ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000348853

Ethics application status

Approved

Date submitted

27/01/2021

Date registered

26/03/2021

Date last updated

27/02/2023

Date data sharing statement initially provided

26/03/2021

Date results information initially provided

27/02/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Can clinical tests accurately diagnose chronic acromioclavicular joint pain?

Scientific title

Utility of Clinical Testing for Chronic acromioclavicular joint (ACJ) Injury: Reliability and Diagnostic Accuracy.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1260-5847

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

shoulder pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The first 20 consecutive participants will be included the inter-rater reliability component. These participants will undergo a standardised interview and physical examination with either the orthopaedic surgeon or an experienced physiotherapist (based on current practice). For each of the physical tests, the participant will grade the intensity of their pain using the Numeric Pain Rating Scale. Following this examination, the patient will be given a minimum of a 30 minute interval before a second clinician repeats the physical examination. All patients will be given standard care management after this assessment.

The next consecutive patients will be recruited into the diagnostic accuracy arm and examined using the standardised assessment as above by either the physiotherapist or an orthopaedic surgeon. The physical assessment however will differ from the reliability study as the it will only include tests that meet a threshold of 70% agreement and 04.1 PABAK in the reliability section. As a result we have included 17 physical tests instead of 22.
If they fit the inclusion criteria and have consented, they will be offered a diagnostic sub-acromial anaesthetic injection.
10 minutes following the injection participants will undergo the physical examination a second time to rate their pain scores. The 3 most painful tests from the first examination will be compared at the second assessment and the change will be calculated.
Patients with an 80% or greater reduction in pain intensity following this injection will be considered to have sub-acromial pain.
Patients who have less than an 80% reduction in pain intensity will offered an appointment (within 1-2 weeks) for an image guided anaesthetic injection into their ACJ. The lead researcher will call all Maaori participants the day before their radiology appointment to check if they have any questions or concerns and to encourage them to bring a support person should they wish. At this second appointment, the standardised physical examination will be repeated to establish baseline pain intensity prior to the ACJ injection. The injection will be performed by a radiologist or radiology registrar who will be blinded to the findings of the physical examination. Thirty minutes after this injection, the physical examination will be repeated so that any change in pain scores can be determined and recorded. Those participants with 80% or more relief of their pain following the ACJ injection will be diagnosed with ACJ pain.

All sessions will last 1.5-2 hours, this includes the reliability component and the 1st and 2nd appointments for the diagnostic accuracy component.
For the reliability component participants will fill out the questionnaires initially then the standardised assessment (interview, physical testing) will take 30 minutes, they will then be asked to wait in the waiting room for 30minutes before undergoing the physical assessment again (15minutes). Following this they will be offered standard management (15minutes).

In the diagnostic accuracy component participants will fill out their questionnaires, undergo their assessment (30 minutes) then have their subacromial injection and wait in the waiting room for a further 30 minutes. After this they will be taken through the physical assessment a second time (15 minutes). If they have a positive subacromial anaesthetic response they will then be offered standard management (15minutes). If they do not they will be booked in for a second appointment for an ACJ injection.
At the second appointment the physical assessment will be undertaken (15minutes), participants will have their anaesthetic injection into the ACJ performed by the radiologist and then wait 10minutes before repeating the physical assessment (15minutes). They will then be offered standard management options.

This process reflects standard care management which is being assessed then offered a diagnosis. The patient is then given treatment options which can include physiotherapy, a steroid injection, surgical management (not likely in this cohort) or perhaps further investigation i.e. imaging or blood tests.

5 examples of the physical tests are acromioclavicular palpation, active\passive range of motion and resisted flexion, abduction, external and internal rotation, paxinos test, resisted AC extension and the O’Briens compression test.
For a full list of the tests please see the appendix of the PGR1 attached.

The first injection into the subacromial space will not be image guided. The decision to perform this injection without image guidance is a pragmatic one. This is standard practice at the outpatient clinic and it is not appropriate to change this component of their diagnostic workup. Research by Kane and Koski (2016) demonstrates the accuracy rate for a blind subacromial injection is 70-91%. This compares favourably to blind ACJ injections which have only 24% accuracy (Javed et al., 2017). Should the blind SAI be inaccurate participants are very unlikely to demonstrate a positive anaesthetic response and therefore still go on to have a guided ACJ injection.

The subacromial injection will be performed in the clinic. Participants will be seated with their arm relaxed by their sides and the posterior shoulder exposed. Under aseptic conditions, a 22-gauge needle will inserted into the subacromial space using a direct posterior approach. Approximately 5 mL of 1% lidocaine hydrochloride (xylocaine™) will be administered.

The ACJ injection will be administered by a radiologist under ultrasound guidance. Subjects will be positioned supine with the arm in external rotation. Under aseptic conditions, a 22-gauge needle will be inserted into the ACJ using a direct anterior approach. Approximately 5 mL of 1% lidocaine hydrochloride (xylocaine™) will then injected into the ACJ. The radiologist will record whether the ACJ is successfully infiltrated, whether the joint was difficult to access, whether the patient had a painful response and whether the injectate was contained within the joint.

4 experienced clinicians with a minimum of 10 years’ experience will be performing the assessments. Should the participant not perform the physical test correctly this will be repeated. If they are too sore or are unable to complete the test this will be recorded as “unable to complete the test” and a reason will be recorded. Should there be an indeterminate result this will also be recorded.

Counties Manukau DHB has a central computer database which records patients attendance and the participant’s outcomes will then be recorded in Redcap (data collection tool). Should they not attend they will be contacted and offered another appointment. If they wish to withdraw from the study their data will be marked as incomplete and a reason will be recorded.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Pain level following an anaesthetic injection (NPRS)

Timepoint [1]

10 minutes following injection to be assessed at the first and second appointment.

Secondary outcome [1]

Oxford shoulder score

Timepoint [1]

performed during the first assessment only. This will be filled out following the signing of the consent form and prior to the participant interview and physical assessment.

Secondary outcome [2]

shoulder subjective examination
This examination is based on the clinic's standard practice and has been standardised for this study. We have included questions that have been shown to link to predictors of ACJ pathology in the research.
-questions asked about the shoulder including aggravating factors, pain location, pain duration and functional limitations

Timepoint [2]

performed during the first assessment only.

Secondary outcome [3]

Central sensitisation index

Timepoint [3]

performed during the first assessment only. This will be filled out following the signing of the consent form and prior to the participant interview and physical assessment.

Secondary outcome [4]

Diagnostic accuracy of scapula range of motion tests with overpressure. This includes scapula retraction, elevation, depression and protraction. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [4]

scapula elevation and depression will not be included in the second part (diagnostic accuracy) of the study, they were included in the reliability study. Only retraction and protraction will be carried forwards.

Secondary outcome [5]

Diagnostic accuracy of a Patient generated provocative movement (the action will be described in the data collection). The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [5]

performed at both the first and second appointments prior to the injection and following the injection

Secondary outcome [6]

Diagnostic accuracy of presence of unilateral or bilateral ACJ deformity.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [6]

performed at the first appointment prior to the injection

Secondary outcome [7]

Diagnostic accuracy of palpation over the ACJ. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [7]

This test was part of the reliability study but will not be included in the diagnostic accuracy section of the study

Secondary outcome [8]

Diagnostic accuracy of the cross arm adduction stress test. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [8]

performed at both the first and second appointments prior to the injection and following the injection- Only in the reliability study

Secondary outcome [9]

Diagnostic accuracy of a external rotation adduction test. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [9]

performed at both the first and second appointments prior to the injection and following the injection

Secondary outcome [10]

Diagnostic accuracy of the AC resisted extension (resisted horizontal abduction). The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [10]

performed at both the first and second appointments prior to the injection and following the injection

Secondary outcome [11]

Diagnostic accuracy of Active compression test (O’Briens). This is positive if external rotation resisted is less painful than internal rotation. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [11]

performed at both the first and second appointments prior to the injection and following the injection

Secondary outcome [12]

Diagnostic accuracy of Paxinos Sign. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [12]

performed at both the first and second appointments prior to the injection and following the injection

Secondary outcome [13]

Diagnostic accuracy of Bell Van Reit test. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [13]

performed at both the first and second appointments prior to the injection and following the injection

Secondary outcome [14]

Diagnostic accuracy of the Hawkins Kennedy Test. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [14]

performed only at the first appointment

Secondary outcome [15]

Diagnostic accuracy of shoulder active range of motion measured with a bubble inclinometer (the participant sitting on the plinth). This will include flexion, scaption, internal rotation and external rotation. Internal rotation will be assessed by an indirect test of the participant putting their hand up their back. The level of spinous process the participant can reach up their back will be recorded. Pseudoparalysis or a painful arc will be noted. The pain rating will be measured (NPRS) and whether the test was provocative of their pain.
This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [15]

performed at both the first and second appointments prior to the injection and following the injection

Secondary outcome [16]

Diagnostic accuracy of shoulder resisted testing measured by manual muscle testing. This will include flexion, abduction, belly press (internal rotation) and external rotation with the participant standing and their arm at their side or in 20 degrees flexion or abduction. The pain rating will be measured (NPRS) and whether the test was provocative of their pain. This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [16]

performed at both the first and second appointments prior to the injection and following the injection

Secondary outcome [17]

Diagnostic accuracy of shoulder passive range of motion measured by a bubble inclinometer. This will include flexion, abduction, internal and external rotation (at 90 degrees abduction) with the participant supine. The pain rating will be measured (NPRS) and whether the test was provocative of their pain. This will be compared to a positive or negative positive anesthetic response (80% pain reduction) to an ACJ injection. This will be determined via assessment of specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

Timepoint [17]

performed at both the first and second appointments prior to the injection and following the injection

Eligibility

Key inclusion criteria

• Age 18 and above
• Legally able to give consent and fluent in English
• Persistent shoulder pain of 3 months or more in patients referred to the outpatient shoulder clinic at CMDHB
• Shoulder pain identified as the dominant symptom by both the participant AND clinician
• Pain of an intensity of two or more as determined by the Numeric Pain Rating Scale (NPRS) during testing
• X-ray or relevant imaging (e.g. MRI or CT) that depicts bone quality/morphology of the shoulder complex taken within 6 months prior to the date of data collection
• A provisional diagnosis of either chronic acromioclavicular (ACJ) pain or subacromial pain based on the standardised baseline assessment.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• a current or previous history of cancer of the head, neck, chest, thorax and upper limb.
• known rheumatological conditions with musculoskeletal manifestation e.g. polymyalgia rheumatica, spondyloarthropathy or rheumatoid arthritis
• current or previous osteomyelitis, avascular necrosis, fractures or dislocations around the shoulder complex
• previous ipsilateral shoulder or neck surgery
• any contra-indications to having an anaesthetic injection
• pain likely to be associated with a frozen shoulder, glenohumeral osteoarthritis (OA) and glenohumeral instability based on their imaging and standardized examination for stiffness or history of dislocation/subluxation.
• ipsilateral upper limb neuropathic pain (e.g. cervical radiculopathy, brachial plexopathy or other peripheral neuropathy)
• Clinical differential diagnoses requiring further investigation (laboratory, other imaging or referral to other medical specialty). i.e. suspicion of metastases, a clinical history that suggests an undiagnosed inflammatory arthritis or suspicion of an infection.
• Stage 5 Renal Failure on dialysis (Davison et al., 2021)

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment

Single group

Other design features

The radiologists administering the ACJ injection will be blinded to the assessment results
and the two clinicians during the reliability study will be blinded to the initial assessment results

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Demographic and other baseline characteristics, as well as prevalence of sub-acromial and ACJ pain diagnoses, will be reported as proportions for factor data and mean, standard deviation, extrema and quartiles for continuous data, stratified by Level 1 total response ethnicity, which will include Maori-specific descriptive statistics (Health Information Standards Organisation, 2017). Stratified results for total response non-Maori, non-Pasifika, as well as Polynesian (Maori or Pasifika) and non-Polynesian, will also be presented for comparison purposes. Given that there is no available research which examines prevalence of shoulder pathologies in Maori and Pasifika populations, this research presents an opportunity to explore potential inequity as a secondary aim. The study is not powered on this aim, which is opportunistic and in accord with guidelines from the Counties Manukau Health Ko Awatea Research and Evaluation Office

Reliability will be measured with Cohen’s k pooled over the 23 tests (De Vries et al., 2008). A 95% confidence interval for the Cohen’s pooled k will be obtained using the bootstrap (Efron & Tibshirani, 1993).

A mean pain intensity score will be calculated by averaging the reported pain intensity (using the NPRS) of the three most provocative of the 23 tests (Appendix 2), performed in the baseline physical examination for each participant. This mean pain score will be calculated again after the repeat examination that follows the FGAI. A positive anaesthetic response (PAR) will be considered to be an 80% or greater reduction in this mean score. A PAR will be considered evidence that the ACJ is the source of the patient’s pain.

Two by two tables will be utilised to calculate various measures of diagnostic accuracy, including specificity, sensitivity, positive and negative likelihood ratios and positive and negative predictive values.

The accuracy of combinations of test findings will explored via logistic regression analysis. Models of up to 8 predictors of the diagnosis (including some interactions to be determined) will be fitted and evaluated based on the criteria of area under the ROC curve (AUC) and misclassification using 10-fold cross-validation after parameter selection and shrinkage through the use of the elastic net (Friedman et al., 2010). The goal will be to obtain a well-performing 5-predictor model, but larger numbers of predictors will also be assessed for completeness. Analyses will be carried out using the current version of R (Core Team, 2020). The cross-validation and shrinkage will be carried out using the glmnet package (Friedman et al., 2010).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

8/04/2021

Actual

8/04/2021

Date of last participant enrolment

Anticipated

26/08/2022

Actual

8/12/2022

Date of last data collection

Anticipated

31/03/2023

Actual

8/12/2022

Sample size

Target

156

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

The New Zealand Manipulative Physiotherapists Association

Address [1]

39 Anzac Road, Browns Bay, Auckland 0630

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Dr Steve White

Address

Senior Lecturer Physiotherapy
Program Leader, Postgraduate Musculoskeletal Physiotherapy
Auckland University of Technology
AA 254C, Akoranga Campus, Northcote 0627
Private Bag 92006
Auckland

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/11/2020

Approval date [1]

03/12/2020

Ethics approval number [1]

20/STH/203

Summary

Brief summary

Chronic acromioclavicular joint (CACJ) pathologies are often misdiagnosed due to the limited diagnostic accuracy of individual tests and a poor correlation with radiographic imaging (Cadogan et al., 2011; Javed et al., 2017). This can result in negative impacts on a patient’s quality of life and increased healthcare costs (Deyo, 2002).This research includes an inter-rater reliability study with 20 participants and a prospective diagnostic accuracy study with 136 participants. The studies will be conducted in a tertiary care environment in collaboration with patients reporting shoulder pain who have been referred for specialist evaluation and treatment. Each patient will undergo a standardised clinical examination and a fluoroscopy guided anaesthetic injection (FGAI) into the acromioclavicular joint.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Monique Baigent

Address

Middlemore Hospital physiotherapy outpatients
100 Hospital Road
Otahuhu
Auckland 2025

Country

New Zealand

Phone

+64 21 051 0780

Fax

[email protected]

Contact person for public queries

Name

Ms Monique Baigent

Address

Middlemore Hospital physiotherapy outpatients
100 Hospital Road
Otahuhu
Auckland 2025

Country

New Zealand

Phone

+64 21 051 0780

Fax

[email protected]

Contact person for scientific queries

Name

Dr Steve White

Address

Senior Lecturer Physiotherapy
Program Leader, Postgraduate Musculoskeletal Physiotherapy
Auckland University of Technology
AA 254C, Akoranga Campus, Northcote 0627
Private Bag 92006
Auckland

Country

New Zealand

Phone

+64 9 921 9999

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Attachment
10346	Ethical approval	381295-(Uploaded-27-01-2021-10-21-22)-Study-related document.pdf
10347	Informed consent form	381295-(Uploaded-27-01-2021-10-21-55)-Study-related document.docx
10348	Study protocol	381295-(Uploaded-24-03-2021-06-06-13)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically