Effectiveness of a treatment involving soft tissue techniques and/or neural mobilization techniques in the management of tension-type headache. A randomized controlled trial

Accepted Manuscript Effectiveness of a Treatment Involving Soft Tissue Techniques and/or Neural Mobilization Techniques in the Management of the Tension-Type Headache: A Randomized Controlled Trial Alejandro Ferragut-Garcías, PT., Gustavo Plaza-Manzano, PT, PhD., Cleofás Rodríguez-Blanco, PT, PhD., Olga Velasco-Roldán, PT, PhD., Daniel Pecos-Martín, PT, PhD., Jesús Oliva-Pascual-Vaca, PT, PhD., Bartomeu Llabrés-Bennasar, PT., Ángel Oliva-Pascual-Vaca, PT, PhD. PII: S0003-9993(16)30958-3 DOI: 10.1016/j.apmr.2016.08.466 Reference: YAPMR 56659 To appear in: ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION Received Date: 23 March 2016 Revised Date: 10 August 2016 Accepted Date: 15 August 2016 Please cite this article as: Ferragut-Garcías A, Plaza-Manzano G, Rodríguez-Blanco C, Velasco- Roldán O, Pecos-Martín D, Oliva-Pascual-Vaca J, Llabrés-Bennasar B, Oliva-Pascual-Vaca Á, Effectiveness of a Treatment Involving Soft Tissue Techniques and/or Neural Mobilization Techniques in the Management of the Tension-Type Headache: A Randomized Controlled Trial, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2016), doi: 10.1016/j.apmr.2016.08.466. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 1 Running head: Neural mobilization & tensional headache EFFECTIVENESS OF A TREATMENT INVOLVING SOFT TISSUE TECHNIQUES AND/OR NEURAL MOBILIZATION TECHNIQUES IN THE MANAGEMENT OF THE TENSION-TYPE HEADACHE: A RANDOMIZED CONTROLLED TRIAL Alejandro Ferragut-Garcías 1 , Gustavo Plaza-Manzano 2 , Cleofás Rodríguez-Blanco 3 , Olga Velasco-Roldán 4 , Daniel Pecos-Martín 5 , Jesús Oliva-Pascual-Vaca 6 , Bartomeu Llabrés-Bennasar 7 , Ángel Oliva-Pascual-Vaca 8 The study was performed at Rehabilitation Department of Son LLàtzer Hospital and Fisioplanet Centre of Physiotherapy 1. PT. Department of Nursing and Physiotherapy, University of the Balearic Islands, E-07122, Palma de Mallorca, Spain. E-mail: alejandro.ferrag[email protected] 2. PT, PhD. Departmento de Medicina Física y Rehabilitación, Facultad de Medicina, Universidad Complutense de Madrid. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Spain. Email: [email protected] 3. PT, PhD. Faculty of Nursing, Physiotherapy and Podiatry. Department of Physiotherapy, University of Seville, E-41009, Seville, Spain. Email: [email protected] 4. PT, PhD. Department of Nursing and Physiotherapy, University of the Balearic Islands, E-07122, Palma de Mallorca, Spain. Email: olga.ve[email protected] MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 2 5. PT, PhD. Department of Physiotherapy and Nursery. University of Alcalá. Alcalá de Henares, E-28871. Madrid, Spain. Email: [email protected] 6. PT, PhD. Faculty of Nursing, Physiotherapy and Podiatry, Department of Physiotherapy (Head), University of Seville, E-41009, Seville, Spain. Email: [email protected] 7. PT. Free professional practice. Fisioplanet Center. The Balearic Islands, Palma de Mallorca, Spain. Email: [email protected] 8. PT, PhD. Faculty of Nursing, Physiotherapy and Podiatry, Department of Physiotherapy (Head), University of Seville, E-41009, Seville, Spain. Email: [email protected] Acknowledgments We would like to recognize for their invaluable contribution Dr. Antonio Figuerola Roig, Dra. Maria Àngels Farreny Ballcells, Sra. Petra Vidal Barcelo, Sr. Pau Mas Valens and Son Llatzer`s hospital physiotherapists No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. No conflicts of interest are reported for this study. No reprints are available for this study. MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 3 Corresponding author: Ángel Oliva-Pascual-Vaca: PT, PhD. Faculty of Nursing, Physiotherapy and Podiatry, Department of Physiotherapy (Head), University of Seville, E-41009, Seville, Spain. Fax: +34 954 486527, Tel: +34 954 486528. Email: ang[email protected] Clinical trial registration number: the study was approved by the Ethical Committee of the Balearic Island /CEI-IB) and was registered in the Australian New Zealand Clinical Trial Registry (ANZCTR) with the registration number ACTRN12615000698572. This study began in 2013, so a retrospective registration was made. MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 1 EFFECTIVENESS OF A TREATMENT INVOLVING SOFT TISSUE 1 TECHNIQUES AND/OR NEURAL MOBILIZATION TECHNIQUES IN THE 2 MANAGEMENT OF THE TENSION-TYPE HEADACHE: A RANDOMIZED 3 CONTROLLED TRIAL 4 ABSTRACT 5 Objective: To evaluate the effects of a protocol involving soft tissue techniques and/or 6 Neural Mobilization Techniques in the management of patients with Frequent episodic 7 tension-type headache (FETTH) and Chronic tension-type headache (CTTH). 8 Design: Randomized controlled, double blind, placebo control and before-after trial. 9 Setting: Rehabilitation area of Son Llatzer Hospital and Fisioplanet Centre 10 Participants: Ninety-seven patients (78 women; 19 men) diagnosed with FETTH or 11 CTTH, were randomly assigned to groups A, B, C or D. 12 Interventions: (A) placebo superficial massage; (B) soft tissue techniques; (C) neural 13 mobilization; (D) a combination of (B) and (C). 14 Main Outcomes Measures: The pressure pain threshold (PPT) in the temporal muscles 15 (PPT 1 , PPT 2 ) and supraorbital region (PPT 3 ), the frequency (Freq) and maximal 16 intensity (Int) of the pain crisis, and the punctuation using the Hit-6 questionnaire (Hit6) 17 were evaluated. All variables were assessed before, at the end of the treatment and 15 18 days and 30 days post-intervention. 19 Results: Groups B, C, and D had an increase of PPT and a reduction of Freq, Int, and 20 Hit-6 in all time-points after the intervention compared to baseline and Group A (p < 21 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 2 0.001 in all cases). Group D had the highest PPT values and the lowest values in Freq 22 and Hit-6 after the intervention. 23 Conclusions: The application of soft tissue techniques and neural mobilization in 24 FETTH or CTTH patients induces significant changes in pressure pain threshold, the 25 characteristics of the pain crisis, and its impact on daily life activities compared to the 26 application of these techniques as isolated interventions. 27 Keywords: tension-type headache; musculoskeletal manipulations; soft tissue; nerve 28 tissue. 29 Abbreviations: 30 Tension-type headache: TTH 31 Frequent episodic tension-type headache: FETTH 32 Chronic tension-type headache: CTTH 33 Neural mobilization techniques: NMT 34 Soft Tissue techniques: STT 35 Pressure pain threshold in the temporal muscles: PPT 1 , PPT 2 36 Pressure pain threshold in supraorbital region: PPT 3 37 Frequency: Freq 38 Maximal Intensity: Int 39 Hit-6 questionnaire: Hit6 40 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 3 Trigeminal Caudal Nucleus: TCN 41 Evaluation before the beginning of the study: Pre 42 Evaluation one hour after the latest session: Post 43 Evaluation fifteen days later: Post15days 44 Evaluation thirty days later: Post30days 45 46 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 4 Introduction 47 Tension-type headache (TTH) is the most prevalent form of benign primary 48 headache 1 . The prevalence for episodic TTH is 33.8% in a year and 2.3% for chronic 49 TTH 2 , being TTH the second most prevalent pathology in the world 3 . These situations 50 make the TTH a shocking pathology in its social and economic aspects 4 . 51 To explain the whole symptomatology, authors refer to peripheral sensitization 52 that involves myofascial pain in the cranio-cervical musculature, as well as higher 53 mechanical sensitivity in the nerve trunks 5, 6 . However, as a consequence of the 54 continuous nociceptive afferents, previous studies also suggest a central sensitization 55 with an alteration in the processing and/or the inhibitory mechanisms of pain that set the 56 chronic character of this pathology, being the Trigeminal Caudal Nucleus (TCN) one of 57 the structures that can be sensitized 7-9 . 58 Despite the great impact of the TTH, studies to date have not established the best 59 treatment to manage the symptomatology 10 . Although previous studies reported benefits 60 of manual therapy by including soft tissue techniques (STT) to manage the myofascial 61 pain, these studies were often low-quality, making it difficult to draw clear 62 conclusions 11 . 63 Neural mobilization techniques (NMT) intend to improve the adaptability, 64 reduce mecanosensitivity and activate analgesic mechanisms by mechanically 65 stimulating the nerves with palpation, elongation, and sliding 12-14 . In this regard, 66 previous studies have shown that increases in the mechanosensitivivity may induce pain 67 with neuropathic, nociceptive and mixed characteristics 14 and increases in the muscle 68 contraction 15, 16 . For this reason, the therapies that mechanically stimulate the nervous 69 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 5 tissue could decrease the local mechanosensitivity and increase the mechanic tolerance 70 as consequence of activating the central mechanisms of analgesia 12-14, 17-20 . However, to 71 the current authors’ knowledge, no studies to date have included this type of 72 intervention in the management of the TTH. 73 Based on these arguments, the present study aimed to analyze the effects of a 74 protocol involving STT combined or not with NMT in the management of patients with 75 Frequent episodic tension-type headache (FETTH) and Chronic tension-type headache 76 (CTTH). It was hypothesized that the combination of both therapies is more effective in 77 decreasing the sensitivity of the neuromusculoskeletal structures and thus, improves the 78 central sensitization and chronic trend of this pathology, compared to the isolated 79 techniques. 80 Methods 81 Design 82 The present study refers to a randomized, double-blind, controlled trial, with 83 four intervention groups. 84 Participants 85 Participants were recruited randomly from the local hospital and other health 86 centers from the region. 87 Criteria for inclusion in this study were: patients aged between 18 and 65 88 years and diagnosed with FETTH and CTTH with increased pericranial tenderness on 89 manual palpation by neurologists according the International classification of headache 90 disorders 21 . 91 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 12 the rest of the groups (p <0.001). Also, in PPT 2 and PPT 3 , the patients treated with the 230 combined protocol (group D) experienced a significant increase compared to the rest of 231 the groups by the Post, Post 15days , and Post 30days time points (p <0.001) (Table 2). No 232 difference in PPT was found only respect to group B or group C (p>0.05 in all cases). 233 The mixed model linear analysis revealed significant group*time interaction for 234 frequency and maximal intensity of the crisis of pain (p <0.001), in which patients 235 treated with NMT (group C), STT (group B), and the combined protocol (group D), 236 experienced a maximum reduction of 45.2% (d = 1.7), 47.5% (d = 2.1), and 57.2% (d = 237 2.1), respectively, compared to baseline measurements in frequency (p <0.001) and a 238 maximum reduction of 37.2% (d = 1.6), 30.0% (d = 1.9), and 43.6% (d = 2.2), 239 respectively, compared to baseline in maximal intensity. The between-group differences 240 showed that the control group had higher values of frequency and maximal intensity 241 compared to the rest of the groups in all the post-intervention measurements (p <0.001) 242 and the group receiving the combined treatment had statistically significant lower 243 values compared to the soft tissue treatment group (p <0.01) (Table 3). Participants who 244 received the sham intervention (group A) also showed significant differences compared 245 to the baseline in frequency, with a reduction of 6.9% (d = 0.2), and maximal intensity, 246 with a reduction of 4.1% (d = 0.2) (p >0.05). No difference in frequency, maximal 247 intensity or Hit-6 was found only respect to group C (p>0.05 in all cases). 248 Additional analysis to calculate the percentage of individual improvements in 249 frequency of crisis showed that 13 from group B, 14 participants from group C, and 24 250 participants from group D achieved improvements equal to or greater than 50% in the 251 frequency of crisis after the intervention. No participant from group 1 achieved 50% of 252 improvements in the frequency of the crisis. 253 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 13 Table 3 also shows that the mixed model linear analysis revealed significant 254 group*time interaction for punctuation in the impact questionnaire (p <0.001), with 255 subjects receiving STT (group B), NMT (group C), or the combined treatment (group 256 D) experiencing a maximum reduction of 13.1% (d = 1.48), 13.5% (d = 1.48), and 257 16.3% (d = 1.57), respectively, compared to baseline measurements. Furthermore, 258 participants who received the sham intervention also showed significant differences, 259 with a reduction of 4.7% (d = 0.53) compared to the baseline (p <0.05). The between- 260 group differences showed that the control group (A), had statistically significant lower 261 values than the rest of the groups in all the post-intervention measurements (p <0.001). 262 Out of the twenty-one participants who took medication in their crisis episodes 263 during the study period, nine belonged to control group, three to the NMT group, five to 264 the STT group, and four to the combined protocol group. All of these twenty-one 265 patients took medication just once during the study, except four participants in the 266 control group, who took medication during two crisis (3 subjects) or three crisis (1 267 subject). 268 Discussion 269 The main finding of the present study was that four weeks of treatment, 270 combined or not, of soft tissue and NMT, is effective in improving the pressure pain 271 threshold in the head region, maximal intensity and frequency of the pain crisis, and 272 Hit-6 of the TTH patients. However, results showed that the combined treatment is a 273 more effective option in the management of the TTH than these techniques applied 274 separately. These findings support previous studies that determined the combination of 275 SST and mobilization techniques as the best option to manage TTH patients 34 and other 276 types of headaches 35 . In this regard, the NMT combined with SST stimulates the 277 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 14 peripheral and central receptors, producing an interaction of the mechanic and 278 neurophysiologic factors that could lead to improvements in the mechanosensitivity of 279 these structures and thus, a reduction in the pain level of patients with TTH 36 . 280 In contrast with previous studies 36-39 , a neural mobilization component to the 281 mobilizations was included due to the NMT’ ability to activate inhibitory mechanisms 282 that modulate the mechanosensitivity of the neuromusculoskeletal tissues 12-14, 17-20 . 283 In this regard, the most extended theory about the TTH refers to a peripheral 284 process for the episodic TTH, in which one or more neuromusculoskeletal structures are 285 sensitized and send nociceptive inputs to the central nervous system. 40, 41 . This 286 nociceptive inputs from trigeminal nerve and cranio-cervical muscles are integrated in 287 the TCN 42 , whose continuous stimulation will sensitize the TCN and the central nervous 288 system 8, 43-46 . 289 Therefore, mechanical stimulation of the neuromusculoskeletal tissues, that send 290 their inputs to the TCN, could decrease these nociceptive inputs and thus the 291 nociceptive information to the central nervous system. Also, this stimulation would 292 activate the inhibitory mechanisms, normalizing the TCN. Also, the decrease of the 293 mechanosensitivity of the nervous tissue can reduce the muscle responses, which intend 294 to protect the nerve tissue against tension and deformation stimulus due to the 295 movement 15, 16 . 296 Previous studies report clinical relevance of the findings when frequency 297 reduction reaches 50% 47 . Therefore, it is important to highlight the number of subjects 298 who achieved a reduction equal or greater than 50% in the frequency of crisis in any of 299 the post-intervention measurements, where group D had the higher number with 24/25 300 subjects and group A the lower with 0/24 subjects. It must be also taken into account 301 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 15 the large effect size and the 57% reduction shown in the frequency of the crisis in 302 patients receiving the combined protocol, in contrast with the 47% and 45% obtained in 303 patients who received soft tissue and NMT separately, respectively. Despite the fact that 304 groups receiving the techniques separately did not reach clinical significance according 305 to previous studies 47 , they equaled and even overcame the reduction of 40% that is 306 normally achieved thanks to pharmacologic treatment 48 . Similar results were found in 307 Hit-6 questionnaire, where previous studies reported that the reduction should reach 308 eight points to be clinically relevant 49 . In the present study, the groups receiving the 309 NMT or STT separately reached eight points on the impact questionnaire, while the 310 combined treatment group experienced a reduction of 9.8 points. 311 Improvements were found even in the control group in variables such as the 312 frequency of the crisis and Hit-6, although with less significant differences and small 313 effect sizes. These improvements could be explained by the observational effect 314 (patients being observed in strict investigations may report better outcomes), the 315 placebo effect, a simple random variation or the normal course of the disorder. These 316 same reasons support similar results obtained in previous studies where the control 317 group also improved in some variables 36, 39 . 318 Apart from the variability of the techniques applied, the nature and location of 319 the structures where the treatment is applied seems to be important 50 . In this way, the 320 current study managed more types and number of structures than most studies involving 321 combined protocols. In this regard, the inclusion of the neural mobilization component 322 may be other important mechanism to reduce the mechanosensitivity of the TCN, but 323 future studies are needed to confirm its importance. 324 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 16 Study limitation 325 As limitations, our sample included mainly women, which may influence the 326 results. However, epidemiologic studies have determined women are the more prevalent 327 population to suffer any type of tensional-type headache and even a risk factor for this 328 pathology 51 . Therefore, the present study sample may refer to the most representative 329 population suffering TTH. Other limitations refer to the follow-up, which may have 330 been short if taking into account the chronic character of the TTH. Another limitation of 331 our study is the impossibility to blind to the physiotherapists with respect to the 332 interventions that they were applying. 333 With respect to the medication consumption, we highlight that it mainly referred 334 to the initial days of the intervention period in the groups who received intervention 335 protocols. In this regard, we suggest the local effects of the techniques that could remain 336 any minimal inflammatory process as main reason, or even due to any misunderstanding 337 about the level of pain that the patients should feel. Conversely, on the control group the 338 ibuprofen intake happened during the whole period of the study. 339 For future studies, it is recommended to increase the duration of follow-up to 340 identify the long-term effects of the treatment, apart from including the NMT in 341 combination with other frequent treatments, such as manipulation or even therapeutic 342 exercise, to obtain the most effective clinical approach to the TTH. 343 Conclusions 344 A protocol combining soft tissue and NMT is more effective in the management 345 of FETTH and CTTH patients than the application of these techniques separately. 346 347 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT 17 348 References 349 1. Bendtsen L, Jensen R. Tension-type headache: the most common, but also the 350 most neglected, headache disorder. Curr Opin Neurol 2006;19(3):305-9 351 2. Russell MB. Tension-type headache in 40-year-olds: a Danish population-based 352 sample of 4000. J Headache Pain 2005;6(6):441-7. 353 3. 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Craniofacial inputs to upper cervical 468 dorsal horn: implications for somatosensory information processing. Brain Res 469 2005;1044(1):93-106. 470 MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT Variable Group A Group B Group C Group D (n = 24) (n=23) (n=25) (n=25) Mean ± SD Mean ± SD Mean ± SD Mean ± SD Gender Women 20 17 20 21 Men 4 6 5 4 TTH FETTH 14 15 14 13 CTTH 10 8 11 12 Age (y) 40.5 ± 12.0 38.1 ± 10.9 39.4 ± 11.0 40.8 ± 12.1 Height (m) 1.70 ± 0.07 1.66 ± 0.01 1.64 ± 0.08 1.63 ± 0.06 Weight (kg) 69.2 ± 10.2 68.2 ± 11.8 67.9 ± 12.1 66.3 ± 7.8 BMI (kg/m 2 ) 25.3 ± 3.0 24.7 ± 3.4 25.1 ± 3.3 24.9 ± 3.0 Group A = no treatment; Group B = soft-tissue treatment; Group C = neural mobilization treatment; Group D = combined treatment; BMI = Body mass index; SD = Standard Deviation. Table 1. Anthropometric characteristics of participants. MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT Variable Group A (n = 24) Group B (n=23) Group C (n=25) Group D (n=25) Mean ± DE Mean ± DE Mean ± DE Mean ± DE PPT 1 (kg/cm 2 ) Pre 1.9 ± 0.3 2.1 ± 0.4 2.0 ± 0.3 2.0 ± 0.4 Post 2.0 ± 0.4* 3.1 ± 0.4¥ 2.9 ± 0.3¥ 3.2 ± 0.4¥ Post 15days 2.0 ± 0.4* 3.1 ± 0.4¥# 2.9 ± 0.4¥ 3.2 ± 0.4¥ Post 30days 1.9 ± 0.4* 3.0 ± 0.4¥ 2.9 ± 0.4¥ 3.2 ± 0.4¥ PPT 2 (kg/cm 2 ) Pre 1.8 ± 0.3 1.9 ± 0.4 1.9 ± 0.4 2.0 ± 0.3 Post 1.8 ± 0.4* 2.9 ± 0.5¥ 2.8 ± 0.4¥ 3.3 ± 0.3*¥ Post 15days 1.8 ± 0.4* 2.9 ± 0.5¥ 2.8 ± 0.4¥ 3.3 ± 0.4*¥ Post 30days 1.8 ± 0.4* 2.8 ± 0.5¥ 2.8 ± 0.4¥ 3.3 ± 0.4*¥ PPT 3 (kg/cm 2 ) Pre 1.0 ± 0.3* 1.1 ± 0.3 1.0 ± 0.3 1.2 ± 0.3 Post 1.0 ± 0.3* 1.6 ± 0.3¥ 1.6 ± 0.3¥ 2.0 ± 0.4*¥ Post 15days 1.0 ± 0.3* 1.6 ± 0.3¥ 1.6 ± 0.3¥ 2.0 ± 0.4*¥ Post 30days 1.0 ± 0.3* 1.6 ± 0.3¥ 1.6 ± 0.3¥ 2.0 ± 0.4*¥ Pre = measurement previous the intervention period; Post = measurement one hour after the intervention period; Post 15days = measurement fifteen days after intervention period; Post 30days = measurement thirty after the intervention period; Group A = no treatment; Group B = soft-tissue treatment; Group C = neurodynamic treatment; Group D = combined treatment; PPT 1 = Pressure pain threshold in point 1 of the temporal muscle; PPT 2 = pressure pain threshold in the point 2 of the temporal muscle; PPT 3 = Pressure pain threshold in the supraorbital region; * = differences compared to the rest of the groups p < 0.001; ¥ = differences compared to the baseline measurement p < 0.001; #= differences compared to the previous measurement p < 0.01. Table 2. Values of the pressure pain threshold test in the three points. MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT Variable Group A (n = 24) Group B (n=23) Group C (n=25) Group D (n=25) Mean ± DE Mean ± DE Mean ± DE Mean ± DE Frequency (d/15 days) Pre 7.2 ± 2.7 8.6 ± 2.3 7.9 ± 2.7 8.0 ± 2.6 Post 6.7 ± 2.5* 4.7 ± 1.7¥ 4.2 ± 1.7¥ 3.5 ± 1.7¥ ψ Post 15days 6.9 ± 2.5*¥ 4.7 ± 1.4¥ 4.3 ± 2.2¥ 3.5 ± 1.7¥ ψ Post 30days 6.8 ± 2.3* 4.8 ± 1.7¥ 4.3 ± 2.2¥ 3.4 ± 1.9¥ ψ Intensity (0-10 points) Pre 5.6 ± 1.1 4.4 ± 1.1 5.7 ± 0.8 5.1 ± 1.0 Post 5.4 ± 1.2*¥ 2.8 ± 1.0¥ 4.0 ± 1.0¥ 2.9 ± 1.0¥ Post 15days 5.4 ± 1.0*¥ 2.8 ± 0.8¥ 4.0 ±0.9¥ 2.9 ± 1.0¥ Post 30days 5.4 ± 1.1*¥ 2.8 ± 1.0¥ 4.1 ± 0.9¥ 3.0 ± 1.1¥ Hit6 (36-78 points) Pre 60.0 ± 5.9 60.8 ± 5.7 59.0 ± 5.3 59.7 ± 6.0 Post 57.2 ± 4.5*¥ 52.8 ± 5.1¥ 51.0 ± 5.5¥ 50.0 ± 6.2¥ Post 15days 57.5 ± 4.8*¥ 52.9 ± 4.7¥# 51.8 ± 5.2¥ 50.0 ± 5.7¥ Post 30days 57.7 ± 5.5*¥ 52.9 ± 5.1¥ 51.7 ± 5.4¥ 50.3 ± 5.4¥ Pre = measurement previous the intervention period; Post = measurement one hour after the intervention period; Post 15days = measurement fifteen days after intervention period; Post 30days = measurement thirty after the intervention period; Group A = no treatment; Group B = soft-tissue treatment; Group C = neural mobilization treatment; Group D = combined treatment; d/15 days = days with pain every 15 days; Hit6 = Impact Hit-6 questionnaire; * = differences compared to the rest of the groups p < 0.001; ¥ = differences compared to the baseline measurement p < 0.001; # = differences compared to the previous measurement p < 0.001; ψ = differences compared to group B p < 0.01. Table 3. Values of the frequency and intensity of the crisis of pain and punctuation in the Impact Hit-6 questionnaire. MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT MANUS CRIP T ACCEP TED ACCEPTED MANUSCRIPT