal of orthopaedic & sports physical therapy
ing a single-arm design, as it allows for a of the clinical prediction rule results in im- and reporting in orthopaedic physical therapy:
large number of variables to be studied.42 proved outcome and decreased costs in the application to the cervical spine. J Orthop
treatment of individuals with neck pain. t
Sports Phys Ther. 2010;40:455-463. http://
It is worth noting that all patients in
dx.doi.org/10.2519/jospt.2010.3229
this study had the benefit of a detailed 7. Childs JD, Cleland JA, Elliott JM, et al. Neck
history and physical examination prior KEY POINTS pain: clinical practice guidelines linked to the
to receiving TJM to the cervical spine FINDINGS: A preliminary clinical predic- International Classification of Functioning, Dis-
ability, and Health from the Orthopaedic Section
and ROM exercises. This study, there- tion rule with 4 attributes to identify
of the American Physical Therapy Association.
fore, developed a clinical prediction rule individuals with mechanical neck pain J Orthop Sports Phys Ther. 2008;38:A1-A34.
that identified individuals with neck who respond to cervical TJM was iden- http://dx.doi.org/10.2519/jospt.2008.0303
pain who would respond favorably to the tified: symptom duration of less than 8. Childs JD, Flynn TW, Fritz JM, et al. Screening
for vertebrobasilar insufficiency in patients with
combination of a thorough examination 38 days, positive expectation that ma-
neck pain: manual therapy decision-making in
(history and physical), cervical TJM, and nipulation will help, side-to-side differ- the presence of uncertainty. J Orthop Sports
ROM exercises. We cannot determine ence in cervical rotation ROM of 10° or Phys Ther. 2005;35:300-306. http://dx.doi.
the contribution of the examination to greater, and pain with posteroanterior org/10.2519/jospt.2005.1312
Copyright © 2012 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
prised a prospective case series in which cal TJM by using select attributes from physical examination in patients with me-
improvement after the clinical predic- the clinical examination. chanical neck pain. Arch Phys Med Rehabil.
tion rule treatment (TJM) was highly CAUTION: Future studies are necessary to 2006;87:1388-1395. http://dx.doi.org/10.1016/j.
apmr.2006.06.011
likely.2 According to Straus et al,62 this validate these results and should also
12. Cleland JA, Childs JD, Fritz JM, Whitman JM,
provides low-level evidence that pa- include long-term follow-up and a com- Eberhart SL. Development of a clinical predic-
tients in the clinic who are positive on parison group to further examine the tion rule for guiding treatment of a subgroup of
the clinical prediction rule are also likely predictive value of the attributes identi- patients with neck pain: use of thoracic spine
manipulation, exercise, and patient educa-
to improve after cervical TJM. Finally, fied in the clinical prediction rule.
tion. Phys Ther. 2007;87:9-23. http://dx.doi.
this single-group-design study to derive org/10.2522/ptj.20060155
a clinical prediction rule should be seen 13. Cleland JA, Mintken PE, Carpenter K, et al.
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of patients with headache. In: Fernández-de- acute low back pain. Man Ther. 2003;8:29-36. naire (FABQ) and the role of fear-avoidance
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2006;11:241-242. http://dx.doi.org/10.1016/j. ers to cervical manipulation in patients with therapy, and exercise. Spine (Phila Pa 1976).
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58. Ross JK, Bereznick DE, McGill SM. Determining dx.doi.org/10.1016/j.math.2005.08.009 76. Webb AL, Collins P, Rassoulian H, Mitchell BS.
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@ MORE INFORMATION
2002;10:69-81. placebo mechanism studies conducted between
62. Straus SE, Richardson WS, Glasziou P, Haynes 2002 and 2007. Pain. 2009;145:36-44. http://
RB. Evidence-Based Medicine: How to Practice dx.doi.org/10.1016/j.pain.2009.04.008 WWW.JOSPT.ORG
journal of orthopaedic & sports physical therapy | volume 42 | number 7 | july 2012 | 591
TREATMENT EXPECTATIONS
Downloaded from www.jospt.org at UCSF Lib & CKM/RSCS Mgmt on December 6, 2014. For personal use only. No other uses without permission.
Indicate by circling the comment next to the treatment that corresponds to your amount of agreement with the following statement. Substitute each
treatment into the blank as you consider your response.
I believe ________________ will significantly help to improve this episode of my neck pain.
Note: If you have never received a particular treatment, base your answer on how much you think it would help if you were to receive this treatment.
Ask your physical therapist about any treatment that is not familiar to you.
Medication Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
Rest Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
Surgery Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
Modalities (ie, heat packs, ultrasound, TENS, etc) Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
Massage Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
Manipulation (ie, having your neck or back Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
Copyright © 2012 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
“cracked” or “popped”)
Traction (lying on your back or stomach with Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
straps with a harness strapped on that
stretches out your neck or back)
Aerobic exercise (ie, walking, stationary cycling, Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
StairMaster, etc)
Range-of-motion exercises (ie, stretching) Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
Strengthening exercises Completely disagree Somewhat disagree Neutral Somewhat agree Completely agree
The above form was used to collect the data on expectation for this study. A similar form should be used to assess patient expectation in the clinic and
determine the presence of this attribute.
You can basically disregard all answers except the manipulation question.
If the patient circles “completely disagree,” “somewhat disagree,” or “neutral,” then there is NOT a positive expectation that manipulation will help their
neck pain, that is, negative for that predictor in the newly developed clinical prediction rule.
If the patient circles “somewhat agree” or “completely agree,” then there IS a positive expectation that manipulation will help their neck pain, that is,
positive for that predictor in the newly developed clinical prediction rule.
592 | july 2012 | volume 42 | number 7 | journal of orthopaedic & sports physical therapy
1. Emmanuel Yung, Michael Wong, Haddie Williams, Kyle Mache. 2014. Blood Pressure and Heart Rate Response to
Posteriorly Directed Pressure Applied to the Cervical Spine in Young, Pain-Free Individuals: A Randomized, Repeated-
Measures, Double-Blind, Placebo-Controlled Study. Journal of Orthopaedic & Sports Physical Therapy 44:8, 622-626.
[Abstract] [Full Text] [PDF] [PDF Plus] [Supplemental Material]
2. Renata Salvatori, Robert H. Rowe, Raine Osborne, Jason M. Beneciuk. 2014. Use of Thoracic Spine Thrust Manipulation
for Neck Pain and Headache in a Patient Following Multiple-Level Anterior Cervical Discectomy and Fusion: A Case
Downloaded from www.jospt.org at UCSF Lib & CKM/RSCS Mgmt on December 6, 2014. For personal use only. No other uses without permission.
Report. Journal of Orthopaedic & Sports Physical Therapy 44:6, 440-449. [Abstract] [Full Text] [PDF] [PDF Plus]
[Supplemental Material]
3. Suzanne J. Snodgrass, Joshua A. Cleland, Robin Haskins, Darren A. Rivett. 2014. The clinical utility of cervical range of
motion in diagnosis, prognosis, and evaluating the effects of manipulation: a systematic review. Physiotherapy . [CrossRef]
4. Todd E. Davenport. 2014. Clinical Case Reporting in the Peer-Reviewed Physical Therapy Literature: Time to Move
Toward Functioning. Physiotherapy Research International n/a-n/a. [CrossRef]
5. Anat Lubetzky-Vilnai, Marcia Ciol, Sarah Westcott McCoy. 2013. Statistical Analysis of Clinical Prediction Rules for
Rehabilitation Interventions: Current State of the Literature. Archives of Physical Medicine and Rehabilitation . [CrossRef]
6. Mark D. Bishop, Paul Mintken, Joel E. Bialosky, Joshua A. Cleland. 2013. Patient Expectations of Benefit From
Interventions for Neck Pain and Resulting Influence on Outcomes. Journal of Orthopaedic & Sports Physical Therapy 43:7,
457-465. [Abstract] [Full Text] [PDF] [PDF Plus]
7. Laurence N. Benz, Timothy W. Flynn. 2013. Placebo, Nocebo, and Expectations: Leveraging Positive Outcomes. Journal
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of Orthopaedic & Sports Physical Therapy 43:7, 439-441. [Abstract] [Full Text] [PDF] [PDF Plus]
8. Robert J. Nee, Bill Vicenzino, Gwendolen A. Jull, Joshua A. Cleland, Michel W. Coppieters. 2013. Baseline Characteristics
of Patients With Nerve-Related Neck and Arm Pain Predict the Likely Response to Neural Tissue Management. Journal
of Orthopaedic & Sports Physical Therapy 43:6, 379-391. [Abstract] [Full Text] [PDF] [PDF Plus]
9. Cheryl Sparks, Joshua A. Cleland, James M. Elliott, Michael Zagardo, Wen-Ching Liu. 2013. Using Functional Magnetic
Resonance Imaging to Determine if Cerebral Hemodynamic Responses to Pain Change Following Thoracic Spine Thrust
Manipulation in Healthy Individuals. Journal of Orthopaedic & Sports Physical Therapy 43:5, 340-348. [Abstract] [Full
Text] [PDF] [PDF Plus]
10. Michael Masaracchio, Joshua Cleland, Madeleine Hellman, Marshall Hagins. 2013. Short-Term Combined Effects of
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Thoracic Spine Thrust Manipulation and Cervical Spine Nonthrust Manipulation in Individuals With Mechanical Neck
Pain: A Randomized Clinical Trial. Journal of Orthopaedic & Sports Physical Therapy 43:3, 118-127. [Abstract] [Full Text]
[PDF] [PDF Plus] [Supplemental Material]
11. Raquel Martínez-Segura, Ana Isabel de-la-Llave-Rincón, Ricardo Ortega-Santiago, Joshua A. Cleland, César Fernández-
de-las-Peñas. 2012. Immediate Changes in Widespread Pressure Pain Sensitivity, Neck Pain, and Cervical Range of Motion
After Cervical or Thoracic Thrust Manipulation in Patients With Bilateral Chronic Mechanical Neck Pain: A Randomized
Clinical Trial. Journal of Orthopaedic & Sports Physical Therapy 42:9, 806-814. [Abstract] [Full Text] [PDF] [PDF Plus]