Trial Review

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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
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] 303266 0
None
Universal Trial Number (UTN)
U1111-1260-5847
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 320452 0
Condition category
Condition code
Musculoskeletal 318344 318344 0 0
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] 319567 0
Diagnosis / Prognosis
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326314 0
Pain level following an anaesthetic injection (NPRS)
Timepoint [1] 326314 0
10 minutes following injection to be assessed at the first and second appointment.
Secondary outcome [1] 391013 0
Oxford shoulder score
Timepoint [1] 391013 0
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] 391014 0
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] 391014 0
performed during the first assessment only.
Secondary outcome [3] 392201 0
Central sensitisation index
Timepoint [3] 392201 0
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] 392240 0
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] 392240 0
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] 393252 0
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] 393252 0
performed at both the first and second appointments prior to the injection and following the injection
Secondary outcome [6] 393253 0
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] 393253 0
performed at the first appointment prior to the injection
Secondary outcome [7] 393254 0
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] 393254 0
This test was part of the reliability study but will not be included in the diagnostic accuracy section of the study
Secondary outcome [8] 393255 0
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] 393255 0
performed at both the first and second appointments prior to the injection and following the injection- Only in the reliability study
Secondary outcome [9] 393256 0
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] 393256 0
performed at both the first and second appointments prior to the injection and following the injection
Secondary outcome [10] 393257 0
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] 393257 0
performed at both the first and second appointments prior to the injection and following the injection
Secondary outcome [11] 393258 0
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] 393258 0
performed at both the first and second appointments prior to the injection and following the injection
Secondary outcome [12] 393259 0
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] 393259 0
performed at both the first and second appointments prior to the injection and following the injection
Secondary outcome [13] 393260 0
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] 393260 0
performed at both the first and second appointments prior to the injection and following the injection
Secondary outcome [14] 393261 0
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] 393261 0
performed only at the first appointment
Secondary outcome [15] 393262 0
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] 393262 0
performed at both the first and second appointments prior to the injection and following the injection
Secondary outcome [16] 393263 0
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] 393263 0
performed at both the first and second appointments prior to the injection and following the injection
Secondary outcome [17] 393264 0
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] 393264 0
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?
No
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
58
Recruitment outside Australia
Country [1] 23412 0
New Zealand
State/province [1] 23412 0
Auckland

Funding & Sponsors
Funding source category [1] 307677 0
Other Collaborative groups
Name [1] 307677 0
The New Zealand Manipulative Physiotherapists Association
Country [1] 307677 0
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] 308375 0
None
Name [1] 308375 0
Nil
Address [1] 308375 0
Nil
Country [1] 308375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307713 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 307713 0
Ethics committee country [1] 307713 0
New Zealand
Date submitted for ethics approval [1] 307713 0
01/11/2020
Approval date [1] 307713 0
03/12/2020
Ethics approval number [1] 307713 0
20/STH/203

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108238 0
Ms Monique Baigent
Address 108238 0
Middlemore Hospital physiotherapy outpatients
100 Hospital Road
Otahuhu
Auckland 2025
Country 108238 0
New Zealand
Phone 108238 0
+64 21 051 0780
Fax 108238 0
Email 108238 0
[email protected]
Contact person for public queries
Name 108239 0
Monique Baigent
Address 108239 0
Middlemore Hospital physiotherapy outpatients
100 Hospital Road
Otahuhu
Auckland 2025
Country 108239 0
New Zealand
Phone 108239 0
+64 21 051 0780
Fax 108239 0
Email 108239 0
[email protected]
Contact person for scientific queries
Name 108240 0
Steve White
Address 108240 0
Senior Lecturer Physiotherapy
Program Leader, Postgraduate Musculoskeletal Physiotherapy
Auckland University of Technology
AA 254C, Akoranga Campus, Northcote 0627
Private Bag 92006
Auckland
Country 108240 0
New Zealand
Phone 108240 0
+64 9 921 9999
Fax 108240 0
Email 108240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

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



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