RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
Annexure – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1 / Name of the Candidateand Address / JYOTI GULIA
K.L.E.’S INSTITUTE OF PHYSIOTHERAPY,
JAWAHARLAL NEHRU MEDICAL COLLEGE,
BELGAUM – 590 010 KARNATAKA
2 / Name of the Institution / K.L.E.’S INSTITUTE OF PHYSIOTHERAPY,
JAWAHARLAL NEHRU MEDICAL COLLEGE,
BELGAUM – 590 010 KARNATAKA.
3 / Course of Study and
Subject / MASTER OF PHYSIOTHERAPY (MPT)
(NEUROLOGICAL AND PSYCHOSOMATIC
DISORDERS)
4 / Date of Admission to the
Course / 1st JUNE 2007.
5 / Title of the Topic / “COMPARISON OF BIPHASIC SURGE
CURRENT STIMULATION AND TAPING
IN HEMIPLEGIC SHOULDER PAIN:
A CLINICAL TRIAL”
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 Need for the study :
The term Stroke is synonymous with cerebrovascular accident or CVA. According to ‘World Health Organization’ it can be defined as “a rapidly developed clinical sign of a focal disturbance of cerebral function of presumed vascular origin and of more than 24 hours’ duration.” The onset is usually sudden with maximum deficit at the onset1.
To be classified as stroke, focal neurological deficit must persist for at least 24 hours. Motor deficits are characterized by paralysis (hemiplegia) or weakness (hemiparesis), typically on the side of the body opposite the site of lesion. Impairments may resolve spontaneously with neurological recovery (reversible ischemic neurological deficit) generally within 3 weeks.
Stroke is the third leading cause of death and the most common cause of disability among adults in United States. The incidence of stroke increases dramatically with age, doubling every decade after 55yrs of age2. It is estimated that in USA, more than 7 lakh incidents of stroke occur each year resulting in more than 1 lakh 60 thousand deaths annually3. Prevalence of stroke is 55 lakh survivors at present4.
Risk factors for stroke are: (1) Potentially modifiable [transient ischemic attack(TIA), hypertension(HTN), atrial fibrillation, left ventricular hypertrophy, congestive heart failure, cigarette smoking, coronary artery disease, alcohol consumption, obesity, diabetes mellitus, high serum cholesterol] (2) Not modifiable [prior stroke, age, race, gender, family history of stroke].
Etiology of stroke may be classified broadly into (1) Ischemic stroke [cerebral thrombosis, cerebral embolus, subtotal] (2) Hemorrhagic stroke [intra cerebral, subarachnoid, subtotal] (3) Other or cause uncertain2. 80% of strokes are due to ischaemia5.
The symptoms of stroke depend on the type of stroke and the area of the brain affected. In most cases, the symptoms affect only one side of the body, that is
on the opposite side to the defect in the brain5. Symptoms may include paresis of contralateral lower limb, mental impairment, sensory impairment, apraxia, abulia, urinary incontinence in case of anterior cerebral artery syndrome. In middle cerebral artery syndrome there is paresis and sensory impairment of contralateral face, arm, and leg, motor speech disorder, aphasia, ataxia, perceptual problem. Whereas in posterior cerebral artery syndrome there is contralateral sensory loss and homonymous hemianopia, memory defects, visual agnosia, topographic disorientation, involuntary movements, contralateral hemiplegia2.
A common sequelae of stroke is hemiplegic shoulder pain that can hamper functional recovery and subsequently lead to disability. Poduri et al reported that hemiplegic shoulder pain can begin as early as 2weeks post stroke but typically occurs within 2-3 months post stroke6. Shoulder pain is known to have a negative affect on functional recovery, impeding rehabilitation. Muscle changes, particularly adaptive stiffness and shortening of internal rotators – adductor muscles and weakness of glenohumeral joint external rotators and abductor muscles are linked to the development of shoulder pain7. However, perceived loss of arm function has been reported as a major problem in approximately 65% of patients with stroke8. Incidence of shoulder pain in patients with hemiplegic stroke, through clinical trials has been estimated to be 16% to 84%6. Thus there is a strong need to develop effective treatment for hemiplegic shoulder pain.
There are various causes of hemiplegic shoulder pain like shoulder subluxation, spasticity, reflex sympathetic dystrophy, adhesive capsulitis, subacromial bursitis and brachial plexus traction neuropathies. There are specific therapeutic interventions for these causes like slings, arm boards, laptrays, ROM and stretching exercises, optimal positioning of the limb, modalities like ultrasound, manual mobilization exercises and supportive care6.
The use of electrical stimulation and taping along with specific therapeutic exercises for upper extremity, functional training with transfers and bed mobility are known to benefit patients with hemiplegic shoulder pain. Shoulder taping is one intervention that has been used in the management of shoulder subluxation and pain in patients who have had a CVA. Taping (or strapping) is the use of tape applied to the body to provide structural support9. Taping in conjunction with other therapeutic interventions may facilitate or inhibit muscle function, support joint structure, reduce pain and provide proprioceptive feedback to achieve and maintain preferred body alignment10. Electrical stimulation is another interventional approach with research supporting the reduction of shoulder pain and subluxation in patients with stroke9. Many clinical applications of electrical stimulation are associated with the augmentation of muscle force, motor control, improved joint range of motion and enhanced venous blood flow11. Electrical stimulation is extensively used for the control of pain. Although the idea had been proposed for many years, the rationale was provided by the gate control theory of pain proposed in mid 1960`s by Melzack and Wall (1965) 12. Taping and electrical stimulation might facilitate strengthening of shoulder muscles.
Studies have shown that the combined effect of taping and electrical stimulation have been useful in central cord syndrome. Also the effectiveness of taping in hemiplegic shoulder pain was studied and found to be beneficial. Electrical stimulation in hemiplegic shoulder pain, through researches, have made positive outcomes. To our knowledge and literature search, the comparison of taping and electrical stimulation in hemiplegic shoulder pain are sparse and hence the present study has been undertaken to find out the effectiveness of the same and to compare the two therapies.
Hypothesis
Null Hypothesis: There is no effectiveness of taping and electrical stimulation in acute and subacute hemiplegic shoulder pain.
Alternate Hypothesis: Taping is more effective than electrical stimulation in reducing shoulder pain in acute and subacute hemiplegics.
Or
Electrical stimulation is more effective than taping in reducing shoulder pain in acute and subacute hemiplegics.6.2 Review of Literature :
In a study done to know the effects of the shoulder taping to delay the onset of pain in the shoulder joint of patients with hemiplegia, it was found that subjects who were taped had a mean of 21 days before the onset of pain as compared with a mean of 5.5 pain free days for the control group13.
The effectiveness of taping in reducing hemiplegic shoulder pain was carried by Peters S. Beth and Lee Gregory in 2003 and it was concluded that taping is more effective treatment over traditional immobilization method for hemiplegic shoulder pain14.
A study to compare high intensity and low intensity transcutaneous electrical nerve stimulation versus placebo effect was conducted in 1990 by Leandri M. It was found that there was significant improvement in passive range of motion(PROM) in high intensity stimulation group15.
A study was conducted on the management of shoulder pain in stroke in 2001. It was found that strapping prevents shoulder pain and if shoulder pain persists, transcutaneous electrical stimulation or functional electrical stimulation may be helpful.16To find whether electrical stimulation applied soon after stroke prevented shoulder subluxation, pain and impaired motor function, a study by Linn S.L. was done in 2000. The results concluded that subluxation and pain were significantly less in the stimulated group than in the control group17.
A study was undertaken to find out the effect of scapular girdle taping in hemiplegic shoulder pain and it was found that there was statistically significant improvement in terms of pain18.
A comparative study was done to find the validity and sensitivity of various pain behaviour scales for geriatric patients with and without communicative limitations and Doloplus 2 scale was found to be statistically most significant and valid with no significant differences in inter-rater correlation test and with high score in quality judgement196.3 Objectives of Study :
1. To find out the effectiveness of taping and conventional treatment in acute and subacute hemiplegic shoulder pain.
2. To find out the effectiveness of electrical stimulation and conventional treatment in acute and subacute hemiplegic shoulder pain.
3. To compare the effectiveness of taping with electrical stimulation in reduction of shoulder pain in acute and subacute hemiplegics.7. / MATERIALS AND METHODS :
7.1 Source of Data :
KLES Prabhakar Kore’s Hospital and Research Center, Belgaum.
7.2 Method of Collection of Data (Including sampling procedure if any):
Participants: Male and female individuals with history of acute or subacute stroke, who are referred to physiotherapy department with in the study period and are willing to take treatment for 2 weeks period of time at KLES Prabhakar Kore’s Hospital and research center, Belgaum.Study design: Clinical trial
Sampling design: Simple Random Sampling by Lottery Method.
Sample size: 40 Participants- Group A- 20
Group B- 20
Sampling method: Convenience sampling.
Allocation of subjects:
Participants will be divided into two groups namely:
(a) Group A: Electrical stimulation and conventional treatment
(b) Group B: Taping and conventional treatment.
Materials used:
- Record or data collection sheet
- Consent form
Equipment used:
- Paper
- Pencil
- Tape-4cm rigid tape and hypoallergenic tape
- powder board
- Electrical stimulator – Phyaction Guidance E, Uniphy.Inclusion criteria:
1. Participants with history of stroke for less than or equal to 2 – 3 months.
2. Patient with good cognition level and who can follow simple commands.
3. Patient with intact sensations on affected upper extremity.
4. Individuals willing to participate in the study.
5. Upper limb MMT grade of less than or equal to 2 on affected side.
6. Subjects with either complain of post stroke shoulder pain or post stroke adhesive capsulitis, subacromial bursitis or shoulder subluxation on affected side.
Exclusion criteria:
1. Other neurological conditions except stroke.
2. Patients with affected skin integrity and skin infections at treatment site.
3. Patients who are allergic to tape .
4. Patients with history of shoulder pain due to musculo skeletal injury.
5. History of shoulder pathology like arthritis on hemiplegic side.
Procedure:
All the participants with acute and sub acute stroke, who report to Physiotherapy Department in KLES P.K. Hospital and Medical Research Centre during the study period will be included. Their suitability as per the inclusion and exclusion criteria will be made before enrollment. A written informed consent after explaining the advantages and disadvantages of the study, will be taken from them. Demographic data and history including pain history will be noted. Baseline data of pain (in terms of Pain Behavior Scale DOLOPLUS 219) and muscle strength (in terms of manual muscle testing or MMT by MRC grading system) will be assessed prior to the commencement of the intervention. All measurements will be repeated on day 7th and on day 15th at the end of the treatment period. Participants will be allocated in 2 groups viz. Group A (Electrical Stimulation and Conventional treatment) and GroupB (Taping and Conventional treatment) by lottery method. Participants in Group A will receive conventional treatment ( positioning in supine and sitting, specific therapeutic exercises for upper extremity consisting of passive range of motion and active- assisted exercises with progression to active and then resisted exercises and passive stretching) on the affected side. In addition to this the participants will be treated on the affected side with electrical stimulation which will consist of biphasic surge current with pulse width of 300 microseconds and frequency of 30 Hz. Stimulation will be given for supraspinatus, middle deltoid and posterior deltoid muscles through surface electrodes for 15 minutes twice a day for 2 weeks. Intensity of stimulation will be adjusted according to sensory threshold level of participants. Participants in Group B will receive same conventional therapy as Group A. In addition to this they will be treated on the affected side with shoulder taping using non-stretch or rigid adhesive tape applied over non-allergic or hypoallergenic tape to prevent skin reactions. Taping method – participant seated with the arm by the side in neutral posture with scapulae in retracted, depressed posture. Using hypoallergenic tape, lay the tape from coracoid process posteriorly across the lateral aspect of the acromion to a point just lateral to the T7 spinous process. Using rigid tape of 4 cm, lay over the hypoallergenic tape to the posterior aspect of the shoulder and finally apply a firm pressure medially to position the scapula in a retracted and depressed posture. Then cover the area to be taped with the hypoallergenic tape in the same sequence as the rigid tape to follow. Start from the middle deltoid insertion and lay the rigid tape of 4 cm down to just before the acromion. Then, pull firmly to a point halfway between the neck and shoulder on the upper trapezius fibres. Repeat with a second strip, starting from the posterior deltoid, overlapping the first and finishing at the same point. Then apply an anchor around the arm just above the biceps muscle and ensure that it is not too tight to compromise the circulation. The tape will be removed before taking measurements of pain in terms of Pain Behavior Scale DOLOPLUS 2 and muscle strength in terms of MMT by MRC grading system. The affected shoulder will be retaped after taking the measurements. All the measurements will be taken on day 1 before commencement of treatment, on day 7 and on day 15 at the
end of the treatment period.
Statistical Analysis
Data will be computed and analyzed by various statistical methods. Statisticalmean, S.D. will be calculated and tests of significance like paired and un-
paired ‘t’ test will be done.
7.3 Does the study require any interventions or investigations to be conducted on patients or other human or animals? If so please describe briefly.
No.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes.
8. / LIST OF REFERENCES1. J.P.H. Wade, Cash’s textbook of Neurology for Physiotherapists, Clinical Aspects of Stroke, Jaypee Brothers, 4th Ed., London: Wolfe. 1993; 240.