RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.NAME OF THE CANDIDATE AND ADDRESS

KAVAN TK, 26, KSRP OFFICERS

QUARTERS, GODAVARI SANKIRNA,

KORAMANGALA, BANGALORE

[KARNATAKA]

2.NAME OF THE INSTITUTION KRUPANIDHI COLLEGE OF

PHYSIOTHERAPY, BANGALORE

3.COURSE OF THE STUDY AND SUBJECT

MASTER OF PHYSIOTHERAPY IN MUSCULOSKELETAL DISORDERS AND SPORTS PHYSIOTHERAPY

4.DATE OF ADMISSION TO THE COURSE

19th MAY 2011

5. TITLE OF THE TOPIC:

MULTI -MODAL TREATMENT APPROACH FOR CHRONIC SHOULDER IMPINGEMENT SYNDROME - A RANDOMIZED CONTROL TRIAL

6 BRIEF RESUME OF THE INTENDED WORK

INTRODUCTION

Chronic shoulder pain is a term that refers to pain that occurs for duration longer than four to

six months1. An estimated 20 percent of the population in the world suffers from shoulder pain

during their lifetime2.

Shoulder pain is second only to low back pain in patients seeking care for musculoskeletal

ailments3. Shoulder pain is responsible for approximately 16% of all musculoskeletal

complaints4, with a yearly incidence of 15 new episodes per 1,000 patients seen in the primary

care setting5.

The prevalence of shoulder pain in the general population ranges from 6.9% to 34%. For

people greater than 70 years of age, the prevalence of shoulder pain was reported to be 21% in

one study. Forty percent of the population probably will suffer from shoulder pain at some

point of their life time6.

The four most common conditions that lead to chronic shoulder pain are1:

Rotator cuff tears,

Shoulder impingement syndrome (SIS)

Frozen shoulder and

Shoulder arthritis.

Shoulder impingement is among the most common function-limiting disorders of the

musculoskeletal system7-8. The point prevalence of shoulder symptoms has been reported to

range from 20 to 33%9, and the incidence of shoulder complaints in the general population

is increasing10. Furthermore, several authors have reported low rates of perceived recovery

(patient reports of ‘being cured’) for patients with a new episode of shoulder pain10 -13. Less

than 25% of patients with a first episode of shoulder pain may recover and be symptom free

after 3 months5. Recovery rates at 18 months have been reported only between 49% and 59%11,

12, 14, and 25% of patients with shoulder or neck pain experience at least one episode of

recurrence within 12 months15. These findings suggest that shoulder pain can be recurrent and

frequently progresses to the chronic stage.

The rotator cuff muscles of the shoulder are sandwiched between the arm bone and the top

of the shoulder (acromion). This unique arrangement of muscle between bone leads to the

condition of impingement syndrome (shoulder bursitis, rotator cuff tendinitis) 16.

Neer first introduced the concept of rotator cuff impingement in 1972. He described the

syndrome as a mechanical impingement of the rotator cuff tendons beneath the anterior-

inferior portion of the acromion occurring when the shoulder is placed in the forwardly flexed

and internally rotated position17. It is important to remember that the function of the rotator

cuff, in addition to generating torque, is to stabilize the glenohumeral joint; thus, stronger

rotator cuff muscles result in better glenohumeral joint stabilization and less impingement18.

Conservative management for chronic shoulder pain involves specific strengthening program

for the rotator cuff for the prevention of future injuries. The motions of the rotator cuff that are

emphasized for strengthening the internal rotation, external rotation and abduction. Patients

may require a formal physical therapy program18. Thus, the shoulder exercises should be done

with a fixed weight rather than a variable weight such as a thera band. Repetitions are

emphasized, and a relatively light weight is used. Sometimes, sports-specific techniques are

useful, particularly when strengthening the throwing motion, the serving motion or swimming

motions. In addition, physical therapy modalities such as electro galvanic stimulation,

ultrasound treatment and transverse friction massages can also be helpful.

Some authors routinely advocate the usage of ultrasound in conjunction with other modalities

and report positive outcomes19, 20, 21. The physiologic benefits of ultrasound have been

attributed to its thermal actions; these involve an increase in peripheral blood flow, increased

tissue metabolism and greater tissue extensibility22.

In addition to this transverse friction massage has been advocated by a number of authors in

the management of shoulder disorders. Hammer describes friction massage as a technique

where an involved muscle, tendon or ligament is massaged by applying pressure with a

reinforced finger. The transverse motion across the involved tissue and the resultant

hyperaemia are said to be the chief healing factors of friction massage. The transverse action is

said to prevent the formation of scar tissue while longitudinal friction effects the transportation

of blood and lymph23, 24.

The goals of manual therapy of subacromial impingement are to decrease subacromial

inflammation, to allow healing and strengthening of a dysfunctional rotator cuff

and to restore pain-free shoulder function18.

Studies have also shown that incorporation of joint mobilizations to treat shoulder

impingement results in superior outcomes compared with therapeutic exercise alone25, 26, 27.

Some researchers propose that a mobilization force can be selectively directed to a specific

area of the capsule to restore capsular extensibility26, 28. Studies have found that individuals

with shoulder impingement often have a tight posterior capsule resulting in altered

glenohumeral arthrokinematics29, 30 and a decrease in glenohumeral internal rotation range of

motion (ROM) 31, 32, 30.

Many studies have reported the effectiveness of exercise therapy programs in treatment of

chronic shoulder impingement syndrome as a non surgical intervention, research on the

combination of multimodality treatment in treating a shoulder impingement syndrome is

insufficient. Mario Pribicevic and Henry Pollard reported that there is a significant

improvement in pain, range of motion and in functions of those individuals who were been

diagnosed with shoulder impingement syndrome using a multi- modal treatment approach like

therapeutic ultrasound, soft tissue release, joint mobilization and exercise therapy33.

It seems reasonable to suggest that multimodality treatment in treating a shoulder impingement

syndrome may be helpful in the management of shoulder impingement that do not respond to

conservative management. Unfortunately, there is little evidence on the efficacy of these types

of interventions for patients with chronic subacromial impingement syndromes not responding

to conservative management.

Thus, the aims of this study were to investigate the effectiveness of a combination of multi-

modal therapy which includes therapeutic ultrasound, soft tissue release, spinal and peripheral

mobilization and exercise therapy on pain, function and Range of motion of chronic shoulder

impingement syndrome patients and if beneficial, to develop a more effective intervention

protocol.

6.1 NEED FOR THE STUDY

Various studies in the past showed that conventional therapy approaches in treating

impingement syndrome was more effective than patient opting for surgery.

Studies have also suggested that multiple modality treatment approach is helpful in reducing

pain, improving ROM and restoring functional activities.

Limited randomized control studies have been conducted on chronic shoulder impingement

syndrome and also on limited number of patient samples.

Thus, the proposed study intends to find the efficacy of a multi-modal treatment approach for

chronic shoulder impingement on a larger group of randomized targeted population.

6.2 OBJECTIVES OF THE STUDY

(A) OBJECTIVES:

To investigate the effectiveness of multi-modal treatment approach to reduce pain in

chronic shoulder impingement syndrome.

To investigate the effectiveness of multi-modal treatment approach to restore the lost

range of motion in chronic shoulder impingement syndrome.

To investigate the effectiveness of multi-modal treatment approach to restore lost

functional activities in chronic shoulder impingement syndrome.

(B) HYPOTHESIS

NULL HYPOTHESIS:

There is no significant effect of multimodal treatment approach in treating chronic shoulder

impingement syndrome.

EXPERIMENTAL HYPOTHESIS:

I. There is a significant effect of multimodal treatment approach in reducing pain in

chronic shoulder impingement syndrome.

II. There is a significant effect of multimodal treatment approach in restoring the lost

range of motion in chronic shoulder impingement syndrome.

III. There is a significant effect of multimodal treatment approach in restoring lost

functional activities in chronic shoulder impingement syndrome.

6.3 REVIEW OF LITERATURE

1. Phil Page (2011) suggested that Subacromial impingement is a frequent and painful

condition among athletes, particularly those involved in overhead sports such as baseball and

swimming. There are generally two types of subacromial impingement: structural and

functional. While structural impingement is caused by a physical loss of area in the

subacromial space due to bony growth or inflammation, functional impingement is a relative

loss of subacromial space secondary to altered scapulohumeral mechanics resulting from

glenohumeral instability and muscle imbalance.

2. Carel Bron, et al (2011) suggested that patients who received 12-week comprehensive

treatment of myofacial trigger point release technique in shoulder muscles reduces the number

of muscles with active myofacial trigger points and is effective in reducing symptoms and

improving shoulder function in patients with chronic shoulder pain.

3. Hidalgo-Lozano A, Fernández-de-las-Peñas C, (2011) suggested that twelve patients

diagnosed with unilateral shoulder impingement attended four sessions for 2 weeks received

trigger point pressure release and neuromuscular interventions showed that manual treatment

of active muscle trigger points can help to reduce shoulder pain and pressure sensitivity

in shoulder impingement syndrome.

4. Jeffrey A. Fleming (2010) suggested that exercise is beneficial for reducing pain and

improving function in individuals with rotator cuff impingement syndrome. The effects of

exercise might be augmented with implementation of manual therapy. In addition, supervised

exercise might not be more effective than a home exercise program.

5. F. Angst, J. Goldhahn (2009) suggested that the German Shoulder Pain and Disability

Index (SPADI) is a practicable, reliable and valid instrument, and can be recommended for the

self assessment of shoulder pain of shoulder pain and function.

6. Aimie F. Kachingwe (2008)39 suggested that patients diagnosed with shoulder impingement

syndrome received physical therapy interventions of glenohumeral mobilizations and MWM in

combination with a supervised exercise program showed significant decrease in pain and

improved function compared to the patients who were only managed by supervised exercise

and control groups. Hence suggesting that manual therapy techniques can be an important

adjunct to supervised exercise in the treatment of individuals with shoulder impingement

syndrome.

7. Gamze Senbursa, Gul Baltac, Ahmet Atay (2007) suggested that patients diagnosed with

impingement syndrome treated with manual physical therapy applied by experienced physical

therapists combined with supervised exercise in a brief clinical trial showed improvement of

symptoms including increasing strength, decreasing pain and improving function earlier than

with exercise program.

8. Joy C MacDermid (2006) suggested that Shoulder Pain and Disability Index (SPADI) is a

valid measure to assess pain and disability in community-based patients reporting shoulder

pain due to musculoskeletal pathology.

9. Kenneth Hing-Sum Tsui (2005) suggested that impingement syndrome is common in

clinical practice. Knowledge of basic anatomy of the shoulder and mechanism of the disease

process is essential for management. Non-steroidal anti-inflammatory drug has only very

limited evidence of effectiveness. Subacromial steroid injection has some evidence of

effectiveness but the optimal type of steroid, dosage, frequency and timing of injection is still

unclear. Structured and supervised exercise programs have been shown to offer long-term

benefit. Weight pendulum exercise and other simple exercises could be recommended to

patients in the clinic setting. Orthopedic surgery is indicated for refractory cases of shoulder

impingement syndrome.

10. Karen A. Ginn and Milton L. Cohen (2005) suggested that patients who underwent

individually-tailored exercise therapy which was aimed at restoring dynamic joint stabilizing

mechanisms and muscle coordination or a combination of various physical modalities and

ROM exercises is equally effective in the short term improvement in chronic shoulder pain.

11. Per Jonsson et. al (2004) suggested a specially designed painful eccentric training model

for the supraspinatus and deltoideus muscles showed promising short-term clinical results on a

small group of patients with severe pain from impingement of the shoulder.

12. Wing K. Chang (2004) suggested that Shoulder impingement syndrome and rotator cuff

disease are increasingly more common in athletes whose sports involve repetitive overhead

motions. The increased forces and repetitive overhead motions can cause attritional changes in

the distal part of the supraspinatus tendon, which is most at risk due to its poor blood supply.

No commercial party having a direct financial interest in the results of the research.

13.Markus Walther,Andreas Werner,Theresa Stahlschmidt,Rainer Woelfel,

Frank Gohlke,(2004) suggested that patients with subacromial impingement syndrome of the

shoulder treated with guided self-training program and by conventional physiotherapy or a

functional brace, showed a significant improvement in shoulder function as well as a

significant reduction in pain.

14. E.John   Gallagher , Polly E.   Bijur , Clarke   Latimer , Wendy   Silver ,(2001) suggested that

VAS is a methodologically sound instrument for quantitative assessment of acute abdominal

pain and for detecting clinically important changes in such pain.

15. Review of goniometry emphasizing reliability and validity by richard l. gajdosik and

richard w. bohannon (1987): Clinical measurement of range of motion is fundamental

evaluation procedure with ubiquitous application in physical therapy. The purpose of this

article is to review the related literature on the reliability and validity of goniometric

measurements of the extremities. They conclude that clinicians should adopt standardized

methods of testing and should interpret and report goniometric results as ROM measurements

only, not as measurements of factors that may affect ROM.

16. Griffin et al [41] (1967) showed in his comparative study the effectiveness between

phonophoresis and ultrasound in patients suffering from shoulder impingement syndrome that

patients receiving phonophoresis showed significant improvement in range of motion and

pain as compared to the patients receiving ultrasound group.

7.MATERIALS AND METHOD

7.1 SOURCE OF DATA

(A) POPULATION:

Patients diagnosed with shoulder impingement syndrome.

(B) SAMPLE SIZE:

30 subjects who fulfill inclusion criteria will be recruited from the population given above and

divided into two groups- 15 subjects in each group.

GROUP 1: Experimental group; Multimodality treatment approach.

GROUP 2: Control group; Conventional physiotherapeutic approach.

MATERIALS USED FOR THE STUDY:

1. Universal goniometry

2. Assessment chart

3. Therapeutic Ultrasound

4. Couch

5. Mobilization belt

6. Cold packs

7.2 METHOD OF COLLECTION OF DATA:

(A) SAMPLING TECHNIQUES:

Simple random sampling.

(B) TOOLS:

Standard universal goniometry for range of motion (ROM).

Subjective/objective visual analog scale (VAS) for pain assessment.

Shoulder pain and disability index scale (SPADI) for function.

(C) METHODOLOGY:

(I) STUDY DESIGN:

Randomized control trial.

(II) INCLUSION CRITERIA:

In order to participate in this study, subjects will have to fulfill following criteria’33

A positive clinical Neer’s test

Shoulder pain resistant to rest

Shoulder pain resistant to anti-inflammatory drugs

Shoulder pain resistant to subacromial steroid injections

Shoulder pain resistant to conventional physiotherapy with a minimum history of three

months

(III) EXCLUSION CRITERIA:

Glenohumeral or acromioclavicular arthritis’33

Glenohumeral instability

Total rupture of the rotator cuff

Cervical syndrome

Adhesive capsulitis

Neuropathy of the shoulder region

(IV) PROCEDURE and INTERVENTION:

Subjects who fulfill the selection criteria will be included in the study. They will be taken in to

the research once they sign the informed consent.

A total of 30 subjects will be selected and divided into 2 groups of 15 subjects each by simple

randomization.

The study will be carried out in three stages-

a) Pre- intervention measurement

b) Intervention

c) Post-intervention measurement.

a) Pre- intervention measurement

Here the subjects are measured for pain, range of motion and function.

Pain measurement using subjective/objective visual analog scale

The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to

indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and

this rating is then measured from the left edge. The VAS score correlates well with acute pain

levels34.

Hawkins test involves positioning the arm at 90 degrees of flexion with subsequent internal

rotation.

Neer's impingement test is performed with the patient sitting as the practitioner stands behind

the patient with one hand supporting the scapula to prevent scapula rotation and the other hand

holding the forearm. The shoulder is brought into maximum flexion with a small degree of

internal rotation. The test is considered positive if there is pain in the last 10–15 degrees of

flexion. Pain is produced because the greater tuberosity is compressed against the anterior

acromion or coracoacromial ligament, hence this test may aggravate an inflamed bursa

(subacromial), the supraspinatus tendon or the anterior structures of the coracoacromial arch33.

Pain will also be measured at rest, motion and at night pre and post intervention18.

Joint range of motion using universal goniometer

Universal goniometer measurements A 12-inch, 3601 goniometer, marked in 11

increments, with two adjustable overlapping arms was used. Shoulder flexion ROM was taken

by asking the patient to raise their arm straight over-head as far as possible. Standard

measurement positioning was used by placing the stationary arm parallel to the midline of the

thorax, and the moving arm aligned with the shaft of the humerus and lateral epicondyle.

Shoulder ER was taken by passively placing the patient’s arm in 90degree abduction with the

elbow flexed 90degree and asking the patient to rotate their arm backward as far as possible so

that their palm was facing the ceiling. Standard goniometric positioning was used by placing

the stationary arm perpendicular to the floor, and the moving arm was aligned with shaft of the

ulna and styloid process.

Shoulder IR was taken by passively placing the patients arm in 90degree abduction with the

elbow flexed 90degree and asking the patient to rotate their arm forward as far as possible so

that their palm was facing the floor. Positioning of the goniometer for measurement was also

used in a standardized fashion (Norkin and White, 1988)35.

Functional assessment using Shoulder pain and disability index (SPADI)

The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that

consists of two dimensions, one for pain and the other for functional activities. The pain

dimension consists of five questions regarding the severity of an individual's pain. Functional

activities are assessed with eight questions designed to measure the degree of difficulty an

individual has with various activities of daily living that require upper-extremity use. The

SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid

region-specific measure for the shoulder.

Scoring instructions

To answer the questions, patients place a mark on a 10cm visual analogue scale for each

question. Verbal anchors for the pain dimension are ‘no pain at all’ and ‘worst pain

imaginable’, and those for the functional activities are ‘no difficulty’ and ‘so difficult it

required help’. The scores from both dimensions are averaged to derive a total score36.

b) Intervention

GROUP 1: Experimental group; Multimodality treatment approach.

The subject will be given multi modal treatment which includes soft tissue release

technique, ultrasound therapy, peripheral joint mobilization and therapeutic exercises. The

treatment would be given for a week period, with each subject in groups 1 and 2 receiving

respective interventions one time a day. The subjects would be tested at approximately same

time each day. During this period, the subjects will be asked to refrain from any kind of sports

activity or exercise. Pre- test measurement will be taken on 1st day and intervention will be

carried out for 5 days in the week with post-test measurement taken on 5th day. 6th day will be

a resting day and on the 7th day measurement will be taken to check maintenance of gained

ROM.

All of the patients receive soft tissue therapy that involves the application of ischaemic

pressure to the supraspinatus and infraspinatus muscles, as well as the rhomboids, upper

trapezius and levator scapulae. The application involves palpating the muscle bellies and

applying a sustained pressure into areas of muscle spasm until a release of the barrier of

resistance was felt. Release meaning the relaxation of the point of muscle spasm with a

decrease in the sensitivity and muscle tone after re-palpating the area. Care was taken not to

cause increased discomfort to the patient (to the level of pain tolerance).

Longitudinal and transverse friction massage will be applied to the posterior tenomuscular

junction of the infraspinatus muscle, the coracoacromial ligament (postero-inferior aspect) and

the insertion of the supraspinatus on the greater tuberosity of the humerus. The friction

massage application will be achieved by palpating the capsular or tendinous adhesions and

frictioning over its surface with the practitioner's index finger. This will be maintained until

friction anaesthesia is achieved and till the patient could not feel any discomfort. A new point

will be chosen and the process repeated. Once again care will be taken to not cause excessive

discomfort to the patient. At the end of the treatment sessions ice application is advised at a

frequency of three applications of 15 minutes with two 20-minute breaks.

Ultrasound phonophoresis will be applied to the areas that previously underwent friction

massage with a topical corticosteroid [1%]. Ultrasound was applied with a continuous wave

form for 7 minutes at a setting of 2.2 W/cm2 to the rotator cuff insertion on the anterior-

inferior aspect of the humerus and posterior inferior aspect of the acromioclavicular joint.

Peripheral thrust manual manipulation will be applied to the glenohumeral joints in external

rotation (progressive) and inferiorly to the acromioclavicular joint and anterior to posterior to

the sternoclavicular joint in all of the patients where a likely motion restriction was detected.

Diversified spinal manipulations were used to manipulate the thoracic and cervical spines at

the level of T3/4 and C5/6. All patients will be given a basic exercise program with initial

emphasis on isometric strengthening of the supraspinatus and infraspinatus muscles. This was

implemented once a reduction in pain and improved range of motion was noted at a frequency

of 4 sets of 10 repetitions, 2–3 times per day. Theraband (extendable elastic) exercises were

also implemented at the same frequency after the initial isometric strengthening period. This

also included shoulder shrugs, wall push-ups and scapula retraction exercises33.

GROUP 2: Control group; Conventional physiotherapeutic approach.

The subjects will be instructed with self training program which includes active range of

motion exercises, stretching and strengthening exercise program including rotator cuff

muscles, rhomboids, levator scapulae and serratus anterior with an elastic band at home at least

seven times a week for 10–15 min and the exercises were taught by physio.therapist. Same

exercise program will be given to each patient as shoulder exercise brochure37, 18.

C) Post- intervention measurement

Post-intervention measurement will be performed in the same manner as pre intervention

measurement for pain, range of motion and function. These measurements will be taken after 1

week of treatment and even after one month post treatment.

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9. SIGNATURE OF CANDIDATE

SD/-

(KAVAN TK)

10. REMARKS OF GUIDEPRESENTED TO THE RESEARCH

COMMITTEE AND APPROVED

11. 11.1 NAME AND DESIGNATION OF GUIDE DR.MARITTA BABY THOMAS

( ASSISTANT PROFESSOR)MPT (ORTHOPAEDIC AND MANUAL

THERAPY)

11.2 SIGNATURESD/-

11.3 CO-GUIDE (if any)

11.4 SIGNATURE

11.5 HEAD OF THE DEPARTMENT DR.MASIH MUHAMMAD KHAN

MPT (MUSCULOSKELETAL DISORDERS AND SPORTS PHYSIOTHERAPY)

11.6 SIGNATURESD/-

12 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL

APPROVED AND FORWARDED

12.2 SIGNATURE

SD/-