Medical understandings of Spasticity and its Clinical Evaluation


Medical understandings of Spasticity
and its Clinical Evaluation

ISLAMABAD: Medical understanding of spasticity and its clinical evaluation was discussed in detail by various speakers at a meeting organized by Novartis Pharma Pakistan here on May 24, 2015. It was attended by Neurosurgeons, Neuro Physicians, Orthopaedc Surgeons, and Rheumatologists besides experts from Rehabilitation Medicine.

Mr. Asif Qureshi, Group Product Manager at Novartis in his welcome address said that this meeting is being attended by healthcare providers from different specialties. It will be a great opportunity to interact with each other and share experiences to manage the spasticity patients which have increased tremendously.

Dr. Ahson Siddiqi, Chief Scientific Officer and Head of Regulatory Affairs at Novartis talked about Pharmacovigilance – Quality as a differentiator. This he said, is a neglected subject. Four types of drugs are available in Pakistan which includes, original molecules, which has solid scientific data based on clinical efficacy, have quality and safety. Genericsrely on originator documentation and label. Bioequivalence have also established their quality. Substandard drugs rely on originator documentation, has no bioequivalence and their quality is not established. Counterfeit drugs are those which, have no data, have unknown origin and composition.Tracing the history, he said that Thalidomide was approved as a sedative in Europe in the late 1950’s.The FDA never approved the drug, but samples were sent to US doctors. By 1961 thalidomide was shown to be very harmful to the fetus, interfering with the normal development of arms and legs. This resulted in children born without limbs. Every drug has some side effects but there is no Adverse Drug Reactions reporting system in Pakistan. Over two million serious ADRs and about 100,000 deaths are reported in United States every year. It is fourth leading cause of deaths and more than fifty percent of fatal ADRS were preventable, he added.

Dr. Ahson Siddiqi

Frequency of side effects Dr. Ahson said is increasing because of better public awareness, awareness of medical community, better reporting system, regulatory compliance, rapid and early entry of new research products, better acute care in hospitals, besides empowerment of Pharmacists. In Pakistan no data of ADR is available because we do not know our denomination due to various reasons.

Dr. Khalid Mahmood

Dr. Ahson further said that it takes about fifteen years to synthesize one compound. One out of ten thousand compounds reach the market. To develop a molecule pre-clinical animal studies, phase I,II, III, IV and even phase V trial is also carried out to check the efficacy of the product on regular basis because it is used by millions and some hidden side effects can be reported.

Talking about types of serious side effects which need to be reported he mentioned deaths, life threatening adverse drug experiences, inpatient hospitalization or prolongation of existing hospitalization. All serious events, all non-serious events and labeled events must be reported, he added. Efforts should be made to have four elements liaison which is being practiced by Novartis for reporting of ADR which includes, person who reported the drug reaction, Patient, adverse event and a drug of the company. What will happen after your report, Within 24 hours, it will be forwarded to central PVOwhere data from across the worlds being forwarded, notification to Health Authorities for information and necessary action besides update of prescribing information to increase knowledge of scientific (medical) community which will ensure Patients’ safety.

M/s. Novartis Pharma Pakistan organized Spasticity Summit at Islamabad recently.
Group photograph taken at the occasion shows some of the participants with the speakers.

Replying to various questions Dr. Ahson Siddiqi said that it is the State responsibility to tackle the issues which are obstacles in ADR reporting. Low literacy, ADR is not part of the undergraduate curriculum and postgraduate courses and not part of research programs. Quacks, GP,s, small hospitals, large private hospitals are the obstacles because they think that an ADR report would be taken as poor performance and would affect their reputation and fear of punitive actions. He concluded his presentation by stating that “There are three types of people, one who make things happen, one who watch things happen &one who wonders what happened.


Dr. Shahid Hussain Sheikh

On second day of the meeting Mr. Mansoor Ali Jafari, Business Franchise Head of Novartis welcomed the participants of the Event and remarked that Novartis has a long history to provide quality care products and it is a World leader in Research and Development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. With Headquarters in Basel, Switzerland, Novartis is present in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in Pakistan through Novartis Pakistan Limited. The group headed by Mr. Mansoor Jaffari has the products Voltral ,Caflam, Ternelin, Aclasta and Miacalcic.


Dr. Farooq Rathore

Prof. Shahid Hussain Sheikh, Chairman Neuro Immune Dysfunction Syndrome (NIDS) Treatment & Research Center from Lahore was the next speaker. He talked about new Dimensions of Neurology. Patient care, he opined demands the intellectual strengths, empathy, commitment and courage along with continuous improvement in the profession. Neurology, he stated, is presidential system of the body. Neuro Invasive Viral Induced Neuronalitis is a biggest threat, if unnoticed it can be life threatening. It emerged in 1998. There is no place in the World which is safe from this virus. Pakistan is in double trouble. Research is the logical necessity to understand the most complex and ever changing pathological paradigms. Innovation in the Skillman ship only shines the professional stature and intellectual integrity, that help us grow in our society, make us a determined leader in our profession and a valuable asset of our community, by providing quality care.

Continuing, Dr. Shahid Hassan said that conventionally, the understanding of any given human ailment aligns from system to organ to tissues to cells. We call it “Cyto-Pathology”, we engage in a variety of diagnostic tools to evidence such cyto-pathology to confirm our diagnoses and tailor a medical or surgical management plan according to the given established protocols. Atomic Force Microscopy (AFM) has brought a new paradigm in the view to best clear our understanding of the emerging patho-physiology of a given symptomatic pathology. We can no more logically treat a disease based on the symptomatic realm, admitting “Etiology Unknown”. Today, majority of the ailments have only symptomatic relief/treatment. There is an urgency to take a deeper look at the source of ailments and try to define the possible etiology. We all are familiar with the Nucleus of a given cell being the controlling entity for that cell’s homeostasis, timely development and its functions. So is true of the controlling Neurons of the Brain. Cyto-pathology is no longer an absolute reliable tool to finalize the proper diagnoses. Currently, so called treatments are merely a symptomatic pacification to borrow time for the resident immune system to revitalize against the pathogens in question.

Mr. Mansoor Ali Jafari, presenting shields to Dr. S.A. Siddiqui, Dr. Shakil Absassi, Dr. Sahibzada Nasir Mansoor
and Dr. Farooq Rathore during Spasticity Summit organized by Novartis Pharma Pakistan at Islamabad recently.

Dr. Shahid Hasan further stated that the Nucleo-pathology of the controlling neurons indeed is the paradigm shift, the grass root instigator of the basic symptomatology that results into the disruption of the normal homeostasis. However, pacifying the symptoms is not the final treatment of the chronic ailment. On the contrary it is the opportunity given to the pathophysiology to continue to grow the bigger challenge. To date, this phenomenon has been a hidden secret of nature. Now that is opened, it is unraveling the possible etiologies of the unknown nature of the conventional diseases.

The “Sheikh’s Syndrome”, he opined is rightfully a very well established guideline to see any disease’s root cause etiology and possible treatment to eradicate the ailment. We have found the positive results for many ailments like, Amenorrhea, Allergies ,Alzheimer, Anemia, Asthma, Cancer, Atherosclerosis, Cognitive Disorder, Encephalitis, IBS, Neuralgia Parkinson’s and Chromosomal Disorder etc. Antiviral therapy has an important role even patients suffering from hypertension were cured without antihypertensive therapy. NIDS (Neuro Immune Dysfunction Syndrome) Treatment & Research Center is continuously striving to find the root causes of the untreatable ailments connecting with scientific work globally. Zero Mortality in treating 1298 patients inflicted by the Dengue Virus, Hypercholesterolemia and Hypertension are some of our leading discoveries. From primary care to treating care we should get united to tackle this problem, he concluded.

Dr. Sahibzada Nasir Mansoor

Dr. Khalid Mahmood from Lahore General Hospital shared his experience of Surgery of Deep Brain Stimulation (DBS) for those living with Parkinson`s disease. It is a rare procedure. The DBS is a neurosurgery procedure involving the implantation of a medical device called a `brain pacemaker`, which sends electrical impulses through implanted electrodes to specific parts of brain(brain nucleus) for the treatment of movement and affective disorders. Punjab government has provided a Rs.50 million grant for the purchase of specialized equipment for the LGH for conducting DBS procedure. Our team is now available to attend such patients at the LGH and hence these patients would not have to go abroad for treatment .Although the treatment, he said, was very expensive in Pakistan as it costs Rs. 2 million, this cost was only 20% of expenses in foreign countries. He said the operation lasts for about six to nine hours. symptoms of Parkinson`s disease include shaking of legs, arms and hands and patients feel stress in their legs. In its acute form, it becomes difficult for patients to keep their head still and such patients become dependent for the rest of their life, he added.

Dr. Ashraf Mahmood

While explaining the process of DBS operation, he said, very delicate electrodes connected with a battery are installed in small holes drilled on both sides of the head of a patient. `The battery is placed under the skin in the chest of the patient which works like a heart pacemaker. LGH is going to become state of the art hospital of the region after completion of Institute of Neuro Sciences in near future. It will be a unique centre in Pakistan he added. The Institute would provide more opportunities of research and training to young doctors and treatment facilities would be available under one roof at a large scale for patients of all age groups, he assured.

Patients considered for DBS surgery should have clear diagnosis of idiopathic disease ,patient should have intact cognitive function because it is a long operation and surgeon has to interact with patient .Clear evidence of motor improvement with good motor function, best on medication state, patients should be ambulatory in best on state without much assistance. Patients more than seventy five years of age should not be operated. In Parkinson disease early medical treatment usually in first five years should be started. When the patient starts losing ability to perform meaningful activities, it means the effectiveness of the drug is decreasing and patient need surgery but it cannot rescue patients with end stage disease.

Technology, Dr. Khalid said has revolutionized management of such patients. We visualize the target and then hit at it. First case of MDS was performed on modern lines in April 2012. Since then more than eighty procedures have been performed. Lesional surgery in some cases is as effective as DBS surgery. Partial reoccurrence of the symptoms, bilateral tremors and limited effectiveness of ablation are the limitation of lesional surgery. Patients who should not be considered for surgery includes whose symptoms do not respond to medication, severe disability, dementia, end stage and those with unrealistic expectations. Even in best hand success rate is about 75%. Effects of drug therapy of dystonia are poor and surgery is the only option available. Lack of training, problems with STN visualization, availability of trained staff and financial constraints are the challenges. It requires a team approach and at least fifteen people are involved in it. DBS has improved emotion in patients which cannot be done with medication, he added.

Dr. Arslan Ahmed (C) along with Dr. Shakil Absassi and Dr. Sahibzada
Nasir Mansoor replying to questions during case presentation in Spasticity summit.

Dr. Farooq Rathore, Assistant Professor, Department of Rehabilitation Medicine ,CMH Lahore Medical College presented an overview of assessment and management of spasticity. Spasticity, he stated, increases muscle tone, resistance to passive muscle, stretch at a joint velocity and joint-angle, dependent, has to be palpated and other features like clonus, increased reflexes etc. while Dystonia had sustained and repetitive muscle contractions & abnormal postures, visible involuntary movements, suggests active rather than passive movement. Velocity is not usually dependent on mental state, alertness, emotion. Causes of Spasticity includes, Stroke, Multiple sclerosis, Spinal Cord Injury, Cerebral Palsy and other neuro-degenerative disorders, Brain Injury (Traumatic and non-traumatic), Amyotrophic lateral sclerosis and hereditary spastic parparesis.

Talking about current scenario in Pakistan Dr. Faooq said that the eye cannot see what the mind doesn’t know. Wrong descriptions, patient has increased tone, lack of formal assessment and documentation, lack of coordination and communication among team members are the major issues. There are twenty assessment scales available while choosing an assessment scale one should keep in mind that it iseasy to administer with no steep learning curve, no specialized equipment needed, good inter and intra rater reliability, reproducible, addresses the patient’s complaints and issues and should be Practical. Complications and issues with untreated spasticity includes increased falls, fatigue, contractures, Joint subluxation and dislocations, pressure ulcers and Pain besides diminished self-image due to abnormal limb posture, skin maceration, Poor orthotic fit and Poor quality of life.

Goals of spasticity treatment Dr. Farooq Rathore said should be to decrease pain, prevent or decrease medical complications, facilitate activities of daily living, ease rehabilitation care and interventions, save caregiver’s time, improve sleep pattern, facilitate functional mobility and transfers, decrease frequency and intensity of spasms. Principles of management of spasticity is early is better. An integrated team is required to successfully manage spasticity as no single treatment is effective, he added.

Mr. Mansoor Ali Jafari

Oral medications, for spasticity includes Tizanidine( Maximum 36 mg), Lioresal ( Max 100-120mg, Benzodiazepines (Diazepam, clonazepam), Others are (Eperisone, Cyclobenzaprine) Injections Local anesthetics, Ethanol and Phenol Blocks and Botulinum Toxin, Ethanol and phenol denaturation of proteins, eithertemporally or permanently. It affects motor and sensory fibers. Surgical management includes Neurosurgical selective dorsal rhizotomyIntrathecal baclofen pump placement. Orthopedic surgery for Musculotendinous lengthening, Tendon transfers and contracture release, Neurectomyand Joint fusion surgery. Spasticity is a component of the UMN syndrome. It is a common squeal of many neurological disorders which can affect any age group. Comprehensive spasticity management is a multi-disciplinary team work. Accurate assessment and goal settings results in better management strategy. Simple things do make a difference, he concluded.

Case Presentation

Dr. Farooq Rathore then presented a case for discussion. A forty five years old male businessman from difficulty in handling things with his right hand. The panelist of this session were Dr. Arslan Ahmed, Professor of Neurology, PNS Shifa Hospital Islamabad , Dr. Samina Ghazanvi, Rheumatologist from Liaquat National Hospital Karachi, Dr. Shakil Absassi, orthopedic surgeon from Sukkur and Dr. Sahibzada Nasir Mansoor from CMH Pano Aqil.

Mr. Asif Qureshi

Dr. Arslan said that spasticity is present in this case which could have been avoided with rehabilitation. His weakness has to be judged. Botox is good option because other medication will have sedation. Dr. Shakil Abbasi said that the situation of Karachi was the major cause of this problem. Dr. Rukhsana Zuberi said that we have to consider risk factor in this case. If he is diabetic, suffers from hypertension and kidney problem, it will be a lethalcombination for which secondary prevention is needed. Dr. Nasir Mansoor said that Tizanidine can be tried in this case and for positioning physiotherapists help must be availed for this patient. If he has depression, we must involve psychologist/ Psychiatrist before going for Botox injection. Replying to a question regarding use of SSRI’s in stroke, Prof. Arslan said that the younger the patient we do go for Fluoxetine 20mg once a day in morning for at least six months to one year. We should see that the drug is approved by FDA, it is indicated and recommended. We can rely on the products approved by FDA and European standard is also acceptable. One should be extra careful about other preparations available in the market. Botox injection has its limitation, after three months its effects are vanished and it has to be repeated. Exact dose, location and person who is administering it should be expert in it. Catheter should be removed as early as possible in stroke patients to prevent bladder infection. These are all preventable conditions. It should not have happened. Tizanidine can be tried in such cases. In advance scenario orthopedic surgery must be done. Management strategies should be tailor made based because every patient cannot afford costly treatment..

Dr. Sahibzada Nasir Mansoor talking about complications of spasticity said that it is a subject of major clinical importance and a major contributor to motor functional disability in patients suffering from upper motor neuron (UMN) lesions. Spasticity does not come alone and its common conditions include Stroke, Spinal cord Injury, cerebral palsy, multiple sclerosis, traumatic brain injury. Possible advantages of spasticity includes , maintains muscle tone, prevents osteoporosis, helps support circulatory function, may prevent formation of deep vein thrombosis, may assist in activities of daily living and assist with postural control. The most reasonable approach is to treat spasticity whenever it becomes disabling or problematic. Factors which need to be considered in spasticity treatment are chronicity, severity, distribution, locus of injury, Co-morbidities, availability of care and support.

Treatment goals of spasticity should be to improvement in speed, balance, quality, and safety of gait,energy of walking, hygiene, Sexual functioning, reduction in Pain/Spasms,reduction in oral drugs, improved positioning,decreased pain and spasms, orthotic fit, relief for caregiver burden and prevention of complications.

Factors that may Increase spasticity includes UTI, Kidney stones, menstruation, bowel impaction, Pneumonia, Wounds or infections, Stress, Ingrown nails, Restrictive clothing and Psychological factors. Ultimate aim is the quality of life of the patient and the care giver in terms of time, comfort, energy, finances and psychological wellbeing. Every patient is different and should have a customized management plan. Identification of treatment goals is the first step in devising a treatment program for spasticity. Goals should be specific and function-oriented, and should be developed in consultation with the patient and caregiver. Functional goals of treatment may include the improvement of hygiene, pain, activities of daily living, ease of care, cosmesis, limb position, and gait to decrease the frequency of spasm, and to improve or enable orthotic fit. Technical goals, which sub serves the functional goals, may include increased range of motion, reduced muscle tone, and improved joint position. Prevention of secondary complications such as contractures, skin maceration, and decubitus (pressure) ulcers may also be important goals of treatment.Clear treatment aims, early multi-disciplinary assessment & management, developing clinical standards, simple measure done earlier can prevent complications later, he concluded.

Dr. Ashraf Mahmood, Associate Professor of Neurosurgery, Services Institute of Management Sciences Lahore discussed the management of spasticity with enhanced treatment options. Talking about gravity of the problem, he stated that 12 million people throughout the World are suffering from Spasticity. More than 85% have at least mild spasticity, with more than 30% being forced to at least frequently modify their activities because of the spasticity. Cerebral palsy is estimated to affect 2 to 4 out of every 1,000 children in the World who are between 3 and 10 years of age. Stroke affects almost 2,000 out of every one million people per year worldwide. Almost 40% of people who have a stroke continue to have spasticity one year later.

Spasticity, Dr. Ashraf stated is an involuntary, velocity-dependent, increased resistance to stretch. It is caused by an injury to any part of the central nervous system (the brain or spinal cord) that controls voluntary movements. The damage causes a change in the balance of signals between the nervous system and the muscles. This imbalance leads to increased activity (excitability) in the muscles. The most common causes of spasticity are lack of oxygen to the brain before, during, or after birth (cerebral palsy)Physical trauma, blockage of or bleeding from a blood vessel in the brain, multiple sclerosis or infection of the brain (encephalitis) or the covering of the brain and spinal cord (meningitis). When the damage occurs, the muscles are usually flaccid before they become spastic. Spasticity may not be present all the time, it may be related to a trigger, or stimulus, such as pain, pressure sores, a urinary tract infection, ingrown toenails, tight clothing, or constipation.

Treatment goals of spasticity should be to relieve the signs and symptoms , reduce pain, frequency of spasms, or irritating stimuli. Improve gait, hygiene, activities of daily living, or ease of care through counseling. Improve voluntary active motor function, that is the behaviors and functions that are under the patient's control, such as reaching for, grasping, moving, and releasing an object. A combination of various types of treatment is usually required to attain the specific goals of treatment for a particular patient. Most people with spasticity require physical and occupational therapy to improve or maintain the range of motion in their spastic limbs. Physical and occupational therapy, oral medications and surgical treatments are all very effective and useful.

Mr. Mansoor Ali Jafari, Business Franchise Head of Novartis Pharma presenting Certificates
to some of the participants of Spasticity summit held at Islamabad recently.

The use of oral medication (Muscle Relaxant) to treat spasticity is indicated when stiffness, spasms, or clones interfere with daily functioning or with sleep. Effective spasticity management may require the use of two or more drugs or a combination of oral medications. Muscle Relaxant are Biclofen, Benzodiazepines, Dentroline sodium, Imidazolines, Pre Gablin, Gabapentinetc. Tizanidine’s principal site of action is the spinal cord by stimulating pre-synaptic alpha2-receptors, it inhibits the release of excitatory amino acids that stimulate n-methyl-d-aspartate (NMDA) receptors. It has all mild and transient side effects like dry mouth, drowsiness, weakness, fatigue and dizziness etc. Other muscle relaxants have more side effects and higher dose is required. Regular follow-up, just give the patient at least one month to three months time which will ensure good results.

In the concluding session Dr. Farooq Rathore suggested that to organize such meeting in future we should have better coordination, group discussion, and interactive session. Dr. S.A. Siddiqui appreciated the efforts of the organizers of the event which will help the participants tomanage the spasticity patients. He also suggested that the organizers include work done in the field of neurosurgery and orthopedic surgery. Dr. Nasir Mansoor said that hands on workshop of spasticity and patient discussion should be part of such types of programmes. Mr. Abdul Sameer Brand Manager of Tizanidine informed the participants that they are trying to get this preparation registered in 6mg strength. At the end of programme Mr. Mansoor Ali Jafari presented Shields to the speakers and certificates to the participants.

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