INTRODUCTION

INTRODUCTION:
Shoulder pain is one of the most common symptoms among patients with advancing age and associated risk factors to generally about 4% to 26 %. Majority of the complains have the root cause in subacromial space but may cause radiating pain from various other conditions such as cervical spine radiculopathy, abdominal viscera pathologies, lung apex and even accompanying myocardial ischemia 1. Leading causes of shoulder pain is Adhesive Capsulitis (AC) of the shoulder, which may be associated with minor trauma, environmental stresses, autoimmune processes, or disease like diabetes mellitus and so forth . Inflammation, fibrosis, and contracture of the joint capsule or adjacent bursa leads to AC, which manifests as a progressive loss of active and passive shoulder movement accompanied by pain.2,3,4 Frozen shoulder is a condition with no known cause which slowly progresses with increase in pain and decrease Range Of Motion (ROM) eventually leading joint capsule fibrosis. Frozen shoulder is seen mostly in between 40 to 60 years of age with 2-4 time more prevalent in female as compared to male, occurs in approximately 2-5% of the general population .further increased with existing co-morbidities such as diabetes mellitus, rotator cuff lesions, thyroid disorders, Chronic Obstructive Pulmonary Diseases, cerebro-vascular accident, myocardial infarction, inflammatory arthritis, trauma, and prolonged immobilization. Frozen shoulder may result in many complications like sleep disturbance, reduced ability to perform daily activities and personal grooming. The disease progresses through three phases before resolving completely
In the first phase (pain phase) disease starts with synovitis, thickening of the joint capsule, synovial fluid loss, and decreased ROM are primarily seen. This phase lasts for about 10-36 weeks followed by second phase (frozen phase), in which pain is decreased and joint capsule fibrosis is more marked along with thickening of the rotator cuff tendons, and loss of joint space are seen. The duration of this phase is approximately 4-12 months. In the final third phase (resolution phase), joint ROM again starts to increase gradually and the patient gradually starts returning to daily activities. The duration of this phase is approximately 12-42 months. 5-7
Rotator Cuff (RC) calcifications are diagnosed by the presence of calcium hydroxyapatite crystal deposits in tendons at multiple sites with no known cause .The most common site of this calcium deposit is at the supraspinatus tendon 2(80%), followed by infraspinatus (15%), teres minor and subscapularis tendon in approximately 5%.The initial treatment of choice is conservative, typically including rest, analgesics, nonsteroidal anti-inflammatory drugs, rehabilitation and corticosteroid injections, with favorable results in 90–99% of cases. Treatment by ESWT has emerged as an alternative when conservative treatment fails and prior to invasive procedures.8-10
Ultrasound is successfully used in the treatment of many musculoskeletal diseases. Ultrasound applied at target points in tendinopathies and many other musculoskeletal disorder has achieved marked improvement in shoulder pain.11
Extracorporeal shock wave therapy is an intervention which is increasing in use for treatment of musculoskeletal problems. Many researchers have been performing investigating the effectiveness of ESWT in various conditions, among them are calcific tendinopathies of rotator cuff, adhesive capsulitis, chronic plantar fasciitis, lateral and medial epicondylitis, Achilles tendinopathies and painful heel spurs can be enumerated.. ESWT has been reported to be effective for promoting tissue healing through improvement of revascularization and reduction of local inflammation.12
NEED OF THIS STUDY:
To find out the progression of the patients during the course of treatment and to compare the effectiveness of ESWT versus Ultrasound.
Assess the efficacy of ESWT in patients with calcific and non-calcific tendinitis as there are many studies which support the use of ESWT on calcific tendinitis but not many studies for non-calcific tendinitis as supported by Huisstede BM1, Gebremariam L, van der Sande R, Hay EM, Koes BW. 13 There are many studies which confirm the efficiency of use of ESWT for calcific tendinitis but there have been no studies to confirm the use of the ESWT for non-calcific tendinitis but that is also has limitation of not big enough sample size.14
To determine the efficacy of ESWT in long term, it has already been proven that it is helpful in short term however, will the long term use will cause any complications or not. Leading to surgical indication as has been found in the study 15.
OBJECTIVES OF THIS STUDY
The primary objective of this study is to evaluate effectiveness of shockwave therapy on painful shoulder conditions (frozen shoulder and impingement syndrome) and compare the results with conservative line of management for reducing pain and increasing range of motion .
Secondary objective is to assess decrease in psychological stress related to pain and loss of functional activities.
HYPOTHESIS OF THIS STUDY
Alternate hypothesis: Extracorporeal shockwave therapy is more useful for treatment of painful shoulder syndromes.
Null Hypothesis: no significant differences in improvement of selected variables.

REVIEW OF LITERATURE
ESWT can be used a s a preventive measure that can halt the progression of an acute case to chronic by early intervention and resolving the inflammation as proved in study conducted for epicondylitis by Köksal, Güler , Mahiro?ullar? , Mutlu , Çakmak , Ak?ahin in 2015.
The classification system of tendinopathy as described by Nirschl et al. in 2003 also described in the picture given below the phases of pain of patients who participated was between IV-VII

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In rotator cuff tendinitis,acutetreatmen includes physiotherapy, non-steroidal anti-inflammatory drugs, and corticosteroid injections. But even if the symptoms still persists then the treatment method preferred is surgical repair but the alternative therapy to be used before surgery is ESWT as it also helps in chronic cases of tendinitis and this has been proven by Huisstede BM1, Gebremariam L, van der Sande R, Hay EM, Koes BW. 16
The application of ESWT is usually considered when conservative treatment has failed for 6 months.17
Non-calcified tendinopathy of RC present extrinsic and intrinsic pathogenic mechanisms. The term “non-calcified tendinopathy” generally includes degenerative processes determining tendinosis and partial tendon ruptures not eligible for surgery. The foremost include functional and structural disorders and mechanically affect the rotator cuff. The intrinsic includes the degenerative processes suffered by the muscles and tendons over the course of several years. ESWT cannot modify extrinsic factors but could improve vascularization of RC and stimulate the release of growth factors.so instead of going for a surgical repair, it would be better to wait for the revascularization of the injured tissue and improved healing, according to histological results reported in treated tendons.18-19
Engebretsen et al revealed that supervised exercises were better than radial extracorporeal shockwave treatment for short term improvement of the shoulder pain and disability index in patients with subacromial shoulder pain.20
Huisstede et al assessed the 17 studies, in which ESWT was applied due to rotator cuff tendinitis (calcified rotator cuff patients were included in 11 studies, and patients who did not have non-calcified tendinitis were included in 6 studies). They reported that ESWT application was efficient in the treatment of calcified tendinitis, and that it was not more efficient than the placebo and other treatment methods in non-calcified rotator cuff tendinitis.21
In the study conducted by Erasmus MC ESWT did not show any positive results for the treatment of non-calcific rotator cuff tendinitis but showed effective results for its use in calcific rotator cuff tendinitis.22

• CHAPTER 3: MATERIALS AND METHODOLOGY
Study design
This randomized and experimental study conducted at this hospital from March 2018 to June 2018. Twenty eligible patients were randomly divided into an intervention group or a control group, each group 10 patients. Patients in the intervention group received ESWT, whereas subjects in the control group received conservative treatment with ultrasound.
Study setup
The study was conducted in Umm-Al-Quwain hospital
Study population
20 patients with shoulder pain syndromes including frozen shoulder and impingement syndrome.
Study criteria
Inclusion:
• not improving shoulder pain
• have Neer’s stage 1 and 2 according to Neer’s classification.
• ROM restriction (>75% ROM loss in ?2 directions including abduction, flexion, external rotation, and internal rotation) for at least 3 months
• no treatment other than analgesics within the past 3 months.
• Pre-calcific and calcific tendinitis patients.
• conservative treatment has failed for 6 months.
Exclusion:
• pregnancy
• surgical intervention on the affected shoulder
• extensive scar around the shoulder
• joint infection
• lack of stability
• rheumatoid arthritis
• full thickness tear of shoulder rotator cuff,
• cervical radiculopathy
• damage to the spinal cord,
• history of cortisone injection in the affected area in the previous 6 weeks, or if t
• other contraindications to shock wave treatment, including artificial pacemaker, use of anti-blood clotting medications, known bleeding disorder, known malignancy in the area intended for treatment, or epilepsy.
SAMPLING METHOD AND SAMPLE SIZE:
Convenient sampling and 20
VARIABLES OF THIS STUDY:
Pain intensity, Range of Motion, DASH outcome score and GROC score.
Study protocol:
The subjects were 20 female patients; aged 29 to 72, diagnosed with painful shoulder syndrome based on clinical findings and data obtained from such medical investigative procedures such as MRI were diagnosed as impingement syndrome or frozen shoulder. The subjects were chosen from among the outpatients at Umm-Al-Quwain hospital in Umm-Al-Quwain, United Arab Emirates. Patients who had neurological diseases, malignancy, dislocation, subluxation, rheumatism, or had received surgery were excluded. On average, the control group (n=10) members were of mean age 45.5 ± 14.3, mean height of 164.5 ± 5.4 cm , and mean weight of 89.1 ± 8.6 Kgs; the experimental group (n=10) members were 43.70 ± 10.4 years of age, 161.40 ± 5.96 cm in height, and 86.6 ± 8.88 kg in weight. The study was conducted after its entire process was fully explained to the subjects and their approval was gained. This study was approved by ethical community and written consent has been obtained from each patient.
The control group was treated with a range of conservative physical therapies, including hot packs (10 minutes), ultrasound (8 minutes), and interference current therapy (100 bps, 15 minutes). The experimental group received conservative physical therapy, and then was additionally treated with a magnetic ESWT unit (REGENWAVE, HNT Med, and Korea). Waves of 4 Hz were applied 2,000 times using a focus-type head, while adjusting the intensity of the energy according to the patients’ degree of tolerance to the pain resulting from the treatment. Prior to the treatment, the patient received a physical examination to determine the target region for the accurate delivery of the shock wave energy. All the subjects were treated three times a week over a four-week period. The ESWT was given in neutral position as the main objective was to find out the effective of ESWT when compared to US however there have been studies which show that ESWT in case of calcific tendinitis when given in hyper extended position were proven to be more effective result. The rate of absorption was higher in patients treated with the arm positioned in hyperextension and internal rotation (66.6%) compared with those treated in neutral position (35.3%). 23
OUTCOME MEASURES;
A Visual Analogue Scale (VAS) is a measuring tool that tries to measure a characteristic or attitude that is believed to range across a continuum of values and it cannot be measured easily or directly. The VAS ranges from 0-10 where 0 indicates no pain and 10 indicate extremely painful. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. 24
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. Testing has shown that the DASH performs well in both these roles. 25
GROC Score:
The following rating scale allows us to review the overall outcome of your condition with physical therapy intervention. It allows us to review your physical therapy outcome, which helps guide our treatment to better serve our patients in the future. The Global Rating of Change (GROC) has been well documented and extensively used in research as an outcome measure as well as to compare outcome measures. 26-27
STATISTICAL ANALYSIS METHOD:
Microsoft Excel Stats

• CHAPTER 4: RESULTS AND DISCUSSION
Data was collected pre and post treatment of each week in order to provide comparison between weekly and to find the trend of improvement. This was done to compare sets of data to provide insights on how ESWT differ in healing as compared to Ultrasound.
Table 1 : Baseline characteristics with the mean and standard deviation of patients enrolled in the study
Group Age Height Weight Duration of pain ( in months)
Control N 10 10 10 10
Mean 45.50 164.50 89.10 13.800
Std. Deviation 14.316 5.401 8.465 12.2275
Experimental N 10 10 10 10
Mean 43.70 161.40 86.60 17.350
Std. Deviation 10.436 5.967 8.884 16.5228

Table 2: Pre and post treatment analysis of parameters, pain (VAS), disability (DASH), and change (GROC) and shoulder active range of motion within experimental group.
Variable Rank Median Z-value P-value
Negative Positive Pre Post Difference
Vas 10 0 9 1.5 -7 -2.83 0.005
Dash 10 0 39.4 19.9 -19.2 -2.83 0.005
GROC 0 10 -3.5 5.5 9 -2.82 0.005
Arom-abd 0 10 95 142.5 43.5 -2.80 0.005
Arom-flex 0 10 96 140.5 46 -2.80 0.005
Arom-er 0 10 45 74 28 -2.80 0.005

Table 2 ; 3 shows the mean decrease in VAS scale, DASH and increase in GROC,AROM-abduction,AROM-Flexion and AROM External Rotation for both the groups before and after intervention. Wilcox on signed-rank test was used for pre and post intervention comparisons.
Wilcox on signed-rank test : It is test use to determine the median differences between the related groups in the population.
Table 3: Pre and post treatment analysis of parameters, pain (VAS), disability (DASH), and change (GROC) and shoulder active range of motion within control group.

Variable Rank Median Z-value P-value
Negative Positive Pre Post Difference
Vas 10 0 9 3.5 -6 -2.9 0.004
Dash 10 0 43.4 29.15 -14.1 -2.8 0.005
GROC 0 10 -3 5 8 -2.8 0.005
Arom-abd 0 10 90 142 48 -2.8 0.005
Arom-flex 0 10 105 142 41 2.8 0.005
Arom-er 0 10 42.5 65 23.5 2.8 0.005

A Mann-Whitney U test was done to determine whether there is any difference between the pain scores in the post intervention for control and experimental group.

Table 4: Intergroup comparison of post treatment analysis of parameters, pain (VAS), disability (DASH), and change (GROC) and shoulder active range of motion, experimental versus control group.
Diff_VAS Diff_DASH Diff_GROC Diff_AROM_ABD Diff_AROM_FLEX Diff_AROM_ER
Mann-Whitney U 20.500 28.500 29.000 36.000 30.500 36.000
Z -2.424 -1.631 -1.632 -1.061 -1.478 -1.061
p-value .023 .105 .123 .315 .143 .315

Median score for VAS (-6 for Control and -7 for experimental) was found to be statistically significantly different for both control and experimental group U=20.5, z=-2.42, p= 0.023. However, all the other variables did not show any statistical significant difference in the median scores.
VAS in the experimental group as compared to control group: Ten patients were assessed to find the difference in the pain before and after the intervention. For all the 10 patients, who were in experimental group, the intervention decreased the pain, i.e. the test determined that there was a statistically significant median decrease in the pain scale (-7), when the patients were given the intervention (1.5) when compared to the pre test (9), z=-2.836, p

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