Changes of Pain and Functional Parameters in Back Pain Patients With or Without Radiculopathy Over Time
Conditions: Changes Over Time in Pain and Functional Parameters
Sponsor: University of Applied Sciences and Arts of Southern Switzerland

s w i s s e t h i c s  
Swiss Ethics Committees for Research on Human Subjects 
Commissions d'éthique suisses relative à la recherche sur l'être humain 
Commissioni etiche svizzere per la ricerca sull'essere umano 
Swiss Ethics Committees on research involving humans 
 
Project plan template 
Human research other than clinical trials 
 
v2.1, 07.10.17 
 
Change in pain and functional parameters in back patients with or without 
radiculopathy. 
 
 
Research legislation: 
 Ordinance on human research with the exception of Clinical trials 
(HRO) [1]. 
 
 
Type of Research Project: 
Research project involving human subjects  
 
 
Risk Categorisation:  
Risk Category A Acc. to ordinance HRO Art.7 
 
 
Project Leader: 
 
PD Dr. med. Christian Zweifel 
Department of Surgery 
Neurosurgery 
Loëstrasse 170 
CH-7000 Chur 
Phone: 081 256 62 33 
Email: christian.zweifel@ksgr.ch 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To ensure readability, only the male version is chosen throughout the document as a substitute 
for men and women. 
 
Originally in German, translated into English 

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TABLE OF CONTENTS 
TABLE OF CONTENTS 
3 
GLOSSARY OF ABBREVATIONS 
4 
1 BACKGROUND AND PROJECT RATIONALE 
5 
2 PROJECT OBJECTIVES AND DESIGN 
5 
2.1 Hypothesis and primary objective  
5 
2.2 Primary and secondary endpoints 
7 
2.3 Project design 
9 
3 PROJECT POPULATION AND STUDY PROCEDURES 
9 
3.1 Project population, inclusion and exclusion criteria 
9 
3.2 Recruitment, screening and informed consent procedure 
10 
3.3 Study procedures 
10 
3.4 Withdrawal and discontinuation 
12 
4 STATISTICS AND METHODOLOGY 
12 
4.1. Statistical analysis plan 
12 
4.2. Handling of missing data 
12 
5 REGULATORY ASPECTS AND SAFETY 
14 
5.1 Local regulations / Declaration of Helsinki 
14 
5.2 Notification of safety and protective measures (HRO Art. 20) 
14 
5.3 Serious events (HRO Art. 21) 
14 
5.4 Radiation 
14 
5.5 Amendments 
14 
5.6 End of project 
15 
5.7 Insurance 
15 
6 FURTHER ASPECTS 
15 
6.1 Overall ethical considerations 
15 
6.2 Risk-Benefit Assessment 
15 
6.3 If applicable: Rationale for the inclusion of vulnerable participants 
15 
7 QUALITY CONTROL AND DATA PROTECTION 
15 
7.1 Quality measures 
15 
7.2 Data recording and source data 
16 
7.3 Confidentiality and coding 
16 
7.4 Retention and destruction of study data and biological material 
16 
8  FUNDING / PUBLICATION / DECLARATION OF INTEREST 
16 
9 REFERENCES 
17 
 
 
 

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GLOSSARY OF ABBREVATIONS 
 
BASEC 
Business Administration System for Ethical Committees 
CRF 
Case report form 
FOPH 
Federal Office of Public Health 
HRA 
Humane Research Act 
HRO  
Ordinance on Human 
 
 
 

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1 
BACKGROUND AND PROJECT RATIONALE  
The spectrum of symptoms from which back patients suffer is wide-ranging. Symptoms can be 
constant or intermittent, are partly movement- and exertion-dependent, and include pain, sensory 
disturbances, mobility restrictions, and loss of strength (Huang and Sengupta 2014). Based on 
the duration of the symptoms, back pain is classified as chronic, sub-acute or acute. Furthermore, 
a subdivision can be divided into specific back complaints, with a recognizable anatomical or 
physiological cause, or non-specific back complaints, with no recognizable anatomical or 
physiological cause (Eckardt 2012, Ehrlich and Khaltaev 1999). Possible specific back problems 
are a herniated disc or narrowing of the spinal canal. In this case, one or more spinal nerves can 
be threatened/pinched, causing the patient to suffer from radiating symptoms in the supply area 
of the affected nerve. These radiculopathy symptoms vary in severity and duration and can in 
turn be dependent on movement and exertion. The longer and more intensively the spinal nerve 
is compressed, the more pronounced the symptoms manifest themselves and the longer it takes 
for the regeneration of the nerve tissue and the associated reduction of symptoms. The sensory 
disturbances in the supply area can develop to numbness, the reduction in strength to complete 
paralysis of the corresponding characteristic muscles.  
 
The symptoms of pain, sensory disturbances and loss of strength limit the patient's ADL functions 
and ability to work (Hartvigsen et al. 2017). Therefore, rapid recovery and restoration of function 
is also important from a socio-economic point of view. The method of choice for non-acutely 
threatening findings is physiotherapeutic treatment. Physiotherapy is prescribed by doctors in 
Switzerland. The medical clinical diagnosis and findings include an anamnesis, imaging 
procedures (Bertilson et al. 2010), a functional examination of the sensory system (sensitivity 
test) (Tschugg et al. 2017, Iversen et al. 2013), motor skills (force measurement) (Rainville et al. 
2003) and nerve mobility (Tawa, Rhoda and Diener 2017). If necessary, the clinical diagnosis of 
nerve root compression is confirmed or excluded with imaging techniques. In the case of acutely 
threatening symptoms, such as cauda equina syndrome, surgical decompression of the affected 
nerve is often carried out, followed by physiotherapeutic follow-up treatment.  
 
For the rehabilitation process, therapy planning and protection vis-à-vis health insurers, proof of 
efficient and goal-oriented physiotherapeutic therapy through appropriate assessments is 
indispensable. Although physiotherapeutic (follow-up) treatment for back patients is successful, 
some of the assessments and treatment methods are insufficiently validated and standardised. 
 
The aim of this prospective observational study is to objectify and validate the pain and functional 
parameters motor and sensory function. In addition, we would like to record these over time in 
order to evaluate possible connections with physical impairment and physiotherapeutic 
objectives.  
From the point of view of evidence-based practice, the inventory of the relationships between pain 
and objective functional parameters is intended to substantiate and optimize physiotherapeutic 
(after) treatment. 
 
 
 
2 
PROJECT OBJECTIVES AND DESIGN  
2.1 Hypothesis and primary objective  
The following working and null hypotheses are to be statistically proven or discarded. 
Pain Drawing (VAS) 

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H0 There is no correlation between pain and physical impairment and health-related quality 
of life. 
H1 There is a correlation between pain and physical impairment and health-related quality 
of life. 
H0 There is no correlation between pain and activity diary. 
H1 There is a correlation between pain and activity diary. 
H0 There is no correlation between pain and strength and muscle fiber alignment. 
H1 There is a correlation between pain and strength and muscle fiber alignment. 
H0 There is no correlation between pain and trunk mobility and trunk fluctuations. 
H1 There is a correlation between pain and trunk mobility and trunk fluctuations. 
H0 There is no correlation between pain and sensory activity. 
H1 There is a correlation between pain and sensory activity. 
 
Physical impairment, health-related quality of life (ODQ, SF-36) 
H0 There is no correlation between physical impairment, health-related quality of life and 
activity diary. 
H1 There is a correlation between physical impairment, health-related quality of life and 
activity diary. 
H0 There is no correlation between physical impairment, health-related quality of life and 
strength. 
H1 There is a correlation between physical impairment, health-related quality of life and 
strength. 
H0 There is no correlation between physical impairment, health-related quality of life and 
trunk mobility and trunk fluctuations. 
H1 There is a correlation between physical impairment, health-related quality of life and 
trunk mobility and trunk fluctuations. 
H0 There is no correlation between physical impairment, health-related quality of life and 
sensory perception. 
H1 There is a correlation between physical impairment, health-related quality of life and 
sensory perception. 
H0 There is no correlation between physical impairment and thickness of the subcutaneous 
fat layer and muscle fiber alignment. 
H1 There is a correlation between physical impairment and thickness of the subcutaneous 
fat layer and muscle fiber alignment. 
 
Strength (isometric force measurement of the affected characteristic muscles) 
H0 There is no correlation between isometric force and trunk mobility and trunk fluctuations. 
H1 There is a correlation between isometric force and trunk mobility and trunk fluctuations. 
H0 There is no correlation between isometric force and sensing. 
H1 There is a correlation between isometric force and sensing. 
H0 There is no correlation between isometric force and thickness of the subcutaneous fat 
layer and muscle fiber alignment. 
H1 There is a correlation between isometric force and thickness of the subcutaneous fat 
layer and muscle fiber alignment. 
H0 There is no correlation between isometric strength and physiotherapeutic objective. 
H1 There is a correlation between isometric strength and physiotherapeutic objectives. 
H0 There is no correlation between isometric strength and physical impairment and health-
related quality of life. 
H1 There is a correlation between isometric strength and physical impairment and health-
related quality of life. 
 
Trunk mobility and trunk fluctuations 
H0 There is no correlation between trunk mobility and trunk fluctuations 
 and sensor technology. 

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H1 There is a correlation between trunk mobility and trunk fluctuations and sensor 
technology. 
H0 There is no correlation between trunk mobility and trunk fluctuations and 
physiotherapeutic objectives. 
H1 There is a correlation between trunk mobility and trunk fluctuations and 
physiotherapeutic objectives. 
H0 There is no correlation between trunk mobility and trunk fluctuations 
and thickness of the subcutaneous fat layer and muscle fiber alignment. 
H1 There is a correlation between trunk mobility and trunk fluctuations and thickness of the 
subcutaneous fat layer and muscle fiber alignment. 
2.2 Primary and secondary endpoints 
The primary objective of this observational study is to objectify the subjective parameters 
indicated by the patient (pain, physical impairment, health-related quality of life, activity diary) and 
the objective parameters measured by the investigator (strength, trunk mobility and trunk 
fluctuations, sensory, neurodynamics, thickness of the subcutaneous fat layer, muscle fiber 
alignment and physiotherapeutic objectives). 
The secondary objective includes the evaluation of possible relationships between the subjective 
and objective parameters. 
 
Subjective parameters and their objectification: 
- 
health-related quality of life 
The health-related quality of life prevailing at the time of measurement is assessed using 
the German version of the SF-36. The patient fills out the questionnaire independently 
during the measurement appointment, without being influenced. The examiner adds up 
the total score achieved and transfers the value to the patient's data sheet.  
 
Objectification of health-related quality of life: 
SF-36 Questionnaire, German Version 
 
- 
Physical impairment 
The physical impairment prevalent at the time of measurement is assessed using the 
German version of the Oswestry Disability Questionnaire (ODQ). The patient fills out the 
questionnaire independently during the measurement appointment, without being 
influenced. The examiner adds up the total score achieved and transfers the value to the 
patient's data sheet.  
 
Objectification of physical impairment: 
Oswestry Disability Questionnaire, German version 
 
- 
Pain  
The pain radiation and the intensity of pain are subjectively assessed by the patient. For 
this purpose, he is given a sheet with a body chart (pain drawing). With 3 different colors 
(red = pain, yellow = paresthesia, green = numbness), the patient draws the current 
sensations at this measurement time. In addition, the patient is surveyed using the visual 
analogue scale (VAS 0 (no complaints) – 10 (maximum complaints)) to record the intensity 
of the complaints. 
 
Objectification of radiation area: 
The pain drawings are scanned and evaluated with the MATLAB software 
(www.ch.mathworks.com). Here, the radiation area is quantified as a percentage of the 
total body surface. 
 
Objectification intensity: 

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VAS - Scale 
 
- 
Activity diary 
In order to record the patient's daily activities during the duration of the study, the patient 
will be asked to document their activities in the activity diary on a daily basis. The activity 
diary is given to the patient and instructed by the study management.  
 
Objectification of everyday activities: 
Activity diary 
 
Objective parameters and their objectification: 
- 
Force 
The maximum isometric force and the force development of the muscles supplied by the 
affected spinal nerve are tested in a standardized starting position. For this purpose, a 
dynamometer held by hand by the tester is used. The patient is asked to press against 
the examiner's hand as hard and as long as possible. In addition, a superficial 
electromyography is performed, in which the electrodes are glued to the points provided 
for this purpose on the skin. To ensure that the test situation remains isometric, the 
examiner applies exactly as much force as the patient is willing to deploy. The test is 
carried out 3 times in a row with a 30-second break. The values are transferred to the data 
sheet. The measurements take place on both sides, starting with the subjectively weaker 
side. 
 
Objectification power: 
The hand-held dynamometer (NOD, www.to-nod.com) graphically and numerically 
records the strength and duration of the isometric power delivery. Superficial 
electromyography is performed with the PLUX EMG device (www.biosignalsplux.com) 
and evaluated with the associated software. 
 
- 
Trunk mobility and trunk fluctuations 
Mobility 
The maximum mobility of the spine is measured during forward bending (flexion), leaning 
backwards (extension) and tilting sideways to the left and right (lateral flexion) using the 
Sway StarÔ system. The inspector makes sure that the pelvis remains fixed. 
 
Trunk swaying during 30 s - one-leg stand 
In order to record the ability to balance and the corresponding trunk reactions, the patient 
tries to stand as still as possible on one leg barefoot for 30 seconds. In this case, the 
patient stands to the side of the treatment table so that he or she can hold himself with his 
hand. The examiner stands behind the patient during testing. The fluctuations that occur 
during the balance test are measured using the Sway StarÔ system. The measurements 
take place on both sides, starting with the subjectively weaker side. 
 
 
Hull Swaying during 8 m – Walking 
In order to measure the trunk movements during walking, the patient walks at a pace of 8 
m. The trunk movements are recorded using the Sway StarÔ system. 
 
Objectification: 
The fluctuations of the hull are recorded and evaluated with the Sway StarÔ System 
(www.b2i.info). The Sway StarÔ is a measuring instrument that contains gyroscopes. It is 
attached to a belt that is placed around the patient's waist. The data is evaluated with the 
associated Sway Star Ôsoftware and transferred to the data sheet. 
 
- 
Sensors 

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The sensory system of the affected area (segmentally associated dermatome) is tested 
directly on the skin in the radiation area. The results are transferred to the data sheet. The 
pain threshold is raised on a Valleix point along the iliac crest. Measurements are always 
taken at the same measuring points, on the affected side. 
 
Objectification of sensor technology: 
The pressure sensation is recorded by means of a monofilament, the 2-point 
discrimination with the Greulich star, the sense of vibration with the tuning fork (according 
to Rydel-Seiffer), the muscle reflex with the reflex hammer in a left/right comparison 
including acceleration measurement (accelerometer MSR165, www.msr.ch) and the pain 
threshold with the algometer (NOD, www.to-nod.com). 
 
- 
Neurodynamics 
The neurodynamics of the affected spinal nerve are tested using the appropriate pain 
provocation test. For this purpose, a hydrogoniometer is required, with which the exact 
number of degrees at which the symptoms are triggered is measured. The number of 
degrees is transferred to the data sheet. The tests are carried out in a standardised 
manner. If the spinal nerve L2/L3 is affected, the crossed Lasègue test is performed, and 
for L4/L5/S1 the Lasègue test.  
 
Objectification of neurodynamics: 
Hydrogoniometer 
 
- 
Subcutaneous fat tissue and muscle fiber alignment 
The thickness of the subcutaneous fatty tissue is measured on the rectus femoris muscle, 
10 cm above the patellar base, and on the medial gastrocnemius muscle at the level of 
the largest calf circumference, in both legs.  
 
Objectification Thickness Subcutaneous Fat Tissue and Muscle Fiber Alignment: 
The portable ultrasound device from Telemed (www.pcultrasound.com) is used for this 
purpose. The images are evaluated with the Osirix (www.osirix-viewer.com) software and 
the number of millimetres, fat thickness and muscle fibre degree angle are transferred to 
the data sheet. 
2.3 Project design  
The study is a prospective observational study. There is no intervention. No influence is exerted 
on the normal physiotherapeutic and medical treatment of patients. At the Graubünden Cantonal 
Hospital in Chur, repeated measurements are being carried out. Therefore, a single-center study 
is available here. 
3 
PROJECT POPULATION AND STUDY PROCEDURES 
3.1 Project population, inclusion and exclusion criteria  
Participants will be recruited by PD Dr. med. Christian Zweifel. The study will include people who 
suffer from back pain, with or without radiculopathy, and who present themselves to the 
neurosurgery department at the Graubünden Cantonal Hospital in Chur. Included are those 
patients who speak and write German, who will go to physiotherapy treatment because of their 
back problems and are willing to record their daily activities and intake of pain medication in a 
diary at home. Excluded are patients who do not suffer from back pain, with or without 
radiculopathy, or who do not attend physiotherapy treatment due to their back problems, or who 
are not willing to keep an activity diary with a log of painkiller intake at home.  
 

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The German language must be understood orally and in writing in order to understand the patient 
information and sign the informed consent form. Patients will be definitively included if they meet 
the inclusion criteria and have signed the informed consent form for participation in the study. 
 
Inclusion and exclusion criteria are summarized in the table below. All inclusion criteria must be 
met in order to participate in the study. In the case of the exclusion criteria, one unfulfilled point 
is sufficient to be excluded. 
 
Overview of inclusion and exclusion criteria 
Inclusion Criteria  
Exclusion criteria 
- 
Back problems with / without 
radiculopathy 
- 
Understanding of German orally and 
in writing 
- 
Physiotherapeutic treatment for back 
pain 
- 
Willingness to keep an activity diary, 
including a protocol for taking 
painkillers 
- 
No back problems with / without 
radiculopathy 
- 
No understanding of German orally or 
in writing 
- 
No physiotherapy treatment due to 
back pain 
- 
No willingness to keep an activity 
diary and/or log of painkiller intake 
 
3.2 Recruitment, screening and informed consent procedure 
After approval of the study protocol by the Cantonal Ethics Committee Zurich, the recruitment of 
suitable subjects is to begin from October 2018 to December 2020. The data collection will take 
place continuously from October 2018 until June 2021 (see Chapter 3.3).  
When the patient with back problems, with or without radiculopathy, is presented to the 
neurosurgery department at the Graubünden Cantonal Hospital in Chur, he or she is informed 
that the study is taking place. Both conservative and surgical patients are included. If the patient 
wants to participate in the study, he or she will be given the written study information, which he 
or she should read through at his leisure. If you have any questions, you can contact the director 
of studies at any time. Once all questions have been clarified and the patient is willing to 
participate in the study, he or she signs the study information and the declaration of consent. 
Once the signed study information and signed declaration of consent have been submitted by the 
study management, the health questionnaire is filled out together with the patient, which checks 
the inclusion and exclusion criteria. If the patient meets the inclusion criteria, the measurement 
points are planned by the examiner.  
3.3 Study procedures 
After oral study information by PD Dr. med. Christian Zweifel, after signing the written study 
information and declaration of consent and clarifying the inclusion and exclusion criteria (health 
questionnaire), the measurement points are planned. A total of 6 measurement points are 
determined. The first 5 appointments take place once a month, followed by a 3-month 
measurement-free period, after which the last and 6th measurement takes place. In the event of 
complications or worsening symptoms, the head of the study, who is also the attending physician, 
is informed immediately.  
 
If a conservatively treated patient needs surgery during the study (e.g. due to a worsening of his 
symptoms), the preoperative data set will be recorded and a new postoperative data set will be 
opened, provided that the patient wishes to continue participating and/or is not excluded by the 
study management. The study includes conservatively treated (physiotherapy) and surgically 
treated patients equally.  
 

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If imaging techniques are used in the context of medical diagnosis, these images are included in 
the data collection and taken into account as far as possible in the interpretation of the data. 
 
Overview of the procedure for recruiting subjects (by PD Dr. med. Christian Zweifel) 
Expiration 
Screening 
Overhead 
- 
Medical diagnosis / clarification 
- 
Oral study information 
Medical history, findings, 
diagnostic imaging 
10 min 
- 
Return of the signed study information 
and declaration of consent 
Examination of inclusion 
and exclusion criteria 
10 min 
- 
Filling out the health questionnaire 
Examination of inclusion 
and exclusion criteria 
5 min 
 
Planning of measurement dates 
 
During the first measurement, the test person is instructed and given to keep the activity diary 
with a protocol for taking painkillers. 
 
Overview of the measurement process 
Expiration 
Data collection 
Instrument 
Time exposure 
- 
Questionnaire 
subjective health-related 
quality of life 
SF-36 
Questionnaire 
5 min 
- 
Questionnaire 
subjective physical 
impairment 
ODQ 
Questionnaire 
5 min 
- 
Pain Evaluation 
subjective pain radiation 
and intensity 
VAS 
Pain Drawings 
5 min 
- 
Demography 
Height, body weight, 
body fat percentage 
Stadiometer, 
Tanita – Scale 
5 min 
- 
Ultrasound 
measurement of the 
rectus femoris and 
gastrocnemius 
medialis muscles 
Thickness of 
subcutaneous fatty 
tissue, alignment of 
muscle fibers, bilateral 
Portable 
Ultrasound 
Machine 
(TeleMed) 
10 min 
- 
Trunk mobility 
Mobility of the spine in 
flexion, extension, lateral 
flexion 
Sway StarÔ 
2 min 
- 
Hull swaying 
Torso movements during 
30 s – one-leg stand, 
both sides 
Sway StarÔ 
2 min 
- 
Hull swaying 
Trunk Movement during 
8m - Walking 
Sway StarÔ 
5 min 
- 
Neurodynamics 
Pain provocation test, 
bilateral 
Hydrogoniometer 
2 min 
- 
Evaluation of the 
sensor technology 
Sensation of pressure, 
2-point discrimination, 
sense of vibration, 
muscle reflex, pain 
threshold 
bilateral 
Monofilament, 
Greulich 
Star, 
Neurological 
Tuning 
Fork, 
Reflex 
Hammer, 
Accelerometer, 
NOD Algometer 
10 min 
- 
Force measurement 
maximum isometric 
force, force 
development, bilateral 
NOD – isometric 
load cell, surface 
electromyography 
5 min 
The maximum time required per measurement appointment is one hour. With 6 measurement 
points, the time required adds up to 6 hours and extends over 8 months. 

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In addition, the patient keeps an activity diary at home and logs the painkiller intake, which takes 
about 5 minutes a day. 
 
The treating physiotherapist records the content of all therapy sessions. The protocol to be used 
for this purpose is explained and instructed to the physiotherapist by the investigators at the 
beginning of the study. The documentation of physiotherapeutic treatment is one of the duties of 
a physiotherapist, so there is no additional effort for him. All he has to do is use the protocol 
template. Furthermore, the treating physiotherapists are asked to continue their usual 
interventions and treatments regardless of the study participation of their patients. 
 
The following biases could occur: 
- 
Sociodemographic and personal characteristics of the subjects: men/women, age 
- 
Duration of back pain 
- 
Truthful keeping of the activity diary and painkiller intake log 
- 
physiotherapeutic treatment 
 
By the time a patient presents to the neurosurgery department, the back pain has already reached 
a high degree of severity. The duration and intensity of symptoms vary and should be stratified in 
evaluation. The measurement times should be strictly adhered to in order to ensure comparability 
in time between the test subjects. 
 
The study ends in the 8th month after the start of the study after the 6th and last measurement. 
 
3.4 Withdrawal and discontinuation 
Participants will be excluded from the study if they do not (or cannot or do not want to) fulfill their 
obligations that entail participation in the study, or if they wish to voluntarily withdraw from 
participating in the study. Data that has already been collected is included in the data analysis as 
far as possible. If a conservatively treated patient needs surgery during the study (e.g. due to a 
worsening of his symptoms), the preoperative data set will be recorded and a new postoperative 
data set will be opened, provided that the patient wishes to continue participating and/or is not 
excluded by the study management. 
4 
STATISTICS AND METHODOLOGY 
4.1. Statistical analysis plan 
The required number of subjects was determined a priori with G*Power (version 3.1.9.2; Franz 
Faul University of Kiel, Germany). The following design specifications were used: statistical test 
= Correlation Type of Power Analysis 'Computer required sample size – given a, power and effect 
size'; tails = two; effect size = 0.5; a = 0.05; power = 0.95. The target number of subjects was n 
= 42 based on these design specifications. The SPSS version 24 software is used for statistical 
data analysis (IBM, Armonk, NY, USA).  
 
The data are first checked for normal distribution with the 'Shapiro-Wilk test'. The normally 
distributed data are analysed by means of parameteric test procedures. Non-normally distributed 
data as well as non-metric data are checked with non-parametric tests. The correlations are 
recorded using the 'Pearson Correlation tests' and 'Spearman Correlation tests'. 
 
Correlations between the subjective parameters (pain, physical impairment, activity diary), 
between the objective parameters (strength, balance, sensory, neurodynamics, muscle thickness 

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and physiotherapeutic objectives), as well as between the subjective and objective parameters 
are of interest and should be calculated. 
 
The following working (H1) and null hypotheses (H0) are statistically proven or rejected: 
 
Pain Drawing (VAS) 
H0 There is no correlation between pain and physical impairment and health-related quality 
of life. 
H1 There is a correlation between pain and physical impairment and health-related quality 
of life. 
H0 There is no correlation between pain and activity diary. 
H1 There is a correlation between pain and activity diary. 
H0 There is no correlation between pain and strength and muscle fiber alignment. 
H1 There is a correlation between pain and strength and muscle fiber alignment. 
H0 There is no correlation between pain and trunk mobility and trunk fluctuations. 
H1 There is a correlation between pain and trunk mobility and trunk fluctuations. 
H0 There is no correlation between pain and sensory activity. 
H1 There is a correlation between pain and sensory activity. 
 
Physical impairment (ODQ), health-related quality of life (SF-36) 
H0 There is no correlation between physical impairment, health-related quality of life and the 
activity diary. 
H1 There is a correlation between physical impairment, health-related quality of life and the 
activity diary. 
H0 There is no correlation between physical impairment, health-related quality of life and 
strength. 
H1 There is a correlation between physical impairment, health-related quality of life and 
strength. 
H0 There is no correlation between physical impairment, health-related quality of life and 
trunk mobility and trunk fluctuations. 
H1 There is a correlation between physical impairment, health-related quality of life and 
trunk mobility and trunk fluctuations. 
H0 There is no correlation between physical impairment, health-related quality of life and 
sensory perception. 
H1 There is a correlation between physical impairment, health-related quality of life and 
sensory perception. 
H0 There is no correlation between physical impairment, health-related quality of life, and 
subcutaneous fat layer thickness and muscle fiber alignment. 
H1 There is a correlation between physical impairment, health-related quality of life and 
thickness of the subcutaneous fat layer and muscle fiber alignment. 
 
Force (isometric force measurements) 
H0 There is no correlation between isometric force and trunk mobility and trunk fluctuations. 
H1 There is a correlation between isometric force and trunk mobility and trunk fluctuations. 
H0 There is no correlation between isometric force and sensing. 
H1 There is a correlation between isometric force and sensing. 
H0 There is no correlation between isometric force and thickness of the subcutaneous fat 
layer and muscle fiber alignment. 
H1 There is a correlation between isometric force and thickness of the subcutaneous fat 
layer and muscle fiber alignment. 
H0 There is no correlation between isometric strength and physiotherapeutic objective. 
H1 There is a correlation between isometric strength and physiotherapeutic objectives. 
 
Trunk mobility and trunk fluctuations (SwayStar Ômeasurements) 
H0 There is no correlation between trunk mobility, trunk fluctuations and sensor technology. 

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H1 There is a correlation between trunk mobility, trunk fluctuations and sensor technology. 
H0 There is no correlation between trunk mobility, trunk fluctuations and physiotherapeutic 
objectives. 
H1 There is a correlation between trunk mobility, trunk fluctuations and physiotherapeutic 
objectives. 
H0 There is no correlation between trunk mobility, trunk fluctuations and thickness of the 
subcutaneous fat layer and muscle fiber alignment. 
H1 There is a correlation between trunk mobility, trunk fluctuations and thickness of the 
subcutaneous fat layer and muscle fiber alignment. 
 
4.2. Handling of missing data  
Since statistical values of the individual relationships are determined, the data is also included if 
a test subject does not participate in all measurement points and/or measurements. Incomplete 
data from individual assessments (aborted tests) are not included in the final data analysis, but 
are recorded and stored. 
5 
REGULATORY ASPECTS AND SAFETY 
5.1 Local regulations / Declaration of Helsinki 
This research project will be conducted in accordance with the protocol, the Declaration of 
Helsinki [3], the principles of Good Clinical Practice, the Human Research Act (HRA) and the 
Human Research Ordinance (HRO) [1] as well as other locally relevant regulations. The Project 
Leader acknowledges his responsibilities as project leader and the sponsor as sponsor.  
5.2 Notification of safety and protective measures (HRO Art. 20) 
The project leader and the sponsor are promptly notified (within 24 hours) if immediate safety and 
protective measures have to be taken during the conduct of the research project. The Ethics 
Committee will be notified via BASEC of these measures and of the circumstances necessitating 
them within 7 days. 
5.3 Serious events (HRO Art. 21) 
If a serious event occurs, the research project will be interrupted, and the Ethics Committee 
notified on the circumstances via BASEC within 7 days according to HRO Art. 211. 
5.4 Radiation 
In addition to the standard imaging techniques used to make a diagnosis, no additional radioactive 
methods will be used in the study. 
5.5 Amendments 
Substantial changes to the project set-up, the protocol and relevant project documents will be 
submitted to the Ethics Committee for approval according to HRO Art. 18 before implementation. 
Exceptions are measures that have to be taken immediately in order to protect the participants.  
 
1 A serious event is defined as any adverse event where it cannot be excluded, that the event is attributable to the 
sampling of biological material or the collection of health-related personal data, and which:a. requires inpatient 
treatment not envisaged in the protocol or extends a current hospital stay; 
b. results in permanent or significant incapacity or disability; or 
c. is life-threatening or results in death. 

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5.6 End of project 
If the project is completed, the ethics committee will be informed within 90 days. After completion 
of the project, the encrypted data will be stored for another ten years at the Graubünden Cantonal 
Hospital in Chur, Department of Surgery, Neurosurgery. Only encrypted data will be used for the 
study and all persons involved will be subject to confidentiality, even after the end of the project. 
5.7 Insurance 
If damage is suffered as a result of the study project, the liability insurance of the Cantonal 
Hospital of the Grisons in Chur is liable, in the case of actions by PD Dr. Christian Zweifel, who 
is an employee of the Cantonal Hospital of the Grisons in Chur. His actions in this study are 
carried out during his regular working hours and include standard procedures as part of his 
medical activity. If a patient experiences damage during actions by the examiner, the insurance 
company of "Thim van der Laan AG", the employer of the examiner, is liable. This applies as long 
as the damage suffered is not based on disregard or neglect of the requirements. The 
requirements and the procedure are regulated by law. If damage is suffered, the head of the study 
(PD Dr. med. Christian Zweifel). 
6 
FURTHER ASPECTS 
6.1 Overall ethical considerations 
The additional effort for the participants is a total of six hours. This involves travel expenses or 
the like, as the measurements take place at the Graubünden Cantonal Hospital in Chur. 
Therefore, participants will be compensated with CHF 20 per measurement time. 
The generalizability of the resulting results is limited and limited to back patients with or without 
radiculopathies. Participants have the right to information at any time and, if desired, will also be 
informed about the results and their significance for people with radiculopathy (verbally or in 
writing). The test subjects are not exposed to any additional risks, all measurement methods used 
here are used in physiotherapy or as part of the medical examination.  
6.2 Risk-Benefit Assessment  
Participation is not associated with any benefit and no disadvantage for the test subjects. Thanks 
to participation in the study, the results can benefit other people suffering from back pain with or 
without radiculopathy in the future, as possible connections between objective and subjective 
parameters become recognizable. It is hoped that this will further increase treatment and 
understanding for back patients. There are no risks for the participants. There is only the 
possibility that an increase in pain occurs for a short time after the measurements, due to the pain 
provocation test. 
6.3 Rationale for the inclusion of vulnerable participants  
No vulnerable people are examined. 
7 
QUALITY CONTROL AND DATA PROTECTION 
7.1 Quality measures  
The measurements and surveys are carried out exclusively by trained personnel. The examiners 
who carry out the measurements and interviews are trained physiotherapists with experience in 
dealing with back patients. Patient recruitment is carried out by the head of the study, PD Dr. 
med. Christian Zweifel will take place. 

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For quality assurance, the Ethics Committee may visit the research sites. Direct access to the 
source data and all project related files and documents must be granted on such occasions. 
7.2 Data recording and source data 
Data protection and confidentiality are guaranteed and no personal data is presented or 
published. The signed study information, informed consent, completed questionnaires, data 
sheets and all documents containing personal data are stored in a locked cabinet. Only the head 
of studies has access to the key. The encryption of the identity of the test persons is not digitally 
recorded. The encrypted data is transferred to Excel and digitized, printed out with the test subject 
and version number so that no falsification is possible. At the time of evaluation, the data is 
transferred by the auditors to the SPSS, where the correlations are calculated. 
7.3 Confidentiality and coding 
Project data will be handled with uttermost discretion and is only accessible to authorized 
personnel who require the data to fulfil their duties within the scope of the research project. On 
the CRFs and other project specific documents, participants are only identified by a unique 
participant number.  
7.4 Retention and destruction of study data and biological material 
After completion of the project, the data will be stored for another ten years at the Graubünden 
Cantonal Hospital in Chur. Data protection remains guaranteed throughout the entire period. 
8  FUNDING / PUBLICATION / DECLARATION OF INTEREST 
There is no conflict of interest in this study. Financing is provided by the sponsor University of 
Applied Sciences and Arts Southern Switzerland, Landquart (SUPSI). The study is being carried 
out as part of a research project at the University of Applied Sciences and Arts Southern 
Switzerland (SUPSI). The goal is to publish several articles from the collected data and their 
evaluations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9 
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compilation/20121176/201401010000/810.305.pdf  
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