TO STUDY THE EFFICACY OF TRANS-DERMAL PHONOPHORESIS IN REDUCING PAIN AND DISABILITY IN PATIENT WITHLOW BACK PAIN

By

Z.D LALRUATSANGI

Dissertation research proposal submitted to the

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

In partial fulfilment of the requirements for the Degree of

MASTER OF PHYSIOTHERAPY (M.P.T)

IN

MUSCULOSKELETAL &SPORTS

Under the guidance of

Dr. Swati Gupta

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCESBANGALORE

PERFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / Z.D LALRUATSANGI
#2, 3rd CROSS, LINDEN STREET, AUSTIN TOWN, Y.G PALLYA, BANGALORE 47
2. / NAME OF THE INSTITUTION / HOSMATCOLLEGE OF PHYSIOTHERAPY
3. / COURSE OF STUDY AND SUBJECT / MASTERS OF PHYSIOTHERAPY
(MUSCULOSKELETAL DISORDER AND SPORTS)
4. / DATE OF ADMISSION TO COURSE / 01-06-2013
5. / TITLE OF THE TOPIC / TO STUDY THE EFFICACY OF TRANS-DERMAL PHONOPHORESIS IN REDUCING PAIN AND DISABILITY IN PATIENT WITHLOW BACK PAIN

6. INTODUCTION

6.1 Need of study------04

6.2 Objectives------06

6.3 Hypothesis------06

6.4 Review of Literature------07

7. MATERIALS AND METHODS------10

7.1 Source of data------10

7.2 Method of collecting data------10

7.2.1STUDY DESIGN------10

7.2.2 STUDY SAMPLE DESIGN------10

7.2.3 SAMPLE SIZE------10

7.2.4 SELECTION CRITERIA------10

7.2.5 Material used------11

7.2.6 Sample Duration------11

7.3 Intervention to be conducted------11

7.3.1 Methodology------11

7.3.2 Statistical analysis------12

7.3.3 Questionnaire------12

7.3.4 Questionnaire------12

7.4 Ethical clearance------12

8 LIST OF REFERENCE------13

6. BRIEF RESUME OF THE INTENDED WORKS:

6.1 NEED OF THE STUDY

Lowback disordersare extremely prevalent in all societies, and probably have not increased substantially over the past two decades. What has increased is the rate of disability, the reasons for which are uncertain. Not only has this phenomenon heightened the awareness of low back pain, but it has led to an explosion in costs. Although a precise estimate is impossible, it is plausible that the direct medical and indirect costs of these conditions are in the range of more than $50 billion per annum, and could be as high as $100 billion at the extreme. Of these costs, 75% or more can be attributed to the 5% of people who become disabled temporarily or permanently from back pain-a phenomenon that seems more rooted in psychosocial rather than disease determinants. Within this overall equation, spinal surgery plays a relatively small role, although the contribution to disability probably has more than passing significance. The future challenge, if costs are to be controlled, appears to lie squarely with prevention and optimum management of disability, rather than perpetrating a myth that low back pain is a serious health disorder.26

Back pain is one of humanity's most frequent complaints. In theU.S., acutelow back painis the fifth mostcommon reason for physician visits. About nine out of ten adults experience back pain at some point in their life, and five out of ten working adults have back pain every year.3Back pain is second only to upper respiratory conditions as the stated cause of work loss.4Also, it's the single leading cause of disability worldwide as Americans spend at least $50 billion each year treating it5 Back pain is regularly cited by national governments as having a major impact onproductivity, through loss of workers onsick leave.

Abnormal movement patterns can have important influences on the connective tissues that surround and infiltrate muscles. A hallmark of connective tissue is its plasticity or “remodelling” in response to varying levels of mechanical stress.27 Both increased stress due to overuse, repetitive movement or hyper mobility, and decreased stress due to immobilization or hypo mobility can cause changes in connective tissue. 28 A chronic, local increase in stress can lead to micro injury and inflammation (overuse, cumulative trauma disorder) 29

Phonophoresis is the use ofultrasoundto enhance the delivery oftopicallyapplied drugs. It has been used in an effort to enhance theabsorptionof topically appliedanalgesicsand anti-inflammatory agents through thetherapeuticapplication of ultrasound. Phonophoresis is effective for treating pain symptomatically as well as reducing inflammation2. It has been a common and an effective treatment for back pain.

There have been many studies regarding treatment for back pain and the effect of Ultrasound therapy and Phonophoresis for different conditions. But there is very little study and evidence regarding the effectiveness of trans-dermal phonophoresis for the treatment of back pain. Therefore, the study might be helpful in giving a better insight into the effects of phonophoresis in treating back pain and further help physiotherapists in providing information and better care to the patients.

6.2 OBJECTIVES OF THE STUDY

To study the efficacy of transdermal phonophoresis in reducing pain and disability in patients with low back pain.

6.3 HYPOTHESIS

NULL HYPOTHESIS

There will be no significant effect of transdermal phonophoresis in reducing pain and disability in patients with low back pain.

ALTERNATE HYPOTHESIS

There will be a significant effect of transdermalphonophoresis in reducing pain and disability in patients with low back pain.

6.4 REVIEW OF LITERATURE

Review based on Definition & Pathomechanics

1. Ehrlich Ge, Khaltaev NGet.al, (1999) conducteda test on low back pain initiative: world health organization.According to this article, Low back pain is neither a disease nor a diagnostic entity of any sort. The term refers to pain of variable duration in an area of the anatomy afflicted so often that it is has become paradigm of responses to external and internal stimuli.The study concluded that back pain is not a disease but a constellation of symptoms that is usually acute and self-limited. Coping with back pain is the biggest obstacle to improvement, and heroic treatments that ultimately fail to help and mayeven be harmful should be avoided.30

2.Jitendra Kumar Arya, Pramod Kumar Sharma et al (2012) conducted a study on role of centrally acting muscle relaxant in low back pain. According to the study, the most common pain complaints are musculoskeletal, and back painis the most common of these. In the lumbar region (or low back region)which consists of five vertebrae (L1 to L5), the fibro cartilage discs (or intervertebral discs) are present in between these vertebrae, which work as cushions. Its presence is to support the spinal cord as well as prevents the vertebrae from rubbing together at the time of injury. LBP is caused by disorders of the intervertebral discs. Cytokines like matrix metalloproteinase, nitric oxide, phospholipase A2, and also tumour necrosis factor (α) are assumed to contribute to the production of low back pain. Most lumbar disc herniations or diseases are produced by the bouts of various degrees and time duration of back pain.31

3. Benedict Martin WandandNeil Edward O'Connell (2008) conducted a study on chronic non-specific low back pain– sub-groups or single mechanism?In the study, the biomechanical aspects of LBP have been widely investigated, and the range of mechanical manifestations seen in CNSLBP patients is vast. The back is moved less during functional tasks and there is greater asymmetry and variability in performance. There is a consistent decrease in the velocity of movement. Muscles are activated in a dys-coordinated manner in static and dynamic situations. When lifting, the back muscles are recruited earlier and stay on for longer and there is a greater amount of co-contraction. There are altered patterns of muscle recruitment with limb movements, with sudden loading and unloading, and balance is impaired. There is some suggestion of poorer proprioception and there are delays in reaction times to a variety of tasks.32

Review based on Incidence & Prevalence

4. M Hillman, A Wright, G Rajaratnam et al (1996) conducted a study on theprevalence of low back pain in the community: implications for service provision in Bradford, UK.The annual incidence rate for the onset of back problems was found to be 47 per 1000 (CI: 29, 55/1000) for men and 54 per 1000 (CI: 40, 71/1000) for women. Chronic back pain did appear to be significantly more prevalent amongst the 45-54 year old age group (14% CI: 10-7, 18-1) than. Amongst the younger (25-44) age range. For 62-2% of those with chronic LBP and 51-8% of all phase 2 responders, LBP was a long standing problem with a history of five or more years.33

5. Damian Hoy, Christopher Bain et al(2012)conducted a study on a systematic review of the global prevalence of low back pain. The objective of the article was to perform a systematic review of the global prevalence of low back pain, and to examine the influence that case definition, prevalence period, and other variables have on prevalence.The mean overall prevalence of low back pain, which was defined as all prevalence regardlessof prevalence period, was 31.0%.The mean point prevalence was 18.3%, and 1-year prevalence was 38.0%. 34

Review of literature related to Phonophoresis

6.Dilek Durmus, Gamze Alayli (2012)conducted a study onthe effectiveness of phonophoresis in the treatment of chronic low back pain. A single-blind randomized controlledtrial.The aim of the trial is to investigate and compare the effects of phonophoresis and ultrasound therapy on pain, disability, trunk muscle strength, walking performance, spinal mobility, quality of life, and depression in the patients with chronic low back pain.It was observed that Ultra Sound and Phonophoresis treatments were effective in the treatment of patients with Chronic Low Back Pain but Phonophoresis was not found to be superior over ultrasound therapy.35

7. Yueh-Ling Hsieh (2006)conducted a study on effects of ultrasound and Diclofenacphonophoresis on inflammatorypain relief: suppression of inducible nitric oxide synthase in arthritic rats. The study investigates the evidence concerning the effects of central spinal nociceptive modulation through the use of ultrasound and phonophoresis with the use of NSAIDS.Peripheral use of Diclofenac phonophoresis offers little advantage over US alone in affecting the central mechanisms of nociception. The peripheral influences of US and phonophoresis on the central modulation of the spinal nociceptive processing system are important and may reflect the work being done through the neuroplasticity of spinal cord in response to peripheral input of US and phonophoresis.36

Review of literature on the validity and reliability of VAS scale

8.Boonstra AM, Schiphorst PreuperHR, Renema MF(2008) conducted a test on reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. To determine the reliability and concurrent validity of a visual analogue scale (VAS) for disability as a single-item instrument measuring disability in chronic pain patients was the objective of the study. In the reliability study rho values varied from 0.60 to 0.77; and in the validity study rho values of VAS disability scores with SF-36 domain scores varied from 0.16 to 0.51, with Roland-Morris Disability Questionnaire scores from 0.38 to 0.43 and with VAS pain scores from 0.76 to 0.84. The conclusion of the study was that the reliability of the VAS for disability is moderate to good. Because of a weak correlation with other disability instruments and a strong correlation with the VAS for pain, however, its validity is questionable.37

Review of literature on the validity and reliability of modifiedoswestry disability index

9. Julie M Fritz and James J Irrgang (2001)conducted a study ona comparison of a modified oswestry low back pain disability questionnaire and the Quebec back pain disability scale.The study concluded that the construct validity of the global rating of change was supported by the stability of the Physical Impairment Index across the study period in patients defined as stable by the global rating and by the decrease in physical impairment across the study period in patients defined as improved by the global rating. The modified OSW demonstrated superior measurement properties compared with the QUEBEC.38

7. MATERIALS AND METHOD:

7.1 SOURCE OF DATA

Hosmat Hospital

7.2. METHOD OF COLLECTING DATA

7.2.1STUDY DESIGN:

Experimental Study design with pre and posttest data taken for both the experimental group and control group.

7.2.2STUDY SAMPLE DESIGN

Simple random sampling

7.2.3SAMPLE SIZE

Sample size is 30(15 samples in each groupi.e. intervention and controlled group).

7.2.4SELECTION CRITERIA

INCLUSION CRITERIA

  1. Individuals with acute back pain
  2. Individuals with pain of mechanical origin
  3. Both sexes
  4. Age: 30 - 45 years

EXCLUSION CRITERIA

  1. Pregnant women
  2. Patient with acute bone or tissue infection
  3. Thrombophlebitis
  4. Care should be taken with patient with cardiac pacemaker

7.2.5MATERIAL USED

  • Ultra sound machine
  • Diclofenac diethylamine
  • Couch
  • Pillows
  • Aquasonic gel
  • Cotton
  • STUDY DURATION

5 sessions per week for 2 weeks. Total study duration 3months

7.3 INTERVENTION TO BE CONDUCTED

7.3.1 METHODOLOGY:

Informed consent will be taken from 30 subjects who satisfy the inclusion and exclusion criteria. Later the subjects will be randomly selected for experimental and control group with 15 in each group.

All participants will undergo two measurements: one on entry to the study (pre-test) and one after the 2 weeks intervention period (post-test). All pre-test measures will be assessed prior to randomisation.

Experimental group:

The experimental group of 15 will be treated with trans-dermal phonophoresis along with Diclofenac diethylamine for 10 sessions. The ultrasound will be given for 5 minutes each for each patient with intensity of 1 MHz in pulse mode (1:1)

Control group:

The control group of 15 will be treated with ultrasound therapy technique for 10 sessions as well. All the patients are requested to apply diclonac diethylamine1 hour prior to the Ultra Sound therapy.The same intensity and mode will be used.

OUTCOME MEASUREMENT:

Using

VAS scale

Modified Oswestry Disability Index

Total duration:

5 sessions per week for 2 weeks

7.3.2STATISTICAL ANALYSIS:
STUDY DESIGN: Experimental study.
TEST:Paired and unpaired T test, Mann Whitney U test.

7.3.3 Does the study require any investigations to be conducted on patients or other humans or animals? If so please describe briefly.

The study intends to give the treatment to the individuals having low back pain

7.3.4 Has ethical clearance been obtained from your institution in case of 7.3.3?

Yes. Consent has been taken from the Institute ethical committee.

7.4 ETHICAL CLEARANCE

Ethical clearance has been obtained from the institution.

8. LIST OF REFERENCE

  1. Steven C. Ludwig M.D., Chief Spine Surgery, University of Maryland Medical centre. What causes muscle spasms and what is the best way to treat muscle spasms?November 10, 2008.
  2. Yueh- Ling Hsieh. Effects of ultrasound and diclofenac phonophoresis on inflammatory pain relief: suppression of inducible nitric oxide synthase in arthritic rats. vol. 86no. 139-49
  3. A.T. Patel, A.A. Ogle."Diagnosis and Management of Acute Low Back Pain".American Academy of Family Physicians. Retrieved March200015; 61(6):1779-1786.
  4. Institute for Health Metrics and Evaluation."2010 Global Burden of Disease Study"
  5. Burke, G.L., Backache from Occiput to Coccyx. Chapter 1.
  6. T.J. Antich, Ms, PtPhonophoresis: The Principles Of The Ultrasonic Driving Force And Efficacy In Treatment Of Common Orthopaedic Diagnosis . 1982;4:99-102.
  7. Michelle H Cameron and Linda. Relative Transmission of Ultrasound by Media Customarily Used for Phonophoresis.Monroe 1992; 72: 142 – 148
  8. Yuri Dancik, Yuri G Anissimov and Michael S RobertsConvective transport of highly plasma protein bound drugs facilitates direct penetration into deep tissues after topical application. 2012 may 05; 73 (5): 841
  9. Robertson VJ, Baker KG (July 2001)."A review of therapeutic ultrasound: effectiveness studies".Phys Ther81(7): 1339–50.PMID
  10. Zhang L, Shung KK, Edwards DA. Hydrogels with enhanced mass transfer for transdermal drug delivery.1996 Dec; 85(12):1312-6.

11.Nancy N. Byl, PhD, PT Alison McKenzie, PhD, PTZ Betty Halliday, BA, Teressa Wong. The effects of Phonophoresis with Corticosteroids: A Contolled pilot study . November 1993; 590-598

  1. Robertson VJ, Baker KG."A review of therapeutic ultrasound: effectiveness studies".July 2001Phys Ther(7): 1339–50.PMID
  2. Clinicalevidence.bmj.com.Interventions— Low back pain (chronic) - Musculoskeletal disorders— Clinical Evidence". Retrieved 2010-06-02. 2005 May 3;142(9):776-85
  3. Hayden J, Van Tulder M, Malmivaara a, Koes B. "Exercise therapy for treatment of non-specific low back pain.".Cochrane Database Syst Rev(3): CD000335
  4. Amit Joshi, Jaideep RajeSonicated transdermal drug transport. Volume 83, Issue 1, 18 September 2002, pages 13-22.
  5. Ciccone Cd, LegginBg, CallamaroJj. Effects of Ultrasound and trolamine salicylate phonophoresis on delayed onset of muscle soreness.1991 Sep; 71(9):666-75; discussion 675-8.
  6. Nancy N. The use of ultrasound as an enhancer for transcutaneous drug delivery: phonophoresis.Byl Phys Ther 1995: 75: 539-553
  7. Keefe FJ, Hill RW:An objective approach to quantifying pain behavior and gait patterns in low back pain patients.Pain1985,21:153-161.
  8. Lamoth CJ, Meijer OG, Wuisman PI, van Dieën JH, Levin MF, Beek PJ:Pelvis-thorax coordination in the transverse plane during walking in persons with nonspecific low back pain.Spine2006 Jan;15(1):23-40.
  9. Selles RW, Wagenaar RC, Smit TH, Wuisman PIJM:Disorders in trunk rotation during walking in patients with low back pain: A dynamical systems approach.Clin Biomech2001Mar;16(3):175-81
  10. Vogt L, Pfeifer K, Portscher M, Banzer W:Influences of nonspecific low back pain on three-dimensional lumbar spine kinematics in locomotion.

Spine2001Sep 1;26(17):1910-9.

  1. Marras WS, Parnianpour M, Ferguson SA, Kim JY, Crowell RR, Simon SR:Quantification and classification of low back disorders based on trunk motion.Eur J Phys Med Rehab1993;3:218–235
  2. Cassisi JE, Robinson ME, O'Conner P, MacMillan M:Trunk strength and lumbar paraspinal muscle activity during isometric exercise in chronic low-back pain patients and controls.Spine1993 ;18:245–251
  3. Grabiner MD, Koh TJ, El Ghazawi A:Decoupling of bilateral paraspinal excitation in subjects with low back pain.Spine1992 ; 17:1219-1223
  4. Marras WS, Davis KG, Ferguson SA, Lucas BR, Gupta P:Spine loading characteristics of patients with low back pain compared with asymptomatic individuals.Spine2001Dec 1;26(23):2566-74..
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  2. Tillman LJ, Cummings GS,mechanism sof connective tissue mutability vol.8. Philidelphia: FA 1992 p. 1-44
  3. Carpenter JE, Flanagan CL, Thomopoulos S. The effects of overuse combined with intrinsic or extrinsic alterations in an animal model of rotator cuff tendinosis. Am J sports med 1998:26(6): 801-7
  4. Etterma AM, Amadio PC, Zhao C, Wold LE. A histological and immunohistochemical study of the subsynovial connective tissue in idiopathic carpel tunnel syndrome. 2004:86(7): 801-7
  5. George E. Ehrlich. Low back pain. 1999 671-672
  6. Jitendra Kumar Arya*, Pramod Kumar Sharma. ROLE OF CENTRALLY ACTING MUSCLE RELAXANT IN LOW BACK PAIN.2012 93-98
  7. Benedict martin wandandneil edward o'connell. Astudy on chronic non-specific low back pain (cnslbp) – sub-groups or single mechanism
  8. M hillman, a wright, g rajaratnam et al. The prevalence of low back pain in the community: implications for service provision in bradford, uk. 1996;50:347-352
  9. Damian hoy, christopher bain et al. A study on a systematic review of the global prevalence of low back pain 2012 Vol. 64, No. 6, June 2012, pp 2028–2037
  10. Dilek durmus, gamze alayli (2012)A study on the effectiveness of phonophoresis in the treatment of chronic low back pain. July 2013 , Vol. 33 Issue 7, p1737
  11. Yueh-ling hsie. A study on effects of ultrasound and diclofenac phonophoresis on inflammatorypain relief: suppression of inducible nitric oxide synthase in arthritic rats.January 2006vol. 86no. 139-49
  12. Test on reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. 2008
  13. Juliem fritz and james j irrgang.A study on a comparison of a modified oswestry low back pain disability questionnaire and the quebec back pain disability scale. 2001. pp 901-910 and pp 911-919

9. / SIGNATURE OF THE CANDIDATE :
10. / REMARKS OF GUIDE
11. / 11.1 GUIDE
11.2 SIGNATURE
11.3 CO-GUIDE
11.4 SIGNATURE
11.5 HEAD OF THE
DEPARTMENT.
11.6 SIGNATURE / Dr. Swati Gupta
Dr. Dipika Verma
Dr. Vikranth. G.R
12. / 12.1 REMARKS OF THE
CHAIRMAN AND
PRINCIPAL.
12.2 SIGNATURE.

APPENDIX- I