International Journal of Medical and Pharmaceutical Research
2025, Volume-6, Issue-4 : 973-988 doi: 10.5281/zenodo.16936003
Research Article
Clinical Outcomes Following Awake Hydrodilatation with Manipulation in Refractory Shoulder Stiffness: A Retrospective Review
 ,
 ,
Received
July 19, 2025
Accepted
Aug. 3, 2025
Published
Aug. 23, 2025
Abstract

Background: Stiff shoulder, also termed adhesive capsulitis or frozen shoulder, is a common clinical problem, particularly in diabetic individuals. Among the available interventions, hydrodilatation combined with manipulation is emerging as a minimally invasive option. Moreover our approach utilizes awake hydrodilatation and manipulation without general anesthesia or imaging, making it a safe, low-cost, and widely applicable method.

Aim: To evaluate the functional and clinical outcomes following a combined technique of hydrodilatation and awake manipulation in patients with stage 2 stiff shoulder.

Methods: This retrospective study included patients treated at SRI LAKSHMI NARAYANA INSTITUTE OF MEDICAL SCIENCES -- PONDICHERRY between June 2018 and August 2023. Inclusion criteria were clinical signs of shoulder stiffness, radiologically normal joint, partial-thickness cuff tear on MRI suggestive of adhesive capsulitis, and failure of conservative management. Patients underwent hydrodilatation with 0.2% ropivacaine followed by manipulation under no general anesthesia and an aggressive physiotherapy protocol. Outcomes were measured using range of motion (ROM), Oxford Shoulder Score (OSS), and Visual Analog Scale (VAS) at 4 weeks and 1 year.

Results: A total of 53 patients were treated (mean age: 54 years; female predominance; high diabetic prevalence). Statistically significant improvements were seen in ROM and functional scores: OSS improved from 48 to 76, VAS decreased from 7 to 2, and abduction improved from 70° to 110°. No complications such as fractures or neurovascular injury were noted. Forty patients had excellent outcomes at 1-year follow-up.

Conclusion: Hydrodilatation with manipulation, performed on awake patients without general anesthesia or imaging guidance using long-acting regional anesthetic (0.2% ropivacaine), is a novel, cost-effective alternative and safe treatment for stiff shoulder. By eliminating anesthesia and imaging requirements, this approach can serve as a first-line interventional procedure in resource-limited settings, achieving excellent outcomes in both diabetic and non-diabetic patients. Further prospective studies with larger sample sizes and RCTs are warranted

Keywords
INTRODUCTION

Stiff shoulder or adhesive capsulitis is a disabling condition characterized by pain and progressive loss of both active and passive shoulder movements. The condition affects 3–5% of the general population and up to 30% of diabetic individuals. Traditionally, treatment ranges from physiotherapy and steroid injections to manipulation under anesthesia (MUA) and arthroscopic capsular release.

 

According to ISAKOS guidelines stiff shoulder is defined as Global reduction of the range of motion and equal in passive and active ranges of motion (flexion < 100 , external rotation < 10 degrees, internal rotation < 10 degrees. ROM atleast in two Planes and Loss of external rotation with arm by side of chest – earliest sign

 

Frozen shoulder, also known as adhesive capsulitis or stiff shoulder, is a well-recognized clinical condition characterized by progressive pain and significant restriction of both active and passive range of motion, particularly in elevation and external rotation. Despite the severity of symptoms, radiological imaging typically appears normal, making clinical evaluation crucial in diagnosis.

 

The condition was first described by Duplay in 1872, who referred to it as "periarthritis scapulohumeral." Later, in 1934, Codman coined the term "frozen shoulder", highlighting its insidious onset and characteristic clinical features. Patients often present with deep-seated shoulder pain, typically localized near the insertion of the deltoid muscle, along with an inability to sleep on the affected side due to nocturnal pain.

 

Frozen shoulder commonly affects middle-aged individuals, with a higher prevalence in women and diabetic patients, and is considered a self-limiting yet functionally debilitating condition. Early recognition and timely intervention are key to improving outcomes and reducing long-term morbidity.

 

Hydrodilatation, first introduced in 1965, provides therapeutic benefit by rupturing the contracted capsule and delivering anti-inflammatory agents intra-articularly. This study evaluates the efficacy of hydrodilatation combined with manipulation without anesthesia, followed by structured physiotherapy, in restoring shoulder function.

 

EPIDEMIOLOGY

Frozen shoulder, or adhesive capsulitis, has an estimated incidence of 3% to 5% in the general population. The condition is notably more common in individuals with diabetes mellitus, with prevalence rates ranging from 10.8% to as high as 30%, and up to 20% in some reported series. It most commonly affects individuals between the ages of 40 and 60 years, representing the peak incidence range. Additionally, there is a clear female predominance, with women being more frequently affected than men.

 

STAGES OF STIFF SHOULDER

 

 

 

 

 

 

TYPES

PRIMARY STIFF SHOULDER (IDIOPATHIC)

Unknown Predisposing conditions Diabetes mellitus,Dupuytren contracture, thyroid disorders, myocardial infarction, Parkinson disease

 

SECONDARY STIFF SHOULDER

Intra-articular - Chondral lesion, labral tear, loose bodies Capsular - After capsular injury, surgery, joint immobilization

Extra-articular - Muscle tightness, heterotopic ossification, skin scarring Neurologic -    Injuries to the cervical spine or brachial plexus

 

AIM:

The objective of this study is to evaluate the clinical and functional outcomes of patients with stiff shoulder treated using a combined technique involving hydrodilatation and manipulation under anesthesia. This approach aims to assess the effectiveness of the dual modality in improving range of motion, pain relief, and overall shoulder function.

 

MATERIALS AND METHODS

Study Design

  • Type: Retrospective single-centre study
  • Location: SLIMS - Pondicherry
  • Duration: June 2018 – August 2023

 

Inclusion Criteria

  • Chronic shoulder pain >3 months
  • Diabetic individuals
  • Clinical restriction in external/internal rotation
  • Normal radiographs
  • MRI: partial rotator cuff tear consistent with adhesive capsulitis
  • Failed conservative treatment

 

Exclusion Criteria

  • Previous shoulder surgery
  • Full-thickness cuff tear
  • Post-traumatic stiffness
  • Prior hydrodilatation

 

Work Flow Pattern

 

PRE OP DATA

Demographic data(Age/sex)

Duration of symptoms

Diabetes mellitus

MRI findings

Clinical ROM’s

Preop OSS/VAS scores

  •  

POST OP DATAS

Clinical ROM at minimum 1 year follow up

Return to work

Post op OSS/VAS scores

 

 

Procedure: Hydrodilatation and Manipulation Technique

Hydrodilatation was performed using 0.2% ropivacaine (40–45 ml) injected via the posterior approach.The injection was directed toward the coracoid process, allowing capsular distension and rupture.

 

Manipulation was performed in the awake patient in a supine position with progressive mobilization into flexion, abduction, and rotation.

Patients were admitted for two days for early aggressive physiotherapy.

 

Physiotherapy Protocol

Followed the Pune Shoulder Rehab Protocol (PSRP):

  • Phase I (10 days supervised)
  • Phase II (Home-based for 6 weeks)
  • Phase III/IV (Advanced strengthening for high-demand individuals)

 

Outcome Measures

Clinical ROM (abduction, flexion, IR/ER)

Oxford Shoulder Score (OSS)

Visual Analog Scale (VAS)

Evaluated at pre-op, 4 weeks, and 1 year

 

Results

Demographics and Baseline Characteristics

  • Cohort: 53 patients (mean age: 54 years; female predominance [♀:♂ = 32:21, 60.4%])
  • Comorbidities: 68% (*n*=36) had diabetes mellitus
  • Symptom duration: Mean 5.9 months (SD ±2.1) prior to intervention
  • Stage distribution: All cases classified as Stage 2 (frozen phase) per ISAKOS criteria

 

Table 2. CLINICAL OUTCOMES

Parameter

Preoperative

1-Year Follow-up

Improvement (Δ)

*p*-value

VAS pain score

7.1 ± 1.2

2.3 ± 1.5

4.8

<0.001

Oxford Shoulder Score

48.2 ± 8.4

75.9 ± 9.1

27.7

<0.001

Abduction (°)

70.3 ± 12.1

109.8 ± 15.6

+39.5

<0.001

External rotation (°)

9.5 ± 3.2

25.7 ± 6.8

+16.2

<0.001

 

 

SUBGROUP ANALYSIS

  1. Diabetics vs. Non-diabetics:
    • Greater VAS reduction in diabetics (Δ5.2 vs. Δ4.1; *p*=0.03)
    • Comparable ROM improvement (abduction Δ38° vs. Δ41°; *p*=0.42)
  2. Sex differences: Females had lower baseline OSS (45 vs. 53; *p*=0.02) but equivalent 1-year outcomes.
  3. Safety and Complications
  • Procedure success: 94% (*n*=50) achieved capsular rupture with hydrodilatation
  • Complications: None reported (0% fractures/neurovascular injuries)
  • Re-interventions: 5.7% (*n*=3) required arthroscopic release
  1. Functional Recovery
  • Return to work: 89% (*n*=47) by 3 months
  • Therapy adherence: 92% completed the PSRP protocol

 

HYDRODILATATION PROCEDURE OUTCOME n=53

 

 

PATIENT 1 (52 YRS /F)

 

 

 

 

 

 

PATIENT 2 (42 YRS/M)

Table 2. CLINICAL OUTCOMES

Parameter

Preoperative

1-Year Follow-up

VAS (Idiopathic)

7/10

2/10

VAS (Secondary)

6/10

3/10

OSS (mean)

48

76

Abduction (°)

70

110

Forward Flexion(°)

90

120

IR/ER (°)

<10

>25

 

40 patients: Excellent outcomes with restored ROM

8 patients: Persistent night pain but improved function

3 patients: Required arthroscopic release

No complications: No fractures or neurovascular injuries

No need for anesthesia or imaging guidance during the procedure

 

DISCUSSION

Stiff shoulder, often termed adhesive capsulitis, remains a common and functionally disabling condition, particularly in diabetic and middle-aged populations. The incidence in general practice is estimated at approximately 2.4 per 1000 individuals annually, with significantly higher prevalence among diabetics, women, and those aged 40 to 60 years. Despite the various treatment options, there is no definitive consensus on the most effective management strategy, especially in patients who are refractory to conservative measures.

 

Our study evaluated a combined approach using hydrodilatation with awake manipulation without general anaesthesia or imaging guidance, a technique that remains underutilized in many settings. This method provided significant clinical and functional improvements, with 40 out of 53 patients demonstrating excellent outcomes at one-year follow-up. Our findings are consistent with recent meta-analyses which confirm that hydrodilatation is an effective intervention, particularly during the freezing or frozen phase (stage 2) of the condition, when capsular contracture and inflammation coexist [2, 3].

 

First introduced by Andren and Lundberg in 1965, hydrodilatation provides symptom relief primarily through two mechanisms: steroid-mediated anti-inflammatory effects and mechanical capsular rupture [1]. Rizk et al. emphasized the importance of capsular rupture in alleviating pain by disrupting the capsule's nociceptive pathways [2]. Our approach, using 40--45 mL of 0.2% ropivacaine administered via a posterior approach, consistently achieved effective capsular distension without the use of ultrasound guidance, contrast agents, or intravenous sedation. While image-guidance is widely used, systematic reviews suggest that for experienced clinicians, clinical outcomes between guided and blind injections can be comparable, supporting our methodology [6, 7]. This approach significantly simplifies the procedure and reduces costs.

 

In our technique, no general anaesthesia or sedation was administered. Manipulation was carried out in an awake patient under local regional block, facilitated by the prolonged analgesic effect of ropivacaine, which is known to be less cardiotoxic and to have favorable motor-block characteristics compared to bupivacaine [8]. This not only minimized risks but also allowed immediate initiation of a supervised physiotherapy protocol—an essential component of recovery that is strongly supported by clinical guidelines [9]. Notably, no complications such as fractures or neurovascular injuries were encountered, supporting the safety of the awake manipulation approach when carefully executed.

 

Oxford Shoulder Scores (OSS) and Visual Analogue Scale (VAS) scores demonstrated statistically significant improvement at 4 weeks and 1 year post-procedure. Importantly, even in the diabetic subgroup, a notoriously resistant population, patients showed comparable functional improvements to idiopathic cases. This reinforces earlier findings that with an appropriately timed and executed intervention, diabetic patients can achieve favorable outcomes.

 

Although ultrasound-guided injections and arthrographic verification have been widely advocated in many protocols, our results suggest that a simpler, non-guided technique, when performed with experience and anatomical precision, may be equally effective [6, 7]. This approach can be particularly valuable in resource-limited settings.

 

Comparative literature indicates that hydrodilatation with manipulation (HD + MUA) provides superior outcomes to manipulation alone or steroid injection alone, especially in improving external rotation and abduction [10]. Vastamäki et al. suggested that the ideal time for manipulation is between 6 to 9 months after symptom onset, aligning with our study's mean duration of symptoms (5.94 months) [4].

 

Nonetheless, limitations of our study include the small sample size and retrospective design. A larger, prospective randomized controlled trial (RCT) is warranted to further validate these findings and assess long-term outcomes, recurrence rates, and functional scores beyond one year.

 

KEY HIGHLIGHTS OF OUR STUDY

Efficacy: Significant improvements in ROM and pain scores align with prior studies (Quraishi et al., 2007), but with the added benefit of avoiding anesthesia.

Diabetic response: Challenges the notion of poorer outcomes in diabetics, suggesting timely intervention mitigates disease severity.

Cost-effectiveness: Eliminating imaging/contrast reduced procedural costs by ~40% versus guided techniques.

 

Table 2. COMPARISON OF OUR STUDY WITH OTHERS

Study

Sample Size

Technique

Improvement in ROM

Pain Relief (VAS)

Guidance Used

Our Study (2025)

53

HD + MUA (awake, no anesthesia)

Abd: +40°, ER: +15°

3/10 → 9/10 (idiopathic)

No US/arthrogram

Quraishi et al. (2007)

36

HD vs. MUA

Abd: +30°, ER: +10°

Significant

Fluoroscopy + contrast

Carette et al. (2003)

93

Steroids + physio

Moderate

Early benefit

Intra-articular

Watson et al. (2000)

53

HD + physio

Gradual improvement

Recurrence in some

Ultrasound

Vastamäki et al. (2012)

118

MUA (timed)

Good improvement

Long-term benefit

Not specified

 

INTERPRETATION

Our results demonstrate that awake hydrodilatation combined with manipulation, followed by structured physiotherapy, can achieve outcomes comparable or superior to more complex techniques involving sedation, imaging guidance, or arthroscopic surgery. Importantly, our approach is cost-effective, low-risk, and practical for outpatient settings. This supports the use of our method as a first-line interventional treatment, especially in resource-constrained environments.

 

However, as with all retrospective studies, further validation through RCTs with larger sample sizes and longer follow-up is warranted to substantiate the long-term efficacy and reproducibility of our findings.

CONCLUSION

Hydrodilatation with awake manipulation is a safe, minimally invasive, and cost-effective technique for treating stiff shoulder. Performing the procedure without general anesthesia or imaging using 0.2% ropivacaine allows immediate mobilization and early physiotherapy, a critical factor for success [9]. This approach results in significant improvement in pain, ROM, and function, especially in diabetic patients. Larger prospective trials and randomized studies are recommended to validate these findings against standard image-guided or anesthesia-dependent protocols.

 

 

 

 

 

X-axis (horizontal) → Represents the clinical outcome categories:

Y-axis (vertical) → Represents the proportion of patients in each category (from 0.0 to 0.5).

 

Statistical Appendix

  1. Tests Used:
    • Paired *t*-tests (pre/post)
    • Chi-square for categorical variables (e.g., diabetic vs. non-diabetic)
    • ANOVA for multi-group comparisons
  2. Effect Sizes:
    • Cohen’s *d* = 2.1 (large effect for OSS improvement)
    • 95% CI for Δ Abduction: 36.2°–42.8°
  3. Missing Data: <5% (excluded from analysis

STATISTICAL ANALYSIS OF HYDRODILATATION WITH MANIPULATION IN STIFF SHOULDER

 

  1. Descriptive Statistics

Variable

Value (n=53)

95% CI

Mean Age (years)

54 ± 9.2

51.6–56.4

Female Sex

60.4% (n=32)

46.2–73.2%

Diabetic Patients

68% (n=36)

54.3–79.3%

Symptom Duration (mo)

5.9 ± 2.1

5.3–6.5

  1. Preoperative vs. 1-Year Outcomes

*(Paired t-tests, α=0.05)*

Parameter

Preop

1-Year

Mean Difference (Δ)

p-value

Effect Size (Cohen’s d)

VAS Pain (0–10)

7.1 ± 1.2

2.3 ± 1.5

4.8 ↓

<0.001*

2.41 (Large)

Oxford Shoulder Score

48.2 ± 8.4

75.9 ± 9.1

27.7 ↑

<0.001*

3.12 (Large)

Abduction (°)

70.3 ± 12.1

109.8 ± 15.6

+39.5

<0.001*

2.89 (Large)

External Rotation (°)

9.5 ± 3.2

25.7 ± 6.8

+16.2

<0.001*

2.67 (Large)

Key:

  • ↓ = Reduction; ↑ = Improvement
  • *Statistically significant (Bonferroni-corrected threshold: p<0.0125 for 4 comparisons)

 

  1. Subgroup Analysis

(A) Diabetics (n=36) vs. Non-Diabetics (n=17)

Outcome

Diabetics (Δ)

Non-Diabetics (Δ)

p-value

Δ OSS

+26.3

+30.1

0.18

Δ Abduction (°)

+37.2

+43.1

0.09

Δ VAS

5.1 ↓

4.2 ↓

0.03*

(B) Sex Differences

Outcome

Females (Δ)

Males (Δ)

p-value

Δ OSS

+25.9

+30.5

0.04*

Δ ER (°)

+14.7

+18.3

0.12

 

  1. Safety & Re-intervention Rates

Metric

Value

Comparison to Literature

Intraoperative Complications

0%

MUA studies: 3–8%

Re-intervention Rate

5.7% (n=3)

Steroid-only: 15–20%

Therapy Adherence

92% (n=49)

Typical range: 70–85%

 

  1. Correlation Analysis
  • Symptom Duration vs. ΔOSS: *r* = -0.42 (p=0.002)
    Longer symptoms → Smaller functional gains
  • Age vs. ΔAbduction: *r* = -0.31 (p=0.02)
    Older age → Less ROM improvement

 

REFERENCES
1. Andren L, Lundberg BJ. Treatment of rigid shoulders by joint distension during arthrography. Acta Orthop Scand. 1965;36(1):45–53. 2. Sun, Y., Zhang, P., Liu, S., Li, H., Jiang, J., Chen, S., & Feng, X. (2021). Intra-articular steroid injection versus hydrodilatation for frozen shoulder: A systematic review and meta-analysis of randomized controlled trials. Journal of Orthopaedic Surgery and Research, 16(1), 1-12. 3. Cho, C. H., Kim, D. H., & Lee, Y. K. (2020). Is hydrodistension with corticosteroid injection an effective treatment for frozen shoulder? A systematic review and meta-analysis. Journal of Clinical Medicine, 9(8), 2633. 4. Vastamäki H, Kettunen J, Vastamäki M. The natural history of idiopathic frozen shoulder: A 10–year follow-up study. Clin Orthop Relat Res. 2012;470(4):1133–1143. 5. Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;(1):CD004016. 6. Ekeberg, O. M., Bautz-Holter, E., Tveitå, E. K., Juel, N. G., & Kvalheim, S. (2010). Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ, 340, c1376. 7. Soh, E., Li, W., Ong, K. O., Chen, W., & Bautista, D. (2011). Image-guided versus blind corticosteroid injections in adults with shoulder pain: A systematic review. BMC Musculoskeletal Disorders, 12, 137. 8. Liu, S. S., & Salinas, F. V. (2003). Ropivacaine: a review of its pharmacology and clinical use. Current Opinion in Anaesthesiology, 16(5), 589-593. 9. Page, M. J., Green, S., Kramer, S., Johnston, R. V., McBain, B., & Buchbinder, R. (2014). Physiotherapy management of adhesive capsulitis (frozen shoulder): an evidence-based clinical guideline. Journal of Physiotherapy, 60(2), 90-91. 10. Quraishi NA, Johnston P, Bayer J, Crowe M, Chakrabarti AJ. Thawing frozen shoulders – a comparison of manipulation under anaesthesia with hydrodilatation. J Bone Joint Surg Br. 2007;89(9):1197–1200. 11. Bunker, T. D., & Anthony, P. P. (1995). The pathology of frozen shoulder. A Dupuytren-like disease. The Journal of Bone and Joint Surgery. British Volume, 77(5), 677-683. 12. Neviaser, A. S., & Hannafin, J. A. (2010). Adhesive capsulitis: a review of current treatment. The American Journal of Sports Medicine, 38(11), 2346-2356
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