Action Observation Training in Patients With Chronic Low Back Pain
Phase: NA
Conditions: AOT, Low Back Pain
Sponsor: Istituto Clinico Humanitas

 
PROTOCOL NAME: Action Observation Training in patients with chronic low 
back pain  
 
PROTOCOL IDENTIFYING NUMBER: CLF19/01 
 
 
PROTOCOL VERSION DATE: 30/01/19 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
Abbreviations glossary  
 
 LBP                                Low Back Pain 
AOT                                Action Observation Training 
ODI-I                              Oswestry Disability Index  
NRS                                Numeric Rating Scale 
SF36                               Medical Outcomes Study Short Form 36  
TSK                                Tampa Scale of Kinesiophobia  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study coordinators: 
Roberto Gatti 
Phone: +39 0282246929 
Fax: / 
e-mail: roberto.gatti@hunimed.eu 
 
 

 
INDEX 
1SYNOPSIS ........................................................................................................................ 6 
2 BACKGROUND AND INTRODUCTION .......................................................................... 8 
3 STUDY RATIONAL .......................................................................................................... 8 
4 STUDY AIMS .................................................................................................................... 8 
4.1 General aims ................................................................................................................................. 8 
4.2 End-points ..................................................................................................................................... 8 
4.2.1 Primary Endpoint .................................................................................................................... 8 
4.2.2 Secondary Endpoint ................................................................................................................ 9 
5 CRITERIA FOR THE RECRUITMENT OF THE PATIENTS ............................................ 9 
5.1 Inclusion criteria .......................................................................................................................... 9 
5.2 Exclusion criteria ......................................................................................................................... 9 
6 STUDY DESIGN ............................................................................................................... 9 
6.1 General design .............................................................................................................................. 9 
7 STATISTICAL CONSIDERATIONS ............................................................................... 10 
7.1 Sampling size .............................................................................................................................. 10 
7.2 Analysis ....................................................................................................................................... 10 
8 STUDY ABANDONMENT .............................................................................................. 10 
9 MODULES AND PROCEDURES FOR DATA COLLECTION AND MANAGEMENT.... 10 
10 ETHICAL CONSIDERATIONS ..................................................................................... 10 
10.1 Patients protection ................................................................................................................... 10 
10.2 Subject identification – Personal data confidentiality .......................................................... 11 
10.3 Informed consent...................................................................................................................... 11 
11 CONFLICT OF INTEREST ........................................................................................... 11 
12 DATA OWNERSHIP ..................................................................................................... 11 

 
13 PUBLICATION POLICY ............................................................................................... 11 
14 TIMING OF THE STUDY .............................................................................................. 11 
15 STUDY SCHEME ......................................................................................................... 12 
16 REFERENCES .............................................................................................................. 12 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
1 Synopsis   
 
 
Title 
Action Observation Training in patients with chronic low back 
pain 
 
Study coordinator 
Roberto Gatti  
 
Protocol number 
CLF19/01 
 
Version and protocol date 
30th January 2019 
Introduction and rational 
 
Low back pain (LBP) represents the pathology of the 
musculoskeletal system with greater prevalence in adults and it 
is one of the main causes of disability. Structural and 
functional brain modifications have been described in patients 
with chronical pain in the musculoskeletal system. In these 
patients, the central nervous system can therefore be 
considered one of the target structures of the treatment. The 
Action Observation Training (AOT) represents an effective 
rehabilitative approach to enhance the motor function in both 
central nervous system and musculoskeletal pathologies. So far 
no study has investigated the effects of AOT in patients with 
chronical LBP. The study aims to determine the efficacy of an 
AOT treatment in patients with chronic LBP. 
Population and patients 
recruitment criteria   
 
N. 50 aspecific chronical LBP diagnosed patients will be 
sorted (duration of the symptoms over 12 weeks). The 
inclusion criteria will be: understanding of Italian language and 
an age over 65 years. Patients with severe sight and/or hearing 
impairment and with cognitive deficit (Mini Mental State 
Examination ≤21) will be excluded. Subjects with specific 
etiology LBP or who have previously undergone AOT will be 
excluded too. 
Design and study duration 
 
The study is a single-blind controlled randomized clinic trial.  
Outcomes 
 
The primary outcome will be the evaluation of the disability 
through a Oswestry Disability Index questionnaire. The 
secondary outcomes will be the rating of the pain (Numeric 
Rating Scale), the quality of life (Short-Form 36) and the fear 
of movement (Tampa Scale of Kinesiophobia). The outcome 
measures will be taken before the treatment (T0), after three 
weeks (T1) and four months upon the end of the treatment 
(T2). At T0 the subjects’ attention skill will be evaluated.  
 
 
 
 
 

 
 
Statistical methods and data 
analysis 
 
Upon data collection the normality and homogeneity of the 
demographic variables and of the outcome measures to the 
baseline will be evaluated. Possible differences after treatment, 
inter-group, intragroup will be investigated through ANOVA 
test for repeated measurements including any possible post hoc 
analysis. 
 
 
Ethical considerations 
 
The subject study is aimed to determine the efficacy of an 
AOT treatment in patients affected by chronic LBP, by treating 
the participants with an intervention and evaluation as it was 
described in literature. They showed no evidence of adverse 
events for the health. The materials used for the study will be 
provided by the Physiotherapy Dept. of Humanitas Clinical 
Institute. The treatments will last 30 minutes while the 
evaluation will last 15 minutes.  
Timing of the study 
 
 
Patients recruiting: May 2019 
Data analysis: July 2020 
Report submitted: September 2020 
 
 
 
 
 
 
 
 
 
 

 
2 Background and introduction 
The Low Back Pain (LBP) represents the pathology of the musculoskeletal system with greater 
prevalence in adults (with a 18.6% to 57.4% variable index) [1]. It is one of the main causes of 
disability with a high rate of chronicity and absenteeism from work [1] [2] [3]. The clinical course 
of the LBP is highly variable and from 3 to 10% of the affected patients develops a chronic pain 
(more than 3 months lasting).  
Different kinds of interventions have been proposed to handle this pathology (including different 
types of pharmacological and chirurgical approaches); they have achieved contrasting and 
sometimes not satisfactory results [4]. The treatment of the LBP traditionally focuses on what is 
defined as “end organ dysfunction”, criteria according to which the symptom experienced by the 
patient derives from structural or functional anomalies of the musculoskeletal system. Hence the 
intervention aims to normalize the peripheral deficit through techniques such as stretching, 
anesthesia or denervation but with scarcely important results [5]. 
Parallelly, many studies have described structural and functional cerebral modifications in patients 
with musculoskeletal system chronic pain; these modifications would have a key role in the 
development and in the continuation of a state of pain which persists over time [5] [6]. The central 
nervous system can therefore be considered one of the target structures of the treatment of patients 
affected by chronical LBP, thus developing approaches such as the Action Observation Training 
(AOT) [7]. It consists in asking the patient to meet some tasks in order to recruit the same neural 
substrates involved while carrying out those tasks [8] The efficacy of this approach has been proven 
by the improvement of the motor function and the functional and structural brain plasticity [9] [10]. 
  
3 Study rational 
So far there have not been studies which investigated the effects of AOT in patients with chronic 
LBP. The AOT enables to activate specific areas of the cerebral cortex, strengthening some 
networks and facilitating the activation of the ones which have been damaged due to a neurological 
damage, pain or immobilization [7]. Functional and structural plastic modifications of the central 
neurological system are subtended to the use of AOT. This approach could therefore give positive 
results in patients with chronic LBP, pathology in which the functional and structural cerebral 
alterations have been described.   
 
4 Study outcomes 
 
4.1 General outcomes 
The outcome of the study is to determine the efficacy of the Action Observation Training in the 
treatment of chronical LBP affected patients. 
 
4.2 End-points  
4.2.1 Primary Endpoint  
The primary outcome will be to evaluate the disability through the Oswestry Disability Index (ODI-
I). This is a specific pathology questionnaire, it is self-administered and validated in Italian [11]. It 
is made of ten items about everyday activities. The scores will be interpreted as described by 

 
Fairbank [12]: 0-20% is considered minimum disability, 21-40% modest disability, 41-60% severe 
disability, 61-80% serious disability and 81-100% total disability [13]. 
 
4.2.2 Secondary Endpoint  
The secondary endpoints will consist in the evaluation of the pain, of the quality of life and of the 
fear of movement. The pain will be examined through the Numeric Rating Scale (NRS); it consists 
in a 10 cm segment numbered from 0 to 10, through which the subject will have to rate his/her 
perception of the pain (0 corresponds to “no pain”, while 10 to “maximum pain”). The quality of 
life will be evaluated through the Medical Outcomes Study Short Form 36 (SF36), while the fear of 
movement through the Tampa Scale of Kinesiophobia (TSK). 
 
5 Criteria for the recruitment of the patients 
5.1 Inclusion criteria 
- Patients with chronic aspecific LBP (documented story of more than 12 week-long symptomatology) 
- Good understanding of Italian language 
- Aged over 65 
 
5.2 Exclusion criteria 
-  Severe sight or hearing impairement  
- Cognitive deficit (objectified by a Mini Mental State Examination score ≤21 [14]). 
- Specific LBP (previous spine surgery, deformation, infection, fracture, malignant tumor, general 
disorders or neuromuscular pathologies) 
- Patients who previously underwent AOT 
 
As confirmation of the eligibility of the subjects in the study the following will be used: their 
clinical history, x-rays of the lumbar spine and in particularly uncertain cases, the computed 
tomography or the nuclear magnetic resonance. Common degenerative modifications such as the 
degeneration of the disc or the spondyloarthrosis will not be considered as exclusion criteria [15]. 
 
6 Study design 
The study is a single-blind controlled randomized clinic trial. See Enclosure A 
 
6.1 General design 
The patients will be recruited and then randomly assigned by an external collaborator (allocation 
concealment) to the experimental group or to a control group. The patients belonging to the 
experimental group will be asked to watch a video showing a person carrying out some exercises 
(12 exercises: 3 stretching exercises, 3 core stability exercises, 3 mobilization exercises and 3 
functional exercises) and later on they will be asked to repeat them. The observation of the exercise 
and its performance will last 8 minutes (4 minutes for observation and 4 minutes to repeat them). 
On the other hand, the patients belonging to the control group will be given a brochure with the 
same exercises the patients of the experimental group received through the video. They will be 
asked to read the exercise 3 times and to carry it out for 4 minutes. Both groups will have to watch 
the video or read the brochure and repeat the exercises 5 times per week for 3 weeks. They will be 

 
provided with a diary to write daily notes about the performance of the exercises (day and time of 
the performance, possible problems, etc). 
The patients will be evaluated before the treatment (T0), three weeks upon its beginning (T1) and  4 
months upon the end of it (T2). The evaluation will consist in the administration of the Oswestry 
Disability Index, of the Tampa Scale of Kinesiophobia, of the Numerical Rating Scale and of the 
Medical Outcomes Study Short Form 36. At T0 the subjects’ attention skill will be evaluated 
through the Brief Cognitive Assessment Tool [16] 
A physiotherapist will instruct the patients about the exercises to repeat while a second blinded 
physiotherapist about the group the patients belong to, will administer the evaluation scales.  
 
 
7 Statistical considerations 
7.1 Sample size 
The Oswestry Disability Index represents the primary outcome measure. The sample size has been 
calculated considering an MCID of 12.8 points among the general population with a 14 point 
standard deviation. Assuming a 80% power and a probability to refuse the null hypothesis when 
true (alpha error) of 5%, 25 patients per group will be recruited.   
 
7.2 Analysis 
The statistical analysis will be carried out upon the data collection through SPSS 20.0. software. 
The categorical variables will be described in terms of proportion, while the continuous variables in 
terms of average and standard deviation or median and interquartile range. The normal intake of the 
demographic variables and of the outcome measures will follow through the Kolmogorov-Smirnov.  
The possible post intervention inter-group and intra-group differences relative to the continuous 
outcome measures will be evaluated through the ANOVA test for repeated measurements and an 
eventual post hoc analysis will be carried out later. The threshold value of the level of significance 
will be set at 0.05.  
 
8 Study abandonment 
The patients who during or at the end of each scheduled evaluations set by the protocol will 
abandon the study will be immediately excluded from it. The patients will be informed about the 
possibility to quit the study also during the follow-up periods, after informing any experimenter. 
The acquisitions which have not been completed by the patients will be excluded from the analysis 
of the results.  
 
9 Modules and procedures for data collection and management 
All data relative to the demographical variables and the outcome measures will be entered 
anonymously in an Excel spreadsheet (Enclosure B). These data will be collected by just two 
experimenters in order to minimize eventual errors and will be filed, protected with a password.  
 
10 Ethical considerations 
10.1 Patients protection 
The study coordinators ensure that the present work will be led following the principles complying 
with the Declaration of Helsinki (Enclosure C) and according to the laws and the rules of the 
country in order to grant the maximum protection of the subjects of the study. Upon the description 
of the protocol the study will be led according to the Guidelines (ICH) for the Good Clinical 

 
Practice. The protocol and its enclosures will be subject to revision and approval by the relevant 
Independent Ethical Committee (ICE). 
 
10.2 Subject identification – Personal data confidentiality 
All data relative to the evaluations along with all the information about each subject will be subject 
to maximum privacy and in compliance with the standards of the current laws. The privacy will be 
therefore safeguarded and no information will be disclosed. Patients will not be asked their name 
and surname; they will be identified with an ID code as indicated in the Enclosure B. The patients 
will be asked about their date of birth, sex, weight and height. Only the people actively part of the 
study will be allowed to access the database. Every subject will be informed about the protection of 
their personal data by a suitable form (Enclosure D) and they will also be required to sign an 
informed consent without which he will not be able to be involved in the study. 
 
10.3 Informed consent 
All subjects will receive information regarding the study, the performance and the relevant outcome 
of the study. They will also be informed about the strict confidentiality their data will be treated.  It 
is underlined that the participation is voluntary and that the subject will be allowed to quit the study 
at any time. The informed consent will be filled by each subject and only when it has been collected 
the relevant data will be entered in the collection sheet (Enclosure E). 
 
11 Conflict of interest 
All the members of the study declare they have no conflict of interest. 
 
12 Data ownership 
In compliance with the Guidelines (ICH) for the Good clinical practice and considering that this is a 
single center study the owner of the data is Humanitas Clinical Institute. 
 
13 Publication policy 
Upon the study completion, the coordinator will issue a manuscript with the final results of the 
study according to the statistical analysis. This manuscript, upon revision, will be sent to a proper 
science journal. All the publications, the abstracts, the presentations, the manuscripts and slides, 
along with the data of the present study will be submitted to revision by the coordinator of the 
study. 
 
14 Timing of the study  
 
1. Patients recruitment: May 2019  
2. Data analysis: July 2020 
3. Report submission: September 2020 
  

 
15 Study scheme 
See Enclosure A. 
 
16 References 
 
1- Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back 
pain. Arthritis Rheum 2012;64(6):2028-2037 
 
2- La Touche R, Grande-Alonso M et al. Diminished Kinesthetic and Visual Motor Imagery 
Ability in adults with Chronic Low Back Pain. PM R 2018; 1482(18): 30311-3 
 
3- Rossignol M, Rozenberg S, Leclerc A. Epidemiology of low back pain: What’s new?. Joint 
Bone Spine 2009;76(6):608-613 
 
4- Daffada PJ, Walsh N, McCabe CS, Palmer S. The impact of cortical remapping 
interventions on pain and disability in chronic low back pain: a systematic review. 
Physiotherapy 2015; 101(1):25-33 
 
5- Apkarian AV, Baliki MN, Geha PY. Towards a theory of chronic pain. Progress in 
Neurobiology 2009;87(2):81-97 
 
6- Tracey I, Bushnell MC. How neuroimaging studies have challenged us to rethink: is chronic 
pain a disease?. The Journal of Pain 2009;10(11):1113-20 
 
7- Wand BM1, Parkitny L et al. Cortical changes in chronic low back pain: current state of the 
art and implications for clinical practice. Manual therapy 2011;16(1):15-20 
 
8- Buccino G. Action observation treatment: a novel tool in neurorehabilitation. Philos Trans R 
Soc Lond B Biol Sci 2014;369(1644): 20130185 
 
9- Rocca MA, Meani A, Fumagalli S, Pagani E, Gatti R, Martinelli-Boneschi F, Esposito F, 
Preziosa P, Cordani C, Comi G, Filippi M. Functional and structural plasticity following 
action observation training in multiple sclerosis. Mult Scler 2018; 7:1352458518792771 
 
10- Sarasso E, Gemma M, Agosta F, Filippi M, Gatti R. Action observation training to improve 
motor function recovery: a systematic review. Archives of physiotherapy 2015; 5:14 
 
11- Monticone M, Baiardi P, Ferrari S, Foti C, Mugnai R, Pillastrini P, Vanti C, Zanoli G. 
Development of the Italian version of the Oswestry Disability Index (ODI-I): A cross-
cultural adaptation, reliability, and validity study. Spine 2009; 34(19):2090-2095 
 
12- Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine 2000; 25(22):2940-2952 
 
13- Il Fisioterapista 2-2014 
 
14- Spencer RJ, Wendell CR, Giggey PP. Psychometric limitations of the mini-mental state 
examination among nondemented older adults: an evaluation of neurocognitive and 
magnetic resonance imaging correlates. Exp Aging Res. 2013; 39(4):382-397 

 
 
15- Monticone M, Ferrante S, Rocca B, Baiardi P, Farra FD, Foti C. Effect of a Long-lasting 
Multidisciplinary Program on Disability and Fear-Avoidance Behaviors in patients with 
chronic Low Back Pain. The Clinical Journal of Pain 2013; 29(11):929-938 
 
16- Rehabilitation Measures Database 
***  ***   *** 
 
List of enclosed documents 
Enclosure A_ Study Scheme  
Enclosure B_ Data Collection sheet 
Enclosure C_ Declaration of Helsinki 
Enclosure D_ Informed consent 
Enclosure E_ Privacy Informative 
Enclosure F_ Devices EEC mark  
Enclosure G_ Devices technical sheet 
Enclosure H_ Roberto Gatti CV 
Enclosure I_ Guido Grappiolo CV