Adhesive capsulitis commonly known as frozen shoulder (FS), is a common and often painful condition characterized by the gradual onset of shoulder pain and progressive stiffness, leading to significant functional impairment. Adhesive capsulitis has an incidence of 2-5% in the general population and in 20% of diabetes mellitus patients. It typically affects individuals between the ages of 40 and 60, with a higher prevalence among women.1,2 The current consensus definition of a frozen shoulder by the American Shoulder and Elbow Surgeons is "a condition of uncertain etiology characterized by significant restriction of both active and passive shoulder motion that occurs in the absence of a known intrinsic shoulder disorder.” 3 The hallmark of physical examination is loss of both passive and active ROM without degenerative changes on X-ray. A combination of pharmacological, rehabilitative, and/or surgical treatment is commonly helpful for the patient afflicted with adhesive capsulitis.4 The untreated shoulder is described as passing through 3 distinct phases consisting of ‘‘freezing,’’ ‘‘frozen,’’ and ‘‘thawing,’’ with most shoulders regaining full function5. However, long-term studies have shown that FS IS self-limiting although the patient subjectively feels that the condition has resolved after 12 to 24 months. The aim of any treatment is to interrupt the natural history of the condition Therefore; treatment of FS should be focused on limiting symptoms and shortening the duration of disabilities. Although the underlying pathophysiology is not entirely understood, studies suggest a chronic inflammatory Cascade leading preliminary to a contracture of the Joint capsule. The cells that are mainly involved are fibroblasts and myofibroblasts. They produce densely packed collagen type III in the extracellular matrix of the articular capsule.5 This leads to a decreased intra-articular volume, often < 5 ml instead of around 20 ml, and a reduced capsular compliance.6 in summary, the frozen shoulder appears to start as an inflammatory reaction in capsule with associated synovitis that progresses to the fibrotic contracture of the capsule. Various therapeutic methods have been introduced for frozen shoulder syndrome: non-surgical options including physiotherapy, oral anti-inflammatory drugs, intra-articular corticosteroid injections (IACI), hydrodilatation, and local nerve blocking. The proposed surgical treatments include manipulation under anesthesia and release of contractions by an open method or arthroscopy.1,2 Hydraulic distension is an interventional procedure in which a sufficient amount of fluid is injected into the stiff shoulder capsule. Hydraulic distension is used clinically for adhesive capsulitis to reduce inflammation of the joint capsule and directly relieve contracture, alleviate pain, and improve ROM.7 It is a safe, reliable, cost-effective modality in treating the chronically distressing painful condition of frozen shoulder. According to current evidence, hydraulic distension has a superior effect in the treatment of adhesive capsulitis compared to other general conservative treatments.7 Local injectable steroid is most frequently deployed medical method to provide relief from severe pain in freezing stage of FS. Systematic reviews and metanalysis have confirmed strong evidence in favour of steroid injections in improving pain and ROM as compared to placebo in the short term, and moderate evidence in the midterm. Steroid injection is certainly superior to physiotherapy (PT) in reducing pain but evidence is conflicting regarding restoration of ROM while comparing steroid injection with PT or manipulation under anaesthesia (MUA).5 In a study comparing a group of patients that received only hydraulic distension, a group that received only intraarticular steroid injection, and a group that received hydraulic distension and intraarticular steroids simultaneously, the improvement in joint ROM was greatest in the group that received both hydraulic distension and steroids.8 Thus, hydraulic distension alongside intraarticular steroids allowed not only the dose of analgesics to be reduced but also a significant improvement in ROM compared to steroid injection alone. Incorporating hydraulic distension with steroids could improve the effectiveness of intraarticular steroid injection in the treatment of the adhesive capsulitis.9 The use of intraarticular steroid as an adjunct in hydraulic distension is not well established in literature. The complication associated like septic arthritis, progressive degeneration and disturbances in glycemic control in diabetics are some debatable topics. Hence this study was conducted.

SOURCE OF DATA The study was conducted on 50 patients with clinically and radiologically confirmed cases of Adhesive capsulitis in Department of Orthopedics, General Hospital, Gundlupete, Chamarajanagar. INCLUSION CRITERIA 1. Age: Above 30 years of either sex with clinically diagnosed cases of adhesive capsulitis of shoulder 2. clinical history of pain and restriction of passive and active ROM of the shoulder for at least one months. 3. pain of more than 4 weeks duration and patient symptomatic even with prior conservative treatment like oral analgesics, non-invasive physiotherapy modalities 4. Patients with history of chronic shoulder pain and decreased range of motion (active and passive) of shoulder. 5. Patients who give consent to participate in study. 6. Diabetic patients whose HbA1c is less than 6.5% and fasting blood sugar levels are less than 126 mg/dl. EXCLUSION CRITERIA 1. Previous history of manipulation under anaesthesia or steroid injection. 2. Chronic local or systemic disease, such as rotator cuff tears, biceps tendinitis, calcific tendonitis or severe glenohumeral arthritis, potential arthritis, rheumatoid arthritis, generalized polyarthritis seronegative arthropathy, neurologic impairments, tumors of the shoulder or scapula. 3. Known hypersensitivity to lidocaine hydrochloride or corticosteroids, allergies to drugs or metal. 4. Current skin or soft tissue infection near the possible injection site. 5. Patients with any bleeding disorder or on anti-coagulant drugs, patients with bilateral planter fasciitis. 6. Previous local surgery, a history of local trauma or other musculoskeletal condition that might impair function of the shoulder. STUDY POPULATION This is prospective randomized, single blind, controlled study. This study was conducted in general taluk hospital, Gundlupete. Fifty patients who were clinically and radiologically confirmed to have primary adhesive capsulitis were enrolled in the study after informed consent. 50 patients were randomized and assigned into 2 groups of 25 patients each. A careful history was elicited, then assessed clinically to evaluate their general condition and the local condition and neurological examination. If Patients has bilateral shoulder symptoms, then the shoulder with the more severe symptoms will be included in the study and treated as per randomisation. If patient chooses then the lesser affected hand was managed, after the treatment for the more severely affected shoulder (as per randomisation) after taking fresh consent from the patient. PROCEDURE AND STUDY GROUPS Patients were subjected to hydrodilation of shoulder capsule (shoulder hydroplasty) using local anaesthetic +/- steroid and normal saline followed by manipulation and home-based physiotherapy plans. GLENOHUMERAL INJECTIONS were performed with the patient in lateral decubitus or sitting postion. The affected shoulder was held between the long finger on the coracoid process and the thumb on the posterior corner of the acromion. The needle was then inserted 1 to 2 cm below the corner of the acromion into the ‘‘soft spot’’ it was gently introduced through the posterior capsule directed towards the index finger (heading toward the coracoid process), then into the glenohumeral joint. STUDY GROUP I (hydraulic distension with steroid as an adjunct) Hydraulic distenson and manipulation of shoulder done using 40 mg of triamcinolone (in 1 mL), 4mL of 2% lignocaine, and 5-10 mL of 0.25% bupivacaine. STUDY GROUP II (hydraulic distension without steroid as an adjunct) Hydraulic distenson and manipulation of shoulder done using 5mL of 2% lignocaine, and 5-10 mL of 0.25% bupivacaine MANIPULATION OF SOULDER10 Patients were placed in supine position, the scapula was stabilized by the supine position, by gripping the top of the shoulder and the surgeon then moving the arm in the scapular plane while trying to use a short lever arm. The shoulder was moved into flexion first, then into abduction, applying gentle pressure to break the adhesions. Subsequently, at three different grades of abduction (0°, 45° and 90°), the arm was externally and internally rotated until a satisfactory recovery of range of motion was obtained. A typical cracking sound, a definitive snap or characteristic feeling of tissue breakdown in the shoulder was frequently reported. CLINICAL AND FUNCTIONAL ASSESSMENT The patients were then assessed clinically to evaluate their general condition and the local condition with provocative test and neurological examination. Pain is assessed by VAS scale varying from 0 to 10. They were assessed clinically and functionally based on SPADI. The SPADI is 13 item self-administered questionnaire designed to quantify shoulder pain and disability. Michener and Leggin (2001) reported a high test–retest reliability and internal consistency for the SPADI, while Williams et al. (1995) have shown that the instrument is responsive to change and accurately discriminates between patients who are improving or worsening. POST PROCEDURE PERIOD They all had a physician directed postoperative physiotherapy program10, which included range of motion, strengthening, and stretching. If symptoms recur following procedure in either study group, participants should contact research team. They will be considered as a case of relapse. MRI will be done to confirm the severity and discuss further treatment options. FOLLOW UP Patient education is the single most important means of preventing and treating peri arthritis of shoulder. Participants advised to modify activities that can aggravate pain (eg, lifting weights, occupation related strains) and avoid other high impact activities for three weeks Following the manipulation session, with the patient resting in supine and the patient’s hand placed behind his/her head, the treated shoulder was wrapped in an ice pack for approximately 10 min. Patients should be cautioned that they might experience worsening symptoms during the first 24 to 48 hours, related to a possible steroid flare, which can be treated with ice and NSAIDs. Patients were then taught physician directed home based exercise program included active, active assisted and passive shoulder range of motion exercises., which consisting of pendular exercises, wall climbing movements, strengthening, and stretching. The purpose of home-based exercise program after intervention is to maintain the shoulder joint ROM that is achieved during the manipulation. physiotherapy exercises were commenced immediately and continued on a daily basis. They were instructed to perform these exercises every 2-4 hr at home, when awake, for the next 24 h. They were also instructed to apply ice packs to the shoulder for 20 min every 2 h with the ice packs circumferentially around the shoulder while lying supine, hand resting behind their head. The Patients were followed up at regular intervals of 4 weeks up to 12 weeks to assess clinical and functional improvement based on SPADI STATISTICAL METHODS Descriptive and inferential statistical analysis has been carried out in the present study. Results on continuous measurements are presented on Mean ± SD (Min-Max) and results on categorical measurements are presented in Number (%). Significance is assessed at 5 % level of significance. The following assumptions on data is made, Assumptions: 1. Dependent variables should be normally distributed, 2. Samples drawn from the population should be random, Cases of the samples should be independent. Student t test (two tailed, independent) has been used to find the significance of study parameters on continuous scale between two groups (Inter group analysis) on metric parameters. Z test for 2 population proportions used to find the significance of study parameters expressed in proportions. Leven1s test for homogeneity of variance has been performed to assess the homogeneity of variance. Data was tested for normality by Kolmogorov-Smirnov test. Chi-square has been used to find the significance of study parameters on categorical scale between two groups. Statistical software The Statistical software namely SAS 9.2, SPSS 16.0, socscistatistics calculators, and MedCalc 9.0.1 were used for the analysis of the data and Microsoft word and Excel have been used to generate tables.

Table1: Age distribution of patients studied Age in years hydraulic distension with steroid hydraulic distension without steroid No. % No. % 31-40 10 40.0 11 44.0 41-50 13 52.0 13 52.0 51-60 2 08.0 1 04.0 Total 25 100.0 25 100.0 Mean±SD 42.1 ± 5.67 42.4 ± 6.19 Samples are age matched with Student t test. The result is not significant at p <.05. Mean age of this study is 42.23 ± 7.08 (34–57 years). Table 2: demographic distribution in two groups of patients studied Demographic details hydraulidistension with steroid hydraulic distension without steroid TOTAL PARTICIPANTS No % No % No % gender Female 16 68.0 16 68.0 32 68.0 Male 09 32.0 09 32.0 18 32.0 Total 25 100.0 25 100.0 50 100.0 laterality unilateral 19 88.0 21 92.0 26 80.0 bilateral 03 12.0 02 8.0 5 20.0 total 25 100.0 25 100.0 50 100.0 dexterity right 16 64.0 14 56.0 30 60.0 left 09 36.0 11 44.0 20 40.0 Total 25 100.0 25 100.0 50 100.0 Table 3: Occupation distribution in two groups of patients studied Occupation STEROID GROUP SURGERY GROUP No % No % Farmer 3 12.0 4 16.0 Housewife 13 52.0 15 60.0 Private Business 3 12.0 1 4.0 Government servant 2 8.0 2 8.0 Labourer 1 4.0 1 4.0 Teacher 3 12.0 2 8.0 Total 10 100.0 10 100.0 OUTCOME MEASURES Group I Group II Before (SD) After 4 weeks (SD) P value Before (SD) After 4 weeks (SD) P value Pain (VAS) 8.1 (0.9) 1.24 (0.9) The value of p is < .00001. The result is significant at p < .05 8.2(0.74) 2.72 (0.9) The value of p is < .00001. The result is significant at p < .05 Forward flexion 70.52 (44.17) 140.34 (30.38) 68.16 (43.14) 125.28(36.24) Abduction 60.35 (45.15) 126.42 (32.65) 62.24 (44.11) 122.6 (33.67) External roatation 51.88 (27.58) 82.24 (14.94) 53.12 (23.69) 80.16 (18.09) SPADI Score 68.24 (23.66) 9.4 (2.38) 68.88 (23.25) 10.2 (3.49) Table 4: Comparison of pre and post treatment values of outcome measures before treatment and after 4 weeks post treatment Table 5: Comparison of pre and post treatment values of outcome measures before treatment and after 12 weeks post treatment OUTCOME MEASURES PRE TREATMENT AFTER 4 WEEKS AFTER 12 WEEKS Group I Group II P value (I Vs II) Group I Group II P value (I Vs II) Group I Group II P value (I Vs II) Pain (VAS) 8.1 (0.9) 8.2(0.74) 0.90 1.24 (0.9) 2.72 (0.9) < 0.0001 1.12 (0.72) 1.43 (0.86) 0.003 Forward flexion 70.52 (44.17) 68.16 (43.14) 0.43 140.34 (30.38) 125.28(36.24) 0.02 167.38 (10.45) 164.22 (16.54) 0.0028 Abduction 60.35 (45.15) 62.24 (44.11) 0.79 126.42 (32.65) 122.6 (33.67) 0.006 160.40 (18.35) 158.25 (24.74) 0.004 External rotation 51.88 (27.58) 53.12 (23.69) 0.58 82.24 (14.94) 80.16 (18.09) 0.16 85.1 (9.63) 84.56 (11.69) < 0.0001 SPADI Score 68.24 (23.66) 68.88 (23.25) 0.94 9.4 (2.38) 10.2 (3.49) < 0.0001 5.72 (2.68) 5.83 (3.16) 0.02

Fifty (50) patients of frozen shoulder were included in this study; There were 32 females and 18 males. Their mean age was 42.3 ± 7.08 (34–64 years). Majority were Right sided (60%). Their duration of illness was 1.7 ± 1.17 (1–3 months). Most of the patients were homemakers 28/50(56%). 14 patients were known case of diabetes on treatment under physician guidance. Five cases had rheumatoid arthritis; 4 had thyroid disorder while 2 had hypertension as co morbidity. After randomization the study population in both groups I and II were comparable. There was no statistically significant difference noted in between the groups Age distribution Our study revealed the mean age of patients to be 42.23 ± 7.08 (34–57 years) years. the peak age of development for adhesive capsulitis is 40-60 years. We have slightly younger age group of patients compared to adhesive capsulitis in general population. Sex distribution In our study, the female predominance of about 68.0% (32) of study population. It correlates with fact that adhesive capsulitis is more common in females. Occupation Majority of our patients are housewives/home makers (56%). They involve in multiple household chores regularly causing repeated stress related activities and causing clinical symptoms. In this study we have used combination of 4 modalities of treatment for peri arthritis as a standarised treatment modality. Hydraulic distension to treat capsule contracture, shoulder manipulation to release adhesions, steroid as a adjunct to decrease inflammation and home-based exercise protocol to improve and prevent recurrence of condition. In both group I and II outcome measurements at 4 and 12 weeks revealed improvement in all categories. Statistical significance, determined by a p value of <.05, was obtained in all outcome measures when compared with the baseline measurements at 4 and 12 weeks of follow-up (Tables 1 and 2) On comparison between the groups the local corticosteroid injection group showed statistically significant improvement at 4 weeks in terms of pain, flexion, abduction and SPADI scores. On further follow up between the 4th week and 12th week, the local corticosteroid group showed significant improvement of efficacy within the group and in comparision with other group in all the parameters of outcome measurements (Table 3). The anti-inflammatory effects of corticosteroids may be due to a down-regulation of pro-inflammatory cytokines and genes. As inflammation is involved in pain-related mechanisms, corticosteroid injections are useful to reduce pain and, consequently, disability. Due to its direct action in the pain related mechanisms corticosteroid may have better results in short term. Our results are comparable to the results of other studies. Jacobs et al8, studied the synergistic effect in the administration of intraarticular steroids with distension in the management of early capsulitis of the shoulder and concluded that analysis of the mean improvements in abduction and forward flexion showed these to be significantly greater in the steroid with distension and steroid only groups than in the distension only group. A metanalysis study by Wang et al11 concluded that intra-articular corticosteroid injections were more effective in pain relief in the short term, but this pain relief did not sustain in the long term. Intra-articular corticosteroid injection resulted in greater improvement in passive ROM both in the short and the long terms. A study by Winters et al12 concluded that for treating shoulder girdle disorders, manipulation seems to be the preferred treatment. For the synovial disorders, corticosteroid injection seems the best treatment. A study by Carette et al13 concluded that intraarticular injection of corticosteroid administered combined with a simple home exercise program is effective in improving shoulder pain and disability in patients with adhesive capsulitis compared with intraarticular saline injection with physiotherapy or physiotherapy alone. A systematic review by Catapano et al14 concluded that combining hydrodilatation with corticosteroid injection potentially expedites recovery of pain-free ROM. The greatest benefit is experienced within the first 3 months of intervention. A systematic review by ladermann et al15 Arthrographic distension/hydrodilatation with corticosteroid provides superior pain relief in the short term and improvement in range of motion across all time frames for frozen shoulder when compared to intra-articular and subacromial corticosteroid injection or physiotherapy. Complications: In this study, the most common adverse effects were short term pain with redness (2 to 4days) over injection site (44%). These were managed by ice packs and tab combiflam BD for 5 days. We had no case of any anaphylaxis with the medications, 8 cases (5 cases in group II) had acute increased pain immediately post procedure which was managed with medications and physiotherapy. 7 cases had rebound stiffness (3 in group I and 4 in group II) at 2 weeks follow up, which was managed with aggressive physiotherapy protocols. None of our patients had any infection, systemic complications, and iatrogenic fracture during manipulation or physiotherapy. Strength and Limitation: The strengths of this study include its prospective and randomized design. Both the intervention was standardised for comparison. Patients follow up with validated and reliable outcome score of SPADI for adhesive capsulitis The total sample size 50 patients is smaller sample size for comparing two treatment modalities in most prevalent clinical condition of Adhesive capsulitis. Still our study will add to strength to further studies with larger study populations. Adhesive capsulitis is said to be a self-limiting disability in which 90% of patients will improve with conservative therapies, and pain relief is usually achieved within one year regardless of treatment. Cost effectiveness and benefits of this combined treatment should be assessed with individual treatment modalities for FS in multi-level analysis studies. The actual choice of treatment in daily practice will depend also on these unresolved issues. Another limitation that should be considered is that there is different injection techniques and different steroid preparations and dosages; it can be argued that alternative injection methods at even higher dosages of steroid may produce more benefit.

At final follow up almost normal range of motion was achieved in both the groups. Both groups achieved significant improvement in pain and restriction of movement and achieved almost normal day to day activity at final follow up. Overall good to excellent results were seen in both the groups without any major complication/recurrence. Even though group with corticosteroid injection showed statistically significant improvement in terms of abduction, flexion, ER and SPADI for short term relief (4 -12 weeks), the hydaulic distension combined with manipulation and exercises wIth or without steroid was found to be an effective treatment option in adhesive capsulitis. Hence, we conclude that Intraarticular steroid can be used as an adjunct in hydaulic distension of shoulder for its short to medium term benefits and the hydaulic distension combined with manipulation and exercises even without steroid can be advised as an effective treatment modality in high-risk patients for steroid injection / general anaesthesia. DECLARATIONS Funding: None Conflict of interest: None declared

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