Rajiv Gandhi University of Health Sciences, Karnataka Curriculum 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 :15/07/2013 Title 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 1
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Rajiv Gandhi University of Health Sciences, KarnatakaCurriculum Development Cell
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.
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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
LIST OF REFERENCES:1. Desai SS. Diabetes mellitus and the frozen shoulder or capsular fibroplasia-The mystery
unfolding. Int J Diab Dev Countries. 1999; 19: 27–30.
2. Dias R, Cutts S, Massoud S. Frozen shoulder. Br Med J 2005; 331:1453–6.
3. Bunker T. Time for a new name for frozen shoulder contracture of the shoulder. Shoulder Elbow
2009; 1(1): 4-9.
4. Balci N, Balci MK, Tuzuner S. Shoulder adhesive capsulitis and shoulder range of motion in
type II diabetes mellitus: association with diabetic complications. J Diabetes Complications 1999;
13:135–40.
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5. Arkkila PE, Kantola IM, Viikari JS, Ronnemaa T. Shoulder capsulitis in type I and II diabetic
patients: association with diabetic complications and related diseases. Ann Rheum Dis 1996; 55:
907–14.
6. Nagy Mathias Thomas, MacFarlane Robert J, Khan Yousaf and Waseem Mohammad. The
Frozen Shoulder; Myths and Realities. Open J Orthop, 2013; 7:352-5.
7. Charnley .Peri-arthritis of the Shoulder. Postgrad. med. J 1959 July;384-8
8. Neviaser Andrew S, Neviaser Robert J. Adhesive Capsulitis of the shoulder. J Am Acad Orthop
Surg 2011;19: 536-42
9. Smith L, Burnet SP, McNe JD. Musculoskeletal manifestations of diabetes mellitus. Br J Sports
Med 2003; 37:30–35
10. Bridgam JF. Peri-arthritis of the shoulder and diabetes mellitus.Ann Rheum Dis. 1972; 31: 69–
71.
11. Ahmad S, Rafi MS, Siddiqui IA, Jharna D, Faruq NM. The Frequency Of Adhesive Capsulitis
In Diabetes Mellitus Patients. PJR 2012;1(2):1-7
12. Attar M S Musculoskeletal manifestations in diabetic patients at a tertiary center. Libyan J Med
2012;7
13. Mavrikakis ME, Drimis S, Kontoyannis DA, Rasidakis A, Moulopoulous ES, Kontoyannis S:
Calcific shoulder peri-arthritis (tendinitis) in adult onset diabetes mellitus: a controlled study. Ann
Rheum Dis 1989; 48: 211-4.
14. Angst Felix , Schwyzer Hans-Kaspar, Aschilimann Andre, Simmen Beat R, and Goldhahn JO
RG. Measures of Adult Shoulder Function Arthritis Care & Research 63; 2011 Nov 11:174–88