RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of the Candidate and Address (in block letters) / REHANA
SHREE DEVI COLLEGE OF PHYSIOTHERAPY
BALLALBAGH, MANGALORE- 575 003.
2. / Name of the Institution / SHREE DEVI COLLEGE OF PHYSIOTHERAPY
3. / Course of Study and Subject / MASTER OF PHYSIOTHERAPY
MUSCULOSKELETAL DISORDERS AND SPORTS PHYSIOTHERAPY
4. / Date of Admission to Course / 26th MAY 2010.
5. / Title of the Topic / EFFECTIVENESS OF HIGH GRADE MOBILIZATION TECHNIQUE COMBINED WITH LOW LEVEL LASER THERAPY IN SUBJECTS WITH ADHESIVE CAPSULITIS.
6.
7.
8. / BRIEF RESUME OF THE INTENDED WORK:
6.1) INTRODUCTION AND NEED OF THE STUDY:
Adhesive capsulitis of the shoulder is characterized by insidious, progressive
pain, loss of active and passive mobility of the glenohumeral joint. The annual incidences
of adhesive capsulitis are 3% to 5% in the general population and up to 20% in people with diabetes.1,2 The etiology and pathology of this syndrome remain enigmatic.3–6
In adhesive capsulitis, capsular extensibility is decreased, the axillary recess becomes adherent, and the flexibility of the biceps tendon in its sheath is reduced.7 As a result, the external rotation of the humeral head to pass under the acromion during abduction is severely restricted. Restoring this mechanism is the primary goal of various treatment strategies for adhesive capsulitis.
A considerable proportion of patients with adhesive capsulitis are treated with nonsteroidal anti-inflammatory drugs, intra-articular corticosteroid injections, and physical therapy. In persistent cases, more aggressive interventions, such as hydrodilatation, arthroscopic release, or manipulation under anesthesia, have been used.8
With respect to physical therapy, a variety of interventions are used; these include heat or ice applications, ultrasound, interferential therapy, transcutaneous electrical nerve stimulation ,active and passive range-of-motion (ROM) exercises, proprioceptive neuromuscular facilitation(PNF) techniques, and mobilization techniques.9–12
In many physical therapy programs, mobilization techniques are an important part of
the intervention. Mobilization techniques can be performed as physiologic movements or accessory movements. Physiologic movements at the glenohumeral joint are movements of the humerus in the cardinal planes (e.g., flexion, extension, abduction, adduction, external rotation, and internal rotation). Accessory movements are movements that are passively induced by a therapist and consist of rolling, gliding (or sliding), spinning, and distraction within the joint.13,14 The intensity of the mobilization techniques with rhythmic oscillatory movements usually is categorized according to the 5-grade classification system of Maitland.15,16
There are various mobilization techniques available in the literature, and have proved effective among these interventions high grade mobilization technique has been proved to relieve pain and improve joint mobility in subjects with adhesive capsulitis.17
There are studies performed to evaluate the various pain relieving modalities in the treatment of adhesive capsulitis and the results have shown low level laser therapy more beneficial in reducing pain and improving function in subjects with adhesive capsulitis.18
Need of the study:
There are various studies using various any manual therapy techniques in the treatment of adhesive capsulitis. Out of which High Grade Mobilisation Techniques has been proved to be very effective in increasing joint mobility in adhesive capsulitis.17 There are studies which has proved Low Level Laser Therapy to be most effective in reducing pain and improving function in adhesive capsulitis18. There are no studies which have been done to prove the combined effectiveness of high grade mobilization techniques and low level laser therapy in the treatment of Adhesive capsulitis. Hence the need of study arises.
Research Question:
Will there be any difference in pain and range of motion with combined effect of high grade mobilization techniques and low level laser therapy in adhesive capsulitis?
Hypothesis:
Null hypotheses:
There will be no significant differences with combined effect of high grade mobilization technique and low level laser therapy in subjects with adhesive capsulitis.
Alternative hypotheses:
There will be significant differences with combined effect of high grade mobilization techniques and low level laser therapy in subjects with adhesive capsulitis.
6.2) REVIEW OF LITERATURE:
Henricus M. Vermeulen,et al 2005, performed a study on the comparison of High Grade Mobilization Technique and Low Grade Mobilization technique in the management of adhesive capsulitis of shoulder.100 subjects and the results concluded High grade mobilization technique be more effective in improving Glenohumeral joint mobility and reducing disability than low grade mobilization technique.
Jing-Ian yang et al carried out a study on mobilization techniques in subjects with frozen shoulder syndrome with the purpose of the study to compare the use of 3 mobilization techniques-End Range Mobilization, Mid range mobilization and Movement with Mobilization with characteristic pain, decreased range of motion and decreased functional ability and concluded that in patients with Frozen Shoulder Syndrome, End Range Motion and Movement with Mobilization were more effective than Mid-Range Mobilization in increasing the range of motion and functional ability.3
Funsun Guler-Ulsal 2004, has done a study comparing two methods of rehabilitation in adhesive capsulitis, first group received cyriax approach which includes deep friction massages and mobilization exercises and other group received conventional physical therapy methods which includes hot packs and short wave diathermy. The conclusion states that cyriax method provides a faster and better response than conventional physical therapy in the treatment of adhesive capsulitis.
Henricus M Vermeulen et al performed a study to find out the effectiveness of End range mobilization techniques in adhesive capsulitis of the shoulder joint and concluded that there is an increase in the glenohumeral mobility in patients with adhesive capsulitis .4
Garvice G Nicholson conducted a study to find out the effects of passive joint mobilization on pain and hypo mobility associated with adhesive capsulitis of shoulder joint by performing a comparative study between joint mobilization and active exercises and exercises alone and concluded that passive joint mobilization is more effective in the treatment of adhesive capsulitis.22
Simunovic conducted a study of low level laser therapy with trigger point technique: clinical study on 243 patients and concluded that low level laser therapy is an effectiveness method in decreasing pain in adhesive capsulitis.5
Apostolos Stergioulas, 2007, performed a study on the effectiveness of low level laser treatment in subject with frozen shoulder and the results suggested that laser treatment was more effective in reducing pain and disability scores than placebo group at the end of the treatment period.14
Vlak J, 1994, performed a study to evaluate the effectiveness of laser and cryotherapy in the treatment of adhesive capsulitis and concluded that laser treatment proved to be more efficient than cryotherapy.15
Brian Tiplady, Stephen H.D. Jackson, Vivienne M Maskrey, Cameron G Swift has conducted a study on the validity and reliability of visual analogue scale in young and older healthy patients by studying the visual analog scales independently of internal interpretations and deduced that visual analogue scale is a reliable method for assessing pain in patients.10
Range of motion of the shoulder joint is measured by using Universal Goniometry, SPADI (shoulder pain and disability index) is an instrument designed specifically for the assessment of pain and function. The validity and reliability of these instruments were well established in the literature. 16-17
6.3) OBJECTIVES OF STUDY:
1)  To find the efficacy of high grade mobilization techniques combined low level laser therapy and improving joint mobility among the subjects with adhesive capsulitis.
MATERIALS AND METHODS :
7.1) Study Design:
Experimental design (comparative study)
7.2) Source of data:
Patients suffering from Adhesive Capsulitis referred to physiotherapy by physician or orthopedic surgeon from in or around Mangalore.
7.2(I) Definition of Study Subjects:
Adhesive capsulitis patients aged 40 to 60 years.
7.2(II) Inclusion and Exclusion Criteria:
Inclusion Criteria:
1.  Age group 40 -60 years.
2.  Both males and females.
3.  Painful shoulder for at least 3 months
4.  Restriction of more than 50% in passive shoulder abduction, flexion in the sagittal plane, lateral rotation compared with the opposite side.
5.  Normal finding on antero-posterior and axillary lateral radiographs of glenohumeral joints
Exclusion Criteria:
1.  Previous manipulation under anesthesia of the affected shoulder
2.  Other conditions involving the shoulder (e.g. Rheumatoid arthritis, osteoarthritis, damage of the glenohumeral cartilage , hill-sachs lesion osteoporosis or malignancies in the shoulder region)
3.  History of fracture.
4.  Neurological deficits affecting shoulder dysfunction in normal daily activities
5.  Pain or disorders of the cervical spine, elbow, wrist, or hand.
6.  Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.
7.  Any skin lesions/bruises around the shoulder.
8.  Non cooperative patients.
7.2(III) Study Sampling Design, Method and Size:
Sample design:
Purposive sampling technique.
Sample size:
40 subjects fulfilling the inclusion and exclusion criteria.
Outcome measures
Visual Analogue Scale – Pain Assessment
Shoulder Pain and Disability Index-Shoulder-Activities of Daily Living (ADL)
Goniometry-Range of Motion.
7.2(IV) Follow Up:
Post test will be conducted on VAS for pain and Goniometer for range of motion and SPADI for function after 4 weeks of the intervention.
7.2(V) Parameters used for comparison and statistical analysis used:
1.  Wilcoxon rank test
2.  Mann Whitney U test
7.2(VI) Duration of study:
The study will be conducted over a duration of 10-12 months.
7.2(VII) Methodology:
Subjects meeting the inclusion criteria and exclusion criteria will be recruited for study. Informed consent will be obtained from the patients. Then the patients will be randomly assigned into two groups, A and B respectively, having 20 subjects in each group.
Pre-treatment assessment of pain and range of motion will be noted for both the groups. Visual Analogue scale, Range Of Motion and Shoulder Pain And Disability Index will be used to measure pain and Range Of Motion.
After a brief demonstration Group A subjects will be receiving high grade mobilization techniques and low level laser therapy twice a week for a period of 4 weeks. (8 treatment sessions).
After a brief demonstration Group B subjects (controlled group)will be receiving only conventional pendular exercise twice a week for a period of 4 weeks (8 treatment sessions).
Post test will be conducted using VAS for pain, Goniometer for Range of motion and SPADI for function.
The results will be recorded and analyzed statistically.
Procedure:
High Grade Mobilization Technique:-
The treatment started with inferior glides aimed at improvement of the extensibility of the axillary recess. Both hands were held close to the humeral head to work with a short-lever arm. Oscillatory movements in the caudal, lateral, and anterior directions were used. To influence the posterior part of the joint capsule, the hand was placed on the anterior part of the shoulder, and the applied force was in the posterior and lateral directions. To treat the anterior part of the capsule, an anterior and medial glide was applied with one hand pushing on the posterior part of the humeral head. Distraction of the humeral head with respect to the glenoid was performed by pulling the humeral head in the superior, lateral, and anterior directions with a firm grip of both hands close to the humeral head and pushing the scapula on the table. If the fixation of the scapula proved to be difficult, a reversed distraction technique was applied, with the subject lying on the unaffected side. The therapist supported the affected arm and moved the shoulder into the end-range of elevation. The heel of the other hand pushed against the lateral border of the scapula in medial rotation to produce distraction within the glenohumeral joint.
If the glenohumeral joint ROM increased during treatment, then mobilization techniques were performed at greater elevation and abduction angles. In these new positions, the changed position of the humeral head and glenoid required an individual adjustment of the direction of the accessory movements in accordance with the concave-convex rules stated by Kaltenborn. Modification of the mobilization techniques consisted of more abduction or adduction, more flexion or extension, more internal or external rotation, more distraction, or a combination of adjustments. The treatment will be given twice a week for 4 weeks(8 Treatment Session).17
Laser:-
Patient position:- patient lying on high couch in position of maximum comfort. In such a way that each aspect of the joint is equally relaxed.
Marks are made on skin on the anterior aspect of the shoulder at the tender point. Whole body is covered except the part to be treated.
THERAPISTS POSITION: Therapist stands on the head end of the couch.
PRECAUTION: both the therapist and the patient should wear protective goggles for safety.
PARAMETRES: Laser will be used with parameters such as
Infrared Diode Laser -904nmhe
Maximum power-60 watt
Peak power value-27 watt
Pulse frequency-1280 Hz
Average point region-2-8 J
Total energy density- 24J/cm3
Scanning method is used with appropriate, frequency and position of the beam.
DURATION: 3 min/session
2 sessions per week in total of 4 weeks.(8 Treatment Session)
7.3) Does the study require any investigations to be conducted on patients or other human or animal? If so, please describe briefly.
NO
7.4) Has ethical clearance been obtained from your institution in case of 7.3.
YES.

LIST OF REFERENCES:

1. Bridgman JF. Periarthritis of the shoulder and diabetes mellitus. Ann Rheum Dis 1972;31 :69– 71.
2. Pal B, Anderson J, Dick WC, Griffiths ID. Limitation of joint mobility and shoulder capsulitis in insulin- and noninsulin-dependent diabetes mellitus. Br J Rheumatol 1986;25 :147– 151.
3 . Hannafin JA, Chiaia TA. Adhesive capsulitis: a treatment approach. Clin Orthop Relat Res 2000;1 :95– 109.
4. Neviaser JS. Adhesive capsulitis of the shoulder: a study of the pathological findings in periarthritis of the shoulder. J Bone Joint Surg 1945;28 :211– 222.
5. Lundberg BJ. The frozen shoulder. Acta Orthop Scand 1969;119 :1– 59.
6. Wiley AM. Arthroscopic appearance of frozen shoulder. Arthroscopy 1991;7 :138– 143.
7. Corrigan B, Maitland GD. Practical Orthopeadic Medicine London, United Kingdom: Butterworths; 1983.
8. Bertoft ES. Painful shoulder disorders from a physiotherapeutic view: a review of literature. Critical Reviews in Physical and Rehabilitation Medicine 1999;11 :229– 277.
9. Bulgen DY, Binder AI, Hazleman BL, et al. Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens. Ann Rheum Dis 1984;43 :353– 360.
10. Stenvers JD. De Primaire Frozen Shoulder [doctoral thesis]. University of Groningen, Groningen, the Netherlands; 1994.