Development of structured orthopedic manual therapy assessment proforma for diagnosing subjects on the basis of orthopedic manual therapy Authors:Radhika Chintamani*, G. Varadharajulu, Amrutkuvar Rayjade Int J Biol Med Res. 2024; 15(1): 7735-7740 Abstract: Background: Proper Diagnosis of orthopedic conditions in the early stage may reduce prevalence of missed diagnosis or wrong diagnosis, thus helping in early and proper intervention and early recovery. Utilizing the highly specified assessment technique for each tissue given in specific manual therapy is limited. Study Design: Validation study to define validity and reliability of Structured Orthopedic Manual Therapy Assessment Proforma. Objective: To analyze the Structured Orthopedic Manual Therapy Assessment Proforma and to assess it’s concurrent validity and reliability. Subjects and Methods: To assess reliability, 100 referred non-operated orthopedic subjects with mean age, 55±2 years were assessed on 2 separate occasions (Group 1). To assess concurrent validity, 200 subjects were assessed with the new format and the old existing format (Group 2). Internal consistency, reproducibility and concurrent validity were determined with Cronbach’s ? coefficient, interclass correlation coefficient and Pearson correlation coefficient, respectively. Results: Cronbach’s ? coefficient for the 10 major domains (Pain, Selective tissue tension testing, Balanced ligamentous tension, Soft tissue assessment, End feel, bony assessment, neural assessment and diagnostic criteria) were high. Intraclass correlation was excellent for all domains along with good concurrent validity and internal consistency. Conclusions: The Structured OMT assessment format outcome instrument has satisfactory internal consistency and excellent reproducibility. It is ready for use in clinical studies on non-operated orthopedic conditions who are capable of physiotherapy treatment. The outcome measure provides a convenient brief measure that can be used to and evaluate and diagnose improvements in Physiotherapy referred subjects with non-operated orthopedic conditions and could potentially be adapted for other painful conditions.

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Journal homepage: www.biomedscidirect.com
International Journal of Biological & Medical Research
Int J Biol Med Res. 2024; 15(1): 7735-7740
Development of Structured Orthopedic Manual Therapy Assessment Proforma for
diagnosing subjects on the basis of Orthopedic Manual therapy
a b c
Radhika Chintamani*, G. Varadharajulu, Amrutkuvar Rayjade
A R T I C L E I N F O A B S T R A C T
Keywords:
Manual therapy assessment
scale
physiotherapy
diagnostic tool
referred subjects.
Original article
Background: Proper Diagnosis of orthopedic conditions in the early stage may reduce prevalence of
missed diagnosis or wrong diagnosis, thus helping in early and proper intervention and early
recovery. Utilizing the highly specified assessment technique for each tissue given in specific
manual therapy is limited. Study Design:Validation study to define validity and reliability of
Structured Orthopedic Manual Therapy Assessment Proforma. Objective: To analyze the Structured
Orthopedic Manual Therapy Assessment Proforma and to assess it's concurrent validity and
reliability. Subjects and Methods:To assess reliability, 100 referred non-operated orthopedic
subjects with mean age, 55±2 years were assessed on 2 separate occasions (Group 1). To assess
concurrent validity, 200 subjects were assessed with the new format and the old existing format
(Group 2). Internal consistency, reproducibility and concurrent validity were determined with
Cronbach's α coefficient, interclass correlation coefficient and Pearson correlation coefficient,
respectively.Results:Cronbach's α coefficient for the 10 major domains (Pain, Selective tissue
tension testing, Balanced ligamentous tension, Soft tissue assessment, End feel, bony assessment,
neural assessment and diagnostic criteria) were high. Intraclass correlation was excellent for all
domains along with good concurrent validity and internal consistency.Conclusions:The Structured
OMT assessment format outcome instrument has satisfactory internal consistency and excellent
reproducibility. It is ready for use in clinical studies on non-operated orthopedic conditions who are
capable of physiotherapy treatment. The outcome measure provides a convenient brief measure
that can be used to and evaluate and diagnose improvements in Physiotherapy referred subjects
with non-operated orthopedic conditions and could potentially be adapted for other painful
conditions.
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Int J Biol Med Res
Introduction
Copyright 2023 BioMedSciDirect Publications IJBMR - All rights reserved.
ISSN: 0976:6685.
c
OrthopedicManualTherapyisabranchofmodernphysiotherapy
which has been evolved from the past decades. One of the pre-
requisite to administer any kind of manual therapy skill is reaching
the actual cause of impairment at the structures causing dysfunction
either in soft tissue of bony parts.1 This has put a high demand on
physiotherapist to follow a structured assessment proform which is
barelyavailableindaytodaypractice.
Therearevarioussortsofdysfunctionsandderangementsseenin
human body, according to which manual therapy authors have
stipulated their respective school of manual therapy. A
physiotherapist who wants to administer the particular manual
therapyprotocol,he/sheneedstohavethoroughknowledgeabout
the each school of manual therapy, along with the cause and
effect on structures which are affected in either dysfunctions or
derangements.1
In current practice all physiotherapists follow different
proforma which may not be practically appropriate and may
sometime lead to poor therapeutic outcome, thus the idea of
formulating structured assessment proforma has been evolved by
the author. Thus, the want of structured proforma has been
evolvedfromtheauthors.
The Usual assessment includes general physical examination
which is commonly used for orthopedic cases as well as soft tissue
or bony alignment diagnosed subjects. The cause in each patient is
different, although the assessment remains unchanged.
Assessment format should assess the entire body along with
specification of the tissue affected. The present assessment format
followed everywhere commonly consists of pain assessment using
Visual Analogue Scale2, On observation, On palpation, ROM3,
Musclestrengthassessment4,Posture5andGait6.Itisverymuch
* Corresponding Author : Radhika Chintamani
Assistant Professor, College of Physiotherapy, Dayananda Sagar University-
Bangalore KARNATAKA:
E-mail:radds2009@gmail.com
Copyright 2023 BioMedSciDirect Publications. All rights reserved.
c
a
Assistant Professor, College of Physiotherapy, Dayananda Sagar University- Bangalore KARNATAKA
b
Dean & Principal Faculty of Physiotherapy, Krishna Institute of Medical Sciences Deemed to be University Karad-MAHARASHTRA
c
Associate Professor, Faculty of Physiotherapy, Krishna Institute of Medical Sciences Deemed to be University Karad-MAHARASTRA

2. Radhika Chintamani et al. Int J Biol Med Res. 2024; 15(1): 7735-7740
7736
needed to target the specific tissue during assessment. Hence
revised edition of assessment format is needed. Also, there are
various schools of manual therapy giving different techniques of
assessment along with their treatment. Utilizing the highly
specified assessment technique for each tissue given in specific
manualtherapyislimited.Hencethiscopyrightisbeenmade.
Tumors of mammary gland can be benign or malignant.
Unfortunately, the distinction between them are considerably
Deductive approach was adopted to generate the content. A set
of pre-identified potential items which were significantly effective
to analyse was used to prompt and facilitate more focused analysis
of patients. The initial 'top down' approach was therefore intended
to make use of existing knowledge. By following established good
practice for scale development (DeVellis, 2012)7, we first identified
potential questionnaire items from previous measures. These
included the Janda's Movement pattern assessment (Arab A et al
2017)8, Combined movement pattern (Monie et al 2016)9 and
Balancedligamentoustension(TozzieP,2018)10.Thisproducedan
initial pool of 35 potential items covering qualitative and
biomechanical analysis of the condition. Items that were not
relevant to Orthopedic manual therapy assessment were
eliminated. The criteria was such that retained items should be
about issues that could focus the orthopedic manual therapy
analysis, so items specifically referring to manual therapy schools
were included. This resulted in a shorter list of 10 main potential
items, with sub-items 3 about pain11, 2 about On observation12, 3
about On palpation13, 2 regarding passive and resisted tension of
soft tissue14, 3 regarding tension within ligament15, 3 related to
soft tissue assessment16, 7 regarding end feel of movement17, 2
regarding bony palpatory assessment18 and 2 regarding neural
assessment19 and 4 regarding Diagnostic criteria of the area
affected after assessment on the basis of somatic dysfunction
diagnostic criteria20. The assessment format also included
syndrome classification on the basis of School of Meckenzie21 for
the purpose of diagnosis. So total items in this scale included were
32, among which 31 were for assessment and 32nd was for
diagnosis.
The Scale:
Development of the Profroma
Setting: Krishna Hospital attached to Krishna Institute of
MedicalSciencesKarad,Maharashtra,India.
Informedconsentwastakenfromthetargetpopulation
Population: All apparently healthy consecutive referred
subjectstophysiotherapydepartmentwereenrolled.
Sample size: N=300: subjects referred to physiotherapy
department with non-operated orthopedic condition were
recruitedinthestudy
Exclusion criteria: operated conditions, balance issues,
neurologicalorcardiacconditions,unstableconditions
100 subjects were recruited for Relaibility purpose and 200
Subjects were divided into two groups of 100 each for the purpose
of New version of assessment format and old version of assessment
formatforValiditypurpose
Variables under study: Pain assessment, On observation, On
Palpation, muscle and ligamentous tension testing, ligamentous
testing,Softtissueevaluation,Endfeelassessment,Bonyandneural
assessment. All the assessment was performed entirely by bare
hands. No other tool was used to assess the subjects in order to
diagnosethem.
Assessment and Diagnosis was made by both the formats and
theresultswerecompiled
Complied Data was analysed by software version 16.0 and the
statisticalsignificancewastabulated.
Recruited subjects were divided into two groups, 1 for
evaluating the reliability and the other for evaluating the validity,
werecarriedoutatasinglecenter.Duringthefirstsurvey(Group1),
a total of 100 subjects attending the outpatient clinic for
physiotherapy were selected at random. After being verbally
informedofthepurposeofthestudy,eachofthepatientscompleted
the first set of the assessment format immediately. A second survey
(Group 2) was carried out 2 weeks later in the same outpatient
clinic, a group of 200 patients were randomly selected and were
assessedusingstructuredOMTassessmentformat.
On completion, they were assessed with usually followed
assessment format. Reliability assessment of the structured OMT
assessmentformatwasdeterminedbycalculatingCronbach'sαand
intraclass correlation coefficient (ICC) values. Concurrent validity
was evaluated by comparing structured OMT assessment format
with relevant domains in the usual assessment format, correlation
wasmadeusingPearsonCorrelationCoefficients(r).
The final form of the Structured OMT assessment proforma is
attachedinAppendixA.
Statistical Analysis: Data were analyzed for normality using the
Kaiser-Meyer-Olkin (KMO) measure (Kaiser, 1970) and Bartlett's
(1950)TestofSphericity.
Validationofthequestionnaire
MaterialsandMethod:
A consecutive sample of 550 referred subjects were included in
the study. The enrollment was started from January 1, 2020, till
desired sample size was reached. Non referred subjects were
excluded [ ]. Thus, the cohort of 550 was analyzed for the
study. In-depth study was done about non-operated orthopedic
conditions, and 300 subjects were recruited in the study from
originalcohort.
Flow Chart
Ethical Consideration: Approval of Institutional Ethical
Committeewasobtained
Approach-Comparative,exploratory
Design-prospectivecohortstudy

3. 7737
The aim of the validation phase was to test the tool as developed
with respect to factor structure, internal reliability, convergent
validityandconcurrentvalidity.
For factor structure, we tested 1-factor, 2-factor and 5-factor
models. The 1-factor model comprised all 32 items. The 2-factor
model comprised pain assessment as one factor and soft tissue &
bony assessment as another, based on a broad distinction between
pain assessment and soft tissue assessment & bony assessment.
The 5-factor model comprised pain, soft tissues, bony assessment,
neural assessment and diagnosis based on specific areas of content
identified during the development phase. Because we wished to
compare specific pre-identified factor structures, confirmatory
factor analysis was used to compare the fit between data and factor
structures of the 1-factor, 2-factor and 5-factor models (Harlow,
2014)22.
Sevenindicatorsofmodelfitwerecomputedforeachmodel:Chi
Square23 was used to assess whether data differed from the
models. The Goodness of- Fit Index (GFI)24, Root Mean-Square
Error of Approximation (RMSEA)25 and Standardised Root Mean
Square Residual (SRMR)26 were used to assess how much of the
variance in the data was explained by the models. The Comparative
Fit Index (CFI), Tucker Lewis Index (TLI) and Normed Fit Index
(NFI)27 were used to test the models against the worst possible
model outcome. The Maximum Likelihood estimator method was
used in each case (Brown, 2015)28. For data scaling, the first
variableforeachscalewassetatone.
The internal reliability or internal consistency of each factor
(the extent to which a given group of items measure the same thing)
was assessed by computing Cronbach's Alpha (α). For the model
with the best fit to the data, subscale scores were computed by
summing across the items in each factor, with higher scores
indicatinggreatersatisfaction.29
Concurrent validity was assessed by comparing assessment
scores between subjects with different profromas of assessment,
using t tests and Pearson correlations30. This bi-variate approach,
tests the associations between assessment satisfaction and
individual variables of the format, was chosen to give the most
comprehensive picture of concurrent validity, in which all the
subjects and assessment factors associated with new proforma
would be identified, and also to test a number of specific
predictions.
Ethicsandgovernance
The study protocol was approved by the Institutional Ethical
Committee of Krishna Institute of Medical Sciences Deemed to Be
University, and copyright was sanctioned with the Indian
government with Reg No. (L-91041/2020)31. The study was self
fundedwithnoconflictsofinterestamongtheauthors.
Results:
ForGroup1,all100subjectswereassessedusingtheStructured
OMT assessment proforma. There were 56 males and 44 females.
Meanagewas55±4years.ForGroup2,200subjectswere(4males,
46 females) assessed using both the formats. Mean age of
patients was 57±2 years. The score distribution for the Structured
OMT assessment format and Old existing assessment format
domains in terms of domain means, maximum ceiling score,
minimum floor score, and the ceiling and floor effect for both the
new and old version of the assessment formats can be found in
Table 1. All of the domains of new format showed a low level of floor
effect (<7% as defined in Table 1). While the old format
demonstrates some ceiling effect in pain and neurodynamics, the
new format also has a high ceiling effect on physical functioning,
pain, selective tissue tension testing, balanced ligamentous tension,
soft tissue assessment, bony and neural assessment and diagnostic
criteriadomains.
Recruited subjects were divided into two groups, 1 for
evaluating the reliability and the other for evaluating the validity,
werecarriedoutatasinglecenter.Duringthefirstsurvey(Group1),
a total of 100 subjects attending the outpatient clinic for
physiotherapy were selected at random. After being verbally
informedofthepurposeofthestudy,eachofthepatientscompleted
the first set of the assessment format immediately. A second survey
(Group 2) was carried out 2 weeks later in the same outpatient
clinic, a group of 200 patients were randomly selected and were
assessedusingstructuredOMTassessmentformat.
Demographicdatabetweengroups:
Characteristics of the participants completing new assessment
proformaandoldversionoftheassessment,andtestsofdifferences
betweenthem,areshowninTable1.
Table 1: Descriptive Statistics on Individual Domain Scores
(n=100)
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4. 7738
Compared with participants who completed new assessment
proforma, respondents to the old assessment format were more
likely to be older, with referred physiotherapy visits for non-
operated orthopedic conditions, most painful episodes to see
doctor, and to get admitted in hospital due to severe pain. However
thegroupsdidnotdiffersignificantlyinanyoftheotherfactors.
Factorstructure
The Kaiser-Meyer-Olkin (KMO) value was 0.944, showing
adequate sampling. Bartlett's test of Sphericity was highly
significant (Χ2=1810.28, df=153, p< .001) indicating that the
correlations were significantly different from zero, making factor
analysisappropriate.
Table 2 shows values of seven fit indices along with the values
they should be at least 'close to' for a good fit between model and
data.The1-factormodelcomprisedall32items.The2-factormodel
comprised pain, soft tissue, bony and neural assessment as one
factor and diagnosis as another, based on a broad distinction
between assessment and diagnosis. The 5-factor model comprised
pain, soft tissues, bony assessment, neural assessment and
diagnosis based on specific areas of content identified during the
developmentphase.
While χ2 was significant in each case, but , χ2 was much lower
for the 5-factor model than both the 1-factor and 2-factor models,
showing that the 5- factor model was a better fit to the data. Indeed,
for all the other fit indices, the values for the 5- factor model were
more favourable than those for the 1-factor or 2-factor models,
suggesting that the 5-factor model fitted the data better than the
other models. Also, the indices (SRMR), the value for the 5-factor
model remained were close to recommended values, indicating the
5-factormodelwasanacceptablefittothedata.
Descriptive statistics for the five subscales and total score
(computed by summing across items) are given in Table 3. Higher
scores indicate greater satisfactory internal consistency in each
case.
Table 3: Cronbach's alpha coefficients (α), for each factor
withinthenewproformagroup
Concurrentvalidity
The concurrent validity in comparison with old formats appear
inTable4.Excellent(r=0.75–1)(1domain),good(r=0.50–0.75)(12
domains), moderate (r = 0.25– 0.50) (3 domains), and poor (r
=0–0.25) (1 domain) correlations can be observed within the 10
relevant old and new domains. For example, the correlation
coefficient between old and new formats between Pain was 0.77
(P_0.001). On the other hand, correlation coefficients between new
andoldformatswithcombinedmovementpattern(painspecificfor
movement) and diagnostic criteria were 0.10 and 0.18respectively
(P=0.05).
Summary of the Structured orthopedic manual therapy format
(5)andOldassessmentformat(6)aregiveninthefollowingtables.
Table 4: Concurrent Validity of new format Domains With
relevant old format Domains as Determined by Pearson
CorrelationCoefficients(n=100)
Notes: Χ2=Chi Square; df=degrees of freedom; p=probability;
GFI=Goodness of fit index; RMSEA=root mean square error of
approximation; SRMR=standardized root mean square residual;
CFI=Comparative Fit Index; TLI=Tucker‐Lewis Index; NFI=Normed
FitIndex.
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5. 7739
Summary of association between New version and Older
version:
Table5:Newversion
The study of concurrent validity showed satisfactory
correlation coefficients when compared with old existing formats,
except the satisfaction with Pain domain. Different scale exist for
assessing pain according to various schools of manual therapy.
Hence, according to various schools of manual therapy, the
satisfaction/dissatisfaction level varies. Ford J et al33 have
d e m o n s t r a t e d , i n a r e c e n t s t u d y t h a t , P a i n
satisfaction/dissatisfaction domain poorly correlated with the
related domains of assessment domain as Pain itself being a major
domain has various features associated, hence may vary by
subjects. The study demonstrated Substantial agreement in one out
of seven items on the initial SAePO comparisons with moderate
agreement in a further four items. Two items had less than
moderate agreement. Thus, we think that the lower correlation
coefficient in our study was a reflection of the intrinsically poor
correlation of satisfaction domain of Structured OMT assessment
format with the domains of usual assessment formats, rather than a
validityproblemoftheassessmentformat.
The scale's validity as a specific measure of assessment with
diagnosis for physiotherapy referred non-operated orthopedic
conditions was also supported by the fact that scores were not
related to more general measures of illness severity, such as
numbers of painful episodes or nights spent in hospital. The
satisfaction with analytical method of the subjects has a strong
emphasis on qualitative and biomechanical aspects of the signs and
symptoms, as do rest school of manual therapy suggests, but this
scale clusters all other school of manual therapy and various
differentaspectsofassessments.
By comparison with various schools of manual therapy
techniques of assessments, the new scale was specifically designed
to analyse and diagnose various referred non-operated orthopedic
conditions from physiotherapy point of view, This resulted in a
shorter list of 10 main potential items, with sub-items 3 about pain,
2 about On observation, 3 about On palpation, 2 regarding passive
and resisted tension of soft tissue, 3 regarding tension within
ligament, 3 related to soft tissue assessment, 7 regarding end feel of
movement,2regardingbonypalpatoryassessmentand2regarding
neural assessment. ThescalealsoincludesDiagnostic criteriaofthe
area affected after assessment on the basis of somatic dysfunction
diagnosticcriteriawhichincluded4items.
Conclusion:
The SOMTAF was developed in close consultation with
orthopedic manual therapy patients in order to identify aspects of
assessment and diagnosis that impact on patients' early diagnosis
and early recovery, consistent with the recommendations of a
Cochrane Review (Dunlop & Bennett, 2006). This is the reason for
the inclusion of so many items that deal specifically with
biomechanical and qualitative aspect of the signs and symptoms in
the view of Orthopedic Manual therapist. This new assessment
format can contribute to a growing number of physiotherapy
patients-reported outcome measures suitable for manual therapy,
including the Mulligan, Meckenzie, Maitland and Janda's schools of
thought. All these measures can contribute to improving clinical
practice and quality of care but, the new scale is best suited for
Discussion
In this study, we have successfully analyzed the satisfactory
reliability and validity of newly developed Structured Orthopedic
Manual therapy with Copyright given by Indian Gov with Reg No. L-
91041/202031. Overall, the newly developed orthopedic manual
therapy assessment format demonstrated good metric qualities
(internal consistency). The wide range of score distribution reflects
variationsinindividualpatient'sperceptionofpain.
Ceiling effects in the pain domain has already been previously
demonstrated,hasbeensuggestedthatthismightbeaconsequence
of change in pain perception, pain threshold level, temporal
variationregardingpain.32
The factor analysis and item analysis supported a 5-factor
structure, making the scale a simple, brief measure of several key
aspects of patient satisfaction, each with very good internal
reliability. Convergent validity was supported by highly significant
negative correlations with scores from the Old format, which is a
widely used and positively evaluated measure of patient
experiencesinhealthcare.
The Cronbach's Alpha coefficients of internal reliability were
extremely high. These indicated that the internal consistency of
itemswithineachindividualsubscale,whereasthemodelfitindices
assess the model as a whole. This indicates that each of the 10
subscales and the total score had very high internal consistency,
eventhoughtheoverallfitofthefive-factormodelcouldbebetter.
Radhika Chintamani et al. Int J Biol Med Res. 2024; 15(1): 7735-7740

6. 7740
evaluations and diagnosis of referred non-operated
physiotherapy patients with orthopedic conditions across different
hospitaldepartments.
Strengths:Thestudydemonstratedthat,thescaleiswellsuited
for its benefit in the assessment of Orthopedic manual therapy
subjects as it demonstrated to have good concurrent validity,
internal consistency and cronbach's α along with best fit model.
Hence can be used as assessment format in various
hospitals/departments.
Conflictofinterestdisclosure
The authors stated that they had no interests which might have
beenperceivedasposingaconflictorbias.
Acknowledgements
We are grateful to all the participants in each stage of the
research; and to my colleagues for helping with the construction of
an initial item pool, selection of 35 items for the 'short list'. We are
also grateful to the reviewers and editorial staff for their helpful
commentsonapreviousdraft.
Funding:Thestudyisselffunded
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