Effects of Pain Neuroscience Education and Therapeutic Exercise on Pain, Catastrophizing, Kinesiophobia and Upper Limb Function in Patients With Non-specific Neck Pain.
Phase: NA
Conditions: Neck Pain, Patient Education, Exercise Therapy, Fear, Pain
Sponsor: Universidad Miguel Hernandez de Elche

1 
Official Title: Effects of Pain Neuroscience Education and Therapeutic 
Exercise on Pain, Catastrophizing, Kinesiophobia and Upper Limb Function in 
Patients With Non-specific Neck Pain. 
2 
 
3 
Brief Title: Effects of Education and Exercise on Pain, Psychosocial Factors, 
and Upper Limb Function in Non-specific Neck Pain. 
 
4 
ClinicalTrials.gov Identifier: NCT06889389 
 
 
5 
Unique Protocol Id: PI 90/2024 
6 
 
7 
 
8 
Document Type: Study Protocol and Statistical Analysis Plan 
9 
 
10  
11 Document Date: 26 September 2024

27 
STUDY PROTOCOL 
 
28 
SUMMARY 
29 
Pain neuroscience education is currently one of the techniques being explored in 
30 
physiotherapy for pain management. The benefits of this technique are gradually 
31 
becoming evident in various published studies. So far, it has been widely studied 
32 
for its short-term effects, but the education provided has typically been generic, 
33 
not focused on exercise. However, it is suggested that this technique should be 
34 
combined with exercise to achieve the expected outcomes. Therefore, pain 
35 
education should be tailored to the specific physical activities the subject will 
36 
perform to maximise its effectiveness. The primary aim of this study is to analyse 
37 
the outcome of combining exercise with tailored pain neuroscience education on 
38 
aspects such as pain, kinesiophobia, catastrophizing, exercise conceptualization, 
39 
and upper limb function in subjects with neck pain. The secondary aim is to 
40 
evaluate the relationship between kinesiophobia and catastrophizing and their 
41 
impact on the results of various upper limb performance tests. Finally, the effects 
42 
of therapeutic exercise alone will be compared with those of therapeutic exercise 
43 
combined with pain neuroscience education, focusing on pain, kinesiophobia, 
44 
catastrophizing, and exercise conceptualization. A double-blind, randomised 
45 
clinical trial has been designed, in which three intervention protocols will be 
46 
applied to 81 subjects with non-specific neck pain: education with exercise, 
47 
exercise alone, and placebo alone. Subjects with non-specific neck pain who 
48 
meet the inclusion criteria will be enrolled. Demographic characteristics of the 
49 
subjects, as well as pain, kinesiophobia, catastrophizing, and upper limb 
50 
performance test scores, will be assessed. This study aims to explore the 
51 
potential relevance of a pain neuroscience education session prior to therapeutic 
52 
exercise, as well as to influence the clinical recommendations made by clinicians 
53 
during treatment. 
 
54 
55 
INTRODUCTION 
56 
Neck pain is considered the fourth leading cause of disability (Cohen, 2015), with 
57 
an age-standardised prevalence rate of 27 per 1,000 individuals in 2019 (Wu et 
58 
al., 2024). Non-specific neck pain (NNP) is the most common type, and as the 
59 
name suggests, the underlying mechanisms are unknown. However, it is 
60 
proposed that musculoskeletal factors, such as deficits and alterations in 
61 
proprioception of the neck muscles, which play a crucial role in motor control of 
62 
the head and cervical joint positioning, may be involved in the maintenance, 
63 
recurrence, 
and progression 
of pain 
(Treleaven, 
2008). Furthermore, 
64 
psychosocial factors such as catastrophising, kinesiophobia, stress, anxiety, and 
65 
depression also play a significant role in influencing pain perception (Bushnell et 
66 
al., 2013; Ortego et al., 2016). Therefore, as reflected in the current evidence, 
67 
exercise and patient education are first-line interventions for managing NNP, 
68 
receiving high levels of recommendation for all subtypes of non-specific neck 
69 
pain, and across all stages of the condition, whether acute, subacute, or chronic 
70 
(Bier et al., 2018; Blanpied et al., 2017). 

71 
Exercise has an analgesic effect on pain (Senarath et al., 2023). The most 
72 
supported mechanism underlying the analgesic effects of exercise, according to 
73 
the scientific community, is the activation of the endogenous opioid system during 
74 
exercise of sufficient intensity. This hypothesis is based on the observation of the 
75 
release of beta-endorphins, which are associated with an analgesic state 
76 
(Goldfarb & Jamurtas, 1997; Stagg et al., 2011). However, exercise can also 
77 
produce pain (Sluka et al., 2018). Moreover, patients with chronic pain often 
78 
exhibit avoidant behaviours towards exercise and movement, a phenomenon 
79 
known as kinesiophobia (Luque-Suarez et al., 2019). It is therefore not surprising 
80 
that patients with chronic pain tend to be more inactive than those without pain 
81 
(Dzakpasu et al., 2021). Additionally, these patients often present other altered 
82 
psychosocial variables in relation to their pain, such as pain catastrophising 
83 
(Thompson et al., 2010). These psychosocial symptoms, in turn, influence the 
84 
perceived pain intensity and dysfunction (Thompson et al., 2010). Consequently, 
85 
cognitive and emotional factors have a significant impact on pain perception 
86 
(Bushnell et al., 2013), meaning that an intervention targeting these factors could 
87 
modify both perceived pain and the analgesic effects of exercise. 
88 
In line with the previous discussion, Pain Neuroscience Education (PNE) is 
89 
increasingly used as part of the treatment for patients with pain, especially in 
90 
cases of non-specific low back pain (Clarke et al., 2011). This approach, in 
91 
accordance 
with 
the 
biopsychosocial 
model, 
involves 
providing 
pain 
92 
neuroscience information to the patient in order to enhance their understanding 
93 
of their condition, change their beliefs, facilitate return to activity, and reduce 
94 
unnecessary  medical  attention  (Louw  et  al.,  2016).  The  literature  now 
95 
recommends combining PNE with exercise, due to favourable results with this 
96 
combination of therapies. However, there remains a need for further research in 
97 
this field (Javdaneh et al., 2021). 
98 
NNP is often associated with upper extremity dysfunction (Osborn & Jull, 2013), 
99 
as patients with severe neck pain or disability also report significant disability in 
100 
the upper limbs (Mclean et al., 2010a). Furthermore, those patients with greater 
101 
upper limb disability tend to avoid or abandon painful tasks due to the potential 
102 
of pain (Ayre & Tyson, 2001; Levin et al., 1996). 
103 
Additionally, when patients believe that pain is directly linked to injury or tissue 
104 
damage, they exhibit a reduced ability to control this pain (Louw et al., 2016). This 
105 
observation supports the notion that patient beliefs not only influence pain 
106 
intensity but also their level of disability. Thus, pain neuroscience education may 
107 
have a positive effect on pain intensity, dysfunction levels, and fear of movement, 
108 
particularly when combined with therapeutic exercise (Louw et al., 2011). 
109 
Most of the current scientific evidence regarding pain neuroscience education 
110 
(PNE) has been explored in patients with chronic low back pain, with less focus 
111 
on other types of pain, such as NNP. Consequently, there is less information 
112 
available to support the role of education combined with exercise for these 
113 
patients, particularly in terms of perceived pain, kinesiophobia, catastrophising, 
114 
and even the conceptualisation of exercise itself. The potential relationship 
115 
between upper extremity dysfunction, as measured by functional or performance 
116 
tests, and the aforementioned parameters is also not extensively studied. 

117 
Addressing these issues is the primary motivation for conducting the present 
118 
study. 
 
119 
 
120 
 
121 
122 
JUSTIFICATION AND OBJECTIVES 
123 
In recent years, education in pain neuroscience has been shown to have a 
124 
positive impact on pain subjects. However, the education provided is often 
125 
generic and not adapted to exercise, although it is recommended that this therapy 
126 
should be combined with exercise. Therefore, the aim of this study is to assess 
127 
the results of the combination of exercise and pain neuroscience education 
128 
focused on the exercise to be performed by subjects in pain or kinesiophobia. 
129 
Therefore, the main objective of the study is to evaluate the effects of pain 
130 
neuroscience 
education in non-specific 
neck pain 
on pain 
intensity, 
131 
kinesiophobia, catastrophizing, exercise conceptualization and upper limb 
132 
functionality itself in subjects with non-specific neck pain. The specific objective 
133 
is to compare the effect of therapeutic exercise alone with the effect of therapeutic 
134 
exercise in combination with pain neuroscience education on pain, kinesiophobia, 
135 
catastrophizing and exercise conceptualization. Similarly, the aim is to determine 
136 
the relationship between kinesiophobia and catastrophism and the results 
137 
obtained in upper limb performance tests. For this purpose, the Closed Kinetic 
138 
Chain Upper Extremity Stability Test (CKCUEST), the Seated Medicine Ball 
139 
Throw test (SMBT) and the Single Arm Military Press (SAMP) have been chosen, 
140 
the first two of which have not been studied in patients with non-specific neck 
141 
pain to date. This study aims to have an impact on the possible relevance of a 
142 
pain neuroscience education session prior to therapeutic exercise, as well as on 
143 
the clinical recommendations made by healthcare professionals during treatment. 
 
144 
145 
DESIGN 
146 
The study consists of a randomised, double-blind clinical trial. Subjects will be 
147 
randomised into 3 groups: control group, where subjects will receive a placebo 
148 
(TENS off, in this case); intervention group 1, where pain neuroscience education 
149 
(PNE) and exercise will be applied; and intervention group 2, to which only 
150 
exercise will be applied. The allocation will be blinded to the subject and to one 
151 
of the two investigators. 
 
152 
153 
SELECTION CRITERIA 
154 
Inclusion criteria: o Adults aged between 18 and 65 years. o Subjects with non- 
155 
specific neck pain at the time of the intervention reaching at least a 3 on the 

156 
Numerical Pain Rating Scale (NPRS scale). Exclusion criteria: o Pregnancy o 
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Severe illnesses: diabetes, cancer, neurological, depression, etc... o Cognitive 
158 
disorders or illnesses. o Subjects who have received physiotherapy treatment in 
159 
the last month. o Subjects who are receiving concomitant physiotherapy 
160 
treatment for this pathology. o Subjects with specific neck pain, such as any 
161 
traumatic pathology, whiplash or with a diagnosis associated with neurological 
162 
compromise  or peripheral nerve damage. o Physiotherapy  students  or 
163 
professional physiotherapists. Subjects included in the study must complete the 
164 
informed consent form, meet the inclusion criteria and not meet the exclusion 
165 
criteria. Prior to any type of procedure, subjects will be informed about the study 
166 
and about their right to discontinue their participation and/or request the 
167 
withdrawal of their data at any time. 
 
168 
169 
DESCRIPTION OF THE PROCEDURE 
170 
At the beginning, all subjects will sign the informed consent form, demographic 
171 
data will be recorded by means of an interview and a questionnaire specifically 
172 
designed for the work. After that, baseline measurements of outcome variables 
173 
will be taken. Fear of movement and kinesiophobia will be measured with the 
174 
Tampa Scale of Kinesiophobia (TSK- 11SV), pain catastrophizing with the Pain 
175 
and Castastrophizing Scale (PCS), and subject's beliefs about pain with the Pain 
176 
Beliefs Questionnaire (PBQ). The Spanish validated versions of  all the 
177 
aforementioned scales will be used. The Numerical Pain Rating Scale (NPRS) 
178 
will be used to assess subjects' current pain and spontaneous or evoked pain 
179 
intensity. Researcher A will then show each subject images of the 3 performance 
180 
tests they will have to perform, as well as provide an explanation of their 
181 
execution: Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), 
182 
Single Arm Military Press (SAMP) and Seated Medicine Ball Throw Test (SMBT). 
183 
Regardless of whether subjects are later assigned to the exercise group or not. 
184 
These tests are among the most widely used tests to measure upper limb 
185 
function, although they have not been studied in subjects with non-specific neck 
186 
pain. The Single Arm Military Press (SAMP) test is the only performance-based 
187 
measure of upper limb disability that was designed specifically for subjects with 
188 
neck pain. All these tests involve active movements that could be conditioned by 
189 
the subject's pain and beliefs related to kinesiophobia, so they could be of great 
190 
use to observe whether an educational approach decreases upper limb 
191 
dysfunction. Finally, subjects' beliefs about the exercises explained in relation to 
192 
their pathology will be assessed by means of a questionnaire specifically 
193 
designed for this purpose. After this procedure is completed by all participants, 
194 
they will be randomised into three groups, using a randomisation website 
195 
(Research Randomizer, n.d.) and will undergo a physiotherapy session that 
196 
includes different approaches for each group. 
197 
In the PNE and exercise group the investigator will proceed with pain 
198 
neuroscience education focused on concepts related to movement-related fear 
199 
and the benefits of exercise for 20 minutes. Specifically, the exercises presented 
200 
in the generic part of the procedure will be discussed. To assess whether the 
201 
education has resulted in changes to the subjects’ beliefs, they will be reassessed 

202 
regarding their beliefs about the exercises in relation to their neck pain following 
203 
the education session. Afterward, subjects will complete psychosocial scales and 
204 
rate their pain and evoked pain at that moment independently, without the need 
205 
for the researcher to be present, in order to ensure blinding. Subsequently, the 
206 
subject will undergo the performance tests in a randomised order (Closed Kinetic 
207 
Chain Upper Extremity Stability Test, Single Arm Military Press, and Seated 
208 
Medicine Ball Throw), which will be conducted by a second investigator who is 
209 
unaware  of  whether  the  subject  has  received  education.  The  exercise 
210 
intervention will then proceed using variations of the performance tests, also 
211 
carried out by the second investigator. Specifically, the load or execution time will 
212 
be increased until the participant reports a perceived fatigue of 4-6 (moderate to 
213 
strong) on the modified Borg scale. Finally, the participant will autonomously 
214 
complete the scales, rate their pain and exercise-related questions for the final 
215 
time. 
216 
The exercise group does not include pain neuroscience education. Following the 
217 
initial assessment, the subject will be left alone for 20 minutes with instructions to 
218 
think about the exercises but not to perform them. Afterward, subjects will 
219 
complete psychosocial scales and will rate their pain and evoked pain at that 
220 
moment independently, without the need for the researcher to be present, in order 
221 
to ensure blinding. Subsequently, the subject will undergo the performance tests 
222 
in a randomised order (Closed Kinetic Chain Upper Extremity Stability Test, 
223 
Single Arm Military Press, and Seated Medicine Ball Throw), which will be 
224 
conducted by a second investigator who is unaware of whether the subject has 
225 
received education. The exercise intervention will then proceed using variations 
226 
of the performance tests, also carried out by the second investigator. Specifically, 
227 
the load or execution time will be increased until the participant reports a 
228 
perceived fatigue of 4-6 (moderate to strong) on the modified Borg scale. Finally, 
229 
the participant will independently complete the scales, rate their pain, evoked 
230 
pain, and exercise-related questions one final time. 
231 
The control group doees not receive pain neuroscience education or exercise. 
232 
Following the initial assessment, the subject will be left alone for 20 minutes with 
233 
instructions to think about the exercises but not to perform them. Afterward, 
234 
subjects will independently complete psychosocial scales and will rate their pain 
235 
and evoked pain at that moment, without the need for the researcher to be 
236 
present, in order to ensure blinding. Subsequently, participants in this group will 
237 
receive a placebo intervention administered by a second investigator. A TENS 
238 
device will be placed on them and kept turned off for 15 minutes. subjects will be 
239 
informed that the device is operating at a very low intensity, too weak to be 
240 
perceived. Additionally, performance tests will not be assessed in this group. 
241 
Finally, the participant will autonomously complete the scales, rate their pain and 
242 
exercise-related questions for the final time. Therefore, all groups will be 
243 
assessed 3 times during the session. The first time they will be accompanied by 
244 
the first investigator, who will answer any questions that may arise. The second 
245 
and third time the subject will do it autonomously, unaccompanied by any 
246 
researcher, to avoid bias. 
 
247 

248 
OUTCOME MEASURES 
249 
Primary oucome measures 
250 
Kinesiophobia: The level of kinesiophobia will be assessed using the Tampa 
251 
Scale for Kinesiophobia (TSK-11SV). This scale evaluates kinesiophobia (fear of 
252 
movement) through 11 statements, which participants must rate on a Likert scale 
253 
from 1 to 4, where 1 indicates strongly disagree and 4 indicates strongly agree. 
254 
Higher scores reflect greater kinesiophobia (minimum score: 11; maximum score: 
255 
44). The validated Spanish version of the scale will be used. Measurements will 
256 
be collected at baseline, after the education session or waiting period (depending 
257 
on the assigned group), and after the exercise intervention or placebo (depending 
258 
on the assigned group). 
259 
260 
261 
Pain beliefs: Pain beliefs will be assessed using the Pain Beliefs Questionnaire 
262 
(PBQ), which evaluates beliefs regarding the causes, consequences, and 
263 
necessary treatment of pain. The questionnaire is divided into two subscales: 
264 
"organic" and "psychological." It consists of 12 items, with 8 items belonging to 
265 
the "organic" subscale and 4 to the "psychological" subscale. The PBQ uses a 6- 
266 
point Likert scale ranging from "Always" to "Never," corresponding to scores of 6 
267 
and 1, respectively. Higher scores on each subscale indicate that the respondent 
268 
considers the corresponding pain-related beliefs to be of greater importance. 
269 
Measurements will be collected at baseline, after the education session or waiting 
270 
period (depending on the assigned group), and after the exercise intervention or 
271 
placebo (depending on the assigned group). 
272 
273 
Catastrophizing: The level of catastrophizing will be assessed using the Pain 
274 
and Catastrophizing Scale (PCS). This scale evaluates catastrophizing in 
275 
response to pain and the negative and exaggerated perception of the painful 
276 
experience. It consists of 13 statements describing different thoughts and feelings 
277 
that may be associated with pain. The participant is required to indicate the extent 
278 
to which they experience these thoughts and feelings when they are in pain. Each 
279 
statement is rated on a Likert scale from 0 to 4, where 0 means "not at all" and 4 
280 
means "all the time." Higher scores indicate a higher degree of catastrophizing. 
281 
The validated Spanish version of the scale will be used. Measurements will be 
282 
collected at baseline, after the education session or waiting period (depending on 
283 
the assigned group), and after the exercise intervention or placebo (depending 
284 
on the assigned group). 
285 
286 
Pain intensity: Pain intensity will be assessed using the Numerical Pain Rating 
287 
Scale (NPRS). This scale evaluates the intensity of pain experienced by the 
288 
participant, using a 10-point scale, where 0 represents no pain and 10 represents 
289 
the maximum possible pain. Higher scores correspond to greater pain intensity. 
290 
Measurements will be collected at baseline, after the education session or waiting 

291 
period (depending on the assigned group), and after the exercise intervention or 
292 
placebo (depending on the assigned group). 
293 
294 
Evoked pain intensity: Evoked pain will be assessed using the Numerical Pain 
295 
Rating Scale (NPRS). Participants will be asked to perform a movement that 
296 
evokes pain related to their condition. Pain intensity will then be evaluated on a 
297 
10-point scale, where 0 represents no pain and 10 represents the maximum 
298 
possible pain. Higher scores correspond to greater pain intensity. Measurements 
299 
will be collected at baseline, after the education session or waiting period 
300 
(depending on the assigned group), and after the exercise intervention or placebo 
301 
(depending on the assigned group). 
302 
303 
Secondary outcome 
304 
Demographic data: Participants will complete a demographic questionnaire, 
305 
including descriptive variables such as age, sex, weight, height, level of physical 
306 
activity, comorbidities, duration of pain, side of pain, and smoking status. Data 
307 
Will be collected at baseline (before any intervention). 
308 
309 
Beliefs about specific exercises: Beliefs about specific exercises in relation to 
310 
pain will be assessed using a custom questionnaire. The questionnaire evaluates 
311 
the participants' beliefs regarding the specific exercises they will perform. 
312 
Participants will first be shown photographs of the exercises they are required to 
313 
do, and then they will respond to the questionnaire by selecting a number on a 
314 
visual analogue scale from 1 to 10, where 1 indicates "strongly disagree" and 10 
315 
indicates "strongly agree." Higher scores reflect stronger beliefs about the 
316 
exercises in relation to their pain. This questionnaire was specifically designed 
317 
for this study and is being used for data collection. Measurements will be 
318 
collected at baseline, after the education session or waiting period (depending on 
319 
the assigned group), and after the exercise intervention or placebo (depending 
320 
on the assigned group). 
321 
322 
Pain intensity and worst pain intensity over last 7 days: Pain intensity will be 
323 
assessed using the Numerical Pain Rating Scale (NPRS). This scale evaluates 
324 
both the average and worst pain intensity experienced by the participant over the 
325 
last 7 days, using a 10-point scale where 0 represents no pain and 10 represents 
326 
the maximum possible pain. Higher scores correspond to greater pain intensity. 
327 
Data Will be collected at baseline (before any intervention). 
328 
329 
Functional performance of the upper extremities (CKCUEST): Functional 
330 
performance of the upper extremities will be assessed using the Closed Kinetic 
331 
Chain Upper Extremity Stability Test (CKCUEST), a test designed to evaluate 

332 
upper limb stability and control. During the test, male participants will adopt a 
333 
push-up position, while female participants will assume a modified push-up 
334 
position (knees on the ground). Both hands will be placed on two strips on the 
335 
floor at the same height, with a distance of 91.4 cm between them. In these 
336 
positions, participants will be required to move one hand to touch the back of the 
337 
opposite hand, then return to the starting position, repeating the movement with 
338 
the other hand, for 15 seconds. The test will be performed for three 15-second 
339 
repetitions at maximum effort, with a 45-second rest between each repetition. The 
340 
outcome measure will be the average number of touches (mean of the number 
341 
of touches from the three attempts). Data Will be collected after the education 
342 
session or waiting period (depending on the assigned group) for the Education 
343 
and Exercise and Exercise groups 
344 
345 
Functional performance of the upper extremity (SAMP test): Functional 
346 
performance of the upper extremity will be assessed using the Single Arm Military 
347 
Press (SAMP). This performance-based measure is designed to assess upper 
348 
extremity strength during an overhead activity, aimed at differentiating between 
349 
healthy individuals and those with varying levels of nonspecific neck pain and 
350 
upper extremity disability. The exercise is performed with participants standing, 
351 
with their feet shoulder-width apart, holding a 1 kg dumbbell at shoulder height 
352 
with their dominant hand. Participants are instructed to lift the dumbbell overhead, 
353 
performing a full shoulder flexion and elbow extension. The test consists of 
354 
repeating this motion as quickly as possible for 30 seconds with maximal effort. 
355 
The SAMP score is determined by counting the number of correct repetitions 
356 
completed in 30 seconds. The test is stopped if the participant is unable to 
357 
complete another correct repetition. Data Will be collected after the education 
358 
session or waiting period (depending on the assigned group) for the Education 
359 
and Exercise and Exercise groups. 
360 
361 
Functional  performance  of  the  upper  extremities  (SMBT):  Functional 
362 
performance of the upper extremities will be assessed using the Seated Medicine 
363 
Ball Throw Test (SMBT). Participants will sit with their back against the wall, legs 
364 
extended, holding a 2 kg medicine ball with arms at 90° shoulder abduction and 
365 
elbows flexed at chest height. They will throw the ball forward as far as possible 
366 
without losing contact with the wall. The distance will be measured by a tape 
367 
placed 10 meters from the subject’s starting point. Three maximum effort throws 
368 
will be performed with 1-minute rests between each, and the result will be the 
369 
average of the three throws. Data Will be collected after the education session or 
370 
waiting period (depending on the assigned group) for the Education and Exercise 
371 
and Exercise groups 
372 
 
373 
HYPOTHESIS 

374 
We hypothesize that pain neuroscience education focused on movement and 
375 
exercise will significantly reduce both kinesiophobia and catastrophising, as well 
376 
as improve the conceptualisation of exercise and upper limb functionality. 
377 
Therefore, pain neuroscience education will modify the subjects' beliefs regarding 
378 
exercise participation. 
379 
Additionally, the group receiving both education and exercise will achieve better 
380 
performance test results compared to the group that only receives exercise and 
381 
the placebo group. 
 
382 
383 
384 
SAMPLE SIZE 
385 
To perform the sample size calculation, an independent measures ANOVA was 
386 
used on the primary variable: the Tampa Scale of Kinesiophobia (TSK-11SV). 
387 
The effect size estimation was based on a previous study with an experimental 
388 
design similar to our proposed one (Beltran-Alacreu et al., 2015). We used 
389 
G*Power 3.1.14 software (Erdfelder et al., 2009; Faul et al., 2007). An effect 
390 
size of F = 0.36 was estimated for the primary variable (TSK-11SV), assuming a 
391 
random error of 5% and a minimum statistical power of 80%. The result was a 
392 
sample size of 27 subjects per group, i.e., 81 subjects in total. 
393 
394 
STADISTICAL ANALISIS PLAN 
395 
Once all data have been coded, the normality of the distribution will be assessed 
396 
using the Shapiro-Wilk test and histogram visualisation. If the data do not follow 
397 
a normal distribution, the corresponding non-parametric tests will be used 
398 
instead. 
 
399 
To examine changes in the variables for each protocol, pre-intervention 
400 
measurements will be compared with post-intervention measurements within 
401 
each protocol. A repeated measures ANOVA will be used for this comparison (or 
402 
the Friedman test if normality is not met). 
403 
To determine whether the intervention groups differ from the TENS control group 
404 
or from each other, a two-way ANOVA will be performed. This analysis will 
405 
consider the within-subjects 
factor (time), the between-subjects 
factor 
406 
(intervention), and their interaction. If normality is not met, the corresponding non- 
407 
parametric test (Kruskal-Wallis) will be conducted. 
408 
If significant differences are found in the ANOVA tests, post hoc comparisons will 
409 
be explored using Dunnett's or Bonferroni tests, depending on the nature of the 
410 
comparison. 
 
411 
 
412 

413 
BIBLIOGRAPHY 
414 
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