Keywords
Chronic Cervical radiculopathy, Structural diagnosis and management, Regional approaches of Physiotherapy, McKenzie MDT, Pain medication
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Siddique MAE, Rahman MM, Islam MS et al. Physiotherapy versus pain medication for managing chronic cervical radiculopathy: protocol for a multi-arm parallel-group randomized clinical trial [version 1; peer review: awaiting peer review]. F1000Research 2023, 12:465 (https://doi.org/10.12688/f1000research.129158.1)
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Study Protocol
Physiotherapy versus pain medication for managing chronic cervical radiculopathy: protocol for a multi-arm parallel-group randomized clinical trial
[version 1; peer review: awaiting peer review]
PUBLISHED 04 May 2023
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Abstract
Corresponding author:
K. M. Amran Hossain
Competing interests:
No competing interests were disclosed.
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The author(s) declared that no grants were involved in supporting this work.
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© 2023 Siddique MAE et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Siddique MAE, Rahman MM, Islam MS et al. Physiotherapy versus pain medication for managing chronic cervical radiculopathy: protocol for a multi-arm parallel-group randomized clinical trial [version 1; peer review: awaiting peer review]. F1000Research 2023, 12:465 (https://doi.org/10.12688/f1000research.129158.1)
First published: 04 May 2023, 12:465 (https://doi.org/10.12688/f1000research.129158.1)
Latest published: 04 May 2023, 12:465 (https://doi.org/10.12688/f1000research.129158.1)
Introduction
Cervical radiculopathy (CR) is characterized by neck pain and radiculopathies towards the upper extremities and is one of the causes of musculoskeletal disability.1 Neck pain and associated disabilities are an increasing concern for working adults. In the last three decades, the global incidence of neck pain was 806.6 per 100000 people with a point prevalence of 3551.1 (95%CI: 3139.5 to 3977.9).2 In 2021, 22.9% of sedentary job holders in Bangladesh have neck pain.3 With an increasing rate, CR has a significant chronicity and recurrence rate. The years lived with disability (YLD) due to neck pain, and CR is 352.0 (245.6 to 493.3) among 100000 people.2 CR is caused mainly by cervical disc herniation; in 80% of patients, the C6 or C7 nerve roots are affected.4 Clinical features include pain in the neck and radicular symptoms in the upper limbs or chest. Radicular symptoms are pain directed towards the shoulder or arms, numbness, paranesthesia, weakness of upper limbs, and altered reflexes. The painful symptoms can be presented solely or with neurological symptoms.4 Diagnosis is confirmed through these clinical features; disc herniation can be evident through Magnetic resonance imaging (MRI) of the cervical spine.4 Chronicity of neck pain is considered if the painful impairments persist for more than 6 months.5 Conservative management is considered the first line of management for cervical radiculopathy; however, operative treatment is suggested when the patient has progressive neurological impairments or persistent or deteriorating painful symptoms.6 Conservative treatment covers a wide range of treatment options, including pain medications, physiotherapy as exercise therapy, and manual therapy in different specialized approaches, along with electrotherapies, minimally invasive techniques, assistive devices, and lifestyle modifications.7 Manual therapy is a passive approach applied by registered professionals and applied as therapeutic messages, oscillatory movements, mobilization, manipulative therapies, stretching, and structural correction that promotes healing reduces painful symptoms, restores mobility, and reduces disability.8 Exercise therapy is prescribed, instructed by therapists, and performed by patients.9 Manual or exercise therapies are applied to different specialized approaches such as the McKenzie concept, Mulligan Concept, and Cyriax concepts.8,9
McKenzie mechanical diagnosis and therapy (MDT) is a widely used specialized physiotherapy approach introduced in 1985; the hypothesis of the approach is based on the centralization of symptoms.10 In the MDT approach, every patient with neck or back problems receives individualized exercise, either in flexion or extension direction, through an assessment and diagnosis process. In a systematic review10 MDT was found to be effective in prompt pain reduction in the short term for less than 3 months for lumbar spine problems, but in the cervical spine trial,11 MDT and other exercise therapies had a similar short-term outcome in pain. However, MDT is evident to have a greater reduction of disabilities in the long term for more than 3 months compared to analgesic pain medications, therapeutic booklet, postural or back care advice, strength training, and spinal mobilization and exercise therapy.10 Regional approaches (RA) and structural diagnosis and management (MDT) are newer approaches than MDT. Regional approaches focus on the regional interdependence model where a region is treated rather than local treatment only. For cervical pain disorders, activating deep neck flexors and scapular muscles and stretching the upper cervical extensor and pectoralis muscles are widely used. It means treating the upper cross syndrome rather than only the cervical spine.12 Regional approaches support treating the cervical spine through repeated retraction, traction, and mobilization but also include the neck, shoulder, and thoracic regions for managing cervical radiculopathy. The study suggests RA is superior to McKenzie MDT and medication alone to reduce pain, improve cervical mobility, improve cervical muscle strength, reduce disability, and improve quality of life in chronic spinal mechanical pain patients.13 Structural diagnosis and management (SDM) is a newly developed approach for mechanical disorders of the spine causing neuromuscular impairments14 that involves a comprehensive assessment of the mechanical problems of a spinal segment focusing not only the affected segment but also the complete spinal and peripheral biomechanics. There are similarities between RA and SDM, but despite seeking the source of musculoskeletal problems in a scattered way, the SDM concept categorizes the problems as muscular dysfunction, myoneural dysfunction, and complete mechanical dysfunction based on the pattern and nature of neuromuscular structures involved. SDM hypothesis is that in mechanical musculoskeletal disorders, the first response comes from muscular tissues affecting their ability to stretch or be strengthened. With more involvement or chronicity, the neural structures respond by altering their ability to stretch or normal afferent, efferent or autonomic function; with prolonged impairment, the neural tissue gets sensitized. In these cases, both the muscles and nerves get involved. In the third stage, the articular surfaces or surrounding biomechanics get involved, too, leading to complete mechanical dysfunction. The manual or exercise therapy is targeted to the affected structures, and the treatment might not be given directly to the affected structures; associated structures are treated first15 to normalize the biomechanics and create the environment for a complete recovery. Till today, no published studies support the SDM approach in spinal mechanical pain and radiculopathies.
Evidence supports the effectiveness of manual therapy components such as therapeutic massage, mobilization, manipulation16–18 and exercise therapy on pain, mobility, and disability in cervical radiculopathy patients. MDT was found to be effective compared to exercise, advice, or pain medication,10,11 and RA was found to have a significant effect over MDT13 for overall spinal mechanical disorders. There is a research gap in examining the outcome of MDT, RA, and SDM separately over pain medication for CR patients.
The study has two-tailed hypotheses: SDM or RA or MDT, or pain medication is differentially effective in the remission of pain, increasing range of motion, reducing disability, and improving the overall quality of life in CR at 14 days and 28 days after baseline recruitment. The specific objectives are:
1) To elicit the within-group difference of SDM, RA, MDT, and pain medication in the remission of pain, increasing range of motion, and reducing disability in CR in mid-test (14 days) and post-test (28 days) compared to baseline.
2) To find out the effectiveness among groups (SDM, RA, MDT, and pain medication) and observations (pretest to post-treatment, pretest to mid-test, and mid-test to post-treatment) comparison in the remission of pain, increasing range of motion, reducing disability, in CR.
Methods
Study design
The study will be a prospective, four-arm randomized control trial (RCT) with the assessor and participant blinded to group allocation. 160 patients with cervical radiculopathy for more than 6 months will be enrolled with a hospital-based randomization process in 4 specialized centers of Dhaka to be recruited between July and December 2022. With a concealed allocation process, the patient will be recruited to any of the specialized physiotherapy approach groups, enrollment in only pain medication groups will be convenient to the respondents who willingly want to take medications only or dropped out from physiotherapy sessions after the initial day of assessment and management. All groups will have a similar number of respondents (n=40). For this trial, we will follow Standard Protocol Items: Interventional Trials 2013 (SPIRIT) guidelines, to maintain the quality of the interventional trial (Table 1).
Table 1. Standard procedure of the study protocols according to SPIRIT guidelines.
Study settings
Participants will be recruited and treated in three specialized physiotherapy set-ups, and one specialized hospital. The specialized physiotherapy setup includes the Agrani Specialized Physiotherapy center, Specialized physiotherapy and arthritis research center, and Unique pain and specialized physiotherapy center. The only pain medication group will be treated and follow up at Impulse hospitals limited. We are not disclosing the specification of centers for therapy group allocation to ensure the physiotherapists and the patients are blinded to group allocation. We are expecting similar baseline criteria of respondents as all of them are enrolled from Dhaka city, moreover, the block design may ensure more similarity of baseline. Collecting respondents from different centers will increase the rigor of the study and ensure that there was no cross-contamination of data.
Eligibility criteria
Participants will be included in this study with (1) any two of three diagnosis criteria of CR6 as (a) unilateral or bilateral radicular pain with or without neck pain, (b) paraesthesia or numbness and/or weakness, and/or altered reflex in the dermatome or myotome of cervical nerve root C2-C8, and (c) Magnetic resonance imaging (MRI) confirmed nerve root compression related with clinical findings. Other inclusion criteria include (2) CR for more than 6 months,5 (3) Brief Pain Inventory (BPI) pain severity score between 1 and 6 on an 11-point scale ranging from 0 to 10, (4) age between 18 and 50 years, to avoid the degenerative changes of the intervertebral disc, and (5) male or female sex. On the other hand, participants will be excluded if (1) any medical condition prevents the application of desired treatment confirmed by a consultant physician, (2) a pathological source of pain including TB spine, spinal tumor, or abscess, (3) early spinal fracture, (4) rheumatoid arthritis or ankylosing spondylitis, (5) red flags syndrome including cervical myelopathy, (6) patient unwilling or declined to participate in either physiotherapy approaches or pain medication, (7) dropped out within the first week of inclusion.
Interventions
Overall, four groups of participants will be receiving four independent treatment approaches for 4 weeks. The treatment will be provided by either McKenzie mechanical diagnosis of therapy (MDT) approach, regional approach (RA), structural diagnosis and management (SDM) approach, or only pain medication. There will be no added treatment to ensure the true effect is documented.
McKenzie mechanical diagnosis of therapy (MDT)
McKenzie MDT Cervical spine assessment, diagnosis, and treatment form of the McKenzie Institute will be used to diagnose and treat CR cases with a customized approach. The components of treatment are the findings from the assessment and test movements. The treatment team will consist of 5 physiotherapists working in the musculoskeletal area supervised by a consultant physiotherapist completing McKenzie A and B Module from the McKenzie Institute.
Regional approach (RA)
The regional approach is applied through an assessment and treatment model (Extended data 132). The assessment model screens CR as the 1st step of problems and examine the whole region of cervical, thoracic and upper limb region as 2nd and 3rd step. In the 4th step, RA categorizes the screened impairments in a biopsychosocial model. Ra is a universal concept, the diagnosis and treatment are based on a hypothetical principle that asks for examining a region instead of any specific structures. The treatment components are basic manual therapy approaches categorized by correction of asymmetry of alignment, treatment of soft tissues, and restoration of mobility. The RA treatment team consists of 5 physiotherapists working in a musculoskeletal physiotherapy set-up supervised by another physiotherapist with a doctoral degree in evaluating RA concepts13 on spinal mechanical problems.
Structural diagnosis and management (SDM)
SDM is an assessment and treatment approach for musculoskeletal problems. SDM cervical spine assessment (Extended data 232) has 5 parts. The components consist of subjective assessment, history, pain assessment at six states, selective cervico-dorsal muscle stretch and strength test, neurological assessment of sensory and motor examination of C1- C8 nerve roots, Dural test or sign, and nerve sensitivity test. From these assessments, a provisional diagnosis of affected structures is made, and the treatment is specified according to the findings of the above assessment. This treatment is provided by a team of 5 physiotherapists supervised by two advanced practice physiotherapists with a minimum experience of 16 years in musculoskeletal physiotherapy.
Pain medication
Physicians will prescribe a wide range of medications to control pain and associated impairments as a simple analgesic as paracetamol, tramadol/paracetamol, codeine-based analgesics, non-steroidal anti-inflammatory pain medication, opioid analgesics, muscle relaxants, corticosteroids, GABA receptor agonists, neuropathic medications.7 The prescribing physicians will be either an orthopedic surgeon, neurologist, neurosurgeon, general practitioner, or physiatrist.
Physiotherapy approaches will be provided once to twice a day for a maximum of 45 minutes session, 5 days a week for 4 weeks, and the pain medication will be prescribed twice or thrice a day, for 4 weeks. The intervention will be monitored through a checklist (Extended data 332). We anticipate no major adverse effects, but a checklist will be maintained (Extended data 432) for monitoring adverse events of the intervention.
Outcome measurement
Primary outcomes
Pain
A Brief Pain Inventory (BPI) will be the outcome measure for pain. BPI measures pain through 3 subscales covering all domains of impairments, 1) pain severity, 2) pain affective interference, and 3) pain physical interference. Pain severity is measured by a 0 to 10-point scale indicating no pain to pain as bad as can be imagined. It is calculated by the mean of four items. The pain affective interference has seven items scoring 0 to 10 and calculated through average. The pain physical interference is three items scoring 0 to 10, measuring how pain interferes with a person’s activity and livelihood. The BPI is a widely used and recommended tool for musculoskeletal neuropathic pain outcomes.19
Range of motion
A goniometer reading will be employed to measure the range of motion (ROM) of the cervical spine. A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry. This is a universal tool to measure ROM, also valid to measure ROM of the cervical spine.20
Disability
The neck disability index (NDI) will be used to determine disability induced by CR. The NDI is the most widely used and most strongly validated instrument for assessing self-rated disability in patients with neck pain. It has been used effectively in both clinical and research settings in the treatment of this very common problem. When measuring neck and arm pain associated with impairment in Serbian patients with cervical radiculopathy, the NDI Scale is a reliable tool.21
Secondary outcome
Quality of life
World Health Organization Quality of life questionnaire (WHOQoL) brief questionnaire will be used to determine the quality of life for CR cases. The WHOQOL evaluates how people see their place in life concerning their objectives, expectations, standards, and worries as well as the culture and value systems in which they live. Over four years, it was jointly created in several centers with varied cultural backgrounds. The WHOQOL was successfully piloted on around 4500 respondents in 15 cultural contexts. The new WHOQOL Field Trial Form has been prepared and is currently undergoing field testing because of this data. The WHOQOL generates a multi-dimensional profile of quality-of-life scores across six categories and 24 sub-domains. The tool is validated for determining the quality of life in people having chronic pain.22
Participant timeline
Sample size
Teare and colleagues23 recommended a minimum of 35 cases in each group of a randomized clinical trial to obtain the precision of the pooled standard deviation and for true effect size. We will be trying to reach 160 samples in total with a minimum of 40 samples for a group.
Recruitment and randomization
We will perform hospital-based randomization to recruit CR patients from the population. Hospital-based randomization is a specialized process of cluster randomization. To prevent trial contamination, we will have separate centers acting as a cluster of samples. Patients attending three physiotherapy set-ups between July and December 2022 will be screened for eligibility and if recruited they will further have assigned to the specific physiotherapy treatment group by concealed allocation. The concealed allocation process for physiotherapy groups will be performed through the randomization of 120 numbers (except for the pain medication group) in Microsoft Excel software. Participants in the pain medication group will be clustered from the fourth setup (specialized hospital). After screening, the participant’s treatment center can be changed based on allocation, the centers are located in the city and have similar costs for treatment. Besides, the trial coordinator conducted written permission for the patient’s exchange. To ensure all the group’s recruitment is running with a similar nature and similar baseline criteria are being achieved, randomized block design24 for group allocation will be adopted.
Study procedure
The study will be followed according to the Consolidated Standards of Reporting Trials (CONSORT) guideline. The study procedure is summarized in Figure 1. After the screening, participants will be briefed about the study and a written informed consent form will be provided to the patients. After consent, four assessors from four centers will take the baseline assessment through the questionnaire. After the baseline assessment is completed, the files will be collected by the research team. Then, participants will be allocated to groups according to concealed process and respondents will be receiving interventions. After 2 weeks, participants will be contacted at their homes or feasible place to take the intermediate assessment by two blinded assessors. These two blinded assessors will also perform the post-treatment in a similar approach. The Baseline measurement includes socio-demographic and clinical information, BPI, ROM, NDI, and WHOQoL, the intermediate test includes BPI, ROM, and NDI and the post-treatment includes BPI, ROM, NDI, and WHOQoL.
Figure 1. Reporting guideline [Consolidated Standards for Reporting Trials (CONSORT)].
Minimization of bias and blinding process
All participants except the pain medication group will be blinded to the interventions. The pain medication group will be chosen according to the patient’s interest in not receiving physiotherapy despite of prescription by a physician or any health professionals. The treatment providers will be blinded to the groups, but they will be aware of the treatment of their group. As this will be a multi-center trial, participants, and intermediate and post-treatment assessors will be blinded in this study. Participants will be blinded to the group allocation but not blinded to the treatment components of their group as they will pay for the interventions. The research team will not participate in the trial execution and there will be a separate assessor, treatment provider, monitoring team, and trial manager to ensure the coordination of the trial.
Monitoring
A monitoring team consisting of 4 physiotherapists, who are not participating in the trial in any other duties will monitor the (1) intervention chart and (2) adverse events chart (Extended data 3 and 432) and execute the blocking process of enrollment of the trial. They will report to the trial manager. The monitoring team will also keep the filled-up questionnaire, audit the data, and carry out any interim analysis. Any kind of changes in the methods or intervention will be reported to the IRB by the principal investigator through the monitoring team.
Safety measures and managing adverse effects
It is expected that the stated protocol will have no major adverse events, but if any unexpected event occurs during or after intervention this will be noted, and primarily reported to the concerned professionals by the monitoring team. The concerned therapist will note it in their Subjective, Objective, Analysis and Plan note (SOAP note) and later inform the principal investigator. Before starting treatment, the patient should be informed that if they feel pain, skin irritation, or any kind of discomfort they must report it to their physiotherapist. Any serious harmful effects will be documented and reported during the final publication of the trial.
Data analysis
Data will be analyzed according to its nature by SPSS version 23, and R-4.2.1 for Windows. Screening for normal distribution will be carried out by bell curve, skewness, kurtosis, Kolmogorov–Smirnov test, and Shapiro–Wilk test. Descriptive analysis will be performed using the arithmetic mean and standard deviation for continuous data, and frequency and percentage for categorical data. Baseline computability, between group intermediate and post-treatment changes among four groups, will be performed using MANOVA or Multivariate Kruskal-Wallis (MKW) test based on the distribution of data. Within-group changes among three measurements will be performed by repeated measure ANOVA or Friedman's ANOVA, and subsequent post-hoc tests will be conducted by Paired sample t-test or Wilcoxon test. For missing data, we will use the intention to treat the analysis process. The level of significance P < .05, in the case of post hoc Bonferroni correction, will be made as P < .0125.
Ethical issues and informed consent
The trial obtained ethical permission from the Institute of Physiotherapy Rehabilitation and Research of Bangladesh Physiotherapy Association (BPA) (IPRR/IRB/24/02/2022/063) on 24th February 2022. Also, the trial is registered to the Clinical Trial Registry India, the primary trial site of the World Health Organization (CTRI/2022/03/040922) on 8th March 2022. The researcher will abide by the Helsinki declaration as per ethical guidelines. Before enrollment, a written informed consent (Extended data 532) will be signed by the trial participants. The participant’s participation will be voluntary, and they will have the right to withdraw from the trial at any time during the trial. The participants will be assured that participation or withdrawal from the study will not make any change to their regular treatment process. The principal investigator and data auditors will have access to the final trial dataset, after making the process anonymous, the authors will have access to the unanimous data. The investigators are independent persons to assess the patients and document in hard copies, they are contracted not to have any disclosure or access to final data. There will be post-trial care if any adverse effects are noted. As the treatment process is mainly based on exercise and manual therapy, we anticipate no serious adverse effects.
Reporting
For generating the protocol, we followed Interventional Trials 2013 (SPIRIT) guidelines (Table 1),32 and for the RCT we will follow Consolidated statements for reporting randomized trials (CONSORT) guidelines (Figure 1).
Dissemination
After the end of the trial, a seminar will be conducted to share the results of the trial with relevant stakeholders. A research paper will be submitted to an indexed journal for publication of the original research. Besides, training sessions for physiotherapy professionals will be arranged based on the most effective treatment concept from the trial. The trial results will be published as open access to ensure the maximum visibility of the original research.
Discussion
Chronic cervical radiculopathy (CR) causes a significant disease burden and has a high chance of recurrence.2 Using pain medications and muscle relaxants mimics the inflammatory responses and provide symptomatic relief. Once painful symptoms reduce, the biomechanics of the cervical spine might be normalized. Pain medications have a significant short-term recovery of up to 8 weeks,25 with recurrent episodes the deviation of normal biomechanics becomes inevitable. McKenzie mechanical diagnosis and therapy (MDT) approach enhances the restoration of normal biomechanics of the cervical spine by promoting postural correction and education and maintains osteokinemetic and arthrokinemetic motion of cervical motion segments through test movements and manipulative approaches.10 Thus MDT provides a longer remission of pain and prevents disability from less than 3 months compared to pain medications.11 With the chronicity for more than 6 months5 and recurrent episodes of CR, the cerivo-dorsal and upper extremity become involved thus new structures contribute to the biomechanical abnormality as secondary consequences. Both Regional approaches and SDM concentrates on the overall cervico-dorsal and upper-cross-region, the treatment approaches and sequences are different. Regional approach (RA) is an open-ended theoretical basis of assessment and figuring out what chain mechanism is impaired and treating a region or multiple joints/structures.13 Structural diagnosis and management (SDM) is a structured process that can detect the specific structure(s) involved in the impairment and measure the extent of involvement. The management approach of the regional approach can be implemented by active means such as self-treatment or passive means when the therapist releases or stretches. So, it is the integration of treatment and formulation of an open-ended approach based on careful physical examination and observation so that any component of the impaired chain does not misses. On the other hand, SDM is very selective in the treatment in terms of structural involvement. The clinical reasoning framework is presented in Table 2.
Table 2. Clinical reasoning framework of interventions.
Musculoskeletal health complaints are a growing concern in Bangladesh, and post-COVID-19 pandemic era, the disease burden of musculoskeletal complaints is being more significant. A study finds26 that 21.4% of post-COVID cases had neck pain compared to non-COVID cases (8.9%), similarly, the increasing prevalence was noted for people with a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in arm pain (10.3% vs 4.3%, P = .001), upper back pain (16.6% vs 7.5%, P ≤ .001), and shoulder pain (17.1% vs 3.2%, P ≤ .001). These health complaints warrant intensive investigation and appropriate treatment approaches,27 and physiotherapy interventions are recommended as first-line management. However, in reality, 12% of Bangladeshi physiotherapists always follow appropriate recommendations for treating musculoskeletal cases.28 So, there is a research gap in evaluating specialized physiotherapy approaches in prevalent musculoskeletal conditions in the Bangladeshi context.
The trial is designed carefully following the standard protocols (SPIRIT and CONSORT) and multiple layers of blinding or masking were applied to maintain the rigor of the trial. The outcomes were chosen with appropriate validity and reliability. Brief pain inventory,29 Goniometry,20 Neck pain disability index,30 and WHO quality of life assessment brief questionnaire,22 all have satisfactory psychometric properties. The translation process of the questionnaire requires an appropriate procedure31 needs to be addressed appropriately. The study has four groups and four enrollment and treatment centers, which is complicated, and synchronized to obtain the true effect of the interventions.
To our best knowledge, this is the first study to examine the comparative effectiveness among one established physiotherapy concept (MDT), two new approaches of physiotherapy (RA and SDM), and pain medication for chronic cervical radiculopathy. The duration of trial outcome is brief (4 weeks), but the study will guide future trials on short-term (<3 months) and long-term (>6 months) outcomes of these interventions. The indicators of outcome are diverse and designed to address the outcome in a Biopsychosocial context. The study will guide clinical practice and address the long-term disabling consequence of CR. The population of the trial is confined to a city; therefore, the external generalization of the findings will be a challenge. But the implication of this trial will guide new inquiries and establish the effect of newer approaches to physiotherapy treatment.
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how to cite this article
Siddique MAE, Rahman MM, Islam MS et al. Physiotherapy versus pain medication for managing chronic cervical radiculopathy: protocol for a multi-arm parallel-group randomized clinical trial [version 1; peer review: awaiting peer review]. F1000Research 2023, 12:465 (https://doi.org/10.12688/f1000research.129158.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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