Rajiv Gandhi University of Health Sciences, KarnatakaCurriculum Development Cell

Registration No. :

Name of the Candidate : BINAYA KANDEL

Address : HN #1053 Kumroj -3 Ghawaii Chitwan , Nepal

Name of the Institution : S.D.M College of Physiotherapy, Dharwad

Course of Study and Subject :MPT(Musculoskeletal disorders and Sports)

Date of Admission to Course :15/07/2013Title of the Topic : A STUDY TO EVAULATE THE IMPACT OF

FROZEN SHOULDER IN TERMS OF PAIN, DISABILITY AND POOR QUALITY OF LIFE IN DIABETIC PATIENTS - A CROSS SECTIONAL STUDY.

Brief resume of the intended work : Attached

Signature of the Student :

Guide Name

Remarks of Guide: Dr. PRAMOD KSHIRASAGAR

Signature of the Guide :

Co-Guide Name :

Signature of the Co-Guide :

HOD Name : Dr. Ravi Savadatti

Signature of the HOD :

Principal Name : Dr. Ravi Savadatti

Principal Mobile No. : 9845051209

Principal E-mail ID

Remarks of Principal

Principal Signature

: sdmcpt@gmail.com

: Recommended for Registration

:

1

A) BRIEF RESUME OF THE STUDY INTRODUCTION:

"This is a class of cases that I find difficult to define, difficult to treat and difficult to explain from

the point of view of pathology." E.A. Codman, 1934.1

The term “frozen shoulder” was first introduced by Codman in 1934. He described it as a painful

shoulder condition of insidious onset that was associated with stiffness and difficulty sleeping on

the affected side. Codman also identified the marked reduction in forward elevation and external

rotation as the hallmarks of the disease. Long before Codman, in 1872, the same condition had

already been labeled “peri-arthritis” by Duplay. In 1945, Naviesar coined the term “adhesive

capsulitis.”2 Although still in use, this more recent term is unfortunate, since frozen shoulder is

associated with synovitis and capsular contracture, it is not associated with capsular adhesions.3

''

It is is also known as adhesive capsulitis, scapulohumeral peri- arthritis, peri-arthritis of Dupley,

peri-arthritis of shoulder, and check-rein shoulder.4 Bunker Tim suggests a new name as

'Contracture of shoulder' for the condition.3

It may have an idiopathic onset without any significant underlying cause or may be secondary to

any of the cause as trauma, tear, fracture, rotator cuff injury etc. Beside the underlying cause, many

factor as 4th or 5th decade of life, increased glucose level, hyperthyroidism, ischemic heart disease,

inflammatory arthritis, cervical spondylosis may predispose the condition.5

Frozen shoulder progresses with its phases of severe pain, increasing stiffness, and the gradual

recovery of full movement of the shoulder.2 These features usually occur over a number of months.

The first stage characterized by episodes of acute pain severe in the night usually lasting for 3 to 6

months also known as ''freezing'' stage. Second stage or ''frozen'' stage involves gradual loss in

movement however pain is slowly diminished lasting for 3 to 18 months. Patient usually complains

of inability to perform overhead activities, reach back pocket, fasten bra, comb hair and wash

opposite shoulder. Finally the condition resolves as ''Thawing'' stage where there is gradual

resolution of movement and diminishing pain.6, 7 In recent arthroscopic studies an additional stage of

'pre-adhesion' is also mentioned before the painful freezing stage, where commencement of fibrous

inflammatory synovitic reaction occurs without the adhesion formation.8 At this stage patient

complains of night pains in shoulder but typically present with full range of motion.

In a prospective study of 41 patients followed up for upto 10 years, Reeves reported that

approximately 40% of patients demonstrated a full recovery. However, more than 50% had some

clinical limitation of movement, without restriction of function. A further 7% had restriction of

2

shoulder function. Similar results were reported by Shaffer et al, who studied 61 patients in a

prospective longitudinal study, with a mean follow up time of 7 years. They reported 50% of

patients complained of pain or stiffness, and 60% had a reduction in range of motion on clinical

review. 11% of cases demonstrated a functional deficit .6

Frozen shoulder is differentiated from all other shoulder condition by one clinical feature,

restriction of passive external rotation in the face of normal radiograph. Restriction of passive

external rotation can also be seen in cases of damage to the joint surface as in arthritis, head

splitting fracture and locked dislocation, but the radiographic changes also accompany the

pathology.3

Hence, in contrast to other disabling condition of shoulder, adhesive capsulitis is characteristic of

its hallmark features of global loss of gleno-humeral range of motion without any change in

radiological views in plain X-ray.6 However, MRI of frozen shoulder may reveal thickening of the

gleno-humeral capsule and the coraco-humeral ligament.

Pathophysiology

Neviaser (1945) described the internal appearance of peri-arthritis of shoulder by exploring ten

patients, and Simmonds (1949) did by exploring four. The essential feature on naked-eye inspection

is best conveyed in Neviaser's own words: ' there was a conspicuous absence of synovial fluid and

the redundant capsule, instead of showing the normal separation from the humeral head, was

adherent to it. This adhesion was similar to that of adhesive plaster applied to the bare skin. These

findings caused Neviaser to suggest the descriptive term ' adhesive capsulitis ' in preference to the

very unsatisfactory word ' peri- arthritis'.7

Simmonds also chooses highly descriptive words to convey the same essential picture: ' The

tendonous cuff also showed increased vascularity and it seemed abnormally thick and closely

applied to the head. The cuff could be likened to a vascular, leathery hood. The joint itself was

normal and there were no intra- articular adhesions.'7

Synovial inflammation with subsequent reactive capsular fibrosis leads to laying down of dense

matrix of type I and type III collagen by fibroblasts and myofibroblasts in the joint capsule, which

contracts causing limited movement of gleno-humeral joint.

The inflammatory and fibrotic cascade seen in frozen shoulder is evident by the increased amount

of growth factor, cytokines in capsular biopsy.2

The initiation and termination of repair process in musculoskeletal tissue is done by cytokines and

growth factor by regulating fibroblast, and by matrix metalloprotinase and their inhibitors in the re-

modeling phase. Absence of matrix metalloprotinase and elevation of MMP inhibitor causes

delayed remodeling of the scar laid down in the capsule.3

3

The normal joint volume of shoulder 28 to 35 ml of injected fluid is diminished to only 5 to 10 ml.

Histological studies of capsule demonstrates chronic inflammatory infiltrate, absence of synovial

lining, and moderate to extensive sub-synovial fibrosis.8

The re-vascularization and termination of the inflammatory reaction in the areas of injury leads to

development of painless shoulder which subsequently regains its movement. This is described by

some authors as a mechanism for resolution of a frozen shoulder with or without treatment.8

Diabetes and Frozen shoulder.

Diabetes Mellitus is a metabolic disorder of the endocrine system characteristic to increases in

glucose level or hyperglycemia. The increased level of glucose can be attributed to decreased

insulin production or impaired glucose uptake respectively termed as Insulin dependent and Non-

Insulin dependent Diabetes Mellitus. The former one usually occurs at earlier age of life due to

destruction in structure or decrease in capacity of B- cell of pancreas, while insidious in later stage

the NIDDM variety has a significant feature of no change in insulin production but its uptake may

be impaired.

The metabolic dys-regulation associated with DM causes secondary pathophysiologic changes in

multiple organ systems. Long standing cases of Diabetes shows greater effect in eyes, kidneys,

nerves, musculoskeletal structure. Here we are more concerned about the musculoskeletal

impairments that are caused secondary to diabetes mellitus. The most outstanding musculoskeletal

disorder resulting due to diabetes mellitus are adhesive capsulitis, Dupuytren’s contracture,

Tenosynovitis, carpel tunnel syndrome, Reflex sympathetic dystrophy, Charcot's joint, limited joint

mobility etc.9,12

The association between Diabetes and frozen shoulder is well documented.1, 4, 9, 11, 12 The incidence

of frozen shoulder in diabetic subjects is much higher than in non-diabetic of same age, sex and

similar physical parameter.

Adhesive capsulitis is also associated with the duration of diabetes and age. The estimated

prevalence of frozen shoulder is 11–30% in diabetic patients and 2–10% in non-diabetics.

Adhesive capsulitis is associated with the duration of diabetes and age. A higher prevalence of

frozen shoulder (20–29%) has been reported in diabetes mellitus patients. However, the outcome

of these patients has only been studied previously in Western countries.11No documentation has

been done in Asian countries.

4

A high frequency of other hand syndromes, such as limited joint mobility, carpel tunnel syndrome,

Dupuytren’s contracture has been found among diabetic patients with adhesive capsulitis.9

Diabetics have a higher incidence of frozen shoulder, probably because poor circulation leads to

abnormal collagen repair and degenerative changes. The theory is that platelet derived growth

factor is released from abnormal or ischemic blood vessels, which will then act as a stimulus to

local myofibroblast proliferation. It has been proposed that microvascular disease, abnormalities of

collagen repair and predisposition to infection may link diabetes with frozen shoulder. 1

In a controlled study done by Mavrikaki M.E. et al., reports that calcific shoulder peri-arthritis is

three times more prevalent in diabetics than in a non-diabetic control group. This could further

justify the limited joint mobility of the shoulder joint in cases of long standing diabetes mellitus.13

NEED FOR THE STUDY:

The level of disability depends not only with the level of impairment but also the co-morbidities

present along with and the cause of the impairment. Frozen shoulder manifest with varying severity

of symptoms and functional limitations from one individual to another. In addition to it, co-

existence of impaired level of glucose may vary the individual's clinical picture. The incidence and

prevalence of frozen shoulder in cases of Diabetes has been in keen research, but the level of

functional limitation is poorly understood.

Diabetes is one of the leading cause of disability in modern society as lifestyle is changing more

sedentary. Long standing case of diabetes result in various musculoskeletal disorders.

Frozen shoulder is one of the early and severe manifestation that results in varying level of shoulder

symptoms and functional limitation.4,5,9,11

Level of shoulder function and severity of symptoms can be assessed by different measuring tools.

Self-administered questioner is a reliable and valid tool that relays on patient’s subjective score on

any scale. One end of each scale shows highest and the other end shows the lowest level of

disability. The study of shoulder function level and quality of life in terms of physical and mental

health due to frozen shoulder in diabetic patient is limited. What has been understood that co-

morbid diabetes if present with frozen shoulder requires more time to resolve then idiopathic one.

Study of disability level in such cases aids to integrate functional abilities in the rehabilitation

protocol and in addition to that the goal can be more targeted towards attaining functional activities.

To the best of our knowledge, though the association between prevalence of frozen shoulder and

5

Diabetes Mellitus is widely studied, but the level of disability and the quality of life caused by

frozen shoulder in diabetic patients in Indian population has been a subject of lesser interest.

Hence the study will be undertaken to evaluate the impact of frozen shoulder in terms of pain,

disability and poor quality of life in diabetic patients.

RESEARCH HYPOTHESIS:

Null hypothesis (H0): There will be no impact of frozen shoulder in terms of pain, disability and

poor quality of life in diabetic patients.

Alternative Hypothesis (H1): There will be an impact of frozen shoulder in terms of pain, disability

and poor quality of life in diabetic patients.

REVIEW OF LITERATURE:

Cross-sectional study with 12-month follow-up in diabetic (n = 189) and medical (n = 99)

6

outpatients employing the Shoulder Pain and Disability Index (SPADI) and SF-36 version 2 found

that the prevalence of current shoulder symptoms was 35% in diabetics and 17% in controls.

Shoulder pain and disability as calculated by SPADI were independently associated with diabetes

(vs controls) and current shoulder symptoms, and worsened over 12 months. Disability scores

worsened with age in diabetics, and pain scores were higher in diabetics than controls among

patients reporting current shoulder symptoms. Poor physical QOL worsened over time in patients

with diabetes and was worse in patients with current shoulder symptoms, whether they had diabetes

or not. Mental QOL was worse only in patients with current shoulder symptoms. The study was

conducted by L.L. Laslett, S.P. Burnet, J.A. Jones, C.L. Redmond, J.D. McNeil1 in The University

of Adelaide Discipline of Medicine, Modbury Public Hospital, Modbury; Biometrics SA, South

Australian Research and Development Institute, Adelaide; The University of Adelaide, South

Australia, Australia.15

Gupta Saumen, Raja Kavitha and Manikaden N Department of Physical therapy, Manipal College

of Allied Science Manipal performed a cross sectional study on ''Impact on quality of life in elderly

subject with diabetic''. In the study 236 elderly diabetic patients were recruited from setting based

on cluster sampling and were evaluated for pain and restriction of ROM in the shoulder joint.

Severities of condition were classified on Oxford Shoulder scale and quality of life was calculated

by SF-36. Study revealed higher prevalence of adhesive capsulitis in women. Majority of subject

without adhesive capsulitis fell in average quality of life. However, the subjects with adhesive

capsulitis presented a different clinical picture. More women tended to be unhealthy, while men fell

on average category. Adhesive capsulitis did not have much impact on mental status of subjects.16

In a review done by Bhowmik Megnathi, Upadhaya Sandeep states that diabetology and

rheumatology are two medical specialties that have much in common including immuno-

pathogenesis. They share many common features. Connective tissue as affected by diabetes cause

alteration in peri-articular and musculoskeletal system. The pathogenesis of such condition resulted

either as intrinsic complication or predisposed to diabetes has been poorly understood. However,

these manifestations are associated with pain, functional disability and affects the quality of life in

diabetic patients.17

A study done by J.F Bridgeman in ST. James Hospital, Balhal during a period of 12 months taking

800 diabetic and 600 non- diabetic patients attending as out-patients, were examined for evidence

of peri-arthritis of the shoulder. The Hospital Records of both groups of patients were also

examined for information of a past history of peri-arthritis of the shoulder over a 10-year period.

The 600 non-diabetics who acted as controls were fully ambulant and were of a similar age range.

7

They attended regularly as out-patients and suffered from a wide variety of medical conditions not

including diabetes. Those diabetics with coexisting illnesses known to be associated with peri-

arthritis of the shoulder were excluded from the study. The duration and the treatment of the

diabetes were recorded. 86/800 diabetics patient(10.6%) and 14/600 non-diabetics (2.3 %) were

found to have peri-arthritis of the shoulder, a statistically significant difference between the two

groups.10

''Musculoskeletal manifestations in diabetic patients at a tertiary center'' was a study done by Attar

Suzan M in Department of Internal Medicine, King Abdulaziz University, Jeddah, Saudi Arabia to

evaluate musculoskeletal manifestations in adult diabetic patients included 252 diabetic patients

among which 45 (17.9%) had musculoskeletal manifestations. Of these 45 patients, 41 (91.1%) had

type 2 diabetes. The most common manifestations were shoulder adhesive capsulitis (n17,

6.7%),carpal tunnel syndrome (n17, 6.7%), and diabetic amyotrophy (n12, 4.8%).12

Mohammed Abdul Sattar examined one hundred consecutive patients with diabetes mellitus and

one hundred patients without diabetes attending Mubarak Al-Kabeer Teaching Hospital for a

variety of medical conditions for evidence of peri-arthritis of the shoulder. Nineteen percent of the

patients with diabetes had peri-arthritis. The duration of shoulder pain correlated with the duration

of the diabetes mellitus. However, the presence of other complications in subjects with peri-arthritis

was not as well correlated with the duration of the diabetes mellitus. These data emphasize the

common occurrence of peri-arthritis in subjects with diabetes mellitus and its extension to people of

diverse backgrounds.18

A controlled study by Mavrikakkis M E, Drimis S , Kontoyannis D A ,Rasidakis A , Moulopolous

E S ,and Kontoyannis S from the Department of Clinical Therapeutics, University of Athens,

Alexandra General Hospital Athens, Greece studied the prevalence of Calcific shoulder peri-

arthritis (tendinitis) in adult onset diabetes mellitus. For the study two groups, one of 824 adult

diabetics and one of 320 age and sex matched non-diabetics, were examined for abnormal glucose

metabolism and calcifications on antero-posterior shoulder x rays. Two hundred and sixty two (31-

8%) of the diabetics had shoulder calcification compared with 33 (10-3%) of the control group,

with a preponderant localization in the right shoulder. Diabetes of long duration treated with insulin

for a long time was associated with a larger percentage of shoulder calcifications. These data and

previous laboratory findings suggest a possible patho-genetic correlation between the prevalence of

calcific shoulder tendinitis and diabetes. Calcification of the peri-articular structure with or without

associated tendinitis may also relate to limited mobility of the shoulder joint and hence diagnosed

as frozen shoulder.13

8

In a review done by LL Smith, S P Burnet, J D McNeil stated that most disabling musculoskeletal

problem in patient with diabetes was frozen shoulder. The estimated prevalence is 11–30% in

diabetic patients and 2–10% in non- diabetics. It is further associated with the duration of diabetes

and age.9

Frozen Shoulder: The Diabetic Connection written by Ronald Grisanti, published in American

Chiropractic Magazine, attributed to the secretion of platelet derived factor from abnormal or

ischemic blood vessels, which will then act as a stimulus to local myo-fibroblast proliferation

resulting in adhesion of joint surfaces limiting its range of motion.19

A study was done aimed to investigate the prevalence of the most frequently occurring hand and

shoulder complications in type 2 diabetes mellitus patients done in Department of Physical

Medicine and Rehabilitation, Faculty of Medicine, Gaziantep University & Division of

Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Adnan

Menderes University Hospital, Aydin, Turkey. The presence of cheiroarthropathy, frozen shoulder,

Dupuytren’s contracture and trigger finger was assessed in 102 type 2 diabetes mellitus patients and

101 age and sex matched non-diabetic controls. The relationship between these complications and

patient’s age, sex, duration of diabetes and glycemic control was also analyzed. Cheiroarthropathy,

frozen shoulder and Dupuytren’s contracture were significantly more prevalent in the diabetic

group than in the control group.20

An observational study done by Shakeel Ahmad et al in which diabetic patients coming to clinic for

their routine checkup were enrolled along with age and gender matched controls. Data was

analyzed on SPSS 20. Demographic data regarding the age, sex, type and duration of diabetes was

noted. 170 men and 155 women aged between 40 to 79 years were selected. 81 out of 325 diabetic

patients presented with the case of adhesive capsulitis. This shows a significant association between

the prevalence of frozen shoulder among diabetic population.11

Sanya A.D. and Obi C.S. compared the range of motion of selected joints in diabetic and non

diabetic subjects. One hundred volunteer subjects comprising 50 diabetic and 50 non-diabetic

subjects participated in this study. The range of motion of the shoulder, elbow, wrist, fingers, hip

and knee joints were measured using a double-armed simple goniometer and recorded in degrees.

The outcome of this study revealed that there was a significant difference between joint mobility in

the diabetic and non-diabetic subjects for all the joint, except the knee and elbow joints.21

Balci Nilufen, Balci Mustafa Kemal &Tuzuner Berdar in Akdeniz University Hospital evaluated

297 consecutive type II diabetic patients attending an OPD. Variables as age, sex, duration of

diabetics, history of smoking, B.P., recent surgery and other disease were noted. The prevalence of

adhesive capsulitis was in 86 patients ( 29% of which 33% male and 25.9% female) which was

9

highest among other musculoskeletal manifestation. Other manifestations included limited joint

mobility, Carpel tunnel syndrome, trigger finger, Dupuytren's disease. Also, adhesive capsulitis was

associated with the age of patient and duration of diabetes.4

Cross sectional comparison of the four shoulder questionnaires: the Dutch Shoulder Disability

Questionnaire (SDQ-NL); the United Kingdom Shoulder Disability Questionnaire (SDQ-UK); and

two American instruments, the Shoulder Pain and Disability Index (SPADI) and the Shoulder

Rating Questionnaire (SRQ) done by Paul A., Lewis M., Shadforth M F, Croft P.R., M van der

Windt D.A.W., Hay E M et al showed they had similar overall validity and patient acceptability.

SPADI and SRQ were most responsive to change. Additionally, SPADI was the quickest to

complete and scores did not change significantly in stable subjects.22

OBJECTIVES OF THE STUDY:

1. To evaluate the impact of frozen shoulder in terms of pain, disability and poor quality of life in

diabetic patients.

B) PROCEDURE, MATERIALS AND METHODS:

SOURCE OF DATA COLLECTION:

Sri Dharmasthala Manjunatheshwara College of Medical Science and Hospital, Physiotherapy Out

Patient Department, Dharwad.

10

MATERIAL :

1.Shoulder pain and disability Score( SPADI )

2.Shoulder function 36 version 2 questionnaire ( SF-36v2)

INCLUSION CRITERIA:

Subjects of frozen shoulder with diabetes diagnosed by the medical practitioner, between 40 and 70 23,24years age group of either gender reporting to physiotherapy OPD at SDM college of Medical

Sciences & hospital Sattur, Dharwad will be taken for the study.

EXCLUSION CRITERIA:

1. Any neurological conditions affecting shoulder.

2. Any musculoskeletal pathology in upper limb other than frozen shoulder.

3. Surgery of head, neck or upper limb.

4. Acute medical illnesses.

STUDY DESIGN: Cross sectional study

STUDY DURATION: 1 year

SAMPLE SIZE:

The Sample size is derived on the basis of previous study, ''Musculoskeletal morbidity: the growing

burden of shoulder pain and disability and poor quality of life in diabetic outpatients''.15

The prevalence of shoulder pain in diabetic patients is 44%.

Based on formula,

Sample size (n) =

11

where, p = positive character ( 44)

q=1-p

l= allowable error in p (taken as 20%)

Sample size worked out to be 150 at 5% alpha error. 25

METHODOLOGY:

Ethical Clearance is obtained from S.D.M. college of Medical Science and Hospital. Diagnosed

cases of frozen shoulder with diabetes referred from medical practitioner at SDM Medical college

and Hospital, Dharwad will be recruited based on the inclusion and exclusion criteria of the study.

Subjects willing to participate will be briefly explained about the study and written consent will be

taken. A valid and reliable Shoulder pain and disability Index (SPADI) and Short Form 36 Version

2(SF 36 V2) questioner will be given to the participant. Any query regarding understanding the

questions will be cleared at the same time by the principle investigator.

The method to fill the questionnaire is to tick their answers in the boxes that apply to them. Then

the duly filled questionnaire will be collected by the principal investigator. The principal

investigator will accordingly score the questionnaires. The scoring from this questionnaire will be

subjected to the statistical analysis.

Shoulder pain and disability Index (SPADI) 26 is a self-administered questionnaire to measure the

level of disability caused by various pathology related to shoulder. It consist of 13 items in 2

subgroups Pain (5 items) and disability (8 items). Each item is scored accordingly to the subjective

perception of pain and disability presented in VAS (Visual analogue scale). After the form is filled

up, total score is summed up referred to SPADI score. The higher is the score gained by a patient,

the more disabling is his/her condition.

Short form-36 (SF-36)27, can be self-administered or interview-administered, is a generic quality of

life questionnaire that measures patients' general health status. The SF-36 contains multi-function

item scales to measure eight domains: physical function (10 items); role physical (four items);

bodily pain (2 items); general health (5 items); vitality (4 items); social functioning (2 items); role

emotional (4 items); and mental health (5 items). It is then summarized into two measures as the

physical component summary (PCS) and the mental component summary(MCS). The PCS and

MCS will be subjected for statistical analysis. The reliability of the eight scales and two summary

measures has been estimated using both internal consistency and test-retest methods and is high.

OUTCOME MERSURE:

1. Shoulder Pain and Disability Index( SPADI)

12

C)

2. Quality of life-Short form 36 Version 2 (SF-36)

3. Visual Analogue scale 0-10 score (VAS)

STATISTICAL TESTS TO BE USED:

1. Descriptive Analysis

2.Chi-Square (χ2) test

3.Odd-ratio

4.One way Analysis of Variance (ANOVA)

5. Turkey’s multiple post hoc tests.

6. Regression analysis.

DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE

CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

IF SO DESCRIBE BRIEFLY – YES

Administration of Shoulder Pain and Disability Index and Shoulder Function Version 2 Scale.

HAS ETHICAL CLEARANCE BEEN OBTAINED BY YOU – YES

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