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71 (); 186-192
doi:
10.1016/j.jor.2025.09.001

Interventional therapies for subacromial impingement syndrome: A systematic review and fragility analysis of randomized controlled trials

, , , , , , , ,
a Department of Orthopaedic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA
b Union College, Schenectady, NY, USA
c Boston University, Boston, MA, USA

⁎Corresponding author: Auston R. Locke. auston.locke@icahn.mssm.edu

Received: , Accepted: ,
Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Abstract

Interventional therapies for subacromial impingement investigated by randomized controlled trials (RCTs) yield conflicting results and overemphasize p-values, with some studies indicating efficacy and others showing no clinical significance. To assess the statistical robustness of these findings, the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) were utilized in the analysis of RCTs examining interventional therapies in the context of subacromial impingement.

From January 1, 2000 to July 1, 2024, PubMed, Embase, and MEDLINE were systematically searched for RCTs or comparative trials that evaluated outcomes for patients with Subacromial Impingement. Of 300 studies screened, 38 RCTs were included for analysis. We calculated the FI and rFI to determine the number of event reversals needed to alter statistical significance. The FQ was then derived by dividing the FI by the study's sample size.

Across 150 outcomes, the median FI was 4 (IQR 3–6) with a median FQ of 0.061 (IQR 0.026–0.100), suggesting that just three outcome event reversals would alter significance. Of these, 31 outcomes were statistically significant also with a median FI of 4 (IQR 2–6) and FQ of 0.066 (IQR 0.033–0.099), while 119 outcomes were nonsignificant with a median rFI of 4 (IQR 3–6) and FQ of 0.060 (IQR 0.025–0.100). Notably, the number of patients lost to follow-up was greater than the outcome's respective FI or rFI in 39.4 % of all outcomes.

The efficacy of interventional therapies for subacromial impingement from RCTs is statistically fragile, particularly significant outcomes and studies with a high proportion of patients lost to follow-up. We recommend combined reporting of p-values with FI and FQ metrics to aid in interpreting clinical findings evaluating interventional therapies for subacromial impingement. Future studies may mitigate outcome fragility by obtaining higher follow-up rates and study sample sizes.

Keywords

Fragility analysis
Subacromial impingement
SAIS
Subacromial pain syndrome
Randomized controlled trials
Systematic review
Level of evidence: I
1

1 Introduction

Subacromial impingement syndrome (SAIS) is a common reason for non-specific shoulder pain, historically comprising 44–65 % of shoulder-related physician visits.48 Additionally, shoulder pain is typically a chronic, or relapsing complaint with 54 % of patients still experiencing persistent symptoms after 3 years from onset.11 With growing incidence and 6.5–9.6 new patients per thousand annually, the need for proven and widely supported treatments is crucial.14 RCTs and comparative studies have compared the efficacy of SAIS interventional treatments, such as surgery, corticosteroid injections and acupuncture, but have reported conflicting findings and lack consensus.4,10,16 Thus, it is unclear whether these interventional or invasive therapies in SAIS, like arthroscopic subacromial decompression, remain effective or require further clinical investigation.7,37,49

Outcomes from RCTs often drive clinician judgment for interventional therapies in SAIS due to their inclusion of the highest degree of evidence.29 While p-values are statistical significance measures of the efficacy of RCTs, their usage has faced criticism due to the p-value's dependence on the alpha 5 % threshold that is not necessarily absolute. Further, the p-values inability to account for different distributions within varying study variables, all design elements, other statistical metrics, and the number of patients lost to follow-up additional concern for conclusions dependent on its sole usage.15,27,51 To supplement and address limitations of the p-value, the FI has begun to be employed in orthopedic literature.47.17.3,5,8,9,16,18,19,28,30–36,39–46,53,54,55 FI is a statistical metric that indicates the number of outcome modifications needed to shift statistical significance from significant to nonsignficant.20 Similarly, rFI is calculated for nonsignificant outcomes by instead recording the number of outcome event reversals needed to achieve significance.2,23,26 Accounting for sample size, FQ reports the fraction of patients in a study that demand an outcome reversal event to alter statistical significance, with low FQs indicating fragility. As FQ can be calculated for both significant and nonsignificant outcomes, it is particularly effective in assessing the robustness of RCTs findings in hand with the p-value.20,52

The primary goal of this study was to analyze the statistical fragility of interventional therapies SAIS outcomes from RCTs using the FI, rFI, and FQ statistics. We hypothesized that SAIS outcomes from RCTs are statistically fragile and would be highly variable in FI, rFI, and FQ.

2

2 Methods

2.1

2.1 Literature review

The preferred reporting items for systematic reviews and meta-analyses (PRISMA) was adhered to in the construction of this systematic review.38 PubMed, Embase, and Medline were searched to develop a repository of RCTs that investigated SAIS treatments published between January 1, 2000 and May 1, 2024 (Fig. 1). SAIS related studies were identified by searching for keywords including (“Subacromial Impingement Syndrome" [Mesh] OR “Subacromial Bursitis" [Mesh] OR “Shoulder Impingement Syndrome" [Mesh] OR “subacromial impingement" [tiab] OR “shoulder impingement" [tiab] OR “subacromial bursitis" [tiab] OR “rotator cuff impingement" [tiab]) AND (treatment OR therapy OR rehabilitation OR surgery OR diagnosis OR prognosis OR outcome).

– PRISMA flow diagram showing identification, screening, and inclusion of eligible PubMed articles.
Fig. 1 – PRISMA flow diagram showing identification, screening, and inclusion of eligible PubMed articles.

Two independent reviewers (SS, JH) conducted the initial screening of studies based on the criteria listed below. Any conflicts were resolved by a third independent reviewer (AL). This screening process ensured that the included studies were RCTs related to SAIS, featuring two treatment groups and dichotomous outcomes, with at least one group involving an intervention such as surgery, injections, or acupuncture.22,24,25,56 Furthermore, studies were excluded if they were not in English or focused on cadaveric, biomechanical or animal results. This systematic review analyzed statistical reporting and significance rather than direct outcomes and did not qualify for the international prospective register of systematic reviews.

2.2

2.2 Included studies

The search for studies regarding interventional therapies (surgical, injection, acupuncture) for SAIS yielded 519 results; 120 were deemed irrelevant according to Covidence, 99 were duplicates, leaving 300 to be reviewed. Only 180 studies met the title and abstract screening requirements and 71 fulfilled the full text screening criteria, with 38 studies eventually included for data extraction (Fig. 1).

2.3

2.3 Data extraction

Two reviewers, SS and JH, extracted data from the 38 studies that met the inclusion criteria, documenting details for each of the 150 dichotomous outcomes identified across all studies. The recorded characteristics of these studies included the author, journal, publication year, minimum follow-up period, type of interventional therapy (surgery, injection, or acupuncture), specific interventions assessed, outcome measures, outcome categories (such as treatment success or failure, and adverse reactions), and the number of patients lost to follow-up. Studies were classified as surgical if they included at least one treatment group involving a surgical intervention. The p-value for each outcome was also recorded when available. SS and JH conducted a subgroup analysis considering factors such as publication year, significance level, outcome category, type of intervention, and patient attrition. The categorical outcome measures examined included the Visual Analogue Scale (VAS), adverse effects (e.g., worsening pain), pain reduction, use of painkillers, Global Rating of Change Scale, Shoulder Pain and Disability Index (SPADI), decisions to opt for surgery or additional surgery, patient satisfaction, duration of symptoms, and the Constant-Murley Scale.

2.4

2.4 Fragility analysis

The p-value (ɑ-threshold set to 5 %) was calculated for each outcome using a two-tailed Fisher's exact test. Significant outcomes yield a FI when determining the minimum number of outcome event reversals needed to lose significance Fig. 2. Similarly, the rFI was calculated by tracking the number of outcome event reversals, but instead for the nonsignificant outcomes to gain significance. The FQ, or the fraction of patients for a given outcome that need to have an outcome reversal event for the significance level to be changed, was determined by dividing the FI or rFI by the total sample size. The median and interquartile range (IQR) were calculated for the FI, rFI and the FQ for all outcomes; additionally, the median and IQR were determined for all groups and subcategories.

– Demonstration of statistical significance reversal with fragility index of 1. Data taken from Wang et al., Archive of Physical Medicine and Rehabilitation.
Fig. 2 – Demonstration of statistical significance reversal with fragility index of 1. Data taken from Wang et al., Archive of Physical Medicine and Rehabilitation.
3

3 Results

38 RCTs met the inclusion criteria of 300 studies screened, yielding 150 total outcomes reported. General information about the included studies is displayed in Table 1. Across these outcomes, the median FI was 4 (IQR 3–6) (Table 2), meaning a median minimum number of 4 outcome reversals would be necessary to shift statistical significance in either direction. The respective value for FQ across all outcomes was 0.061 (IQR 0.026–0.100), indicating an alteration in significance for an outcome reversal in 6.1 out of every 100 patients. In 16 of the 38 studies (42.1 %) and 62 outcomes (41.3 %), the median FI of 4 (IQR 1–6) and FQ of 0.028 (IQR 0.015–0.074) was less than the number of patients lost to follow-up. In the studies where FI greater than number of patients lost to follow-up, the median FI was 5 (IQR 3–6) and the associated FQ was 0.077 (IQR 0.050–0.111). Further, we found 31 (20.7 %) outcomes to be statistically significant with a median FI of 4 (IQR 2–6) and FQ of 0.066 (IQR 0.033–0.099), indicating 25 % of statistically significant studies could become nonsignificant with a reversal of two patient outcomes. Further, considering sample size with the FQ statistic, 25 % of the statistically significant studies would be altered by every 3.3 outcome reversals for every 100 patients. Conversely, a total of 119 (79.3 %) outcomes were determined to be statistically nonsignificant with a median rFI and FQ of 4 (IQR 3–6) and 0.060 (IQR 0.025–0.100), suggesting the nonsignificant outcomes to be slightly more robust than the significant outcomes due to a higher FI. Interestingly, despite a greater number of nonsignificant (119, 79.3 %) than significant (31, 20.7 %), the respective FI, rFI, and FQ values are nearly equal.

Table 1 Study characteristics, including authorship, year published, journal, sample size, and minimum follow-up.
Author Year Journal Total Sample Size Follow-up (mo.)
Bhayana et al. 2018 Journal of Clinical Orthopaedics and Trauma 60 3
Björnsson Hallgren et al. 2017 Acta Orthopaedica 97 3
Charbonnier et al. 2018 International Journal of Computer Assisted Radiology and Surgery 58 6
Crawshaw et al. 2010 British Medical Journal 201 0.25
Dogan et al. 2021 Journal of Experimental and Clinical Medicine 40 0.75
Dogu et al. 2012 American Journal of Physical Medicine and Rehabilitation 46 1.5
El-Sherif et al. 2023 Journal of Orthopedic Surgery and Research 60 2
Ellegaard et al. 2016 Arthritis Research & Therapy 99 3.25
Everts et al. 2007 European Surgical Research 30 0.25
Göksu et al. 2015 Acta Orthopaedica et Traumatologica Turcica 61 1
Haahr et al. 2006 Scandinavian Journal of Rheumatology 79 48
Henkus et al. 2006 Arthroscopy: The Journal of Arthroscopic and Related Surgery 33 0
Hewavithana et al. 2024 Skeletal Radiology 60 0.25
Jarvela et al. 2008 Arthroscopy: The Journal of Arthroscopic and Related Surgery 47 24
Johansson et al. 2005 Physical Therapy and Rehabilitation Journal 85 0
Johansson et al. 2011 Family Practice 89 6
Kardouni et al. 2015 Manual Therapy 45 0
Karthikeyan et al. 2010 The Journal of Bone and Joint Surgery 56 1.5
Ketola et al. 2015 Acta Orthopaedica 50 24
Ketola et al. 2016 Acta Orthopaedica 109 60
Ketola et al. 2009 Journal of Shoulder and Elbow Surgery 134 24
Kim et al. 2012 Journal of Shoulder and Elbow Surgery 80 3
Kolk et al. 2017 Journal of Shoulder and Elbow Surgery 43 108
Lee et al. 2011 The Clinical Journal of Pain 58 1
McCormack et al. 2000 The Bone and Joint Journal 44 6
McInerney et al. 2003 Emergency Medicine 98 3
Merivirta et al. 2012 Regional Anaesthesia and Pain Therapy 82 0.25
Michener et al. 2015 Manual Therapy 56 1.5
Parente et al. 2022 Annals of Rheumatic Diseases 26 1
Poon et al. 2014 The Journal of Bone and Joint Surgery 50 24
Radnovich et al. 2018 Journal of Pain Research 46 1
Rhon et al. 2014 Annals of Internal Medicine 98 12
Rutten et al. 2007 Acta Orthopaedica 20 2
Spangehl et al. 2002 Journal of Shoulder and Elbow Surgery 62 12
Taverna et al. 2007 Arthroscopy 60 3
Vas et al. 2008 Rheumatology 425 3
Wang et al. 2019 Archives of Physical Medicine and Rehabilitation 60 3
Woodmass et al. 2017 The Journal of Bone and Joint Surgery 56 24
Table 2 Fragility indices and quotients for all SAIS Interventional Therapy outcomes with stratification by outcome significance. Abbreviations: RCT - Randomized Controlled Trials, FI - fragility index, rFI - reverse fragility index, FQ = fragility quotient, IQR = interquartile range.
Number of Outcomes FI/rFI, Median (IQR) FQ, Median (IQR)
All RCT Outcomes 150 4 (3–6) 0.061 (0.026–0.100)
Significant Outcomes (P < 0.05) 31 4 (2–6) 0.066 (0.033–0.099)
Nonsignificant Outcomes (P ≥ 0.05) 119 4 (3–6) 0.060 (0.025–0.100)
FI < # of Patients Lost to Follow-Up 62 4 (1–6) 0.028 (0.015–0.074)
FI > # of Patients Lost to Follow-Up 88 5 (3–6) 0.077 (0.050–0.111)

The outcomes were further compared by rough decades (2000–2010 and 2011–2024), revealing similar FI/FQ medians and IQRs as shown in Table 3. Despite consistency between the decades in the number of outcomes (both 75) and FI/rFI (Median 4.5 and 4), there is a stark difference when sample size is accounted for with the FQ being 0.036 (IQR 0.017–0.098) and 0.070 (IQR 0.042–0.100) for years 2000–2010 and 2011–2024, respectively.

Table 3 Fragility indices and quotients for all SAIS Interventional Therapy outcomes with stratification by year published. Abbreviations: FI - fragility index, rFI - reverse fragility index, FQ = fragility quotient, IQR = interquartile range.
Number of Outcomes FI/rFI, Median (IQR) FQ, Median (IQR)
Published 2000–2010 75 4.5 (3–6) 0.036 (0.017–0.098)
Published 2011–2024 75 4 (3–5) 0.070 (0.042–0.100)

After categorizing outcomes by intervention (surgery, injection, acupuncture), injection therapies had the most outcomes with an FI of 4 (IQR 2–6) and FQ 0.051 (IQR 0.024–0.100) (Table 4). There were fewest acupuncture therapy outcomes (18, 12 %) which were determined to be highly variable as the median FI is 5 (IQR 3.5–22) compared to surgery median FI 4 (IQR 3–6) and injections median FI 4 (IQR 2–6). Although the injection group had the most outcomes (89, 59.3 %) it was still more variable by FI/rFI and FQ than surgery with fewer outcomes (43, 28.7 %). While there was variability observed with categorization by intervention, subgroup analysis by outcome category (treatment success, treatment failure, adverse reaction) indicates little variation (Table 5). With treatment success, treatment failure, and adverse reaction categories having an FI of 4 (IQR 3–6), 5 (IQR 3–6), and 4 (IQR 3–5), and FQ of 0.081 (IQR 0.033–0.113), 0.051 (IQR 0.021–0.093), and 0.051 (IQR 0.036–0.069), respectively.

Table 4 Fragility indices and quotients for all SAIS Interventional Therapy outcomes with stratification by intervention category. Abbreviations: FI - fragility index, rFI - reverse fragility index, FQ = fragility quotient, IQR = interquartile range.
Number of Outcomes FI/rFI, Median (IQR) FQ, Median (IQR)
Surgery 43 4 (3–6) 0.087 (0.064–0.116)
Injection 89 4 (2–6) 0.051 (0.024–0.100)
Acupuncture 18 5 (3.5–22) 0.016 (0.009–0.062)
Table 5 Fragility indices and quotients for all SAIS Interventional Therapy outcomes with stratification by outcome category. Abbreviations: FI - fragility index, rFI - reverse fragility index, FQ = fragility quotient, IQR = interquartile range.
Number of Outcomes FI/rFI, Median (IQR) FQ, Median (IQR)
Treatment Success 64 4 (3–6) 0.081 (0.033–0.113)
Treatment Failure 65 5 (3–6) 0.051 (0.021–0.093)
Adverse Reaction 21 4 (3–5) 0.051 (0.036–0.069)
4

4 Discussion

The purpose of this study was to assess the robustness of studies involving interventional therapies, such as surgery, injection, and acupuncture, in SAIS treatment using statistical fragility metrics of the FI, rFI, and FQ without relying solely on the p-value. The fragile findings of this study are consistent with much of the existing fragility index literature and suggest there greater caution in considering the strength of statistical significance.

Considering studies where the number of patients lost to follow-up is less than the FI, the median FI and FQ was found to be greater than the same metrics for all studies and studies where the number of patients lost to follow-up is greater than FI. This suggests a level of robustness attributed with studies that retain patients throughout the duration of the study and have a larger sample size. While not a majority, it should be recognized that over 39 % of studies and 41 % of outcomes lost more patients to follow-up than the magnitude of the FI, which has substantial implications on significance. Further, studies where the number of patients lost to follow-up was greater than the FI greatly contrasted in FI, rFI, and FQ with those with the number of patients lost to follow-up less than the FI. For studies where the number of patients lost to follow-up is greater than the FI, the statistical significance could be shifted by a mere 2 event changes in 25 % of outcomes.

Between significant and nonsignificant studies, there appears to be very little variability between statistics FI, rFI, and FQ, indicating that the efficacy of treatment may not influence statistical robustness with regards to the FI but rather other study parameters and variables (sample size, # of patients lost to follow-up, etc.). Statistically significant and nonsignificant outcomes in RCTs of SAIS appeared in all intervention categories of surgery, injection, and acupuncture, and outcome categories of treatment success, treatment failure, and adverse reaction, suggesting little distinction by fragility by intervention or outcome category. Comparing groups by statistical significance, 25 % of outcomes that were statistically significant had a median FI of 2, indicating a quarter of outcomes that were deemed statistically significant could be nonsignificant with the alteration of two patient outcomes. Thus, studies reporting statistical significance without an FI value may be misleading if the calculated FI is 2. Conversely, studies that do not report a high FI value may not gain as much merit or consideration as they should. These concepts of the FI complementing the reporting of the p-value are further outlined by Dettori et al.13

From 2000 to 2010 to 2011–2024, there appears to be little difference in the median FI and IQR but a two-fold increase in FQ with the second approximate decade, suggesting greater statistical robustness in SAIS interventional therapy studies with time. The difference in FQ despite a similar number of outcomes and magnitudes of FI/rFI among the two decades underscores the importance of reporting the FQ in addition to the FI and p-value.

The p-value threshold, often set at 0.05, is a widely used criterion in clinical studies to determine statistical significance. However, this threshold is not an absolute measure of truth but rather a conventional guideline that helps researchers decide whether to reject the null hypothesis. A p-value below 0.05 suggests that the observed effect is unlikely to be due to chance alone, but it does not guarantee the clinical relevance or reproducibility of the findings. Conversely, a p-value slightly above 0.05 does not necessarily mean there is no effect; it might indicate that the study was underpowered or that the effect size was small. This reliance on a single threshold can lead to the overlooking of potentially important findings or the overemphasis of marginally significant results, influencing clinical decision-making. As such, the p-value should be interpreted within the broader context of study design, sample size, effect size, and clinical significance, rather than being viewed as a definitive indicator of truth.1

Our findings align with other studies in the orthopedic literature that emphasize the clinical importance of incorporating fragility metrics in the analysis of orthopedic interventions. For instance, Cordero et al. conducted a fragility analysis on the use of tourniquets in total knee arthroplasty and reported a FI of 2 and a FQ of 0.200 for all outcomes.9 A periprosthetic joint infection review found a median FI of 4 for all outcomes and a median FI of 1 for significant outcomes.54 Locke et al. reviewed 19 RCTs on patellar resurfacing in total knee arthroplasty and found a median FI of 5 and FQ of 0.041.28 Constant et al. identified a median FI of 3 in RCTs on patellofemoral instability.8

RCTS provide a strong level of evidence and influence clinical decision-making, making them crucial in advancing the literature in interventional therapies for SAIS. These trials help establish clinical standards for treatment options, perioperative decision-making, and postoperative rehabilitation. Traditionally, the p-value has been the gold standard for presenting clinical findings in RCTs, despite having several limitations.6 The inclusion of supplementary metrics like the FI and FQ is rare in existing studies, underscoring the need to incorporate these measures in future research.

As research in this field progresses, it is crucial to incorporate the FI and FQ to enhance the reliability of findings. A systematic review by Gordon et al. demonstrated the use of alternative quality assurance measures, including minimum clinically important difference (MCID), substantial clinical benefit, and patient acceptable symptom state metrics.21 They concluded that increasing the use of these metrics could help derive more reliable clinical markers for best practices. Another review aimed to establish thresholds for MCID values to better quantify effect sizes.12 While these metrics can also experience fragility between groups, they provide valuable context to results summarized by p-values. According to Son et al., these metrics can offer a more objective evaluation and interpretation of clinical effectiveness measures.50 Incorporating the FI and FQ will aid researchers in providing data that enables clinicians to better interpret the robustness of outcomes reported in RCTs.

4.1

4.1 Limitations

Fragility metrics can only be extracted from categorical, dichotomous outcomes, leaving a large percentage of RCTs unanalyzed. RCTs reporting continuous outcomes, for example, could not be included in the review. While the FI and FQ are useful for evaluating significance, they cannot be applied to all outcome measures. Furthermore, established threshold standards for the FI and FQ are lacking, which are necessary for contextualizing results.

5

5 Conclusion

This review underscores the statistical fragility of outcomes associated with interventional therapies in SAIS interventional therapies. The statistical significance of RCT findings can be altered by just a few outcome reversals or patients lost to follow-up. Notably, the statistically significant outcomes were particularly fragile, with a median FI of 3. The topic of appropriate therapies for SAIS remains contentious, and this review's results do not clarify the differences in current practices. Based on this study and the existing orthopedic literature, it is not possible to determine whether interventional therapies for SAIS offer a clear benefit at this time. This highlights the importance of including FI and FQ metrics alongside p-values when reporting the statistical significance of outcomes.

Credit author statement

Auston Locke: Writing, editing, conceptualization.

Niklas Koehne: Data collection, writing.

Jonathan Huang: writing, editing, visualization.

Sohan Shah: writing, editing, data collection.

Avanish Yendluri: writing, editing.

Nikan Namiri: editing, data collection.

John Corvi: writing, editing.

Xinning Li: supervision, editing, conceptualization.

Robert Parisien: editing, supervision, conceptualization.

Ethical statement

This study did not involve human participants, patient data, or animal subjects, and therefore did not require institutional review board (IRB) approval or informed consent. The authors affirm that all methods were carried out in accordance with relevant guidelines and regulations for ethical research and publication.

Funding

There was no funding for this article.

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