Multidomain Response Patterns Following Focused Extracorporeal Shockwave Therapy in Diabetic Adhesive Capsulitis: A Secondary Analysis of a Randomized Controlled Trial
1Department of Physical Medicine and Rehabilitation, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
2Department of General Surgery, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh, India
3Department of Laboratory Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
4Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
Correspondence: Siddharth Rai Department of Physical Medicine and Rehabilitation, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareily Road, Lucknow, UP 226014, India. Tel: +91-9650690822 E-mail: Siddharth.bmc@gmail.com
• Received: March 26, 2026 • Revised: May 28, 2026 • Accepted: June 26, 2026
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
To characterize multidomain response patterns following focused extracorporeal shockwave therapy (fESWT) in patients with diabetic adhesive capsulitis across pain, functional, and mobility domains.
Methods
This secondary exploratory analysis included 100 patients with type 2 diabetes mellitus and adhesive capsulitis who received active fESWT in a randomized controlled trial and completed 4-week follow-up. Clinically meaningful improvement was defined as a ≥2-point reduction in Visual Analogue Scale score, a ≥13-point improvement in Shoulder Pain and Disability Index score, and a ≥10° increase in active external rotation. Participants were classified according to combinations of domain-specific responses.
Results
Global response, defined as concurrent improvement in pain, function, and mobility, was observed in 52.0% of patients. An additional 34.0% demonstrated improvement in pain and function without corresponding gains in external rotation, while 12.0% were classified as minimal or non-responders. Other discordant response patterns were uncommon (2.0%). Domain-specific response rates were 86.0% for pain, 88.0% for function, and 53.0% for external rotation, indicating that symptomatic and functional improvements occurred more frequently than recovery of shoulder mobility.
Conclusion
Short-term response to fESWT in diabetic adhesive capsulitis demonstrates variable concordance across pain, functional, and mobility domains. Recognition of these multidomain response patterns may assist clinicians in interpreting early treatment effects and guiding rehabilitation planning.
Adhesive capsulitis is a prevalent and disabling shoulder disorder marked by progressive pain and global restriction of active and passive motion [1-3]. The burden is disproportionately higher in individuals with type 2 diabetes mellitus, who often present with earlier onset, greater severity, and a more protracted course than non-diabetic counterparts [4,5]. Persistent synovial inflammation, capsular fibrosis, and diabetes-related alterations in collagen turnover and tissue remodeling are believed to underlie the heightened stiffness and delayed recovery observed in this population [6,7]. As a result, diabetic adhesive capsulitis remains a therapeutic challenge in rehabilitation practice.
Focused extracorporeal shockwave therapy (fESWT) has gained attention as a non-invasive modality for managing adhesive capsulitis. Emerging evidence supports its short-term efficacy in reducing pain and improving shoulder function, including among patients with diabetes mellitus [8-13]. Proposed mechanisms include modulation of inflammatory mediators and enhancement of periarticular microcirculation [14,15]. However, clinical response to fESWT is not uniform, and variability appears more pronounced in metabolically compromised individuals [11,13].
Most investigations of fESWT have reported mean changes in pain, functional scores, or range of motion, thereby emphasizing average treatment effects [8-11]. Although such analyses establish overall efficacy, they do not capture heterogeneity in individual recovery trajectories. In clinical settings, improvements in pain and function may not parallel gains in mobility. Some patients achieve meaningful symptomatic relief despite persistent restriction, whereas others demonstrate mechanical improvement without comparable reductions in pain. These discordant patterns remain underexplored.
Prior literature has addressed variability in response to nonoperative interventions in adhesive capsulitis, but largely from a prognostic perspective—focusing on who responds rather than how response unfolds across domains of pain, function, and mobility [7,16]. A multidomain evaluation may therefore yield clinically relevant insights that extend beyond conventional efficacy metrics and enhance interpretation of early treatment outcomes.
This secondary analysis aimed to characterize multidomain response patterns following fESWT in patients with diabetic adhesive capsulitis. By concurrently examining clinically meaningful changes in pain, shoulder function, and external rotation, we sought to delineate concordant and discordant response profiles at short-term follow-up.
METHODS
Study design
This secondary descriptive analysis used data from an assessor-blinded randomized controlled trial evaluating fESWT in patients with primary adhesive capsulitis and type 2 diabetes mellitus. The present analysis addressed a distinct research question concerning multidomain response patterns and did not duplicate previously reported efficacy or predictor analyses from the parent trial; however, it was conducted as a post hoc exploratory analysis and was not prespecified in the trial registry.
The parent trial was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines and was prospectively registered with the Clinical Trials Registry of India (CTRI/2023/07/055143). The study adhered to the principles of the Declaration of Helsinki, and written informed consent was obtained from all participants prior to enrollment.
This secondary analysis was conducted using anonymized data from a previously approved randomized controlled trial (SGPGI Ethics Committee Approval No. 2023-48-IP-130). As the present study involved no direct patient contact and no identifiable patient information, additional ethical approval was not required, and a waiver was applicable in accordance with institutional policy.
Participants
Participants were adults with type 2 diabetes mellitus and a diagnosis of primary adhesive capsulitis enrolled in the original randomized controlled trial according to predefined inclusion and exclusion criteria. Adhesive capsulitis was diagnosed based on clinical features of shoulder pain and stiffness with restriction of both active and passive range of motion, particularly external rotation, in the absence of alternative shoulder pathology.
For this secondary analysis, participants who received active fESWT and completed the 4-week follow-up assessment with complete baseline and follow-up data for pain, shoulder function, and external rotation were included. In addition, participants assigned to placebo shockwave therapy in the parent trial were analyzed descriptively using the same multidomain response classification framework to provide contextual information regarding potential natural recovery and non-specific treatment effects.
Intervention
fESWT was administered according to standardized protocols described in the parent trial. Treatment parameters, including energy flux density, number of shocks, and treatment frequency, were applied in accordance with manufacturer-recommended guidelines and were consistent across participants receiving active treatment. For the present analysis, participants treated with different energy levels were analyzed as a single group, as the aim was to characterize overall multidomain response patterns rather than to compare protocol-specific or dose-specific effects.
Outcome measures
Clinical outcomes were assessed at baseline and at 4 weeks following completion of the intervention. Pain intensity was measured using the Visual Analogue Scale (VAS) [17]. Shoulder function was assessed using the Shoulder Pain and Disability Index (SPADI), with total scores derived from the pain and disability subscales [18]. Shoulder mobility was evaluated by measuring active external rotation using standardized goniometric techniques. All assessments were performed by trained assessors blinded to treatment allocation in the parent trial.
Clinically meaningful improvement in each outcome domain was defined a priori using established minimal clinically important difference (MCID) thresholds derived from shoulder outcome literature [19-21]. A pain response was defined as a reduction of at least 2 points on the VAS, and a functional response as an improvement of at least 13 points in the total SPADI score. A range-of-motion response was defined as an increase of at least 10° in active external rotation.
The 2-point VAS threshold was selected based on prior shoulder outcome studies demonstrating that this magnitude of change exceeds measurement error and corresponds to clinically meaningful improvement in patients with shoulder disorders [21]. Although this threshold was originally derived from postoperative shoulder populations, similar MCID values have been widely applied across diverse operative and nonoperative shoulder conditions and were considered clinically appropriate for this exploratory analysis. Similarly, the 13-point SPADI threshold is supported by published minimal important difference estimates for shoulder pathology [19].
A specific MCID for external rotation in diabetic adhesive capsulitis has not been definitively established. Therefore, a 10° threshold was selected based on prior adhesive capsulitis and shoulder rehabilitation studies indicating that changes of this magnitude exceed typical goniometric measurement error and represent a clinically perceptible improvement in capsular restriction [20]. This threshold has been used in previous shoulder outcome studies and was considered a pragmatic and clinically interpretable marker of meaningful mobility gain.
Participants were classified into multidomain response patterns according to the presence or absence of clinically meaningful improvement in pain, function, and shoulder mobility at 4 weeks. Response categories were defined to reflect clinically interpretable combinations of improvement across domains. Because some discordant response combinations occurred infrequently, rare patterns were grouped together as “other discordant response patterns” for reporting purposes. The primary response categories were:
• Global responders - improvement in pain, function, and external rotation
• Pain-function dominant responders - improvement in pain and function without improvement in external rotation
• Minimal or non-responders - no clinically meaningful improvement in any domain
• Other discordant response patterns - uncommon combinations of improvement involving isolated or partial mobility response
Statistical analysis
Analyses were primarily descriptive, consistent with the exploratory objective of characterizing response patterns. Continuous variables were summarized using means with standard deviations or medians with interquartile ranges, as appropriate. Categorical variables were reported as frequencies and percentages with 95% confidence intervals (CIs) calculated using the Wald method.
The primary analysis involved reporting the distribution of response patterns as the number and proportion of patients in each category. Domain-specific response rates for pain, function, and external rotation were calculated, and overlap between domains was examined descriptively. Baseline demographic and clinical characteristics were summarized across major response categories. A sensitivity analysis was additionally performed using a more stringent threshold of 15° improvement in external rotation to evaluate the robustness of multidomain response classification. An exploratory descriptive analysis of the placebo cohort was additionally performed using the same multidomain response classification framework. Because the present secondary analysis was not powered or prespecified for comparative efficacy evaluation between active and placebo groups, no formal inferential statistical comparisons were performed.
Given the exploratory nature of this secondary analysis and the relatively small subgroup sizes, no formal hypothesis testing or adjustment for multiple comparisons was performed. All analyses were conducted using IBM SPSS Statistics (version 26; IBM Corp.).
Reporting standards
This secondary analysis was reported in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines because the present study represents an observational secondary analysis of trial-derived data intended to characterize multidomain response patterns rather than evaluate comparative treatment efficacy. CONSORT reporting standards apply to the parent randomized controlled trial. The relationship between this analysis and prior publications from the same trial is explicitly disclosed to avoid duplication.
RESULTS
Study cohort
A total of 100 patients with primary adhesive capsulitis and type 2 diabetes mellitus who received active fESWT and completed the 4-week follow-up were included in the analysis. All participants had complete baseline and follow-up data for pain intensity, shoulder function, and shoulder external rotation. Participant flow through the study and selection for the present secondary analysis are shown in Fig. 1.
Distribution of multidomain response patterns
The primary outcome was the distribution of multidomain response patterns defined using clinically meaningful thresholds for pain, function, and mobility (Table 1).
Global responders, defined as improvement across pain, function, and external rotation, comprised 52.0% (95% CI, 42.0%–62.0%) of patients. Pain–function dominant responders, demonstrating improvement in pain and function without corresponding gains in external rotation, accounted for 34.0% (95% CI, 25.0%–44.0%). Minimal or non-responders represented 12.0% (95% CI, 6.0%–20.0%). Other discordant patterns involving isolated or atypical combinations of mobility and functional improvement were observed in 2.0% of patients.
Overall, short-term response to fESWT was characterized predominantly by global or symptom-dominant improvement rather than isolated mechanical recovery. Sensitivity analysis using a 15° threshold for clinically meaningful improvement in external rotation demonstrated a broadly similar distribution of multidomain response patterns, although the proportion of global responders was modestly reduced (Supplementary Table S1).
Domain-specific response rates
Across individual outcome domains, 86.0% (95% CI, 78.0%–92.0%) of patients achieved a clinically meaningful reduction in pain (≥2-point decrease in the VAS score), 88.0% (95% CI, 80.0%–94.0%) achieved a clinically meaningful improvement in shoulder function (≥13-point improvement in the SPADI score), and 53.0% (95% CI, 43.0%–63.0%) achieved a clinically meaningful improvement in external rotation (≥10° gain). Symptomatic and functional improvements were therefore more frequent than recovery of shoulder mobility at short-term follow-up.
Of the 86 patients who achieved a pain response, 52 also met criteria for concurrent functional and mobility response.
Exploratory descriptive analysis of the placebo cohort
An additional exploratory descriptive analysis was performed in participants assigned to placebo shockwave therapy in the parent randomized controlled trial (n=50) using the same multidomain response classification framework.
Response patterns within the placebo cohort differed from those observed following active fESWT. Although a proportion of placebo-treated participants demonstrated clinically meaningful improvement in pain and shoulder function, improvement in external rotation was less frequent, and concurrent multidomain recovery across pain, function, and mobility was not identified within the placebo group.
Within the placebo cohort, 36.0% of participants achieved a clinically meaningful reduction in VAS score, 30.0% achieved clinically meaningful improvement in SPADI score, and 15.0% demonstrated clinically meaningful improvement in external rotation. Pain–function dominant response patterns were observed in 20.0% of placebo-treated participants, while other placebo-treated participants demonstrated discordant response patterns involving partial improvement across individual domains (Supplementary Table S2).
Overlap between response domains
Concurrent improvement across all three domains was observed in 52.0% of active fESWT-treated participants. An additional 34.0% demonstrated improvement in pain and function without corresponding gains in external rotation, indicating partial concordance between symptomatic and mechanical recovery. Other discordant response patterns were uncommon (2.0%). These findings indicate that symptomatic improvement frequently precedes or exceeds recovery of external rotation in the short term.
Baseline characteristics by response pattern
Baseline demographic and clinical characteristics varied descriptively across the major response categories (Table 2). Global responders tended to present with higher baseline pain and disability scores and less severe baseline restriction of external rotation compared with minimal or non-responders. Minimal or non-responders demonstrated comparatively lower baseline symptom severity and greater mechanical limitation. Age, sex distribution, and duration of diabetes showed modest variation across groups. These comparisons are descriptive and should not be interpreted as predictive.
Magnitude of change within response categories
Global responders demonstrated the greatest reductions in VAS and SPADI scores as well as the largest gains in external rotation. Pain–function dominant responders experienced substantial symptomatic and functional improvement with smaller gains in shoulder mobility. Minimal or non-responders demonstrated limited change across outcome domains.
DISCUSSION
This secondary analysis examined multidomain response patterns following fESWT in patients with diabetic adhesive capsulitis. Rather than focusing solely on average treatment effects, the present findings highlight variability in concordance between pain, functional, and mobility outcomes at short-term follow-up.
More than half of patients demonstrated concurrent clinically meaningful improvement across pain, shoulder function, and external rotation. Randomized controlled trials have reported short-term improvements in pain and disability following shockwave therapy in adhesive capsulitis [8,9,11,12]. However, the present analysis extends prior work by examining how improvement manifests across multiple outcome domains. The observed global response pattern suggests that, in a substantial proportion of patients, symptomatic relief and mechanical improvement occur together following fESWT.
Approximately one-third of patients experienced improvement in pain and function without parallel gains in external rotation. In clinical practice, dissociation between symptomatic recovery and restoration of shoulder mobility is well recognized in adhesive capsulitis [6,7]. This finding underscores that early symptomatic improvement does not necessarily imply restoration of mechanical restriction and reinforces the importance of continued rehabilitation even when pain has improved.
Other discordant response patterns were uncommon. Improvement in shoulder mobility without concurrent pain relief was rare, suggesting that mechanical recovery following fESWT is typically accompanied by symptomatic improvement rather than occurring independently. Overall, symptomatic and functional improvements were observed more frequently than gains in external rotation. This pattern is consistent with the known pathophysiology of adhesive capsulitis, in which capsular fibrosis and altered tissue remodeling may delay mechanical recovery despite modulation of pain and disability [6,7].
A clinically relevant minority of patients did not achieve meaningful improvement in any domain at 4 weeks. Prior studies have demonstrated variability in response to nonoperative management of adhesive capsulitis, particularly among patients with diabetes mellitus [11,13,16]. Recognition of this subgroup is important, as it may prompt consideration of adjunctive or alternative therapeutic strategies and closer follow-up.
Baseline differences between response groups were descriptive and should not be interpreted as predictive. Notably, global responders tended to have higher baseline pain and disability scores, which may partly reflect greater capacity for measurable change. The possibility of regression to the mean or baseline severity influencing responder classification should therefore be acknowledged [19,20].
Exploratory descriptive evaluation of the placebo cohort provided additional context for interpretation of the observed multidomain response patterns. Although some placebo-treated participants demonstrated clinically meaningful improvement in pain and shoulder function, concurrent multidomain recovery involving pain, function, and mobility was not identified within the placebo cohort. These findings suggest that isolated symptomatic or functional improvement may partially reflect non-specific influences or short-term fluctuation, whereas concordant multidomain improvement appeared more characteristic of the active fESWT cohort. However, because this analysis was exploratory and not powered for formal comparative efficacy testing, these observations should be interpreted cautiously.
Several limitations should be acknowledged. As this was a post hoc exploratory analysis, the findings should be interpreted in that context. This study represents a secondary exploratory analysis with short-term follow-up, limiting assessment of the durability and longitudinal evolution of response patterns. Placebo-arm findings should be interpreted as exploratory because the present secondary analysis was not designed for formal comparative efficacy evaluation. Comparative longitudinal analyses including control cohorts would help clarify the extent to which these multidomain recovery patterns are treatment-specific.
Categorization based on predefined MCIDs simplifies continuous change scores and may not fully capture the spectrum of clinical response. In addition, baseline differences between response groups were descriptive, and regression to the mean or baseline severity may have influenced responder classification. The relatively small size of some response categories further limits detailed subgroup interpretation. These findings should therefore be interpreted as exploratory and hypothesis-generating rather than inferential.
Despite these limitations, strengths of the study include a well-defined diabetic cohort, standardized outcome assessment, and application of clinically meaningful thresholds across multiple outcome domains. By examining concordance and dissociation between pain, functional, and mobility outcomes, this study provides a pragmatic framework for interpreting early treatment response in clinical rehabilitation settings.
In conclusion, short-term response to fESWT in diabetic adhesive capsulitis demonstrates variable concordance between pain, functional, and mobility outcomes. While more than half of patients experienced concurrent improvement across all domains, a substantial proportion demonstrated symptomatic and functional recovery without parallel gains in shoulder external rotation. This suggests that restoration of external rotation may lag behind early clinical improvement. Recognition of these multidomain response patterns may assist clinicians in interpreting early treatment outcomes and guiding rehabilitation planning in this population. Prospective studies with longer follow-up are needed to determine whether the observed lag in mobility recovery relative to symptomatic improvement persists over time.
CONFLICTS OF INTEREST
No potential conflict of interest relevant to this article was reported.
FUNDING INFORMATION
None.
AUTHOR CONTRIBUTION
Conceptualization: Rai S, Awale R, Suruchi. Methodology: Rai S, Awale R, Suruchi. Formal analysis: Rai S, Gunjiganvi M. Project administration: Rai S, Awale R. Visualization: Rai S. Writing – original draft: Rai S, Gunjiganvi M, Awale R, Suruchi. Writing – review and editing: Rai S, Gunjiganvi M. Approval of final manuscript: all authors.
ACKNOWLEDGMENTS
The authors thank the study participants and clinical staff involved in the parent randomized controlled trial.
DATA AVAILABILITY STATEMENT
The datasets generated and/or analyzed during the current study are not publicly available due to institutional ethical restrictions and protection of patient confidentiality but are available from the corresponding author on reasonable request, subject to approval by the institutional ethics committee.
The CONSORT flow diagram illustrating participant progression from the original trial to the present secondary analysis. hfESWT, high-frequency focused extracorporeal shockwave therapy; lfESWT, low-frequency focused extracorporeal shockwave therapy; pESWT, placebo focused extracorporeal shockwave therapy; RCT, randomized controlled trial.
Table 1.
Distribution of multidomain response patterns at 4 weeks (n=100)
Response pattern
Value
Global responder (pain, function, and ROM improvement)
52 (52.0)
Pain–function dominant responder (pain and function improvement without ROM gain)
34 (34.0)
Minimal/non-responder (no clinically meaningful improvement in any domain)
12 (12.0)
Other discordant response pattern
2 (2.0)
Values are presented as number (%).
Clinically meaningful improvement was defined as ≥2-point reduction in Visual Analogue Scale score, ≥13-point improvement in Shoulder Pain and Disability Index score, and ≥10° increase in active external rotation.
ROM, range of motion.
Table 2.
Baseline demographic and clinical characteristics according to response pattern
Characteristic
Total (n=100)
Global responder (n=52)
Pain–function dominant responder (n=34)
Minimal/non-responder (n=12)
Age (yr)
54.8±6.9
54.1±6.8
55.3±7.2
56.0±6.5
Sex, female
54 (54.0)
29 (55.8)
18 (52.9)
7 (58.3)
Duration of symptoms (mo)
6.2±2.4
5.8±2.1
6.4±2.5
7.2±2.9
Duration of diabetes (yr)
9.0±4.1
8.6±3.9
9.1±4.2
9.8±4.5
HbA1c (%)
8.1±1.0
7.9±0.9
8.2±1.0
8.5±1.1
Baseline VAS score
6.9±1.3
7.4±1.1
6.8±1.3
6.2±1.4
Baseline SPADI total score
67.7±13.5
72.6±11.8
65.9±13.4
59.8±14.1
Baseline external rotation (°)
29.6±10.3
32.4±9.6
28.7±10.4
24.1±11.2
Values are presented as mean±standard deviation or number (%).
Patients with other discordant response patterns (n=2) were not included in subgroup comparisons because of small subgroup size.
HbA1c, glycated hemoglobin; VAS, Visual Analogue Scale; SPADI, Shoulder Pain and Disability Index.
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Multidomain Response Patterns Following Focused Extracorporeal Shockwave Therapy in Diabetic Adhesive Capsulitis: A Secondary Analysis of a Randomized Controlled Trial
Fig. 1. The CONSORT flow diagram illustrating participant progression from the original trial to the present secondary analysis. hfESWT, high-frequency focused extracorporeal shockwave therapy; lfESWT, low-frequency focused extracorporeal shockwave therapy; pESWT, placebo focused extracorporeal shockwave therapy; RCT, randomized controlled trial.
Graphical abstract
Fig. 1.
Graphical abstract
Multidomain Response Patterns Following Focused Extracorporeal Shockwave Therapy in Diabetic Adhesive Capsulitis: A Secondary Analysis of a Randomized Controlled Trial
Response pattern
Value
Global responder (pain, function, and ROM improvement)
52 (52.0)
Pain–function dominant responder (pain and function improvement without ROM gain)
34 (34.0)
Minimal/non-responder (no clinically meaningful improvement in any domain)
12 (12.0)
Other discordant response pattern
2 (2.0)
Characteristic
Total (n=100)
Global responder (n=52)
Pain–function dominant responder (n=34)
Minimal/non-responder (n=12)
Age (yr)
54.8±6.9
54.1±6.8
55.3±7.2
56.0±6.5
Sex, female
54 (54.0)
29 (55.8)
18 (52.9)
7 (58.3)
Duration of symptoms (mo)
6.2±2.4
5.8±2.1
6.4±2.5
7.2±2.9
Duration of diabetes (yr)
9.0±4.1
8.6±3.9
9.1±4.2
9.8±4.5
HbA1c (%)
8.1±1.0
7.9±0.9
8.2±1.0
8.5±1.1
Baseline VAS score
6.9±1.3
7.4±1.1
6.8±1.3
6.2±1.4
Baseline SPADI total score
67.7±13.5
72.6±11.8
65.9±13.4
59.8±14.1
Baseline external rotation (°)
29.6±10.3
32.4±9.6
28.7±10.4
24.1±11.2
Table 1. Distribution of multidomain response patterns at 4 weeks (n=100)
Values are presented as number (%).
Clinically meaningful improvement was defined as ≥2-point reduction in Visual Analogue Scale score, ≥13-point improvement in Shoulder Pain and Disability Index score, and ≥10° increase in active external rotation.
ROM, range of motion.
Table 2. Baseline demographic and clinical characteristics according to response pattern
Values are presented as mean±standard deviation or number (%).
Patients with other discordant response patterns (n=2) were not included in subgroup comparisons because of small subgroup size.
HbA1c, glycated hemoglobin; VAS, Visual Analogue Scale; SPADI, Shoulder Pain and Disability Index.
