Keywords adhesive capsulitis - nerve block - International Classification of Functioning, disability
and health - shoulder - patient reported outcome measures
Introduction
Adhesive capsulitis (AC) is a disabling shoulder disease with a prevalence of 2% to
5% among the general population that most commonly affects females between 40 and
70 years of age.[1 ]
[2 ] Its clinical features are pain and stiffness;[1 ]
[3 ]
[4 ] it often presents bilaterally, and does not affect the same shoulder twice. Adhesive
capsulitis can present in the primary (idiopathic) form or be secondary to previous
surgery, trauma, immobilization, and systemic alterations such as diabetes mellitus
and hypothyroidism.[1 ]
[3 ]
[4 ]
[5 ]
[6 ] The non-surgical approach is mandatory, and suprascapular nerve block (SSNB) is
one therapeutic option with satisfactory results.[7 ]
[8 ]
This condition is limiting and negatively impacts the function and structure of the
affected person's body.[8 ] The International Classification of Functioning, Disability and Health (ICF) was
developed by the World Health Organization (WHO) in 2001 so that the individual can
describe their current state of health-disease-functionality-care.[9 ]
[10 ]
[11 ] Due to its multifaceted nature, the ICF contributes to the assessment of different
health conditions; however, its use has been restricted to rehabilitation professionals.[12 ]
[13 ]
The use of the ICF checklist in the clinical practice can provide important information
to be raised in patient care, with a unified and standardized language based on different
constructs and domains.[14 ]
[15 ]
[16 ] Another widely used instrument in studies on uppers limb diseases is the Disabilities
of the Arm, Shoulder and Hand (DASH) questionnaire, but it is only applied to evaluate
the function and symptoms of this part of the body during the performance of certain
activities.[17 ]
There is an increasing support for the use of patient-reported outcomes to determine
the quality of the treatment and of the therapeutic conduct. These outcomes are obtained
through validated questionnaires that are filled out by the patients according to
their perceptions of their health status, disability and level of impairment. These
questionnaires also enable the comparison of outcomes before and after procedures
to evaluate the efficacy of a clinical intervention from the patients' perspective.
A combination of two types of patient-reported outcome measures is often used.[18 ]
To date, studies on AC with the simultaneous use of the ICF checklist and the DASH
have not been found. This investigation would enable the mapping of the functionality
construct regarding the aspects affected by AC as well as the individual as a whole.[16 ]
[17 ]
Thus, the aim of the present study was to evaluate, through the ICF and DASH simultaneously,
the functionality of patients with AC submitted to SSNB. We hypothesize that those
affected will experience an improvement in both patient-reported outcome measures
after the treatment.
Materials and Methods
Location of the Study and Study Design
The present is a prospective study, of the before-and-after type, performed in a single
center at a tertiary private hospital from March 2019 to July 2020. It was approved
by the institutional Ethics in Research Committee on February 29, 2019, under protocol
08599119.1.0000.8058. All subjects signed the Informed Consent Form.
Participants
The finite proportion sample calculation was used considering a significance level
of 5%, a test power of 80% and a margin of error of 5%. The sample size obtained was
25 participants. The sample, which was non-probabilistic and consecutive, was obtained
after routine appointments at a specialized outpatient clinic.
The eligible cases of AC were those which had constant pain for more than four weeks
and limited active and passive range of motion in every direction, such as: anterior
elevation, external rotation in 0°/90° of abduction, and internal rotation in adduction.
The imaging diagnosis showed local disuse osteopenia on radiographs and volume restriction
of axillary recess, as well as thickening of coracohumeral ligament, on magnetic resonance
imaging.
Patients who had secondary AC were included in the study due to the following factors
established by Zuckerman and Rokito:[4 ] previous surgery, trauma, prolonged immobilization, rotator cuff tear, calcareous
tendinitis, as well as diabetes mellitus, neuropathies and hypo- or hyperthyroidism.
Patients with glenohumeral arthrosis, blocked shoulder dislocation, humeral head necrosis,
malunion of the proximal humerus, and primary AC were excluded.
Data Collection
Data was collected through the following steps: 1) presentation of the research proposal
and signing of the Free and Informed Consent Term; 2) application of the sociodemographic
and clinical questionnaire; and 3) application of the patient-reported outcome measures
(ICF checklist and DASH). All of these steps were performed by the same researcher
(SRN), who was not in charge of performing the SSNB.
The four SSNBs, based on anatomical limits, were performed by the same shoulder specialist
(MRF) in a prepared room in weekly intervals ([Figs. 1 ], [2 ], [3 ]).[19 ] The AC patient was placed in a sitting position with the affected upper limb at
0° of abduction, and the region of the shoulder was sterilized with 70% alcohol before
the injection. A syringe with an 18-gauge venipuncture catheter (Abocath; Bio-Med
Healthcare Products, Haryana, India) was used with 10 mL of bupivacaine at 0.5% associated
with 1:200.000 epinephrine (Neocaine, Cristália, Itapira, Brazil).
Fig. 1 Lateral and indirect technique of suprascapular nerve block based on anatomical limits.
Posterior and superior shoulder view; blue circle: the needle is inserted perpendicularly
to the skin in the craniocaudal direction, 2 cm from the medial acromial border and
2 cm from the upper margin of the scapular spine. White arrow: coracoid process. Abbreviations:
CL, clavicle; AC, acromion; SS, scapular spine.
Fig. 2 Posterior shoulder view during suprascapular nerve block. Abbreviations: AC, acromion;
SS: scapular spine.
Fig. 3 Superior shoulder view during suprascapular nerve block. Blue line: superior border
of scapular spine; red lines: distal clavicle.
All patients were evaluated through the ICF checklist and DASH at baseline (T0 ), one week after the fourth SSNB (T4 ), and three months after the first SSNB (T12 ) ([Fig. 4 ]).
Fig. 4 Flowchart of assessment of the adhesive capsulitis patients through the ICF checklist
and the DASH during the three months of the study. Abbreviations: SSNB, suprascapular
nerve block; T, injection time; ICF, International Classification of Functioning,
Disability and Health; DASH, Disabilities of the Arm, Shoulder and Hand questionnaire.
Instruments
All 54 categories of the ICF checklist were used, and 11 of them concern body functions,
2 concern body structures, 17 are on activity and participation – performance, 17
are on activity and participation – capacity, and 7 involve environmental factors.[20 ] We used the RAW Scale formula, which has a score form 0 to 100, with qualifiers
graded from 0 to 4 to determine the magnitude of the disability: 0% to 4% – none (0);
5% to 24% – slight (1); 25% to 29% – moderate (2); 50% to 95% – serious (3); and 96%
to 100% – complete (4). The lower the value, the better the individual's functionality.[15 ]
[20 ]
The DASH evaluates upper limb disabilities over time through 30 questions about symptoms
and the performance of specific activities, and it can be applied before and after
procedures. Its score goes up to 100 (the higher the score, the greater the disability).[17 ]
[21 ]
Outcomes/Independent Variables
The outcomes were the functionality of individuals and of the upper limb according
to the ICF checklist and the DASH. The independent variables were: age (in years);
gender (male/female); ethnicity (white/black/brown); level of schooling (< or ≥ eight
formal years); monthly income (in multiples of the minimum wage); religion (yes/no);
duration of pain (months); affected side (right/left); dominance (right-handed/left-handed).
Data Analysis
The categorical variables were presented as frequencies and percentages, while the
continuous variables, as mean, standard deviation, maximum and minimum values.
The Kolmogorov-Smirnov test was used to verify the distribution of sample data. The
Cronbach alpha coefficient was calculated to verify the internal consistency and reliability
of the ICF and DASH at T0 , T4 , and T12 . The Chi-squared test was used to verify the homogeneity of the sample. The paired
t -test was used to compare the means of the ICF checklist items and DASH in the different
periods: T0 xT4 , T4 xT12 , and T0 xT12 . Statistical analyses were performed using the Statistical Package for the Social
Sciences (IBM SPSS for Windows, IBM Corp., Armonk, NY, United States) software, version
20.0. The probability of rejecting the null hypothesis was 5%.
Results
The number of patients with AC who were recruited was 52; however, 9 had primary CA,
13 with secondary CA did not want to undergo the SSNB, 3 with secondary CA did not
have time to participate, and 2 did not return with the test results requested. So,
the final sample was composed of 25 participants with AC.
The sociodemographic and clinical data of the sample are summarized in [Table 1 ]. The mean age was of 58.16 years, and the duration of the pain symptoms ranged from
2 to 16 months, with a mean of 5.92 months.
Table 1
Variables
n
%
p *
Gender
Female
16
64.0
Male
9
36.0
0.162
Age
≤ 60 years old
15
60.0
> 60 years old
10
40.0
0.317
Monthly income
1 to 2 minimum wages
7
28.0
3 to 4 minimum wages
8
32.0
0.756
≥ 5 minimum wages
10
40.0
Ethnicity
White
17
68.0
Black
2
8.0
0.001
Brown
6
24.0
Religion
Yes
24
96.0
No
1
4.0
0.000
Level of schooling
< 8 years
4
16.0
≥ 8 years
21
84.0
0.001
Affected side
Right
17
68.0
Left
8
32.0
0.072
Dominance
Left-handed
2
8.0
Right-handed
23
92.0
0.000
Duration of pain
2 to 6 months
12
48.0
> 6 months
13
52.0
0.841
[Table 2 ] shows the reliability and internal consistency analysis of the ICF and DASH at T0 , T4 , and T12 , with a Cronbach alpha > 0.80.
Table 2
Cronbach alpha
Number of items
ICF at T0
0.91
54
ICF at T4
0.87
54
ICF at T12
0.85
54
DASH at T0
0.87
30
DAHS at T4
0.96
30
DASH at T12
0.94
30
[Table 3 ] shows the results of the mean, standard deviation, maximum and minimum values of
the ICF checklist domains, as well as the DASH scores at T0 , T4 , and T12 .
Table 3
n
Mean
SD
Min.
Max.
ICF checklist
T0
Body functions
25
46.82
7.65
31.82
59.09
Body structures
25
62.50
8.84
50
75
Activity and participation –performance
25
38.53
14.96
1.47
64.71
Activity and participation – capacity
25
42.59
12.41
16.18
64.71
Environmental factors
25
57.71
9.26
39.29
75
T4
Body functions
19
32.06
9.90
11.36
52.27
Body structures
19
50.00
12.50
37.5
75
Activity and participation – performance
19
9.91
9.67
1.47
35.29
Activity and participation – capacity
19
25.77
9.55
5.88
39.71
Environmental factors
19
55.45
7.28
35.71
64.29
T12
Body functions
19
19.02
9.62
6.82
36.36
Body structures
19
50.66
11.39
25
62.50
Activity and participation – performance
19
8.90
8.64
1.47
32.35
Activity and participation – capacity
19
22.68
8.21
4.41
33.82
Environmental factors
19
54.89
7.92
35.71
67.86
DASH
DASH at T0
25
50.68
11.18
28
67
DASH at T4
19
42.37
16.88
5
70
DASH at T12
19
29.58
13.33
7
51
The analysis of the general classification of the ICF Checklist enabled us to verify
that, at the beginning of the study (T0 ), the individuals had functional disability, which restricted and limited their activities.
At T12 , they presented lower values in terms of the extent of the disability, represented
by the ICF qualifiers, mainly in the categories of performance and capacity, when
compared with the beginning of treatment. Likewise, the DASH scores decreased, which
expresses an improvement in upper limb function.
[Table 4 ] shows the t-paired test analysis comparing the mean scores on the ICF checklist
and DASH at T0 , T4 , and T12 . The score on the ICF checklist showed improvement in all domains as early as T4, except for the environmental factors, which only improved at 03 months (p = 0.037). In the evaluation of the DASH, the patients had already reported an improvement
in shoulder function at T4 (p = 0.019), which improved even more at the end of data collection (T12 ).
Table 4
T0 X T4
T4 X T12
T0 XT12
p *
p *
p *
ICF Checklist
Body functions
0.000
0.000
0.000
Body structures
0.000
0.841
0.000
Activity and participation – performance
0.000
0.005
0.000
Activity and participation – capacity
0.000
0.000
0.000
Environmental factors
0.134
0.547
0.037
DASH
0.019
0.003
0.000
Discussion
The functionality of AC patients improved after four weeks (T4 ) of SSNB injections (one per week) according to the two patient-reported outcome
measures used: the ICF checklist and the DASH. This improvement continued until three
months after the beginning of the treatment (T12 ). The single ICF domain that improve only in T12 was environmental factors.
We need to know more about the health status of people with AC. The data collected
in the present study contributed to the assessment of the treatment, and they can
point to a new perspective regarding the assessment of functionality in the field
of orthopedics.[22 ] The results of the present study showed that the ICF checklist and the DASH enable
the identification of the level of impairment of the individual and of the upper limb
before the procedure, as well as the clinical evolution after it.
Studies[23 ]
[24 ] on other health conditions that used the ICF checklist highlighted the value of
this tool.[23 ]
[24 ] Magalhães et al.[23 ] evaluated work-related repetitive stress disorders/ musculoskeletal disorders, and
found that, the ICF enabled the identification of the clinical and social aspects
experienced by patients during rehabilitation and their return to work. Silveira et
al.[25 ] evaluated individuals with Parkinson disease, and the results demonstrated that
the ICF seems to have good ability and sensitivity to address aspects of functionality
regarding this disease.
Access to information about functionality has been a priority in the treatment of
certain diseases, and the ICF is a tool with great applicability to guide these functionality
processes.[26 ] Therefore, there is a need to check the importance of including the ICF in the clinical
measures, as it considers the biopsychosocial context in which the individual is inserted.
In the present study, all ICF domains had already improved in the outcome studied
at T4 , except for the “environmental factors.”
These “environmental factors” are composed of the physical, social and environmental
actions through which people live and lead their activities.[9 ]
[12 ]
[15 ] In the present study, the results showed that the environmental factors did not
represent barriers (negative) or facilitators (positive) before T12 , and that the lived experience did not interfere with the disease nor impacted the
individual's functionality. It is important to know that this domain still lacks clarity
about the scope of the personal factors, and if it really represents an influence
on the individual's specific functionality.[10 ]
[12 ]
[26 ]
Jung et al.[27 ] compared the efficacy of SSNB and intra-articular corticosteroid injection in two
intervention groups during a two-month evaluation, and they concluded that the association
of interventions significantly improved the pain and functional outcomes of the patients.
In the present study, the parameters that indicate significant improvement were observed
in the first month of treatment with the SSNBs (T4 ), which was confirmed by the DASH and the ICF checklist.
The strategy used in the present study was composed of four injections of SSNB in
seven-day intervals over the course of four weeks; however, Mortada et al.[28 ] compared single and multiple blocks (nine injections) in three weeks, and they highlighted
that this number of injections yielded better results than a single one. In the present
study, improvement in shoulder function was observed with fewer applications until
12 weeks, which corroborates the findings by Haque et al.,[29 ] who recommended the SSNB as the initial procedure of choice in patients with AC.
The guidance by ultrasound[28 ] or anatomical limits[8 ] is effective regarding the SSNB, with comparable results.[30 ]
The use of the DASH to assess upper limb disabilities before and after the treatment
is satisfactory, as it is easy to apply, and enables the monitoring of the patient
in the clinical setting.[21 ] A wide variety of available outcome tools, including the DASH, demonstrate acceptable
levels of measurement properties, and are appropriate for virtually every patient
with a shoulder disorder.[22 ]
The limitations of the present study include the lack of a control group submitted
to another intervention for comparison. Some risk factors were not analyzed, neither
were the comorbidities and other methods of treatment. The non-probabilistic sampling,
of the consecutive type, may have imposed a selection bias, not enabling all patients
to participate in the study. Moreover, we do not know if more severe AC patients had
worse results.
However, the strengths of the study are the validated instruments (with good internal
consistency that have been translated into Brazilian Portuguese, which enables the
comparison across different cultures); the longitudinal clinical design with follow
up; the well-defined eligibility criteria, and the absence of similar studies in the
literature. All patients were submitted to x-rays and magnetic resonance, as well
as to a complete clinical evaluation performed by the same shoulder specialist who
performed the SSNB, who was not the same researcher who collected the data.
The simultaneous application of the DASH and ICF tools (patient reported outcome measures
) in AC patients is the novelty of the present study. The correlation of these two
instruments applied in AC patients is under analysis to be published in the near future,
which will enable us to understand if they complement each other or not.
Conclusion
According to the ICF and DASH, the SSNBs improve the functionality of AC patients.
This improvement lasted up to three months after the beginning of procedure. The single
ICF domain that only improved at T12 was “environmental factors”.
