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STRIPS: Shoulder Taping Reduces Injury and Pain in Stroke

2014-08-27 03:16:09 | BioPortfolio

Summary

Background and Rationale: Stroke is the second leading cause of death and a major cause of disability worldwide. The most commonly seen disabilities in stroke patients are shoulder injuries such as shoulder pain, glenohumeral subluxation, spasticity of shoulder muscles, soft-tissue trauma, rotator cuff tears, and shoulder-hand syndrome.

Taping is widely used in the field of rehabilitation as both means of treatment and prevention of sports related injuries. Scarce information is available regarding the use of shoulder taping in preventing shoulder injuries in stroke patients. Taping materials are locally available and it could be an affordable solution to prevent shoulder injuries following stroke.

Aims:

To find out the effectiveness of taping technique versus conventional treatment in prevention of shoulder injuries in patients with acute stroke.

Hypothesis:

Taping technique with conventional treatment will be superior to conventional treatment alone in preventing shoulder injuries in patients with acute stroke.

Methods Research setting: Stroke unit, department of Neurology, Christian Medical College (CMC) Ludhiana, Punjab, India and College of Physiotherapy, CMC Ludhiana.

Study design: Prospective Randomized Double Blinded Clinical Trial Study period: Prospective for 18 months from May 2009 All stroke patients with upper limb weakness within 48 hours after the ictus and with Brunnstrom's stage of recovery 1 and 2 will be included in the study. Patients will be randomized into two groups using lottery method. Group 1: patients will be given conventional treatment and taping i.e. positioning, handling technique, passive range of motion exercises and taping of the affected shoulder Group 2: patients will be given conventional treatment alone. A total of 125 patients in each group will be included. The plastic micropore and elastic adhesive tape will be used for taping the affected shoulder. The sham taping will be done using the same tapes but without stretching the concerned muscles and joints. The tapes will be changed every 3 days and will remain for 14 days. The outcome measures are; Pain: Visual Analog Scale; Range of motion: using a Goniometer and Activities of daily living: Shoulder Pain and Disability Index. The outcome will be assessed by an independent physiotherapist who will be blinded to the clinical details. Patients will be followed-up at 14 days and 30 days. Statistical analyses will be done using SPSS software version 16.

Description

Background and Rationale:

Stroke is the second leading cause of death and a major cause of disability worldwide. Two-thirds of stroke deaths worldwide occur in developing countries. According to recent reports from India the incidence and 30-day case fatality rates are higher than the developed countries. In both rural and urban India there has been a rise in the non-communicable diseases like stroke and coronary artery disease. In developing countries the average age of stroke is 15 years less than that of developed countries.

It has been estimated that by 2021, the stroke related "disability adjusted life years" (DALY) would become 61 million, and 52 million would be in developing nations. According to recent studies 55-70% of stroke survivors become fully independent by one year and 7-16% remain completely disabled. Prominent residual spasticity occurs in 46% of patients.

Shoulder Injuries in Stroke The most commonly seen disabilities in stroke patients are shoulder injuries which are more common during sub-acute phase of stroke. Pain in the affected shoulder often referred to as hemiplegic shoulder pain, is a common complication. The other types of shoulder injuries include glenohumeral subluxation, spasticity of shoulder muscles, soft-tissue trauma, rotator cuff tears, and shoulder-hand syndrome or reflex sympathetic dystrophy. Shoulder injuries can negatively affect rehabilitation outcomes as good shoulder function is a pre-requisite for successful transfers, maintaining balance, performing activities of daily living and for effective hand function.

Biomechanics of shoulder injuries in stroke patients A stroke patient with upper limb weakness tends to place the arm in a resting position and this promotes shortening of the shoulder adductors and internal rotators, and the elbow, wrist and hand flexors. This habitual posturing of the upper limb can result in adaptive changes to muscle tissue that impede both passive and active joint movement.As motor power returns, the pattern of recovery may be imbalanced, with individual muscles developing strength at different rates or there may be increased tone in certain muscle groups. Imbalanced motor return and persistent attempts to move with increased activation of just one muscle group can pull the scapula and humerus into abnormal postures. When this posture is maintained, the resting length of the surrounding muscles may either shorten or lengthen, thereby disrupting the normal biomechanics of that joint. In addition in flaccid stage, the scapula assumes a depressed and downward rotated position, as the paretic serratus anterior and upper part of trapezius muscle no longer support the scapula. The combination of flaccid supportive musculature and a downward rotated scapula predisposes the head of humerus to undergo inferior subluxation relative to the glenoid fossa.

Treatment options for shoulder injuries in stroke patients The ideal management of hemiplegic shoulder pain is to prevent it happening in the first place. Various strategies have been employed in the prophylaxis of hemiplegic shoulder pain. For prophylaxis to be effective, it must be begin immediately after the stroke. Early passive shoulder range of motion, and supporting and protecting the involved shoulder in the early flaccid stage, local treatments such as heat and cold therapy, transcutaneous electrical nerve stimulation, functional electrical stimulation, range of motion exercises, EMG biofeedback are regarded as important steps to reduce the development of shoulder pain. Careful positioning and handling of the limb are thought to prevent hemiplegic shoulder pain, but there is a range of opinions about how correct limb positioning is best achieved. Careful positioning of the shoulder serves to minimize subluxation and later contractures as well as possibly promote recovery, while poor positioning may adversely affect symmetry, balance and body image. Through correct positioning, the development of shoulder pain can be prevented. However, the effectiveness of any of these methods in preventing shoulder injuries has yet to be established.

Taping is widely used in the field of rehabilitation as both means of treatment and prevention of sports related injuries.The essential function of tape is to provide support during movement. Taping is a treatment method used in conjunction with other therapeutic techniques in the treatment of various musculoskeletal and neuromuscular deficits. It helps to support or inhibit muscle function, support joint structure, reduce soft tissue inflammation, and reduce pain. It also can produce feedback to the muscle to maintain preferred postural alignment. Various taping materials have been used in rehabilitation (Kinesio tape, Leukotape, Cover-roll stretch tape).

Scarce information is available regarding the use of shoulder taping in preventing shoulder injuries in stroke patients. Peters and Lee, 2003 studied a single stroke patient during the sub-acute phase of stroke. The patient reported decrease in pain, improvement in activities of daily living and range of motion of the shoulder. However there are no controlled studies using large number of stroke patients. Moreover the effectiveness of taping in conjunction with other therapeutic activities to facilitate improvement in restoring functional use of the upper extremity during the acute phase of stroke has not been studied. Shoulder taping may prove to be economically sensible by preventing shoulder subluxation which would decrease the number of therapy treatment sessions. Taping materials are locally available and it could be an affordable solution to prevent shoulder injuries following stroke.

Study goal, objectives and main research questions:

To find out the effectiveness of taping technique versus conventional treatment in prevention of shoulder injuries in patients with acute stroke.

Methods

Setting:

Stroke Unit, Department of Neurology, and College of Physiotherapy, Christian Medical College and Hospital, Ludhiana

Study design: (Describe the type of study design eg cross-sectional, case-control study, etc..) Prospective hospital based randomized double blinded clinical trial

Sample size and sampling techniques:

The population size for finite population correction factor 400. Hypothesised percentage frequency of outcome factor in the population will be 50 % ± 5.Confidence limits as % of 100 (absolute ± %)(d) will be 5 %. Design effect (DEFF) will be 1. Estimate sample size is calculated using the formula:

Sample size n = {DEFF * Np (1-p)}/ {(d2 / Z2 1-œ/2 * (N-1)+ P* (1-P) For 97% confidence level, the estimated sample size will be 217. But in order to overcome dropouts and rejection, we will be taking as 250 i.e 125 patients in each group. Power of sample for this type of study is 80%.

All consecutive stroke patients who give consent will be randomised in a blinded fashion to two treatment groups using lottery method. .

Patient groups The randomization will be done by an office personnel who will be unaware of the clinical details of the patients Group 1: patients will be given conventional treatment i.e. positioning, handling technique, passive range of motion exercises and taping of the affected shoulder Group 2: patients will be given conventional treatment alone which includes sham taping of the affected shoulder

Study definitions Stroke will be defined as per WHO: Syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.

All stroke patients within first 48 hours after the onset of symptoms will be approached for inclusion

Instruments/tools Pain: Visual Analog Scale Range of motion: full circle universal Goniometer Activities of daily living: Shoulder Pain and Disability Index Stroke severity: National Institute for Health Stroke Scale34 Taping: Plastic micropore and elastic adhesive tape (Leucoplast) Brunnstrom stage of stroke recovery Glasgow coma scale

Techniques/ methods

Treatments

1. Positioning technique

2. Handling technique

3. Range of motion exercises

4. Taping technique

Data management and analysis plan:

Data entry operator will enter the patient data. Statistical Analyses will be done using SPSS software version 16. Summary statistics including frequency, mean and standard deviation of variables of interest will be generated. Comparison of means of the continuous variables between the two treatment groups will be done using Student-t test, and the binary variables using Chi-square test. The means of the outcome measures (scores of visual analog scale, range of movements of shoulder and shoulder pain and disability index) at admission will be compared with the values at day 14 and day 30 using Student-t test between the two groups. A p value of <0.05 will be considered significant.

Implications of study results on patient safety practice and/or interventions

This study will be using locally available tapes such as plastic micropore and elastic adhesive tapes for taping the shoulder. They are easily available. This study fulfills the Global research priorities of World Alliance for Patient Safety (i.e. Identification, design and testing of locally effective and affordable solutions).

The results of this study has wider application if the taping technique is found effective, particularly in developing countries where resources are sparse. This simple technique will prevent stroke disability due to shoulder injuries and help in rehabilitation of stroke victims.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Stroke

Intervention

Taping, Sham Taping

Location

Christian Medical College
Ludhiana
Punjab
India
141008

Status

Recruiting

Source

Christian Medical College and Hospital, Ludhiana, India

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:09-0400

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Medical and Biotech [MESH] Definitions

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

Stroke caused by lacunar infarction or other small vessel diseases of the brain. It features hemiparesis (see PARESIS), hemisensory, or hemisensory motor loss.

A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

A condition caused by the failure of body to dissipate heat in an excessively hot environment or during PHYSICAL EXERTION in a hot environment. Contrast to HEAT EXHAUSTION, the body temperature in heat stroke patient is dangerously high with red, hot skin accompanied by DELUSIONS; CONVULSIONS; or COMA. It can be a life-threatening emergency and is most common in infants and the elderly.

A strain of Rattus norvegicus with elevated blood pressure used as a model for studying hypertension and stroke.

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