RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1 / Name of the Candidate
and Address / PADMINI AMEY GURSALE
SRINIVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTER,
PANDESHWARA,
MANGALORE-575001
2 /

Name of the Institute

/ SRINIVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTER, MANGALORE.
3 /

Course of Study and

Subject / Master of Physiotherapy (MPT)
1 year Degree Course.
“ Musculoskeletal and Sports”
4 /

Date of Admission

To Course / 10/06/2011
5 /

Title of the Topic

/ “EFFECT OF TENS ON
POSTURAL SWAY IN PATIENTS WITH CHRONIC LOW
BACK PAIN.”
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7
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Brief resume of the intended work:
6.1 Need for the study:
Low back pain (LBP) is posterior trunk pain between the ribcage and the gluteal folds. Chronic LBP is defined as when a pain, and disability results restriction of the patients life activity more than 3 months. Recurrent LBP presented with an previous episodes of LBP from a similar location, with asymptomatic intervening intervals.¹
A plausible contributing factor to CLBP is poor control of
trunk muscles to the exigencies of day-to-day activities.2
The increased body sway in patients with LBP was hypothesized to stem from, among other things, injury and/or damage to proprioceptive tissues in the lumbar spine. The disparity in postural control was more pronounced in patients with LBP in trials with closed eyes.5
Changes in trunk muscle recruitment have been identified in people with low-back pain (LBP).These differences may be due to changes in the planning of the motor response or due to delayed transmission of the descending motor command in the nervous system.3
The altered postural strategy probably serves to protect the spine in the short term, but it is associated with a cost and is thought to predispose spinal structures to injury in the long term.4
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive therapeutic modality that was added, more than 30 years, ago to existing physical agents used in medicine and physiotherapy for the management of LBP. TENS units
Stimulate peripheral nerves via skin surface electrodes at well tolerated intensities and are capable of being self-administered (APTA 1993; Barr 1999; Deyo 1990a; Sluka 2003). The development and application of TENS was based on the Gate Control Theory conceptualized by Melzack and Wall (Melzack 1982).6
Flower dew and co-workers, found limited evidence for the usefulness of TENS in individuals with chronic LBP, citing the need for more definitive, high quality randomized-controlled studies .6
Study has shown that the application of TENS on the posterior aspect of legs, on postural sway during stance and the result indicated that application of TENS brought about the decrease in postural sway as expressed by average sway velocity, in addition to a decrease in the absolute value of maximal and minimal medio-lateral and anterior-posterior velocity in healthy individuals.7
Force plate is a gold standard tool to measure postural control parameters.
There exists, no study in literature reporting compound and differential effects of TENS on postural sway in patients with CLBP. Hence, this study will focus on the effect of TENS on postural sway in patients with CLBP.
6.2Review of Literature.
1. Alexander Ruhe et al. (2011) examined whether there a relationship between pain intensity and postural sway in patients with non-specific low back pain and concluded that COP mean velocity and sway area are closely related to self-reported pain scores. This relationship may be of clinical use as an objective monitoring tool for patients under treatment or rehabilitation.8
2. Jesse V. Jacobs et al. (2009) investigated about the timing of anticipatory postural adjustments in people with chronic low back pain and concluded that people with chronic low back pain may be less capable of adapting their anticipatory postural adjustment to ensure postural stability during movement.10
3. Danik Lafond et al.(2008) conducted a study with the aim to analyze the control of posture by subjects with CLBP during prolonged unconstrained standing (PS) in comparison to matched healthy adults and result showed that CLBP subjects produced less postural changes in the antero-posterior direction with decreased postural sway during the prolonged standing task in comparison to the healthy group.12
4.Karen L Barker et al.(2008) conducted a study with an aim to compare a novel sensory discriminatory training device (FairMed) with TENS in a Phase I clinical trial in which the theory for the analgesic effect of TENS is suggested to be as a result of counter stimulation of the nervous system modifying the perception of pain and concluded that both FairMed and
TENS were equally effective in CLBP patients.15
5.Lee CE et al.(2007) studied the influence of pain distribution on vertical GRF of patients with low back problems during 2 walking speed conditions: preferred and fastest speeds and reported that pain distribution of people with low back problems differentially influences the vertical GRF they experience during walking.11
6.Ruth Dickstein et al. (2006) examined the effect of TENS applied to posterior aspect of legs, on postural sway during stance and concluded that the application of TENS brought about an decrease in postural sway as expressed by average sway velocity, in addition to decrease in absolute values of maximal and minimal medio-lateral and antero-posterior velocity.7
7.Sharon M. Henry et al. (2005) characterize the differences in automatic postural responses among persons without and with chronic, recurrent mechanical LBP (while the latter had little to no pain) by quantifying center of pressure and center of mass responses following systematic support surface perturbations and concluded that Subjects with LBP demonstrated altered automatic postural coordination, both in terms of magnitude and timing of CM and CP responses, indicating alterations in neuromuscular control.9
8.Khadilkar A et al.(2005) examined the effectiveness of TENS in the management of chronic LBP and concluded that There is limited and inconsistent evidence to support the use of TENS as an isolated intervention in the management of chronic
LBP. Larger, multi-center, randomized controlled trials are needed to better resolve the true effectiveness of TENS.
Increased attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low back pain.6
9. Peter F. Jarzem et al.(2005) conducted a research with an objective to compare conventional transcutaneous electrical nerve stimulation [TENS] with sham therapy using a randomized double blind crossover design and concluded that TENS therapy significantly reduces pain and improves performance on the majority of standardized tests of physical capacity. Transcutaneous electrical nerve stimulation should be considered in the situation where short-term pain relief is desired..14
10.M.I.V Mientjes et al.(1998) examined whether balance responses of chronic low back pain patients differed from healthy controls under various upright standing conditions which challenged the balance system and concluded that The root mean square in the medial-lateral direction was reliable and sensitive enough to measure an increase in postural sway of chronic low back pain patients as a group compared to healthy controls when the task involved increased complexity and removal of visual information.13
11. SergeMarchand et al.(1992) conducted a stydy in which separate visual analog scales (VAS) were used to measure the sensory-discriminative and motivational-affective components of low back pain and the result suggested that TENS reduces both the sensory-discriminative and motivational-affective components of low back pain in the short term but that much of the reduction in the affective component may be a placebo effect. We conclude that TENS should be used as a short-term analgesic procedure in a multidisciplinary program for low back pain rather than as an exclusive or long-term treatment.16
6.2  Objective of the study
To find out the effect of TENS on postural sway in CLBP Patients.
6.3  Hypothesis:
Experimental hypothesis
There will be significant difference on postural sway after application of TENS in subjects with CLBP.
Null hypothesis
There will not be any significant difference in the postural sway after application of TENS in subjects with CLBP.
Material and Methods:
7.1 Source of data: Subjects will be taken from SCPTRC OPD, Srinivas General Hospital Mangalore.
Sampling: Convenience sampling.
7.2 Method of collection of data: Samples will be asked to sign the written consent form stating the voluntary acceptance to participate in this study. Subjects with chronic low back pain will be selected according to the inclusion and exclusion criteria. Then, the Demographic information, [i.e.
Age,
Sex,
Height,
Weight,
BMI,
VAS,
RNDQ,
FDAQ,
DISSTRESS,
GROC,
Education level,
Onset (gradual, sudden),
Site of pain(Body chart),
Duration(weeks, months, years),
Cause(injury, overuse),
Occupation,
Medications(yes/no),
Will be collected from all the selected subjects.
PROCEDURE
1st step: Measurement of postural sway on force plate before the application of TENS will be taken, after that TENS will be applied on posterior aspect of leg for 20min bilaterally with the subjects in supine, following which the postural sway will be measured in stance position.
2ndstep: Measurement of postural sway on force plate before the application of TENS will be taken, after that TENS will be applied on posterior aspect of leg for 20min bilaterally with the subjects in supine, following which the postural sway will be measured in stance position.
3rdstep: Measurement of postural sway on force plate in standing with the application of TENS bilaterally for 20min, following which the postural sway will be measured in stance position.
Functional Reach Test (FRT): will be taken prior and after the application of TENS with the subjects on Force plate.
TASK:
After the explanation of procedure and proper command the subjects stand on faceplate with eyes opened and closed following which the readings will be taken.
Materials to be used:
ü  Force plate.
ü  TENS.
Inclusion Criteria:
ü  CLBP Patients.
ü  Age: 18-50 years.
ü  Pain radiating to hip, knee and ankle.
Exclusion criteria
ü  Subjects with CNS impairment.
ü  Fractures, Spondylolisthesis, PVD.
ü  History of any lumbar, abdominal and limb surgery.
ü  Patients hospitalized for issues related to spine.
Outcome measures:
1.  Postural Balance: The Forceplate will be used to monitor the Postural Sway.
2.  Pain of the patient will be measured by a Numerical Pain Rating Scale (NPRS).
3.  Distress level was measured using Distress Anxiety Stress Scale (DASS).
4.  Success of the outcome was established using Global Rating Of Change(GROC)
5.  Visual analogue scale for pain rating (VAS)
6. The Fear of Daily Activities Questionnaire
7. Rolando Morris Disability Questionnaire.
Statistical analysis
Study design: Experimental study.
TEST: 1. Independent t test.
2. ANOVA.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
YES.
The study intends to analyze the force plate responses in the subjects with chronic low back pain patients.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES.
Consent has been taken from the Institute ethical committee.
List of references.
1.  George E. Ehrlich. Low back pain. Bulletin of the World Health Organization 2003 ;( 81):671-676.
2.  Ramprasad Muthukrishnan, Shweta D Shenoy, Sandhu S Jaspal, Shankara Nelikunja, and Swetlana Fernandes. The differential effects of core stabilization exercise regime and conventional physiotherapy regime on postural control parameters during perturbations in patients with movement and control impairment chronic low back pain. Journal of sports medicine, arthroscopy, rehabilitation, therapy and technology 2010; 2: 13
3.  Paul W. Hodges. Changes in motor planning of feed forward postural responses of the trunk muscles in low back pain. Experimental Brain Research 2001; 41:261–266.
4.  G. Lorimer Moseley, Michael K. Nicholas and Paul W.Hodges. Does anticipation of back pain predispose to back trouble? Brain 2004; 127:2339-2347.
5.  Andrea Radebold, Jacek Cholewicki, Gert K. Polzhofer, and Hunter S. Greene. Impaired postural control of the lumbar spine is associated with delayed muscle response times in patients with chronic idiopathic low back pain. Spine 2001; 26(7):724-730.
6.  Khadilkar A.et al. Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review).The Cochrane library 2008 ;( 3):1-26.
7.  Ruth Dickstein, Yocheved Laufer, Miri Katz. TENS to the posterior aspect of the legs decreases postural sway during stance. Neuroscience Letters 2006;51-55.
8.  Alexander Ruhe, René Fejer and Bruce Walker. Is there a relationship between pain intensity and postural sway in patients with non-specific low back pain? BMC Musculoskeletal Disorders 2011;12:126.
9.Sharon M. Henry , Juvena R. Hitt , Stephanie L. Jones,
janice Y.Bunn. Decreased limits of stability in response to
Postural perturbations in subjects with low back pain.
clinical Biomechanics 2006;21:881-892.
10.Jesse V. Jacobs, Sharon M. Henry and Keith J. Nagle. People With Chronic Low Back Pain Exhibit Decreased Variability in the Timing of Their Anticipatory Postural Adjustments. Journal of behavior neuroscience 2009;123(2):455-458.
11.Lee CE, Simmonds MJ, Etnyre BR, Morris GS. Influence of pain distribution on gait characteristics in patients with low back pain: part 1: vertical ground reaction force. Spine 2007;32:1329-1336.
12.Danik Lafond , Annick Champagne , Martin Descarreaux , Jean-Daniel Dubois, Janina M. Prado , Marcos Duarte.
Postural control during prolonged standing in persons with
chronic low back pain. Gait & Posture 2009;29:421-427.
13. M.I.V. Mientjes, J.S. Frank. Balance in chronic low back
Pain patients compared to healthy people under various
Conditions in upright standing. Clinical Biomechanics
1999;14:710-716.
14.Peter,F.Jarzem,Edward J. Harvey2,Nicholas arcaro and Janusz Kaczorowski4. Transcutaneous Electrical Nerve of
Stimulation [TENS] for Short-Term Treatment of Low Back
Pain-Rrandomized Double Blind Crossover Study of Sham
Versus Conventional TENS.2005; 13:11-17.
15.Karen L Barker, Christopher J Elliott, Catherine M Sackley
And Jeremy CT Fairbank.Treatment of chronic back pain
By Sensory discrimination training. A Phase l RTC of
a novel Device (FairMed) vs. TENS;2008:
16. SergeMarchand, JacquesCharest, JinxueLi, Jean- Rene
Chenard,Benoit Lavignolle, Louis Laurencelle.TENS purely
A placebo effect? A controlled study on chronic low back
Pain;1993:
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Signature of the Candidate
/
PADMINI AMEY GURSALE.
10 /
Remarks of the Guide
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Study is feasible to conduct and highly valid.
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Name & Designation of:

11.1 Guide
11.2 Signature / DR. RAMPRASAD M.
Professor in Physiotherapy and Principal.
11.3 Co-Guide (If Any)
11.4 Signature /
DR. SELVAMANI K.
Assistant Professor in Physiotherapy.
11.5 Head of the Department

11.6 Signature

/
DR. T.JOSELEY SUNDERRAJ PANDIAN
Associate Professor in Physiotherapy and P.G Coordinator.
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12.1 Remarks of Chairman and Principal
12.2 Signature /
DR. RAMPRASAD M.
Professor in Physiotherapy and Principal.
Accepted by scientific and ethical committee reviewers

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