RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE
PERFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATE AND ADDRESS / PATEL JAY INDRAVADAN# 7/ G. E. B. HOUSING SOCIETY
MAKTAMPUR ROAD,
BHARUCH. 392012
GUJARAT.
2 / NAME OF THE INSTITUTION / KEMPEGOWDA INSTITUTE OF PHYSIOTHERAPY. K.R.ROAD, V.V PURAM, BANGALORE-560004.
3 / COURSE OF THE STUDY / M. P. T. (Musculoskeletal Disorders And Sports)
4 / DATE OF ADMISSION / 08th June 2009
5 / TITLE OF THE TOPIC:
“EFFECT OF MCKENZIE METHOD AND TENS IN LUMBAR RADICULOPATHY- A RANDOMIZED CONTROLLED TRIAL.”
6. / Brief resume of the intended work:
6.1 Need for the study:
Lumbar radiculopathy is a disease of the spinal nerve root generally accompanied by radicular pain in a dermatomal distribution and/or neurologic symptoms (eg. paresthesias) or signs (eg. Weakness in the myotomal distribution). (1)
The lumbar radiculopathy is caused by sciatic nerve compression. Several different types of spinal disorders can cause spinal nerve compression and lumbar radiculopathy. The common causes are – a bulging herniated disc, lumbar spinal stenosis, spondylolisthesis, trauma, & spinal tumors. (2)
Because of the above causes the patient develops low back pain which can lead it to chronic low back pain and with certain clinical features of lumbar radiculopathy as – Pain, numbness, weakness, muscle atrophy & abnormal reflexes. (3)
The disc prolapse is investigated radiologically on a MR imaging. Magnetic resonance imaging (MRI) is a noninvasive technique that can be used in several planes (transverse, coronal, or sagittal) to diagnose nucleus pulpous and the anulus fibrosis and differentiated easily because of their different water contents, marking it the preferred imaging modality for disc disease. (4)(5)(6)(7)
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. (8)(9)(10)
Straight leg raise test-also known as Lasegue’s test, the straight leg raising test is done by the examiner with the patient completely relaxed. It is one of the most common neurological tests of the lower limb. It is a passive test, and each leg is tested individually with the normal leg being tested first. If the pain is primarily back pain, it is more likely a disc herniation or the pathology causing the pressure is more central. If pain is primarily in the leg, it is more likely that the pathology causing the pressure on the neurological tissue is more lateral. Disc herniation or pathology causing pressure between the two extremes are more likely to cause pain in both areas.(7)(11)(12)(13)
The modified-modified Schober test also referred as simplified skin distraction method is used for measuring flexion and extension of Lumbar spine. The modified-modified Schober test is easier and quicker to use than the double inclinometer method. (14)
The modified Oswestry low back pain disability index was originally described in 1980. The Modified Oswestry Low Back Pain Disability Questionnaire consists of 3 sections. 1st for the patient information, 2nd for the questionnaire and 3rd for the scoring, It is a tool to find out the disability score.(15)
Robin McKenzie, in 1981 proposed a classification system & a classification based treatment for LBP labeled MDT or simply the McKenzie method. (16)
McKenzie method (MDT) is widely associated with the application of extension loading strategies in the initial treatment of spinal derangement syndromes. The McKenzie classification method identifies approximately 80-90% of lumbar patients with derangement syndrome. The majority of this patient will exhibit a directional preference for extension and lateral movements. (17)
Transcutaneous electrical Nerve Stimulation (TENS) is the application of electrical stimulation to the skin via surface electrodes to stimulate nerve fibers, primarily for pain relief. (18)
Since 1970, the TENS is used for electroanalgesia and chronic neurogenic pain relief after the introduction to Pain Gate Theory by Melzack & Walsh. (18)
Several types of TENS applications, differing in frequency, amplitude, pulse width and waveform, are used in clinical practice. The two most common application modes include: 1) High frequency or conventional TENS (40 to150 Hz, 50 to 100 usec pulse width, low intensity) and 2) Low frequency or so called acupuncture-like TENS (1 to 4 Hz, 100 to 400 usec pulse width, high intensity).Conventional TENS is associated with a faster onset and shorter duration of analgesia compared to acupuncture-like TENS 19). The patients have radiculopathy respond best to higher intensities. (20)
Hypothesis:
Null Hypothesis: After treatment, there may be no significant difference between Group A patients who have been treated with Mckenzie method & Transcutaneous Electrical Nerve Stimulation (TENS); and Group B patients who have been treated with General Exercise & Transcutaneous Electrical Nerve Stimulation (TENS).
Alternate Hypothesis: After treatment, there may be significant difference between Group A patients who have been treated with Mckenzie method & Transcutaneous Electrical Nerve Stimulation (TENS) and Group B patients who have been treated with General Exercises & Transcutaneous Electrical Nerve Stimulation (TENS).
6.2 Review of Literature:
Joel A. Delisa (2005) stated that Lumbar Radiculopathy is a disease of the spinal nerve root generally accompanied by radicular pain in a dermatomal distribution and/or neurologic symptoms (eg. paresthesias) or signs (eg. Weakness in the myotomal distribution). (1)
Brian M. Busanich et .al (2006) stated that Mckenzie therapy results in a decrease in short-term (<3 months) pain and disability for low back pain patients compared with other standard treatments. (21)
S. Brent Brotzman, MD (2009) stated that cyclic ROM (usually in passive extension) is the cornerstone of the Mckenzie program. These repetitive exercises “centralize” pain, and certain postures prevent end-range stress. (12)
S. Brent Brotzman, MD (2009) stated that Mckenzie reported that 98% of symptoms for less than 4 weeks who experienced centralization during their initial assessment had excellent or good results; 77% of patients with subacute symptoms (4 to 12 weeks) had excellent or good results if their pain centralized initially. (12)
Donelson et al. (1990) investigated the centralization phenomenon and concluded that centralization of asymmetric or radiating pain in 87% of patient during the first 48 hours of care. (22)
Machado, Luciana Andrade Carneiro et .al (2006) in their study on the Mckenzie method for low back pain: a systemic review of the literature with a Meta-Analysis Approach stated that Mckenzie method is more effective than passive therapy for acute LBP. (23)
Robin Mckenzie, (1981) straight leg raise will be limited in patients who are in the acute stage of a severe derangement condition. (16)
Ronald Melzack et .al (1983) in their comparative study on TENS & Massage for pain & Range of motion stated that TENS is an effective modality for the treatment of low back pain. (24)
Sottkinkade (2007) stated that the Mckenzie method is superior to other treatments with regard to short-term pain relief and disability. (25)
Julie M. Fritz et .al (2001) stated that Modified Oswestry Low Back Disability Questionnaire consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. (15)
Mc Cormack HM, Horne DJ, Sheather S.; (1988): In their study “clinical application of Visual Analog Scale (VAS) provide a simple technique for measuring subjective experience and it has been established as valid and reliable in a range of clinic and research applications and Visual Analog Scale (VAS) are one of the most frequently used measurement scale of pain in healthcare research and practice. (26)
Fritz JM, Irrgang JJ.(2001) stated in their study on a comparison of a modified Oswestry low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale that the modified OSE was more responsive than the QUE as assessed by GRI and in correlation between scores and the global rating of change.(15)
6.3 Objective of the Study:
§ To evaluate effectiveness of Mckenzie method on reducing symptom of lumbar radiculopathy.
§ To evaluate the effectiveness of Mckenzie method on disability.
§ To evaluate the effect of McKenzie method on lumbar spine ROM.
§ To evaluate the effectiveness of TENS on reducing pain in lumbar radiculopathy.
7. / Materials and Methods:
7.1 Source of Data:
1. Out Patient Department of Orthopaedics in Kempegowda Institute Of Medical Science Hospital and Research Center, Bangalore.
2. Out Patient Department of Physiotherapy in Kempegowda Institute Of Medical Science Hospital and Research Center, Bangalore.
7.2 Methods of Collection of Data:
(a)Study Design: An RANDOMIZED CONTROLLED TRIAL
Sample size: 40
Sample method: Random Sampling method.
Materials Used:
§ A full circle transparent goniometer with long-arm.
§ Inch tape, Pencil or pen.
§ Cotton and Towel.
§ Modified Oswestry Low Back Pain Disability Index questionnaire
§ Exercise mat
§ Treatment couch, Pillows
§ Arm- chair with back support.
§ TENS apparatus
§ Electrodes, Cables , Gel
b) Inclusion Criteria:
§ Age 20-55 years.
§ Both Sexes; males & females
§ Radicular pain in L4, L5 & S1 dermatomes.
§ Disabling leg pain for 6-12 weeks duration.
§ Evidence of disc herniation confirmed on MR imaging.
§ Informed Consent.
c) Exclusion Criteria:
§ Cauda equina syndrome or severe paresis.
§ A history of unilateral disc surgery on the same level
§ Spinal canal stenosis.
§ Degenerative or lytic spondylolisthesis.
§ Pregnancy.
§ Piriformis syndrome.
7.3) Does the study require any investigation or interventions to be conducted on Patients or other humans or animals? If so, please describe briefly:
Yes, an intervention on patients is required.
Methodology:
§ Patient informed consent form will be taken and assessed.
§ Explain the patient about the treatment.
§ Check for the inclusion and exclusion criteria
§ Subjects’ referred will be divided into 2 groups by asking them to pick up chits from a box which is written as Group A or Group B. Each group will consist of 20 patients.
§ Prepare the apparatus and prepare the subject.
§ Group A: will be treated with Mckenzie Method & Transcutaneous Electrical Nerve Stimulation (TENS).
§ Group B: will be treated with General Exercises & Transcutaneous Electrical Nerve Stimulation (TENS).
§ VAS, SLRT, LUMBAR ROM using MMST, MODI will be assessed on the day before the treatment.
§ Subjects in the Group A will receive Mckenzie Exercises & then 30 minutes of TENS for 5 days per week for 6 weeks.
§ Subjects in the Group B will receive General Exercises & then 30 minutes of TENS for 5 days per week for 6 weeks.
§ VAS, SLR, LUMBAR ROM, MODI will be assessed post treatment on the 2nd, 4th, 6th week respectively.
§ The values will be compared and studied to see the effectiveness of treatments statistically.
Method:
Assessment of pain: The Visual Analog or Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.
Measurement of SLR: The patient lies supine on the couch. Then the patients affected limb is carried in passive flexion with the knee in extension upto 60 degrees.
Measurement of lumbar range of motion (MMST): The lumbar spine ROM can be measured using Modified-Modified Schober Method. (14)
Measurement for the disability: Assessment to know the disability by using Modified Oswestry low back pain disability index (MODI)
Intervention:
Mckenzie exercise:
§ Reduction of derangement.
§ Maintenance of reduction.
§ Recovery of function.
§ Prevention of recurrence.
Transcutaneous electrical nerve stimulation:
Transcutaneous electrical nerve stimulation (TENS) a dual channel unit will be used. One channel is placed paraspinally at the level of origin of the sciatic nerve (L4, L5, S1, S2 and S3) and a second channel at the site of referred pain (eg. Posterior thigh). The machine is on with High TENS (frequency of 100Hz & pulse duration of 150µs) for a duration of 30 minutes.
General Exercises:
§ Back extensors (supine): Patient will stay supine lying with knee flexed. Then the trunk is lifted to neutral position.
§ Back extensors (prone): Patient will be lying in prone position with pillow under the stomach. The patient is then instructed to lift the trunk to neutral position.
§ Back Extensors (kneeling): Patient will do 4 point kneeling and then attempt to lift alternate leg and arm in extension
§ Back extensors (standing): patient will do active extension of the back in standing
Frequency: 5 days a week for 6 weeks
Duration of the study: 1 Year.
Statistical analysis:
§ Unpaired t-test
§ Mann-Whitney test
§ Chi-square test.
7.4) Has Ethical clearance been obtained from your institution in case of 7.3?
Yes
8. / List of references:
1) Joel A. Delisa, Bruce M. Gans. Nicolas E. Walsh, William L. Bockenek, Walter R. Fontera, Steve R. Geiringer, Lynn H. Gerber, William S. Pease, Lawrance R. Robinson, Jay Smith, Todd P. Stitik, Ross O. Zafonte. Physical Medicine & Rehabilitation. Principles and Practice. Low Back Pain, 4th edition LIPPINCOTT WILLIAMS & WILKINS. 2005.pp. 654-55
2) Spine universe. Sciatica – causes [online]. Available from URL:http://www.spineuniverse.com/displayarticle.php/sciatica-causes-3101html
3) Jayant Joshi, Prakash Kotwal. Essentials of Orthopaedics and applied physical therapy, Spine, ELSEVIER-2006
4) Prof. M. Natrajan and Prof. Mayilvahanan Natrajan. Natrajan’s Text book of orthopedics and traumatology. Regional conditions of the spine and lower limb. 6th edition. All India Publishers and Distributors. 2005
5) Edward L. Eyerman, MD. MRI evidence of non-surgical, mechanical reduction, rehydration and repair of the herniated lumbar disc. Official journal of the American society of neuroimaging. Volume 8/number 2 April 1998
6) Spinal disorders. Lumbar radiculopathy. [Online]. Available from- URL:http://spinaldisorders.com/lumbar radiculopathy.htm
7) David J. Magee: Orthopedic Physical Assessment; 4th edition; Saunders, An imprint of Elsevier;2006