F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.140402.1 Study Protocol Articles A cross sectional study of high-resolution ultrasound and magnetic resonance imaging findings in shoulder joint pain in a tertiary care hospital in central India

[version 1; peer review: 1 not approved]

 Bhagyasri Nunna Conceptualization Methodology Project Administration Writing – Original Draft Preparation Writing – Review & Editing a 1 Parihar P.h. Conceptualization Project Administration Supervision Validation Writing – Review & Editing 1 Department of Radio-diagnosis, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India bhagyasree.nunna@dmiher.edu.in

No competing interests were disclosed.

 3 10 2023 2023 12 1259 15 9 2023 Copyright: © 2023 Bhagyasri N and Parihar Ph 2023 This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Introduction: Shoulder joint injuries are frequent. The shoulder joint is particularly prone to joint dislocation because of its distinctive anatomy. There are several causes of the sore shoulder, however shoulder impingement is the most common one due to its widespread causes. High-resolution ultrasonography (USG) and magnetic resonance imaging (MRI) are the primary imaging modalities for assessing suspected rotator cuff injuries. Ultrasonography is a method of first choice for evaluating rotator cuff injuries due to its widespread availability, lower price, and improved tolerance. Patients with questionable USG results may be given an MRI.

Aim and objective: To evaluate high-resolution ultrasound and MRI findings in shoulder joint pain.

Methods: A prospective cross-sectional study will be conducted on 93 patients, who come to Acharya Vinoba Bhave Rural hospital associated with Jawaharlal Nehru medical college, a tertiary care center situated in the state of Maharashtra in India between the time frame of July 2022 to July 2024. Patients with shoulder joint pain will be submitted to a primary investigation ultrasound, followed by an MRI if there is any concern, according to the inclusion criteria. Using statistical methods, the strength of agreement between ultrasound and MRI will be found out.

Outcome measures: The outcome will correlate ultrasound and MRI findings in shoulder joint pain and describe the relationship between the two.

 Magnetic Resonance Imaging Rotator Cuff Tears Ultrasonography The author(s) declared that no grants were involved in supporting this work. Introduction

Because it is a ball and socket joint with no fixed rotational axis and a wide range of motion in several planes, the shoulder joint is less stable than mobile. It is used to move the hand in almost any direction, as well as for powerful throwing, climbing, and crawling. 1 The rotator cuff is protected by the capsule and tendons that make the rotator cuff more stable. Shoulder pain can be caused by acute trauma, degenerative diseases, and impingement syndrome. Shoulder pain is the most common problem that brings patients to orthopedics. Soft tissue disorders (impingement syndrome) affecting the tendons and bursae are the most frequent cause of shoulder pain. Physical examination may make it challenging to diagnose the cause of shoulder pain. Clinical diagnosis' accuracy is inferior to that of arthroscopy. 2

Cuff tears, cuff strains, and impingement syndrome are a few different lesions that can cause shoulder joint pain. In clinical settings, it might be challenging to distinguish between cuff lesions and glenohumeral instability. 3 As a result, it is the musculoskeletal ultrasonography that is carried out most frequently. Ultrasound imaging has improved resolution, provides a better understanding of the illness and yields high accuracy in the detection of rotator cuff diseases. Repeated active and passive stresses cause tendon degeneration, which leads to tendon swelling and subluxation. Impingement syndrome occurs due to lack of space between the humeral head and the acromion. Patients who visit the imaging center typically have pain and limitations on movement when abducting the arm, which are symptoms of shoulder joint instability. 4

High-resolution ultrasound is a non-invasive, low-cost treatment that uses no radiation and has a high sensitivity for diagnosing rotator and non-rotator cuff diseases. 5 It is used in conjunction with magnetic resonance imaging (MRI) to examine the shoulder joint. The accuracy of high-resolution ultrasonography in diagnosing partial or full rotator cuff muscle tears is high. The most efficient investigation to find any abnormalities in the shoulder joint's anatomy is now MRI. 5

For the past 20 years, musculoskeletal ultrasonography has had a proper place in the literature alongside MRI. The affordability and accessibility of ultrasound are among its main benefits. Since it enables a more rapid comparison, the ability of dynamic ultrasound imaging of the shoulder to compare one side to the other side in real time is essential. 6 However, learning is difficult because it depends on the operator. It is less helpful in the case of rotator cuff interval. In this study, 93 patients who presented to the hospital with shoulder joint pain will be considered for both the modalities. The study's major goal is to show that ultrasonic examination is as useful as MRI in diagnosing shoulder pain, particularly in rotator cuff disorders.

 Methods Study design

The study will employ a cross sectional design to investigate the high-resolution ultrasound and magnetic resonance imaging findings in shoulder joint pain in patients at an Acharya Vinoba Bhave Rural Hospital setup over the 2022–2023 period.

 Study population

The study population will consist of patients who will be recruited from the patient population attending a rural hospital or clinics that serve as a primary healthcare center for the surrounding rural community.

 Place of study

The current research will be carried out at the department of radiology within the rural hospital setup of Datta Meghe Institute of Higher Education and Research (DMIHER).

 Ethics and consent

The research protocol got approval from the Datta Meghe Institute of Higher Education and Research (Deemed to be university) Institutional ethical committee in the meeting held on 11-07-2022 with DMIMS (DU)/IEC/2022/28. All the participants will be educated about the research, and written and verbal informed consent will be obtained from all the participants prior to the intervention.

 Participants

Inclusion criteria

A history of shoulder pain in one or both joints.

Trauma in the past without any fracture around shoulder joint.

Suspected rotator cuff injury (partial and complete tears), injury to biceps tendon, or calcific tendinitis.

Exclusion criteria

Infective arthritis and rheumatoid arthritis cases that have been identified.

Shoulder surgery or prosthesis in the past.

Patients who have pacemakers, metal implants, foreign bodies in their eyes, or suffer from claustrophobia.

pt?>The trial will include patients who meets the inclusion criteria.

 Sample size consideration

The formula to calculate the minimum sample size for agreement studies is: E = 1 − k 1 − power

Where:

n is the minimum sample size.

Z is the critical value for the desired level of significance (alpha error). For a 5% level of significance, Z is approximately 1.96 (for a two-tailed test).

Pa is the assumed proportion of agreement (the proportion of cases where both MRI and ultrasound evaluate as positive). MRI and ultrasound evaluate 50% of cases as positive, so = 0.5 Pa = 0.5.

E is the margin of error. The desired power (1 - beta) and the kappa coefficient. A kappa coefficient of 0.79 and 80% power, so E calculated as follows:

Substituting the values into the formula: E = 1 − 0.79 1 − 0.80 = 0.4243

Now, plug these values into the formula for n: Sample size N = n 1 = n 2 = 2 1.96 2 ∗ 0.5 ∗ 1 − 0.5 0.4243 2 = 92.52 per group

Rounded up to the nearest whole number, the minimum sample size to achieve a power of 80% and a kappa coefficient of 0.79 with a 5% level of significance is approximately 93 subjects. Reference study. 7

Procedure

All eligible participants meeting the inclusion criteria will be actively recruited for participation in the study. Prior to any procedures, explicit informed consent will be diligently obtained from all participants.

In the initial phase of the study, participants will undergo a high-resolution ultrasonography procedure, utilizing the Aloka Hitachi USG machine Arietta S70, equipped with a linear frequency probe ranging from 12 to 18 megahertz, complemented by color Doppler imaging capabilities. Participants displaying positive findings or any suspicious pathologies during the ultrasonography will subsequently be scheduled for magnetic resonance imaging (MRI), conducted on a state-of-the-art Philips 3 Tesla MRI machine.

This multimodal approach will facilitate the assessment of the agreement between ultrasound and MRI findings. Data collected will be meticulously recorded and formatted using Microsoft Excel spreadsheet version 010123. Subsequently, a comprehensive master chart will be meticulously created, serving as the foundation for subsequent statistical analyses.

 Outcome measures

Primary Outcome: The primary objective of this study is to assess the diagnostic efficacy of ultrasound compared to MRI in identifying rotator cuff injuries, particularly complete rotator cuff tears. The following specific parameters will be evaluated:

Measurement variable: Sensitivity and specificity of ultrasound and MRI in diagnosing complete rotator cuff tears.

Analysis metric: Receiver operating characteristic (ROC) curves will be used to determine the diagnostic accuracy of both imaging modalities.

Method of aggregation: Sensitivity and specificity scores will be aggregated and compared to assess overall diagnostic performance.

Time point: Evaluation will be conducted at the time of initial assessment, before any intervention or treatment.

Secondary Outcome: The secondary objective is to investigate the ability of ultrasound and MRI to detect partial tears of the rotator cuff. The specifics include:

Measurement variable: Sensitivity and specificity of ultrasound and MRI in diagnosing partial rotator cuff tears.

Analysis metric: Receiver operating characteristic (ROC) curves will be employed to evaluate diagnostic accuracy.

Method of aggregation: Aggregated sensitivity and specificity scores will be compared.

Time point: Assessment will be performed at the initial evaluation stage, prior to intervention or treatment.

Data management

The study material will be considered to be confidential documents and they will be safely stored with access only allowed for the principal investigator.

Statistical analysis of the study

To carry out the statistical analysis, R 4.2.0 software will be used. All the relevant statistical data collected will be tabulated on a spread/Microsoft Excel sheet. Statistical tests will be applied to the data using R 4.2.0 software and results will be drawn. The analysis will be done using a 5% level of significance (alpha error), 80% power, and the assumption that 50% of cases have been declared positive by both the MRI and the ultrasonography.

Study status

The study has not yet started. After the protocol publication we will start recruiting participants.

 Discussion

The study's main goal is to compare the imaging findings of high-resolution ultrasonography and MRI in patients with shoulder joint pain. This is cross sectional study that will be carried out in the Department of Radio-diagnosis in Jawaharlal Nehru Medical College. Before getting an MRI, which is a costly and time-consuming investigation, ultrasound can be used as the initial investigation to diagnose rotator cuff muscle tears. Using the data obtained, we will perform statistical analysis to see the agreement of ultrasound and MRI findings.

 Data availability

No data are associated with this article.

 References Naredo E Aguado P De Miguel E : Painful shoulder: comparison of physical examination and ultrasonographic findings. Ann. Rheum. Dis. 2002 Feb;61(2):132–136. 11796399 10.1136/ard.61.2.132 PMC1754006 Nørregaard J Krogsgaard MR Lorenzen T : Diagnosing patients with longstanding shoulder joint pain. Ann. Rheum. Dis. 2002 Jul;61(7):646–649. 12079911 10.1136/ard.61.7.646 PMC1754157 Creech JA Silver S : Shoulder Impingement Syndrome. StatPearls. Treasure Island (FL): StatPearls Publishing;2023 [cited 2023 Sep 5]. Reference Source Shah AB Bhatnagar N : Ultrasound imaging in musculoskeletal injuries-What the Orthopaedic surgeon needs to know. Journal of Clinical Orthopaedics and Trauma. 2019 Aug;10(4):659–665. 31316235 10.1016/j.jcot.2019.05.010 PMC6611988 Naganna HP Rangaswamy SM Puttaraju NC : Study of Rotator Cuff Disorders by Ultrasound with Magnetic Resonance Imaging Correlation. 2018;3:1. Page P Manske RC Voight M : MSK Ultrasound - An IJSPT Perspective. Int. J. Sports Phys. Ther. 18(1):1–10. 36793557 10.26603/001c.68184 Singh A Thukral CL Gupta K : Role and Correlation of High Resolution Ultrasound and Magnetic Resonance Imaging in Evaluation of Patients with Shoulder Pain. Pol. J. Radiol. 2017 Jul 28;82:410–417. 28819463 10.12659/PJR.901540 PMC5545625 10.5256/f1000research.153747.r400748 Reviewer response for version 1 Sam Nuralam 1 Referee https://orcid.org/0000-0003-1238-4091 Hasanuddin University, Makassar, Indonesia

Competing interests: No competing interests were disclosed.

 13 8 2025 Copyright: © 2025 Sam N 2025 This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. recommendation reject

- Ultrasound operator dependence and the absence of inter observer agreement evaluation are important issues that need to be widely addressed.

- Generalizability is limited by single-center design; multi-center validation is required.

- Claims of diagnostic accuracy are undermined when there is no clinical outcome correlation or arthroscopic gold standard.

- Inadequate MRI follow-up or verification bias are not adequately addressed in the proposal.

Is the study design appropriate for the research question?

Partly

Is the rationale for, and objectives of, the study clearly described?

Yes

Are sufficient details of the methods provided to allow replication by others?

Yes

Are the datasets clearly presented in a useable and accessible format?

Yes

Reviewer Expertise:

musculoskeletal consultant in Rehabilitation medicine and electromyographer

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.