International Journal of Caring Sciences September-December 2014 Volume 7 Issue 3 964

STUDY PROTOCOL

Detection and Management of Chronic Neck Pain Effects During

Rehabilitation with the Application of Nursing Advisory Support
[Prot.Number:11682/18.3.11]

Anastasios Tzenalis, RN, MSc, PhD ( c )

ICU, TNP/BLS Instructor, General Hospital Papageorgiou, Clinical collaborator ATEITH,
Paster Private Institute, Greece
Anastasia Beneka, PhD
Associate Professor, Department of Physical Education and Sport Sciences, Democritus
University of Thrace, Greece
Paraskeui Malliou, PhD
Associate Professor, Department of Physical Education and Sport Sciences, Democritus
University of Thrace, Greece
Georgios Godolias, PhD
Professor, Department of Physical Education and Sport Sciences, Democritus University of
Thrace, Greece
Nektarios Staurou, PhD
Lecturer, Department of Physical Education and Sport Sciences, National Kapodistrian
University of Athens, Greece
Correspondence: A.Tzenalis, Intensive Care Unit, General Hospital Papageorgiou, Ring Road of
N.Eukarpia, Thessaloniki, Greece. Telephone:(+30)6947729065 Email: [email protected]

Abstract

Background: In the general population 3050% of adults will experience musculoskeletal neck pain in
any given year. The traditional pathoanatomical (biomedical) approach to the diagnosis of neck pain
disorders is widely acknowledged as inadequate. Psychosocial factors have been reported associated
with increased risk for more disabling chronic neck pain.
Objective: The objective of this article is to present the design of a qualitative study in combination
with a quantitative pretest posttest-control group design study. The aim of the described research is the
construction and performance of a new, valid tool in the form of questionnaire, in order health
professionals to administrate emotional reactions of patients suffering from chronic neck pain, the
effectiveness of which will be explored in conjunction with the implementation of a specific treatment
program and simultaneously, conducting advisory support.
Methods: A qualitative study using semi structured interviews will be conducted in 6 patients with
CNP. The results of the interviews will arise a reservoir of questions available for the new
questionnaire- tool for managing patients emotional reactions. Validity and reliability of the
questionnaire will be reassured checking conceptual validity, content validity and structural validity
with the use of exploratory factor analyses and confirmatory factor analyses.Then, 30 participants will
be separated in two groups: a) the control group where patients will follow the therapeutic exercise
program without parallel counseling, b) the experimental group where participants will follow along
therapeutic exercise program plus counseling.
Outcome measurement: Inclusion and exclusion variables, demographic variables, duration of neck
pain, specific complaint characteristics , smoking , the McGill Pain Questionnaire, the Neck Disability
Index , the Fear Avoidance Belief Questionnaire, the SF-36 Health Survey, the new questionnaire of
this study, neck goniometry measurements will be the standardized outcome measures.

Keywords: biopsychosocial chronic neck pain, rehabilitation, multidisciplinary approach,

musculoskeletal neck pain

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Introduction Medical approach

Background In the treatment of CNP the medical team
traditionally focuses on assessment of a
Chronic neck pain (CNP) is one of the most
physical base for the pain which composed
serious and most common musculoskeletal
from clinical examination, diagnosis,
disorders that appear in the general
treatment and evaluation of the treatment.
population and especially in developed
However, even when medications and
countries, causing significant impact on both
invasive procedures effectively reduce pain,
public health, and cost of hospitalization
they often do not produce concomitant
(Ferrari and Russel, 2003). Millions of
improvements in physical and emotional
people worldwide are affected by the
functioning (Turk et al, 2008). After patients
consequences of chronic neck pain
receive appropriate treatment, because
experience (Cote et al., 2004; Hogg-Jonson
chronic pain is incurable, they are left to
et al., 2008).
manage their residual symptoms on their
The traditional pathoanatomical- biomedical own (Osborne et al, 2006)
approach to the diagnosis of CNP disorders
Psychological approach
is widely known during the past decades.
However, is well recognized that for the vast Psychological factors in CNP include the
majority of the patients no pathology can be affective components of pain: depression,
imaged which can reliably account for anxiety and anger. The above symptoms can
symptoms (Jull and Sterling, 2009). In our lead to decreased energy and no motivation
days, there is no agreement about the to participate in rehabilitative process
multidimensional nature of chronic back and (Adams et al, 2006). Physiologically, anxiety
neck pain, because chronic pain by its own is and distress may maintain autonomic arousal
so complex. A modern approach to chronic with consequent physical symptoms than
pain includes a combination of therapies: arising (Osborne et al, 2006).
drug therapies, psychological therapies,
Social approach
rehabilitative therapies, anesthesiological
therapies, nevrostimulatory therapies, The social variables are influence the pain
surgical therapies and lifestyle changes, as experience at the individual level, because
well as complementary and alternative there is evidence that classical and operant
medicine (Dureja, 2006; Pool et al, 2010). conditioning processes can lead to pain
behaviors and experiences being learned
Available evidence
through interactions with the environment
Researchers described a conceptualization of (Nicholas, 2008). Social factors include
illness, in which symptoms were considered social learning factors, sources of inadvertent
to be the result of a dynamic interaction reinforcement of pain, current or resent
between psychological, social and stressors and compensation or litigation
pathophysiological variables (Moradi et al, (Victor & Richeimer, 2003)
2012).
There are four components that comprise
Biopsychological pain disorders are, by pain management treatment from a
definition, those disorders having three psychosocial perspective. These interrelated
dimensions: biological, psychological and components are:
social (Disorbio et al, 2006). The
1) Patient education. The goal of patient
biopsychosocial model was introduced as a
education is to reestablish a sense of self-
diagnostic and management paradigm to
efficacy in a demoralized patient (Disorbio et
recognize correctly the multidimensional
al 2006; Turk et al, 2008).
nature of pain (Jull and Sterling, 2009).
Evaluating a chronic pain condition such as 2) Cognitive-behavioral therapy. This
CNP from one-dimensional perspective is therapy combines cognitive techniques such
limiting and often fails to explain the as cognitive restricting and thought stopping,
patients symptoms. with behavioral techniques such as role
playing and homework assignments (Turner

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et al, 1982; Moorey, 1996; Lintin et al, 2005; Methodology

Merlijn et al, 2005; Kroner et al, 2009).
Sample
3) Relaxation training and biofeedback. The Entry Criteria
goals of relaxation training include reduction
Symptoms may be referred to the shoulder or
of maladaptive neuromuscular behaviors.
upper end, without radicular origin. Patients
Whereas, biofeedback refers to the
should be diagnosed with cervical pain and
instrumentation that can be used in
duration of symptoms at least 3 months prior
conjunction with relaxation training (Kelly,
to conducting the initial assessment. The age
1994; Dureja, 2006; Turk et al, 2008).
of patients should be 18-70 years old and
4) Active adaptation focuses on aspects of should become from both sexes. Voluntarily
the patients environment or lifestyle that entrance on the research and understanding
have the potential to support or not of the Greek language will be necessary.
rehabilitative process (Kelly, 1994; Patients will verbally assure that they will
Bergmans, 2007; Nicholas, 2008). complete the process.
Why a design article Exclusion criteria
The design of a research should be carefully The investigation will exclude patients who
examined before adopting its conclusions. are seriously injured and in general in any
Because a biased study design can produce medical condition that would contraindicate
incorrect conclusions (Moore, 2001). exercise. Patients with tumor, infection,
inflammatory rheumatic disease,
A design article allows to examine the design
neurological disease, severe psychiatric
objectively without being influenced by the
illness and pregnancy will be excluded.
study results, to check any resulting articles
Inflammatory conditions, such as nerve root
for protocol deviations, and may also reduce
pressure, tendonitis or bursitis in the
the temptation to search for associations
shoulder will be also exclusion criteria.
during data analysis rather than presenting
hypotheses in advance (Godlee, 2001). 1st stage of the research
Further, a published protocol informs others Phenomenology
about which studies are in process thus The approach to patients suffering from
reducing duplication of research effort chronic neck pain will be through the
(Godlee, 2001). phenomenological study, which is used to
form peoples perceptions in life experiences
Finally, a design article prevents publication
(Bowling, 2002; Sahini-Kardasi, 2000).
bias in the case that future articles are not
Phenomenology is defined as "the direct
published, because study results can be
investigation and description of phenomena
retrieved from the author and the study can
as experienced in consciousness, without
therefore still be included in future reviews
theories regarding the causal explanation and
(Ostelo et al, 2002).
with the greatest possible freedom from
Aim prejudices that have not been addressed by
The main objective of this study is the existing cases (Spiegelberg, 1981; Balls,
construction and performance of a new, valid 2009).
tool in the form of questionnaire in order Semi structured interview
health professionals to administrate
Researchers of this study will use the semi-
emotional reactions of patients suffering
structured interview. In this way, all
from chronic neck pain, the effectiveness of
participants will be asked the same structured
which will be explored in conjunction with
questions, but as these questions will be open
the implementation of a specific treatment
every participant can show different
program and simultaneously, conducting
responses to the content (Amstrong et al.,
advisory support which will result from the
1990). With the semi-structured interview
completion of the questionnaire.
the interviewer is likely to obtain data with

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ripe content and close to the subject. The development of the research (Burhard &
researcher can, simultaneously, observe Morrison, 199). The analyses of the
reactions, facial expressions, and body interviews made according to Table 1.
language, which are important for the

Table 1: Analyses of the semi structured interview results

ANALYSES
THEMES
AN ALYSES STEPS

CATEGORIES CATEGORIES

LABELS LABELS LABELS

TEXT TEXT TEXT TEXT

ANALYSES 0 Through the After the interviews After the interviews

LEVEL interviews

Emerged the Through the codes After the

codes codes/Emerged the
connections

Main questionnaire The research tool categorize the questions according to

assessment factors for CNP. Participants will
A reservoir of questions will be constructed
evaluate the level that the questionnaire
after the qualitative analyses of the
assesses the measured characteristics,
interviews results. To create the initial
according to a five-point scale where number
questionnaire a team of experts will select
1 corresponds to the expression low
questions that will be tested about the
identification , number 2 to moderate
content relevance, the clarity, the
identity, number 3 to good match, number
understanding and the phraseology.
4 to very good match and number 5 to the
Testing validity and reliability of the expression great match. The content
questionnaire checking conceptual validity - validity index of Aiken's item content
content validity of the questionnaire. validity coefficient will be measured to
Initially, four evaluators-judges: a evaluate the responses of the participants.
psychiatrist, a nurse, a psychologist and a
physiotherapist will assess the relevance of Checking structural validity and reliability
the questionnaire content on the evaluation of the questionnaire
of CNP. The evaluators will be informed exploratory factor analyses
regarding the construction of the
questionnaire and will be asked to assess the In the second study, the questionnaire will be
suitability (acceptance, delete, modify) of the administered to one hundred fifty (150)
questions in order to measure psychometric patients. This study will examine the
characteristics of the neck pain. construct validity of the questionnaire
through the exploratory factor analysis and
Then twenty patients will complete the the reliability of the measurement
questionnaire and the researchers will collect instrument. Preliminary tests would include:
their responses in order to evaluate the a) Ballets test of sphericity for checking the
validity of the content, the clarity, the independence between the variables and their
understanding and the relevance of the suitability for factor analysis and b) Kaiser-
questions. Also, participants will be asked to

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Meyer-Olkin measure of sampling adequacy To test the appropriate fit of the models
for checking the adequacy of the sample through confirmatory factor analysis the
(Kaizer, 1974). researchers will consider the following
indicators:
The method of factor analysis was chosen to
examine the construct validity of the a) x2 (chi-square), df (degrees of freedom),
instrument. The number of factors the ratio of x2 / df (x 2 / df ratio), Satorra-
determined according the analysis of the Bentler chi-square),
main components in oblique and varimax b) the Comparative Fit Index, CFI,
rotation axes. The exploratory factor analysis c) the Incremental Fit Index, IFI,
determines the exact number of factors that
will be drawn from the analysis (Kline, d) the Adjusted Goodness of Index, AGFI,
1994). Both the varimax rotation and the e) the Standardized Root Mean Squared
oblique rotation (delta = 0) of the axes will Residual, SRMR, and
determine the interrelationships of factors f) the Root Mean Squared Error of
and the degree of their association (Browne, Approximation, RMSEA (Bentler & Chou,
2001; Carmines & Zeller, 1979; Cudeck & 1987; Byrne, 1994; Bollen, 1989; Hoyle &
MacCallum, 2007; Fabrigar, Wegener, Panter, 1995; Hu & Bentler, 1999;
MacCallum, & Strahan, 1999; Thompson, Tabachnick & Fidell, 2006). Concurrent
2004; Widaman, 2007). validit and discriminant validity will also be
The following criteria will be used for examined.
selecting the number of factors: For internal consistency the researchers will
use the following indicators:
1) the screen plot test,
2) the eigenvalue-greater-than-one rule, a) the coefficient Cronbachs a,
3) the variance of each factor, b) the inter-item correlation,
4) the total variation from the exported c) the corrected item-total correlations
factors and
d) the Spearman-Brown coefficient and
5) the number of factors that can
conceptually be interpreted (Nunnally & e) the Guttman split-half coefficient
Bernstein, 1994; Tinsley & Tinsley, 1987; Procedure of questionnaire administration
Tabachnick & Fidell, 2006).
The questionnaire will be administered to
For internal consistency the researchers will
patients with CNP personally and
use the following indicators:
individually following by a cover letter. This
a) the coefficient Cronbachs a, letter will inform the participants about the
b) the inter-item correlation, university-department ID, the researchers
c) the corrected item-total correlations name, title, telephone number and e-mail. It
will also indicate the significance and the
d) the Spearman-Brown coefficient and purpose of the investigation, drawing the
e) the Guttman split-half coefficient. attention of participants during completion of
the questionnaire in order to collect valid and
Confirmatory factor analyses reliable information. The participants will
Before the main analysis of the questionnaire receive oral confirmation about the
with the method of confirmatory factor anonymity of responses and their ability to
analysis in 300 patients, the researchers will be informed about the results of the survey.
test the distribution of the variables with the The duration of completion the questionnaire
following indicators: is estimated at about ten (10) minutes. The
researcher will be present during the process
a) univariate skewness), in order to resolve any questions and to give
b) the univariate kyrtosis and all necessary clarifications and instructions.
c) the Mardia coefficient-relative Patients will complete the questionnaire in
multivariate kurtosis (Mardia, 1970). their treatment place.

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2nd stage of the research: The real applied on the neck for all patients in order
experiment to reduce the pain sensation. All patients will
follow a program in collaboration with
Study design
experienced physiotherapist with:
This research method is a pretest posttest-
control group design. This type of study is a) stretching exercises for the neck muscles,
designed to investigate how really effective the shoulder and the upper limbs,
is an additional intervention in daily practice. b) strength training of the flexor and extensor
It also provides answers for the overall neck muscles from different positions,
patients benefits, suggesting evidence that
will help healthcare professionals to make c) proprioception exercises,
the right choices among appropriate d) dynamic exercises of the shoulder and
interventions (Stevens, 2001; McCarney et upper limbs with weights sets and elastic
al., 2002; McPherson , 2004). resistance bands,
Sampling e) exercises to improve the kinesthetic
The sample size of this experiment will be 30 ability, f) technique of progressive relaxation
patients with CNP. The researchers will use and diaphragmatic breathing exercises
the stratified random sampling from a combined with inhalation-exhalation.
patients list that will fulfill the inclusion All patients will come for treatment 2-3
criteria. Participants will be separated in two times per week until the completion of 12
groups: sessions (about for 4-6 weeks). The duration
a) the control group where patients will of each session for all groups will be
follow the therapeutic exercise program approximately 45 minutes.
without parallel counseling, b) the Outcome measurements
experimental group where participants will
follow along therapeutic exercise program In every intervention is necessary the
plus counseling program which will result determination and evaluation of the results
from the completion of the questionnaire. and their comparison with the intended or
The process will take place in the university projected results. Standardized outcome
departments laboratory (Physical Education measures provide a common language with
and Sports Science at Democritus University which to evaluate the success of
of Thrace). interventions, thereby providing a basis for
comparing outcomes related to different
Therapeutic interventions intervention approaches (Table 2).
Hot compresses ten minutes before and ten
minutes after the therapeutic program will be

Table 2: Overview of variables measured

Variable Range of unit
Baseline Variables
Inclusion and exclusion variables X
Demographic variables X
Specific complaint characteristics X
Duration of neck pain months
Smoking yes /no
McGill Pain Questionnaire marking the words
Neck Disability Index marking the sentences
Fear Avoidance Belief Questionnaire 1-6 Likert scale
SF-36 Health Survey marking words and sentences
The new questionnaire of this study 1-5 Likert scale
Neck goniometry measurements Degrees
The strength of the flexors and extensors Seconds
neck muscles with timer
spirometer measurements FVC/FEV

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Discussion neck pain disorders will inform better

management the aim of the biopsychosocial
According to the research assumptions the
model (Jull and Sterlling, 2009).
average of pain as well as the average of
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