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Journal of Back and Musculoskeletal Rehabilitation -1 (2019) 1–11 1

DOI 10.3233/BMR-181355
IOS Press

Osteopathic manipulation treatment versus

therapeutic exercises in patients with chronic
nonspecific low back pain: A randomized,
controlled and double-blind study
Frederico de Oliveira Meirellesa,b,∗ , Júlio César de Oliveira Muniz Cunhaa and Elirez Bezerra da Silvab
a
Estacio de Sá University, Rio de Janeiro, Brazil
b
Instituto de Educação Física e Desportos, Rio de Janeiro State University, Brazil, Rio de Janeiro

Abstract.
BACKGROUND: Osteopathic manipulation treatment is widely used in the clinical practice in the care of patients with chronic
nonspecific low back pain, however, its benefits still seem uncertain.
OBJECTIVE: This study aimed to verify the efficacy of osteopathic manipulation for chronic nonspecific low back pain.
MATERIALS AND METHODS: Forty-two participants with chronic nonspecific low back pain were selected and randomized
into two groups: Active Control Group (ACG – n = 19) and Osteopathic Manipulation Treatment Group (OMTG – n = 23).
Therapeutic exercises were performed with the ACG and osteopathic manipulation techniques with the OMTG. The interventions
were carried out over 5 weeks of treatment, totaling 10 treatments for the ACG and 5 for the OMTG.
The visual analogue scale (VAS) was used to measure chronic nonspecific low back pain and the Oswestry Disability Index 2.0,
Tampa Scale of Kinesiophobia and Beck Depression Inventory were used to measure disability, kinesiophobia and depression,
respectively.
RESULTS: The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain
(p 6 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p =
0.001).
CONCLUSION: This study demonstrated that the treatments were effective in both groups. However, the efficacy of the osteo-
pathic manipulation treatment was greater than that of the therapeutic exercises.

Keywords: Osteopathy, osteopathic manipulation treatment, chronic nonspecific low back pain

1 1. Introduction effect size in the decrease of pain and functional inca- 5

pacity in the chronic low back pain populations stud- 6

ied [1–3]. Among the types of therapeutic exercises in- 7

2 There is strong evidence that therapeutic exercises
vestigated, those of stretching and strength appear to 8
3 are effective for the treatment of chronic low back pain.
be the most effective for the treatment of chronic low 9
4 Despite the effectiveness, studies have shown a small back pain [2]. Stabilization exercises have shown posi- 10

tive short-term results in the symptoms of chronic non- 11

specific low back pain, when compared to other con- 12

∗ Corresponding author: Frederico de Oliveira Meirelles, Physi- servative interventions. However, long-term results are 13
cal Therapy Department, Institution Estácio de Sá University Coun-
try, Rua Juparaná, 62, bl 2, ap. 202, Andaraí – Rio de Janeiro,
equated with any form of active exercises [4]. 14

RJ, Brazil. Tel.: +55 2141062340; Mob: +55 21981985951; E-mail: Osteopathy is a form of multi-intervention, manual 15

[email protected]. treatment that seeks to rebalance the musculoskele- 16

ISSN 1053-8127/19/$35.00 c 2019 – IOS Press and the authors. All rights reserved
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2 F. de Oliveira Meirelles et al. / Osteopathic manipulation treatment versus therapeutic exercises

17 tal system [5]. Osteopathic manipulation treatment for The level of habitual physical activity (LHPA) was 63

18 patients with low back pain is recommended by the evaluated prior to the treatment using the Baecke ques- 64

19 American Osteopathic Association (AOA) [6]. In their tionnaire on habitual physical activity [15–18]. The 65

20 meta-analysis, Licciardone et al. (2005) concluded that trial was carried out from August 2015 to May 2016 66

21 osteopathic manipulation treatment significantly re- at the FisioNorte Teaching Clinic of the Estácio de Sá 67

22 duces low back pain [7]. In a recently published meta- University, located in the city of Rio de Janeiro, Brazil. 68

23 analysis, Franke et al. (2014) concluded that osteo- The participants received information about the study 69

24 pathic manipulation treatment has beneficial effects on and signed a consent form agreeing to participate in the 70

25 chronic low back pain and functional incapacity [8]. research, in accordance with Resolution 196/96 of the 71
26 Conversely, in two recently published systematic re- National Health Council. The authors received formal 72
27 views the authors concluded that osteopathic manip- authorization from the head of the Physical Therapy 73
28 ulation treatment has no more effect than other in- outpatient service for the analysis of the data from this 74
29 terventions and/or a placebo in reducing low back study. The study was approved by the Research Ethics 75
30 pain [9,10]. Committee of Estácio de Sá University/UNESA/RJ, 76
31 Considering the contradictions found and the lack under authorization number 46194215.9.0000.5284. 77
32 of existing literature on this subject, this study aimed The study was registered at ClinicalTrials.gov under 78
33 to: (1) verify the efficacy of osteopathic manipulation identifier NCT02752620. 79
34 treatment for chronic nonspecific low back pain; and
35 (2) verify the association of chronic nonspecific low
36 back pain with functional incapacity, kinesiophobia 2.3. Sample size 80

37 and depression.
An estimation of the size of a sample representa- 81

tive of the target population was carried out. The sta- 82

38 2. Materials and methods tistical test chosen for this was the two-way repeated 83

measures ANOVA. Accordingly, the sample calcula- 84

39 2.1. Design tion was made, taking into consideration the follow- 85

ing parameters: test power of 0.80, value of α = 0.05, 86

40 The study was a randomized, controlled, double- effect size f of 0.10, number of groups = 2, number 87

41 blind, parallel intervention trial, designed considering of repeated measures = 2 and correlation between re- 88

42 the recommendations of the 2010 CONSORT State- peated measurements = 0.90. The G*Power version 89

43 ment [11]. 3.1.7 software was used. A sample of 42 individuals 90

was estimated for the study, according to the result of 91

44 2.2. Sample the sample size calculation (Supplement 1). 92

45 The participants selected for the trial fulfilled the

2.4. Randomization: Sequence of generation 93
46 following inclusion criteria: an age between 30 and
47 59 years, to have had constant or intermittent low
48 back pain with intensity greater than 30 mm on the From a list of random numbers (Supplement 2) gen- 94

49 visual analog scale (VAS) for a duration of at least erated through the simple randomization method us- 95

50 three months, and to have a medical diagnosis of ing the Microsoft Excel 2010 R software, the partic- 96

51 chronic nonspecific low back pain. The study excluded ipants were allocated into the active control group 97

52 participants who had fractures or dislocations of the (ACG) and the osteopathic manipulation treatment 98

53 spine, ligament ruptures, muscle ruptures, skin lacer- group (OMTG). For the random allocation of the pa- 99

54 ations, sacroiliitis, vertebral osteomyelitis, infections, tients to the ACG (1) or OMTG (2) the function = 100

55 disc herniation with radicular symptoms, rheumatic SE(RAND() < 0.500001; 1; 2) of Microsoft Excel 101

56 disorders, cauda equina syndrome, tumors, visceral re- 2010 R was used, which generated a list of 56 random 102

57 ferred pain [6], red flags [12], or lower limb discrep- “1” or “2” numbers (Supplement 2). According to the 103

58 ancy greater than 20 mm [13,14]. The participants order of entry of the patient into the study, the ran- 104

59 were also excluded if they were absent for more than dom number “1” or “2” generated by Microsoft Ex- 105

60 two weeks of activities in the trial for any reason and cel 2010 R was assigned. The patients assigned a “1” 106

61 if they withdrew from the trial. The sample selection is were allocated to the ACG and those with a “2” to the 107

62 presented in Fig. 1. OMTG. 108

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F. de Oliveira Meirelles et al. / Osteopathic manipulation treatment versus therapeutic exercises 3

Fig. 1. CONSORT 2010 flow diagram.

109 2.5. Interventions 3. Intervention for the OMTG 126

110 Due to being a parallel intervention trial, after ful- The therapeutic approach used was osteopathic ma- 127

111 filling the eligibility criteria, the participants were ran- nipulation treatment only, which was performed by a 128

112 domly allocated into two groups: the ACG and the physical therapist with a graduate degree in Osteopa- 129

113 OMTG. thy. After the pre-intervention assessment, the osteo- 130

pathic manipulation treatment was conducted once a 131

week for a total of five weeks, with a total of 5 treat- 132

114 2.6. Intervention for the ACG
ment sessions. The treatments lasted 30 to 45 minutes. 133

The treatment protocol only included manual tech- 134

115 The ACG was the active control and performed ther-
niques that comprise part of the contemporary osteo- 135
116 apeutic exercises. A total of 10 treatment sessions were
pathic treatment conduct [6,25]: articulation [26] and 136
117 conducted, after the pre-intervention assessment, with myofascial [27,28] techniques. The full description of 137
118 two per week for a total of five weeks. The ACG in- the OMTG treatment protocol is presented in Supple- 138
119 tervention was performed by three Physical Therapy ment 4 and 6. 139
120 students of the Estácio de Sá University, FisioNorte
121 Teaching Clinic, trained and supervised by an experi- 3.1. Control of external activities of the participants 140
122 enced physical therapist. The treatment protocol only between treatments 141
123 included therapeutic exercises [19–24]. The full de-
124 scription of the ACG treatment protocol is presented in The participants were instructed not to perform 142

125 Supplement 3. physical therapy and not to take medication or perform 143
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4 F. de Oliveira Meirelles et al. / Osteopathic manipulation treatment versus therapeutic exercises

144 other types of treatment in the intervals between treat- pacity, kinesiophobia and depression, at two moments: 188

145 ments. In order to control this situation, during each pre and post-intervention. The results were presented 189

146 treatment session the researcher enquired about the ac- as mean values and standard deviation. The assump- 190

147 tivities of the participants in the period between treat- tions of normal distribution of the data (Kolmogorov- 191

148 ments. Failure to comply with these guidelines invali- Smirnov d > 0.06; p > 0.20), homogeneity of vari- 192

149 dated the participation of the individual in the study. ance (Levene’s Test; p > 0.10), level of measurement 193

interval and independent groups were satisfied. The 194

150 3.2. Primary outcome hypothesis of differences in low back pain, functional 195

incapacity, kinesiophobia and depression between the 196

151 Measurement of low back pain: groups was tested using the two-way repeated mea- 197
152 Low back pain was evaluated in both groups before sures ANOVA, with the first factor being the OMTG 198
153 and after the treatment using the visual analogue scale and ACG groups and the second factor pre and post 199
154 (VAS) [29–34]. measures of low back pain, functional incapacity, ki- 200

nesiophobia and depression. In the case of F being 201

155 3.3. Secondary outcomes significant, Tukey’s post-hoc test for unequal samples 202

was used to identify significant differences. For the in- 203

156 Functional incapacity: teraction of the OMTG and ACG with repeated mea- 204
157 Functional incapacity was evaluated in both groups sures of low back pain, incapacity, kinesiophobia and 205
158 before and after the treatment using the Oswestry Dis- depression, the respective effects sizes were calculated, 206
159 ability Index 2.0 (ODI) questionnaire [35–38]. considering the square of the sums, degrees of free- 207
160 Kinesiophobia:
dom and square of the means, obtained from the 2 × 2 208
161 Kinesiophobia, which is the fear of performing
ANOVA with repeated measures. For the differences in 209
162 movements due to pain, is an important factor for
means, the 95%CI between the OMTG and ACG post 210
163 the physical and psychological chronicity of low back
treatment was calculated. The association of chronic 211
164 pain. This was assessed before and after the treatment
nonspecific low back pain with functional incapacity, 212
165 using the Tampa Scale of Kinesiophobia [39–43].
kinesiophobia and depression was assessed using Pear- 213
166 Depression:
son’s correlation coefficient. The α error was 0.05 and 214
167 Because depression is a highly prevalent and im-
β error 0.20. These data were evaluated using the Sta- 215
168 portant factor in patients with chronic nonspecific low
tistica version 13 software. 216
169 back pain, the Beck Depression Scale [44–47] was
The measuring instruments for functional incapacity 217
170 used to measure the depression levels of the study par-
and depression measure an interval level, transforming 218
171 ticipants before and after the treatment.
these values into a nominal level. It was chosen to ana- 219

172 3.4. Blinding lyze the values of these variables considering the inter- 220

val level, in order not to diminish the power of the test 221

173 The screening and pre and post-assessments of the using non-parametric statistics. 222

174 low back pain, functional incapacity, kinesiophobia

175 and depression of the participants were performed
176 blind by an experienced physical therapist. An inde- 4. Results 223

177 pendent student was responsible for randomly allocat-

178 ing the participants to one of the two groups. The grad- The sample size estimated at the start of the study 224

179 uate osteopathy physical therapist responsible for the was 42 participants, however, only 38 participants 225

180 treatment of the OMTG and the supervised students completed the study. Considering the effect size f of 226

181 that applied the interventions for the treatment of the 0.42 and the correlation between repeated measure- 227

182 ACG, did not perform the pre and post-assessments ments of 0.12 obtained, as well as the other parameters 228

183 of low back pain, functional incapacity, kinesiophobia of the initial sample size calculation, the post-hoc test 229

184 and depression. The data analysis was also blinded. carried out using the G*Power version 3.1.7 program 230

determined a test power of 0.97, i.e., a high probabil- 231

185 3.5. Data analysis ity of correctly rejecting the null hypothesis (Supple- 232

ment 5). 233

186 The study design comprised of two groups that were The two-way repeated measures ANOVA for 234

187 measured regarding low back pain, functional inca- chronic low back pain produced F = 6.34; p = 0.02 235
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F. de Oliveira Meirelles et al. / Osteopathic manipulation treatment versus therapeutic exercises 5

Fig. 2. Chronic low back pain before and after the interventions (ver- Fig. 3. Functional incapacity before and after the interventions (ver-
tical bars correspond to 95% CI). * p 6 0.05 intragroup; ** p 6 0.05 tical bars correspond to 95% CI). * p 6 0.05 intragroup; ** p 6 0.05
intergroup and intragroup. intergroup and intragroup.

236 for the groups; F = 85.21; p = 0.0001 for the repeated

237 measures; and F = 19.09; p = 0.0001 for the interac-
238 tion. Tukey’s post-hoc test for unequal samples showed
239 no significant difference between the groups regarding
240 initial low back pain (p = 0.93); the final low back
241 pain of the OMTG was significantly lower than that
242 of the ACG (p = 0.001); and the final low back pain
243 was significantly lower in both groups than the initial
244 low back pain (p 6 0.01). The chronic low back pain
245 scores before and after the interventions are presented
246 in Fig. 2.
247 The two-way repeated measures ANOVA for func-
248 tional incapacity produced F = 7.02; p = 0.01 for the
249 groups; F = 50.81; p = 0.0001 for the repeated mea-
250 surements; and F = 9.40; p = 0.004 for the interac-
251 tion. Tukey’s post-hoc test for unequal samples showed
252 no significant difference between the groups regarding
253 initial functional incapacity (p = 0.84); the final func- Fig. 4. Depression before and after the interventions (vertical bars
254 tional incapacity of the OMTG was significantly lower correspond to 95% CI). * p 6 0.05 intragroup.
255 than that of the ACG (p = 0.04); and the final func-
256 tional incapacity in both groups was significantly lower pression was only significantly lower than the initial 267

257 than the initial functional incapacity (p 6 0.04). The depression in the OMTG (p 6 0.0007). The depression 268

258 functional incapacity scores before and after the inter- scores before and after the interventions are presented 269

259 ventions are presented in Fig. 3. in Fig. 4. 270

260 The two-way repeated measures ANOVA for de- The two-way repeated measures ANOVA for kine- 271

261 pression produced F = 1.01; p = 0.32 for the groups; siophobia showed F = 2.43; p = 0.13 for the groups; 272

262 F = 16.46; p = 0.0001 for the repeated measure- F = 9.92; p = 0.003 for the repeated measurements; 273

263 ments; and F = 3.78; p = 0.06 for the interaction. and F = 9.30; p = 0.004 for the interaction. Tukey’s 274

264 Tukey’s post-hoc test for unequal samples showed no post-hoc test for unequal samples showed no signifi- 275

265 significant difference for initial and final depression cant difference for initial and final kinesiophobia be- 276

266 between the groups (p > 0.47); and that the final de- tween the groups (p > 0.20); and that the final kine- 277
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6 F. de Oliveira Meirelles et al. / Osteopathic manipulation treatment versus therapeutic exercises

Table 1
Characteristics of the Sample
ACG (n = 18) OMTG (n = 20) Total (n = 38) p
Male 6 (60%) 4 (40%) 10 0.38
Female 12 (43%) 16 (57%) 28 0.30
Age (years) 50.1 ± 9.3 46 ± 10.4 48 ± 10 0.21
BMI (kg/m2 ) 26.5 ± 4 27.1 ± 4.2 26.8 ± 4.1 0.64
Time of low back pain (months) 61.1 ± 57.7 58.8 ± 56.3 59.8 ± 56.2 0.90
Education (years) 12.2 ± 4.5 12.9 ± 3 12.6 ± 3.7 0.61
Level of physical activity (Baecke) 8 ± 1.3 8.3 ± 1.3 8.2 ± 1.3 0.47
ACG: Active control group; OMTG: Osteopathic manipulation treatment group; BMI: Body mass index.

Table 2
Mean and standard deviation of the chronic low back pain, functional incapacity, depression and
kinesiophobia of the ACG and OMTG before and after treatment
ACG (n = 18) OMTG (n = 20)
Pre Post Pre Post p
Chronic low back pain (mm) 62 ± 16 44 ± 22* 66 ± 17 17 ± 17** 0.001
Functional incapacity 18 ± 8 14 ± 7* 16 ± 6 6 ± 6** 0.04
Depression 12 ± 7 10 ± 5 12 ± 10 6 ± 5* 0.47
Kinesiophobia 41 ± 8 40 ± 8 40 ± 9 33 ± 8* 0.20
ACG: Active control group; OMTG: Osteopathic manipulation treatment group; * p 6 0.05
intragroup; ** p 6 0.05 intergroup and intragroup.

278 siophobia was only significantly lower than the initial

279 kinesiophobia (p 6 0.0005) in the OMTG. The kine-
280 siophobia scores before and after the interventions are
281 presented in Fig. 5.

282 5. Discussion

283 The osteopathic manipulation treatment and thera-

284 peutic exercises both significantly decreased nonspe-
285 cific chronic low back pain and functional incapac-
286 ity. However, the results obtained with the osteopathic
287 manipulation treatment were significantly better than
288 those obtained with the therapeutic exercises. Further-
289 more, only the osteopathic manipulation treatment sig-
290 nificantly decreased the kinesiophobia and depression
291 (Table 2, Figs 3 and 4). The reduction of chronic non-
292 specific low back pain had a significant and strong as- Fig. 5. Kinesiophobia before and after the interventions (vertical bars
correspond to 95% CI). * p 6 0.05 intragroup.
293 sociation [48] with the decrease in the functional im-
294 pairment (r = 0.64; p = 0.00), a significant and mod- The osteopathic manipulation treatment was clini- 305
295 erate association [48] with the decrease in kinesiopho- cally relevant in reducing chronic nonspecific low back 306
296 bia (r = 0.41; p = 0.00) and a significant and mod- pain and functional incapacity in the study partici- 307
297 erate association [48] with the decrease in depression pants. Ostelo et al. (2008), stated that a 30% reduc- 308
298 (r = 0.48; p = 0.00) (Table 3). Considering the above tion in pain scores measured by the VAS and functional 309

299 results, it can be inferred that the osteopathic manip- disability measured by the ODI indicate clinical rel- 310

300 ulation treatment resulted in a significant reduction in evance [49]. The significant reduction in chronic low 311

301 low back pain, which was reflected in a decrease in the back pain in the OMTG (74% reduction in the VAS) 312

302 fear of carrying out movements, which in turn was re- compared with the ACG (29% reduction in the VAS) 313

303 flected in decreased functional incapacity, resulting in corroborates the findings of the study of Licciardone et 314

304 a reduced depressive state. al. (2013), which also reported a large decrease in low 315
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F. de Oliveira Meirelles et al. / Osteopathic manipulation treatment versus therapeutic exercises 7

Table 3
Correlation between the variables
Variable Correlations (raw data)
Correlations with * are significant (p < 0.05)
N = 76 (pre and post)
Low back pain Functional incapacity Depression Kinesiophobia
Low back pain 1.00 0.64* 0.47* 0.41*
p=— p = 0.00* p = 0.00* p = 0.00*
Functional incapacity 0.64* 1.00 0.60* 0.60*
p = 0.00* p=— p = 0.00* p = 0.00*
Depression 0.48* 0.60* 1.00 0.49*
p = 0.00* p = 0.00* p=— p = 0.00*
Kinesiophobia 0.41* 0.60* 0.49* 1.00
p = 0.00* p = 0.00* p = 0.00* p=—

316 back pain in the study participants, mostly occurring in cle activation, due to anticipating the nociceptive stim- 355

317 the subgroup of patients who had more severe initial uli [53]. Studies suggest that an increase in local mus- 356

318 chronic nonspecific low back pain (VAS > 50 mm). In cle activation generates increased articular load, re- 357

319 this study initial chronic nonspecific low back pain was duces articular movement and decreases the local pro- 358

320 considered when the VAS was greater than or equal to prioceptive ability [54–57]. These changes have a local 359

321 62 mm for both groups. Licciardone et al. (2013) stated protective effect in the short-term, however, the long- 360

322 that this result tends to be maintained over the long- term effect tends to be deleterious [58]. The OMTG 361

323 term [50]. used a protocol of techniques that sought to decrease 362

324 The results in favor of the OMTG are in contrast to muscle tone and increase the arc of joint movement, 363

325 two systematic reviews [9,10], which may be due to favoring the movement in restricted locations, which 364

326 the specific intervention used in the studies that were may have decreased muscle activation. The improved 365

327 included in the reviews. In the present study the treat- joint movement and reduction of muscle activation 366

328 ment protocol used was generalized and the majority may have allowed the individuals to accomplish their 367

329 of the techniques were nonspecific, rather than spe- ADLs more easily, reducing their kinesiophobia and 368

330 cific techniques for only one region of the body. This possibly enhancing the relief of chronic nonspecific 369

331 choice was made based on the characteristic of chronic low back pain and the disability caused by it. 370

332 nonspecific low back pain not presenting an apparent Although kinesiophobia and depression were not the 371

333 cause and being essentially multifactorial. In the re- main outcomes of this study, the reduction of these 372

334 view of Meirelles (2013), studies with any type of back variables in the OMTG shows that osteopathic manip- 373

335 pain were included [9], which was not the situation for ulation treatment can benefit not only the chronic low 374

336 the participants of the present study. Orrock (2013) se- back pain and functional disability variables, but also 375

337 lected only two studies for the systematic review cit- kinesiophobia and depression, which are usually fac- 376

338 ing the low methodological quality of the studies pub- tors that result from low back pain chronicity [59,60]. 377

339 lished in osteopathy related to chronic nonspecific low In the ACG, there were no reductions in kinesiopho- 378

340 back pain up to the time of the data search [10]. bia and depression, which leads us to believe that the 379

341 According to the latest meta-analysis published re- greater reduction in pain that occurred in the OMTG 380

342 garding osteopathic manipulation treatment and low (decrease of 74%) led to a significant reduction in 381

343 back pain [8], it can be noted that, of the meta-analyzed depression and kinesiophobia in the individuals with 382

344 studies published after 2008 [50–52], almost all the re- chronic nonspecific low back pain. In contrast, the 383

345 sults show greater improvements with osteopathic ma- slight decrease in chronic back pain that occurred in 384

346 nipulation treatment compared to the control groups the ACG (29% reduction) was not sufficient to reduce 385

347 used. This indicates a change in the perspective of os- the kinesiophobia and depression in this group. 386

348 teopathic manipulation treatment for low back pain, According to Jarvik et al. (2005), individuals with 387

349 with it being clear that the protocols currently used are depression are 2.3 times more likely to develop low 388

350 being directed toward efficacy in osteopathic manipu- back pain compared to healthy subjects [61]. By re- 389

351 lation treatment for low back pain, corroborating the ducing the degree of low back pain in the participants 390

352 results obtained in this study. there was also a decrease in depression and kinesio- 391

353 Patients with chronic nonspecific low back pain phobia in the OMTG. The literature indicates a bidi- 392

354 present postural changes that increase localized mus- rectional relationship between these variables [62,63], 393
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8 F. de Oliveira Meirelles et al. / Osteopathic manipulation treatment versus therapeutic exercises

394 therefore it is possible that treatment at an appropri- Despite the high level of evidence for the efficacy 445

395 ate time can reduce the chances of depression and of osteopathic manipulation treatment in significantly 446

396 kinesiophobia and/or the chances of nonspecific low reducing chronic low back pain, functional incapacity, 447

397 back pain becoming chronic. Current studies suggest depression and kinesiophobia shown in this study, the 448

398 that an intervention based on a biopsychosocial model following limitations should be mentioned: (1) self- 449

399 should be considered, as promising results have been assessment scales, including the VAS, are the gold 450

400 found regarding this mode of treatment for patients standard scales for pain assessment, widely used in 451

401 with chronic nonspecific low back pain [64–66]. The the scientific literature, validated and reliable, however, 452

402 use of osteopathic manipulation treatment combined the pain assessment is performed subjectively; (2) the 453

403 with a biopsychosocial approach could possibly lead study was limited to only a few techniques used by the 454

404 to more effective treatment for patients with chronic osteopathy professionals. There are, however, numer- 455

405 nonspecific low back pain. ous techniques used daily in osteopathic treatment that 456

406 The results of this study present strong evidence that were not included in this study. Accordingly, it was de- 457

407 the use of osteopathic manipulation treatment in pa- cided to increase the internal validity at the expense of 458

408 tients with chronic nonspecific low back pain should be the external validity as a way to reduce the possibil- 459

409 encouraged considering that it is a manual treatment, ity of bias in the experimental group and facilitate the 460

410 does not require high investments such as expensive replicability of the results. 461

411 devices or tools, medications are not used, it has few

412 side effects, the treatment is less frequent and patients
413 present a high degree of satisfaction when treated with 6. Conclusion 462

414 osteopathic manipulation [67–69]. The random allo-

The present study demonstrated that the treatments 463
415 cation of the participants into the OMTG and ACG
performed in both groups were effective. However, for 464
416 and the inclusion and exclusion criteria of the partic-
the outcomes of chronic nonspecific low back pain, 465
417 ipants resulted in homogeneity of the initial values of
functional incapacity, kinesiophobia and depression, 466
418 both groups regarding gender, age, BMI, length of time
the osteopathic manipulation treatment was superior 467
419 of low back pain, education, physical activity level
to the therapeutic exercises used. Further studies are 468
420 (Table 1), chronic low back pain, functional incapac-
needed to increase the validity of osteopathic manipu- 469
421 ity, kinesiophobia and depression (Table 2), further in-
lation treatment for chronic nonspecific low back pain 470
422 creasing the level of evidence of the results. The fact
and to clarify issues, such as use of other osteopathic 471
423 that the OMTG was compared to an active control
techniques, the ideal length of treatment and duration 472
424 group, which also presented a significant effect, further
of relief of the symptoms, as well as pragmatic studies 473
425 strengthens the evidence for the efficacy of the osteo- that associate osteopathic manipulation treatment with 474
426 pathic manipulation treatment regarding chronic non- other types of intervention. 475
427 specific low back pain.
428 Several studies have reported the efficacy of thera-
429 peutic exercises in the treatment of chronic nonspecific Conflict of interest 476
430 low back pain [1–4]. For this reason, these exercises
431 were performed for the ACG of this study. The sig- None to report. 477
432 nificant decrease in chronic low back pain and func-
433 tional disability in the ACG corroborate the literature
434 on the subject, further enhancing the results obtained Supplementary data 478

435 with the OMTG, which presented a greater significant

436 reduction than the ACG in the chronic low back pain The supplementary files are available to download 479

437 (−74% vs. −29%) and functional incapacity (−59% from http://dx.doi.org/10.3233/CBM-181355. 480

438 vs. −20%). In this study the osteopathic manipulation

439 treatment was conducted once a week and the thera-
440 peutic exercises twice a week. This indicates that the References 481

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