Dolor Lumbar JOSPT

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Title: Short-term Effects of Thoracic Spine Thrust Manipulation, Exercise, and Education
for Individuals with Low Back Pain: A Randomized Controlled Trial
Authors: Laura R. Fisher PT, DPT, PhD,1,2 Brent A. Alvar PhD,3 Sara F. Maher, PT,
DScPT,4 Joshua A. Cleland, PT, PhD5
1. Rocky Mountain University of Health Professions, Provo, UT, United States
2. Michigan Medicine; Ann Arbor, MI, United States
3. Point Loma Nazarene University, San Diego, CA, United States
4. Wayne State University, Detroit, MI, United States
5. Franklin Pierce University, Manchester, NH, United States
Sources of grant support: None
Approval for the study was obtained from the Institutional Review Boards (IRB) at Rocky
Mountain University of Health Professions (150965-03) and University of Michigan
Downloaded from www.jospt.org by Texas A & M University on 12/07/19. For personal use only.
Health System (HUM00105566).
This trial was prospectively registered with the NIH to promote transparency of study
protocol ID: NCT02853357.
Corresponding Author:
Laura Fisher
325 E. Eisenhower Pkwy, Suite 200
Ann Arbor, MI 48108
Phone: (734) 763 – 5206
Fax: (734) 763 - 3715
Email: laurafis@med.umich.edu
J Orthop Sports Phys Ther

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Short-Term Effects of Thoracic Spine Thrust Manipulation, Exercise, and Education for
Individuals with Low Back Pain: A Randomized Controlled Trial
I affirm that I have no financial affiliation (including research funding) or involvement with any
commercial organization that has a direct financial interest in any matter included in this
manuscript, except as disclosed in an attachment and cited in the manuscript. Any other conflict
of interest (ie, personal associations or involvement as a director, officer, or expert witness) is
also disclosed in an attachment.

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Acknowledgements:
The authors acknowledge the following individuals which helped with recruitment, study
materials, data collection, and intervention: Christiana Weber, Kari Katerberg, Dustin
DeLoach, John Kravic III, Jason Mottes, Kara Bland, Stephanie Mundt, Sarabeth
Ballheim, Zaki Afzal, Emily Pappas, Emilie Hock.

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1 Abstract
2 Study Design: Randomized controlled trial
3 Objective: The determine the short-term effectiveness of thoracic manipulation (MAN)
4 when compared to sham manipulation (SHAM) for individuals with LBP.
5 Background: Low back pain is one of the most prevalent and disabling musculoskeletal
6 conditions. The management of LBP has been studied extensively, yet the most
7 effective treatment strategies remain to be elucidated.
8 Methods: Patients with LBP were stratified based on symptom duration and randomly
9 assigned to MAN or SHAM treatment groups. Groups received three visits which
10 included core stabilization exercises and patient education. Factorial repeated
11 measures ANOVA and multiple regression was performed for pain, disability, and fear-
12 avoidance. Mann Whitney-U test was used to analyze patient perceived improvement
13 with the Global Rating of Change scale (GROC) at follow up.
14 Results: Ninety participants completed the study (mean age 38± 11.5 years; 70%
15 female, 72% chronic LBP). The overall group-by-time interaction for the ANOVA was
16 not significant for MODQ, NPRS, FABQ. GROC was not significantly different between
17 the groups.
18 Conclusion: Three sessions of thoracic manipulation, education, and exercise did not
19 result in improved outcomes when compared to a sham manipulation, education, and
20 exercise in individuals with chronic LBP. Future studies are needed to identify the most

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21 effective management strategies for the treatment of low back pain. Registered at
22 clinicaltrials.gov (NCT02853357).
23 Level of Evidence: Therapy, level 1b
24 Keywords: Low back pain, thoracic manipulation, physical therapy


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25 Introduction
26 Low back pain (LBP) is one of the most prevalent and costly musculoskeletal
27 conditions resulting in more chronic disability than any other condition. LBP is the
28 leading cause of activity restriction and work absence across the globe.17 Chronic LBP
29 is associated with higher medication use, healthcare utilization, direct medical costs,
30 physical limitations, activity impairments, and reduced quality of life.15,19,20 Individuals
31 with chronic LBP are more likely to have comorbidities including depression, anxiety,
32 and sleep disorders which could further hinder progress.15

33 As the most common diagnosis seen by physical therapists, LBP treatment
34 continues to be of vital importance in physical therapy (PT) practice. Recent analysis of
35 data revealed involving PT earlier in the treatment process may reduce overall health
36 costs.13 Manual therapy has demonstrated positive therapeutic effects, particularly
37 lumbar spinal manipulation in the short-term.2,10,16,26 However, it has been suggested a
38 more holistic approach, which emphasizes the complex role and interactions of the
39 entire neuromuscular system may have the same treatment effect. The theory of
40 regional interdependence, defined as the “concept that a patient’s primary

41 musculoskeletal symptoms may be directly or indirectly related or influenced by
42 impairments from various body regions and symptoms regardless of proximity to the
43 primary symptoms,” embraces these complex interactions29 The regional
44 interdependence model represents the musculoskeletal manifestation of a larger
45 independent process termed allostatic process, which is responsible for the regulation

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46 of biopsychosocial, neurophysiological, somatovisceral, and musculoskeletal
47 responses.29
48 The effects of thoracic manipulation on adjacent regions have been widely
49 studied and the majority of authors cite regional interdependence as an explanation for
50 its success.28,31 Thoracic manipulation has been shown to be effective in reducing pain,
51 increasing range of motion (ROM), improving self-reported function and disability in
52 patients with neck pain and shoulder conditions.39,53,52,57,58 Positive results have been
53 reported with the use of thoracic manipulation for cervical radiculopathy, cervical
myelopathy, and post-whiplash injuries.56 However, these findings cannot be

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55 generalized to other spinal regions such as the lumbar spine. A previous study
56 compared the immediate effects of thoracic manipulation versus lumbar manipulation in
57 individuals with LBP.8 The results found that both there was no difference between
58 treatments for either pain or pressure pain threshold.8 An additional study compared
59 thoracic mobilization and exercise to thoracic manipulation and exercise to exercise
60 alone for chronic LBP and found that both manual therapy treatments demonstrated
61 improved disability and mental state over exercise alone, but there was no difference
62 between the two manual therapy groups.30
63 Preliminary evidence suggests thoracic manipulation may have potential benefit
64 for individuals with LBP, however this requires further investigation. Additionally, to date
65 no studies have examined the impact of adding thoracic manipulation to exercise and
66 education for the management of LBP. Therefore, the purpose of this study was to

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67 examine the short-term effectiveness of thoracic manipulation, core stabilization
68 exercises and education on pain, disability, and fear-avoidance beliefs compared to a
69 sham manipulation, core stabilization exercises, and education.
70 Methods
71 Subjects
72 Over an 18-month period (November 2016-April 2018), consecutive patients
73 referred to PT for LBP in a large health system (Michigan Medicine Spine Clinic; Ann
74 Arbor, MI) were screened for eligibility. Participants were consecutive patients between
75 the ages of 18-59 referred to PT with a diagnosis of LBP, which was defined as pain
76 located between the 12th thoracic vertebrae and the gluteal folds; participants were not
77 excluded if associated lower extremity symptoms were present. To be eligible to
78 participate subjects had to have a minimum pain intensity score of 3 on an 11-point
79 numeric pain rating scale (NPRS) (ranging from 0-10 points) and had at least a 20%
80 disability rating on the Modified Oswestry Disability Questionnaire (MODQ) at the time
81 of assessment. Subjects were excluded if they had any contraindications to spinal

82 manipulation such as osteoporosis, active cancer, previous spinal surgery, spinal
83 fracture, acute rheumatic disease, active tuberculosis, pregnancy, active infections of
84 the vertebra or intervertebral disc, any neurological evidence suggesting compromise of
85 the nerve roots or spinal cord (changes in myotomal strength, deep tendon reflexes, or
86 sensation), or cauda equina syndrome.4,8 Subjects were also excluded if they had

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87 insufficient English skills to complete questionnaires, or were involved in litigation or a
88 workman’s compensation claim.
89 Approval for the study was obtained from the Institutional Review Boards (IRB) at
90 Rocky Mountain University of Health Professions (150965-03) and University of
91 Michigan Health System: HUM00105566. Informed consent was obtained from all
92 participants prior to enrollment in the study and all rights were protected. This trial was
93 registered at clinicaltrials.gov (NCT02853357).
94 Therapists
95 Three physical therapists, including the primary investigator, with an average of
96 six years’ experience participated in the recruitment and initial assessment of
97 participants in this study. Five additional physical therapists with an average of two
98 years’ experience contributed in treatment of participants. The assessors were
99 orthopedic clinical specialists, and the treating clinicians were currently completing or
100 had recently completed a credentialed orthopedic residency program. All participating
101 therapists were provided with a detailed manual of standard operating procedures and
102 were trained in the study procedures to maximize standardization. Treating therapists
103 underwent training sessions for treatment procedures including manual therapy
104 techniques, sham techniques, exercises, and educational materials to ensure treatment
105 was performed in a standardized fashion. Clinicians completing the initial assessment
106 were blinded to treatment groups; however, it was not possible to blind treating
107 therapists due to the nature of the interventions provided.

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108 Outcomes
109 All participants provided a history, underwent a standard PT examination, and
110 completed the following self-report measures at baseline. The NPRS8 was used to
111 assess pain before and after treatment. The scale ranges from 0 “no pain” to 10 “worst
112 possible pain.” The NPRS had an adequate (r=.62) test-retest reliability when
113 comparing a single pair of values and an excellent (r=.72-.92) test-retest reliability when
114 comparing two pairs of measures.1 A 2-point change on the NPRS represents a
115 clinically meaningful change which exceeds the bounds of measurement error.3 The
116 MODQ is a functional scale assessing the impact of low back pain on daily activities by
117 assigning a disability score according to the answered questions. 11 The scale includes
118 10 questions regard the level of pain and interference with several physical activities
119 including: sleeping, lifting, travelling, self-care, and social life.21 Each question has six
120 possible responses (scored from 0 to 5), and patients are asked to pick the one most
121 accurately responding to their condition.21 The MODQ is one of the most widely used
122 and most comprehensively validated back-specific measures and thus has been
123 deemed acceptable for measuring disability related to LBP.5 The minimum clinically
124 important difference for the MODQ has been reported as 6 points.12 The FABQ is used
125 to quantify individual’s fear avoidance beliefs in relation to LBP, specifically regarding
126 avoiding activity.9 The FABQ is divided into physical activity (FABQ-PA) and work
127 subscales (FABQ-W) in which patients rate their agreement of each statement on a
128 seven point Likert scale (0 is completely disagree and 6 is completely agree). Both

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129 subscales have shown a high level of test-retest reliability with FABQ-PA having a
130 Pearson r=.84-.88 and the FABQ-W with a Pearson r =.88-.91.2,9 The FABQ-W has also
131 demonstrated predictive validity for disability and work loss in patients with LBP.9 Cut off
132 scores for those with elevated fear-avoidance beliefs have been reported as >14 for
133 FABQ-PQ and >29 for FABQ-W.14
134 Informed consent was obtained following the examination and obtaining outcome
135 measures, due to inclusion/exclusion criteria having aspects of both the physical
136 examination and self-report measures.

137 Randomization
138 Participants were stratified into two groups based on duration of current
139 symptoms: less than three months (acute) and greater than three months (chronic).
140 Participants were randomized into either the experimental group (MAN) or the control
141 group (SHAM). Randomization was completed by stratified permuted block
142 randomization by a research assistant not involved in recruitment of subjects. Blocks
143 were completed in groups of 10 assignments for each group. Index cards with
144 concealed group allocation were folded and sealed in envelopes. Envelopes were
145 mixed by two independent clinicians and placed in the folder for its corresponding group
146 by the research assistant. This was completed for each stratified group. The process
147 was repeated once envelopes were used for each group. Once initial assessment was
148 completed, and consent received, the blind assessor informed the treating clinician of
149 the stratified group. The treating clinician would subsequently take the next envelope

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150 from the folder and proceed with intervention according to the group assignment.
151 Interventions
152 All participants received three visits with the average time of completion at
153 10.5±3.5 days. Treatment sessions lasted 30 minutes and consisted of MAN or SHAM,
154 education regarding management strategies for LBP, and core exercises. Three
155 sessions were chosen for intervention procedures in order to include a longer time
156 frame to capture benefits beyond immediate effects as in many previous manipulation
157 studies.
158 Experimental Group (MAN):
159 Participants randomized into MAN group received two thoracic spine
160 manipulations. For the manipulation targeting the middle thoracic spine (T6-8),
161 participants were placed in the supine position with arms crossed over their chest. The
162 clinician then rolled the participant to their side and place the fulcrum (using the pistol
163 grip) at the desired thoracic segment and the participant was then rolled back onto the
164 clinician’s hand (FIGURE 1). The participant was instructed to take a deep breath and
165 exhale. On exhalation, the clinician used his body to push through the participant’s arms
166 to perform a high velocity thrust in an anterior to posterior direction toward T6-8
167 (FIGURE 2).4,7,6 Two attempts were performed regardless of if cavitation occurred.
168 Participants were then placed in the prone position for the lower thoracic spine
169 manipulation. The clinician achieved a “skin lock” with the pisiforms of each hand over
170 the transverse processes of the target vertebra (T8-12) by pushing caudal with one

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171 hand and cephalad with the other. The clinician then used his body to push down
172 through his arms to perform a high-velocity, low-amplitude posterior to anterior thrust
173 (FIGURE 3). Again, two attempts were performed regardless of if cavitation occurred.
174 Following the manipulation, participants were instructed in a standardized
175 protocol of core stabilization exercises proposed to target muscles responsible for
176 segmental stabilization, specifically the transverse abdominis (TrA) and the lumbar
177 multifidi (LM). 11,24,25 Exercises were completed in various positions and could be
178 progressed in subsequent sessions as deemed appropriate by the clinician. (Appendix

179 B) Participants also received education regarding the natural process of LBP, strategies
180 for management of LBP including bending and lifting techniques, and what to avoid
181 during the study period.
182 Control Group (SHAM):
183 Participants randomized into SHAM group received two sham manipulation
184 techniques. The first technique was completed in supine to mimic the middle thoracic
185 spine manipulation. Participants were placed in identical set up position as participants
186 in MAN group with the exception of hand placement. An “open hand” was placed over
187 the target vertebra T6-8 (FIGURE 4).6 Once the “premanipulative position” was
188 achieved, the participant was instructed to take a deep breath and exhale. No high-
189 velocity thrust maneuver was performed during the exhalation (FIGURE 5). The second
190 technique was to simulate the lower thoracic spine manipulation. Participants were
191 positioned in prone and the clinician’s hands were placed with the pisiforms of each

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192 hand over the transverse processes of the target vertebra (T8-12). The clinician applied
193 minimal pressure and slid the hands across the skin to mimic the manipulative thrust.
194 This procedure was deemed an adequate sham comparator for spinal manipulation with
195 similar expectations and believability as active treatment (FIGURE 6).22 After the sham
196 techniques, participants were instructed in the core stabilization exercises and
197 education identical to the MAN group.
198 Follow-up
199 At the end of the third visit, each participant was given the following outcome
200 measures: MODQ, NPRS, FABQ, and well as Global Rating of Change (GROC). The
201 GROC was used to assess self-perceived improvement of the intervention. The GROC
202 is a 15-point scale ranging from -7 (a very great deal worse) to 0 (about the same) to +7
203 (a very great deal better). The scale has demonstrated acceptable levels of reliability
204 and validity and is considered to be a valid reference standard for identifying clinically
205 important change.7 Previous studies have used cut-off scores of +4 and higher as a
206 successful outcome; however, important improvement has been noted at +5 or

207 more.2,10,18 Participants were also polled to determine what treatment they believed to
208 have received and if any side effects were experienced.
209 The sample size was justified by a priori power analysis using a target effect size
210 of 0.8, alpha of 0.05, and power of 0.80 for the variable of MODQ, in order to allow the
211 ability to detect a small to moderate effect on disability in the sampled population which
212 revealed a total sample size of 90 subjects.

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213 Data Analysis
214 Descriptive statistics were calculated for baseline demographic data. Subjects
215 were stratified according to duration of symptoms (acute vs chronic) prior to
216 randomization. Pearson correlation was used to determine if duration of symptoms
217 should be used as a covariate for the main analysis.
218 The effects of treatment on disability, pain, and fear avoidance behaviors were
219 analyzed using a factorial repeated-measures analysis of variance (ANOVA), with
220 treatment group as the between-subject factor and time as the within-subject factor.
221 Separate ANOVAs were performed with MODQ, NPRS, FABQ-work, FABQ-physical
222 activity, and FABQ-total as the dependent variable. Little’s missing completely at
223 random (MCAR) test was completed for missing data. Intention-to-treat analysis was
224 performed by using expectation maximization technique in which missing data is
225 estimated using regression equations. A Mann Whitney-U test was used to determine
226 group differences for the GROC. Pearson correlation evaluated the interaction between
227 baseline and follow up scores. To account for baseline interaction, a multiple regression
228 was used to predict follow up scores, with group, duration of symptoms, and initial
229 scores used as covariates. A chi-square test was performed to determine the
230 effectiveness of the sham technique. The alpha level for all analyses was a priori
231 established at .05 using a 2-tailed test. Data analyses were performed using the SPSS
232 Version 24.0 statistical software package (SPSS Inc. Chicago, IL).
233 Results

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234 Three hundred ninety-three consecutive patients referred to PT for LBP in a large
235 health care system were screened for eligibility. 101 individuals (mean age 38±11.5
236 years, 70% female, 72% chronic) met all inclusion criteria, agreed to participate in the
237 study, and signed the informed consent. Fifty-two were randomized to MAN group and
238 49 were randomized to SHAM group. FIGURE 7 shows a diagram of recruitment and
239 retention. Of the 101 enrolled, 90 (89.1%) completed the study. Eleven participants did
240 not complete the study (MAN=5, SHAM=6). The percentage of drop outs between the
241 groups was not significantly different and none were due to adverse effects. Average
242 time for study completion was 10.49±3.54 days which not significantly different between
243 the groups (p=.268). All baseline demographics were similar between groups (p>.05)
244 with the exception of gender (p=.047). (TABLE 1) Gender was not found to be a
245 significant covariate for disability or pain (p>.05), nor was it a significant predictor of
246 follow up scores.
247 The overall group by time interaction was not significant for MODQ (p=.159),
248 NPRS (p=.890), FABQ-PA (p=.861), FABQ-work (p=.798), or FABQ-total (p=.967)
249 (TABLE 2). While in general the MAN group saw greater declines over time, this was
250 not significantly different from the SHAM. (FIGURES 8-12) Participants demonstrated
251 significant improvement from baseline to follow up when compared within their groups.
252 There was no significant difference between the groups in regard to GROC; however,
253 42% of the total population (45% MAN, 40% SHAM) did report a clinically meaningful
254 improvement (MCID>3) during the study period.

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255 The effects of chronicity were evident in the significant differences between
256 baseline and follow-up for disability, pain, and components of fear-avoidance behaviors.
257 Those with acute LBP had significantly reduced scores on the MODQ with a mean
258 difference -15.07±17.23 compared to -6.52±9.24 for the chronic LBP subgroup (p=.010).
259 Mean difference for pain, FABQ-PA, and FABQ-total were also greater in the acute
260 group; however, these were not significantly different from the chronic LBP group.
261 Although all groups demonstrated improvement, there was no significant differences in
262 those who met the MCID for all outcomes.

263 The effectiveness of the sham technique was examined using a chi-square from
264 a poll taken at follow up. (TABLE 3) [X2 = 10.70, p=.001, OR= 6.62 (2.10, 21.94)] 63%
265 of the participants who received the SHAM suspected they received the true
266 manipulation which suggests it was an effective comparator. No adverse events were
267 reported for either group during the study period.
268 Discussion
269 Thoracic spine thrust manipulation, when added to exercise and education, was
270 not more effective at improving disability, pain, or fear-avoidance behaviors than a sham
271 manipulation, exercise, and education. The findings of the current study differed from
272 those by Sung et al.30 who noted thoracic manipulation yielded significant improvements
273 in disability and fear avoidance when compared to thoracic mobilization and a control.
274 Limitations of the study by Sung et al.30 included a small sample size (n=36 across
275 three groups) and participants receiving 18 total visits over a six week period. The

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276 sample of Sung et al.30 was exclusively comprised of patients with chronic LBP whereas
277 the current study included both acute and chronic. The current study protocol is likely
278 more realistic within the current state of healthcare in the US than the protocol used by
279 Sung et al.30 due to the nature of intervention and elevated number of treatment
280 sessions.
281 The sample used in the current study was largely comprised of patients with
282 chronic LBP. It is well documented acute LBP differs from chronic LBP in its nature and
283 response to treatment9,16 Individuals with acute LBP had significantly reduced scores for
284 disability regardless of the intervention group. However, the study was not adequately
285 powered to identify a difference between interventions in the subgroup with acute
286 symptoms. Previous studies demonstrate acute LBP being more responsive to
287 manipulative intervention, although, the majority of previous studies targeted the lumbar
288 spine.2,9,10,16,26 Evidence surrounding chronic LBP has noted more improvement with
289 exercises and education.9,27 Despite the stratification of groups before randomization to
290 account for differences in chronicity, the intervention may have been effective if the
291 sample was limited to subjects with acute LBP. It is difficult to conclude what accounted
292 for the improved treatment effect in the total sample as it could be attributed to the
293 natural history of LBP or the passage of time.
294 There were several limitations in this study. The study could have been
295 underpowered as the power analysis used to determine sample size did not account for
296 stratification of participants based on chronicity. This may have resulted in

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297 disproportionate percentages of acute and chronic subjects in the treatment groups,
298 consequently limiting valuable findings. Subjects with acute LBP showed a greater
299 improvement in disability. Futures studies should examine the effects of thoracic
300 manipulation on individuals with acute LBP to determine if this would result in significant
301 and clinically meaningful improvements. Although all clinicians underwent training
302 procedures and demonstrated proficiency, variations in clinical experience and levels of
303 comfort administering interventions may have influenced outcomes. Only three
304 sessions were utilized, and it is possible that additional sessions may be necessary to
305 determine the true effectiveness of thoracic manipulation in a population of individuals
306 with chronic LBP. Future studies should focus on acute pain and consider the use of
307 more treatment sessions over a longer duration which would mimic typical PT practice.
308 Conclusion
309 In this randomized clinical trial, three thoracic manipulations in addition to
310 exercise and education, did not result in improved outcomes in individuals with chronic
311 LBP when compared to a sham manipulation in addition to exercise and education. LBP
312 continues to be a significant source of disability and creates significant burden on

313 healthcare costs especially when it is chronic. Continued research is needed to
314 determine the most effective management strategies for chronic LBP. Future research
315 should evaluate manual interventions in conjunction with pain neuroscience.
316 Key Points:

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317 Findings: The results of this study found that a short bout of thoracic manipulation,
318 exercise, and education was no more effective at reducing outcomes than a sham
319 manipulation, exercise, and education in individuals with chronic LBP.
320 Implications: Thoracic spine manipulation did not add additional benefit over a sham
321 manipulation when added to exercise and education for individuals with chronic LBP.
322 Symptom duration remains a significant predictor of treatment outcomes with acute pain
323 responding more favorably to treatment.
324 Caution: The study sample was stratified prior to randomization leading to
325 disproportionate amounts of acute versus chronic LBP which may have limited valuable
326 findings.

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manipulation for the management of musculoskeletal conditions: a systematic
review and meta-analysis of randomized clinical trials. J Man Manip Ther.
2009;17(4):237-246.

21
Figure 1: Manipulation Hand position Figure 2: Middle Thoracic Spine Manipulation

Figure 3: Lower Thoracic Spine Manipulation


22
Figure 4: Sham Hand position Figure 5: Middle Thoracic Sham Manipulation

Figure 6: Lower Thoracic Sham Manipulation


Figure 7: Study Flowsheet
23

Figure 9: Changes in NPRS

Figure 8: Changes in MODQ

24
25

Figure 10: Changes in FABQ-‐PA


Figure 10: Changes in FABQ-‐Work


Figure 12: Changes in FABQ-‐Total

26
27
Table 1 Demographics and Outcome Measures at Baseline
Manipulation Sham Total

(N=52) (N=49) (N=101)
Age (years)* 38.46±12.07 37.78±10.91 38.12±11.11

Gender(female), n(%) 32(61.5) 39(79.6) 71(70.3)
Duration of Symptoms
Chronic n(%) 38(73.1) 35(71.4) 73(72.3)
Study Duration
10.13±3.23 10.88±3.84 10.49±3.54
(Days)*
Race, n (%)
White 44(84.6) 37(75.5) 81(80.2)
Black 7(13.5) 9(18.4) 16(15.8)
Asian 0 2(4.1) 2(2.0)
Other 1(1.9) 1(2.0) 2(2.0)

§
NPRS (0-10) 4.88±1.61 5.29±1.65 5.07±1.65
§
MODQ (0-100%) 32.81±13.55 34.33±14.78 33.54±14.11
FABQ – PA (0-24)§ 14.25±5.75 15.16±5.25 14.69±5.51
§
FABQ – Work (0-36) 10.79±8.39 11.12±9.41 10.95±8.86
§
FABQ – Total (0-60) 25.04±11.15 26.08±12.11 25.54±11.58
Abbreviations: NPRS, numeric pain rating scale; MODQ, Modified Oswestry Disability
Questionnaire; FABQ, Fear Avoidance Belief Questionnaire; FABQ-PA, Fear Avoidance Belief
Questionnaire - physical activity
*Vales are mean ± SD unless otherwise indicated
§
Lower scores are better


28
Table 2 Changes in Outcomes for the 2 Interventions

Mean Difference
Manipulation* Sham*
Variable (Manipulation- P-value
Sham) †
10.50(6.49, 7.18(4.31,10.06)
3.32(-1.61, 8.24) 0.159
MODQ‡ 14.51)
NPRS‡ 1.52(1.07, 1.97) 1.45(0.85, 2.04) 0.70(-0.66, 0.81) 0.890
FABQ-PA‡ 2.98(1.37, 4.59) 3.16(1.86, 4.46) -0.18(-2.24,1.87) 0.861
FABQ-Work‡ 0.92(0.85, 2.70) 0.59(-1.30, 2.48) 0.33(-2.22, 2.89) 0.798
FABQ-Total‡ 3.56(0.92, 6.19) 3.63(1.06, 6.20) 0.07(-3.71,3.56) 0.967
GROC§ 2.44(1.62, 3.27) 2.43(1.75, 3.1) 2.44(1.91, 2.96) 0.861
Abbreviations: NPRS, numeric pain rating scale; MODQ, Modified Oswestry Disability Questionnaire;
FABQ, Fear Avoidance Belief Questionnaire; FABQ-PA, Fear Avoidance Belief Questionnaire -
physical activity; GROC, Global Rating of Change
* Values are within-group mean (95% confidence interval) difference over time
† Values are mean (95% confidence interval) difference in within-group changes between groups
‡ Lower scores indicate improvement
§
Evaluated by Mann Whitney-U
Table 3 Participants’ perceptions of treatment received
Group Assignment Group participant suspected
Suspected Suspected Sham

Manipulation
43 4
Manipulation
91.49% 8.51%
27 16
Sham
62.79% 37.21%

Appendix A: Patient Education
Low Back Pain
Low back pain (LBP) is a very common occurrence with 80% of the population
experiencing at least one episode of disabling low back pain during their lifetime. Acute
LBP is the second most common reason for office visits to primary care physicians in
the United States. Most incidences of LBP will resolve within 6 weeks; however,
recurrence is common and 60-80% of patient’s experience recurrence within two years.
This suggests that LBP is a natural part of life and can be managed with prevention and
conservative measures.
When Experiencing LBP
What not to do
● Bed Rest
○ Prolonged periods of bed rest have been shown to be detrimental to
recovery of LBP
● Sitting or standing for prolonged periods
○ The muscles in your back prefer to be used and don’t respond very well to
extended periods spent in one position

● Lifting heavy weights
○ Resume your daily tasks, but try to avoid lifting heavy weights when your
back is aggravated
● Repetitive twisting or reaching
○ These tasks can put undue stress on your back and demand a lot from the
supporting musculature
Your body is meant to move, so naturally, you will experience more discomfort
with extended periods spent in one position. When experiencing back pain, your
body is more sensitive overall, so these positions and activities may be affecting
you more than usual.
What to do
● Rest
○ Rest from aggravating activity is crucial in allowing a reduction in your
back pain
● Ice and/or Heat
○ May help to relax overactive muscles in your back and can possibly
reduce pain
● Avoid time off work if possible
○ Better outcomes are observed in patients who take less time off of work
● Remain active as tolerated
○ Resume usual activity in a gradual manner dependent on your response
● Gentle exercise and stretching
○ Low level core exercises can be a great way to begin moving the affected
areas without undue stress
○ Walking, cycling, swimming all as tolerated, whatever it takes to get
yourself moving without pain
Overall, keep moving. Discomfort during certain activities may be inevitable at

this point but know that is a totally normal part of healing as long as your pain
doesn’t dramatically increase.
Tips for Managing Throughout your Day
● Try to avoid standing for long periods of time, but if unavoidable, tighten your
stomach muscles and stand with one foot on a stool or elevated surface. Make
sure to alternate your foot at least every five to ten minutes. This will help to
unload your spine.
● While sitting, try to sit straight up and avoid slouching. You can support your low
back with a towel to avoid aggravation with extended periods of low back flexion.
● Driving can be a problematic, especially if driving for long periods of time. Make
sure that your seat is adjusted so that your feet can reach the pedals without
stretching. Make sure to get up and move around if you must remain seated for
any prolonged period.
Lifting
● When lifting an object, make sure you are facing the object you plan on picking
up. Get as close to the object as possible and bend at your hips and knees to
maintain a straight back. Engage your hip and leg muscles to lift the object from
the ground.
○ Do not twist your body while lifting an object, make sure to turn your whole
body while keeping your hips and shoulders in line with each other to
protect your back.
● If the object is light enough to pick up with one hand, try to bend over to pick it up
like a golfer picking up a golf ball. Reach with one hand and lift the opposite leg,
while keeping the leg straight and your stomach tight like you’re reaching over a
fence.
What Not to Do During the Study Period
Things you are to avoid during the study period include:

- Going to a chiropractor or another physical therapist
- Having surgery
- Getting a massage
- Taking narcotics or other pain medications you were not taking prior to beginning
the study
- Pain patches that include lidocaine or other pain-relieving medications
- Obtaining any additional supportive medical equipment including but not limited
to: braces, shoe inserts, splints, or casts.
- Use of modalities like ultrasound or electrical stimulation
Finding Neutral Spine
1. Arch your
back as much
as possible
2. Now flatten
your back as
much as
possible.
3. Now find the

position of least
tension in
between. This is
neutral spine.
TrA Isometrics
Draw your belly in towards your spine

at 5% intensity. You can feel on the
inside of your hip bones for muscle
firmness if done correctly. If you feel
your fingers being pushed outwards,
try to contract the muscle with lower
intensity. At the same time, lightly
contract the muscle you use to stop
the flow of urination.
Now hold for 10 sec x 10. Once per

day.
Prone Multifidus Isometrics

You can perform this with or without a pillow underneath your stomach. Try to imagine drawing the
vertebrae from your lower back towards your belly button without actually moving your spine. An
alternative may be trying to thicken your lower back muscles without moving your spine. Hold for 10
seconds, repeat 10 times. Perform once per day.
1. Arch your
back as much
as possible
2. Now curl
your spine as
much as
possible.
3. Now find the

position of least
tension in
between. This is
neutral spine.
TrA Isometrics in 4-point
Draw your belly in towards your spine at 5%

intensity. At the same time, lightly contract
the muscle you use to stop the flow of
urination.
Now hold for 10 sec x 10. Once per day.

1. Arch your
back as much
as possible
2. Now slouch
your back as
much as
possible.
3. Now find the

position of least
tension in
between. This is
neutral spine.
TrA + Multifidus Isometrics
Draw your belly in towards your spine at

5% intensity. At the same time, lightly
contract the muscle you use to stop the
flow of urination. Try to imagine drawing
the vertebrae from your lower back
towards your belly button without actually
moving your spine. An alternative may be
trying to thicken your lower back muscles
without moving your spine.
Now hold for 10 sec x 10. Once per day.

Day 2
TrA Isometric + Heel slide
Now, while holding the contraction shown before, slide your heel down away from you buttocks while
maintaining both the contraction and neutral spine positioning. Perform 10 times on each leg, once per
day.

TrA Isometric in 4-point + Arm Movement
While maintaining the contraction and a neutral spine position, lift one arm straight up towards the ceiling.
Perform 10 times on each arm, once per day.
TrA + Multifidus Isometric + Arm Movement

TrA Isometric + Toe Taps
While maintaining the contraction and a neutral spine position, lift one arm straight up
towards the ceiling. Perform 10 times on each arm, once per day.
Now, while holding the contraction shown before, bring your knee towards your chest and then repeatedly
tap your toe and then return to the knee to chest position while maintaining both the contraction and
neutral spine position. Perform 10 times on each leg, once per day.

TrA Isometric in 4-point + Leg Movement
While maintaining the contraction and a neutral spine position, lift one leg straight back towards the ceiling
while keeping the knee slightly bent. Perform 10 times on each leg, once per day.
TrA + Multifidus Isometrics + Leg Movement

While maintaining the contraction and a neutral spine position, lift one knee straight up
towards the ceiling. Perform 10 times on each arm, once per day.

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1

Sources of grant support: None

Health System (HUM00105566).

3 Objective: The determine the short-term effectiveness of thoracic manipulation (MAN)

4 when compared to sham manipulation (SHAM) for individuals with LBP.

7 effective treatment strategies remain to be elucidated.

10 included core stabilization exercises and patient education. Factorial repeated

13 with the Global Rating of Change scale (GROC) at follow up.

19 result in improved outcomes when compared to a sham manipulation, education, and

23 Level of Evidence: Therapy, level 1b

24 Keywords: Low back pain, thoracic manipulation, physical therapy

30 physical limitations, activity impairments, and reduced quality of life.15,19,20 Individuals

32 and sleep disorders which could further hinder progress.15

33 As the most common diagnosis seen by physical therapists, LBP treatment

34 continues to be of vital importance in physical therapy (PT) practice. Recent analysis of

36 costs.13 Manual therapy has demonstrated positive therapeutic effects, particularly

37 lumbar spinal manipulation in the short-term.2,10,16,26 However, it has been suggested a

40 regional interdependence, defined as the “concept that a patient’s primary

41 musculoskeletal symptoms may be directly or indirectly related or influenced by

43 primary symptoms,” embraces these complex interactions29 The regional

44 interdependence model represents the musculoskeletal manifestation of a larger

46 of biopsychosocial, neurophysiological, somatovisceral, and musculoskeletal

48 The effects of thoracic manipulation on adjacent regions have been widely

51 increasing range of motion (ROM), improving self-reported function and disability in

myelopathy, and post-whiplash injuries.56 However, these findings cannot be

56 compared the immediate effects of thoracic manipulation versus lumbar manipulation in

59 thoracic mobilization and exercise to thoracic manipulation and exercise to exercise

62 between the two manual therapy groups.30

63 Preliminary evidence suggests thoracic manipulation may have potential benefit

67 examine the short-term effectiveness of thoracic manipulation, core stabilization

68 exercises and education on pain, disability, and fear-avoidance beliefs compared to a

69 sham manipulation, core stabilization exercises, and education.

72 Over an 18-month period (November 2016-April 2018), consecutive patients

77 excluded if associated lower extremity symptoms were present. To be eligible to

78 participate subjects had to have a minimum pain intensity score of 3 on an 11-point

81 of assessment. Subjects were excluded if they had any contraindications to spinal

82 manipulation such as osteoporosis, active cancer, previous spinal surgery, spinal

83 fracture, acute rheumatic disease, active tuberculosis, pregnancy, active infections of

84 the vertebra or intervertebral disc, any neurological evidence suggesting compromise of

87 insufficient English skills to complete questionnaires, or were involved in litigation or a

88 workman’s compensation claim.

90 Rocky Mountain University of Health Professions (150965-03) and University of

93 registered at clinicaltrials.gov (NCT02853357).

95 Three physical therapists, including the primary investigator, with an average of

96 six years’ experience participated in the recruitment and initial assessment of

98 years’ experience contributed in treatment of participants. The assessors were

107 therapists due to the nature of the interventions provided.

109 All participants provided a history, underwent a standard PT examination, and

133 FABQ-PQ and >29 for FABQ-W.14

136 examination and self-report measures.

141 group (SHAM). Randomization was completed by stratified permuted block

142 randomization by a research assistant not involved in recruitment of subjects. Blocks

158 Experimental Group (MAN):

174 Following the manipulation, participants were instructed in a standardized

178 progressed in subsequent sessions as deemed appropriate by the clinician. (Appendix

181 during the study period.

182 Control Group (SHAM):

197 education identical to the MAN group.

206 successful outcome; however, important improvement has been noted at +5 or

208 have received and if any side effects were experienced.

212 revealed a total sample size of 90 subjects.

213 Data Analysis

215 were stratified according to duration of symptoms (acute vs chronic) prior to

Figure 10: Changes in FABQ-‐PA