RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.

NAME OF THE CANDIDATE AND ADDRESS

RASHIM JOSHI C 502, Somerset Apts, Behind Big Kids Kemp, M.G. Road, Bangalore- 560001 THE OXFORD COLLEGE OF PHYSIOTHERAPY J.P Nagar I phase, Bangalore-78 MASTER OF PHYSIOTHERAPY (Physiotherapy in Musculoskeletal Disorders and Sports Physiotherapy) 4TH MAY, 2007

2.

NAME OF THE INSTITUTION

3.

COURSE OF THE STUDY AND SUBJECT

4.

DATE OF ADMISSION TO THE COURSE TITLE OF THE STUDY:

5.

THE EFFECT OF MULLIGAN BENT LEG RAISE TECHNIQUE ON SLR, PAIN AND OSWESTRY DISABILITY QUESTIONNAIRE IN SUBJECTS WITH LOW BACK PAIN A PLACEBOCONTROL EXPERIMENTAL STUDY

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BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY: Low back pain is among the most common ailments in industrialized societies. It affects almost all of us at in our lives and frequently leads to pain, distress and times away from work. Mooney other medical disability. In the United States the number of individuals disabled because of LBA grew at a rate 14 times that of population growth during the decade from 1971 to 1981 (2) . Recent estimates state that up to 6 million people in the USA will be experiencing lower back symptoms in any given time. It is generally accepted that nearly 80% of general population experience LBA at sometime in their life and, that 20-30% are experiencing at any given time (16,17) It has been noted that the costs of treatment and compensation for LBA in industry are greater than the total amount spent on all other industrial injuries combined
(3,4). (1)

in his research notes

that there has been greater growth of low backache (LBA) disability than any

Among many treatment modalities available for LBA, Mulligan (1999) (5) manual therapy techniques are frequently used in clinical practice. Konstantinou et al (2002) (6) , reported that in Britain, according to a postal survey, 41% of physiotherapists treated LBA using Mulligan techniques. In spite of its popularity, the efficacy of Mulligan concept has not been adequately established by clinical trials.

The Mulligan bent leg raise (BLR) technique has been described as a means of improving the range of straight leg raise (SLR) in subjects with LBA or referred thigh pain (Mulligan, 1999) (5) The intention of this technique is to restore normal mobility and reduce LBA and physical impairment. Hence this study is intended to investigate the immediate effect of a single intervention of Mulligan BLR technique on pain, SLR and the disability percentage in the Oswestry disability questionnaire in subjects with LBA.

6.2 REVIEW OF LITERATURE: Mulligan BR 1999(5) In his book mentions the effectiveness of the bent leg raise technique in improving the range of motion of SLR in patients with LBA or referred thigh pain. Tobby Hall, Sonja Hardt, Axel Schafer and Lena Wallin (2005)(7) They investigate the effect of mulligan bent leg raise technique in subjects with limited straight leg raise and low back pain. They found significant increase in the range of motion after intervention that was maintained over 24h. Breig and Troup (1979)(8) ; Butler (1991)(9) They found that the SLR test has biomechanical effects on pelvis movement, on lumbo sacral neural tissues. Beyerlin C, Hall TM, Hansson U, Odemark M, Sainsbury D, Lim HT(2002)(11) In their study noted the significant increase in SLR range in subjects with LBP as an effect of treatment intervention. Goeken and Hof (1994)(13) In their study demonstrated that the increase in range of SLR, following stretching is mediated via an increase in hip flexion and hamstring length, and not related to increased hamstring visco elastic properties. Blunt et al (1997)(10) ; Hall et al (2001) (11) ; Hanten and Chanler (1994) (12) By their studies suggested that improving SLR mobility reduces the degree of impairment in LBP.

Holm I, Bolstad B, Lutken T, Ervik A, Rokkum M, Steen H (2000)(14) as per their study the measures of hip range of motion by goniometer has high degree of reliability (0.83) Polly E. Bijur, Wendy Silver & E. John Gallagher (2001)(15) In their study concluded high reliability of VAS for pain measurement with the Intra Class Coefficient of 0.97

6.3 OBJECTIVES OF THE STUDY:

To investigate the immediate effect of a single intervention of the Mulligan BLR technique on pain, SLR and Oswestry disability questionnaire in subjects with LBP. To check whether the effect of the technique is maintained till 24 hr

6.4 HYPOTHESIS: a) Null hypothesis: BLR technique would not improve range of SLR and reduce pain as compared to a placebo, and that any change would not be maintained 24h later. There is no improvement in the functional outcome after the treatment.

b) Research hypothesis: BLR technique would improve range of SLR and reduce pain greater than a placebo and that any change would be maintained 24h later. There is significant improvement in the functional outcome after the treatment.

MATERIALS AND METHODS:

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7.1 STUDY SETTING AND DESIGN: 7.1.1 7.1.2 Study design: A placebo- control experimental study Source of data: Physiotherapy OPD, The Oxford College of Physiotherapy, Bangalore HOSMAT Hospital, Bangalore

7.2 METHODOLOGY: 7.2.1 7.2.2 POPULATION: Patients with mechanical low back ache of age 25-40 years SELECTION CRITERIA: a) INCLUSION CRITERIA: Subjects with age between 25-40 years Both genders Patients with LBA with limited SLR SLR limitation > 15o Subjects who are willing to participate

b) EXCLUSION CRITERIA: Subjects with lumbar canal stenosis, prolapsed intervertebral disc, piriformis syndrome. Subjects with any lower quarter neurological compromise

7.2.3

SAMPLING: a) SAMPLING METHOD: Simple random sampling

b) SAMPLE SIZE: N= 30 subjects

7.2.4

PROCEDURE:

A total of 30 subjects, fulfilling the inclusion and exclusion criteria, will participate in this study. They will be distributed into 2 groups each containing 15 subjects. 2 examiners blinded to the group allocation, will perform the measurement of range of SLR before, immediately after and 24hr following the treatment. The subjects will be asked to indicate their average level of pain 24hr prior to and 24hr following the intervention and fill up the questionnaire mentioning their functional status. After the measurements, a third investigator will carry out the randomization process and then carries out the assigned intervention. The BLR technique (Mulligan, 1999) consists of 3 repetitions of pain free, 5 seconds, isometric contractions of gluteus maximus muscle, performed in five progressively greater positions of hip flexion along with the added component of hip abduction from the beginning of the technique. The placebo consists of kneading at calf on the ipsilateral side with the patient positioned in crook lying and knee flexed to 20o .

a) Duration and follow up: 3 months (including data collection and evaluation) b) Materials used: 7.3 7.3.1 Goniometer No follow up

OUTCOME MEASURES AND STATISTICAL ANALYSIS: OUTCOME MEASURES: SLR range of motion VAS scale Oswestry Disability Questionnaire

7.3.2

STATISTICAL ANALYSIS: Chi- Square test Fisher Exact test Mann Whitney U test Wilcoxon Signed Rank test Student t test (two tailed, independent) Student t test (two tailed, dependent) Effect size due to Hedge

7.4 a) Does the study require any invtervention to be conducted on patients or other humans or animals? Yes, it requires intervention of Mulligan BLR technique on the patients with LBA. b) Has the ethical consent for the study has been obtained from the institution is case? Yes, it has been obtained from my institution. Ethical clearance form is attached as appendix (I). The informed consent will be obtained prior to study from each subject that is attached as appendix (II).

REFERENCES:

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1. Mooney V: Where is the pain coming from? Spine12:754-759, 1987 2. National Center for Health Statistica(series10,no.134): prevalence of selected impairment, United Stated, Hyattsville, MD: Department of health and human services 1981. 3. Spengler DM, Bigos SJ, Martin NA, et al: Back injuries in industry: a retrospective study. 1. Overview and cost analysis. Spine 11: 241, 1986 4. Akeson WH, Murphy RW: Low back pain. Clin orthop 129: 2-17, 1977 5. Mulligan BR. Other spinal therapies. In: manual therapy: nags, snags, mwms etc. 4th Wellington: Plane view services; 1999.p-6886 6. Konstantinou K, Foster N, Rushton A, Baxter D. the use of reported effects of mobilization with movement techniques in low back pain management: a cross sectional descriptive survey of physiotherapists in Britain. Manual therapy 2002;7(4): 20614 7. Toby Hall, Sonja hardt, Axel Schafer, Lena Wallin: Mulligan bent leg raise technique-a preliminary randomized control trial of immediate effects after a single intervention. Manual Therapy. 11 (2006) 130-135.

8. Breig A,Troup JDG. Biomechanical considerations in straight leg

raising test. Cadaveric and clinical studies of the effects of medial hip rotation. Spine 1979,4(3): 242-50. 9. Butler DS. Clinical neurobiomechanics. In: Mobilization of the nervous system. Melbourne: Churchill Livinstone; 1991 p.35-54 10. Blunt KL, Rajwani MH, Gurriero RC. The effectiveness of chiropractic management of fibromyalgia patients: a pilot study. Journal of Manupulative and Physiological Therapeutics 1997; 20(6): 389-98 11. Hall TM, Cacho A, McNee C, Riches J, Walsh J. Effects of Mulligan traction SLR on movement. The Journal of Manual and Manipulative Therapy 2001; 9: 128-33 12. Hanten WP, Chandler S. Effects of myofacial release leg pull and sagittal plane isometriccontract-relax technique on passive straight leg raise angle. Journal of Orthopedic and Sports Physical Therapy 1994;20:138-44 13. Goeken LN, Hof AL. Instrumental straight leg raising: results in patients. Archives of Physical medicine and Rehabilitation 1994; 75(4):406-11 14. Holm I, Bolstad B, , Lutken T, Ervik A, Rokkum M, Steen H Reliability of goniometric measurements and visual estimates of hip ROM. Physiother Res Int.2000; 5(4): 241-8.

15. Ogon M, Krismer M, Sllner W, Kantner-Rumplmair W, Lampe A. Chronic low back pain measurement with visual analogue scales in different settings. Pain 1996 Mar; 64(3):425-8. 16. Kelsey J, White AA: Epidemiology and impact of low back pain. Spine 6: 133-142, 1980 17. Benn RT, Wood PHN: Pain in back: an attempt to estimate the size of the problem. Rheumatol Rehabil 14: 121-128, 1975

9. 10 . 11 .

Signature of the candidate Remarks of the guide NAME AND DESIGNATION OF 11.1 Guide 11.2 Signature 11.3 Co-Guide 11.4 Signature 11.5 Head of the Department 11.6 Signature
Mr K.G. Kirubakaran M.P.T PRINCIPAL

12.1 Remarks of Chairman and Principal 12 . 12.2 Signature

Mr K.G. Kirubakaran M.P.T

APPENDIX I THE OXFORD COLLEGE OF PHYSIOTHERAPY I PHASE, J.P. NAGAR, BANGALORE-560078 Review Board on Ethics for Research

We hereby declare that the project entitled, THE EFFECT OF MULLIGAN

BENT LEG RAISE TECHNIQUE ON SLR, PAIN AND OSWESTRY DISABILITY QUESTIONNAIRE IN SUBJECTS WITH LOW BACK PAIN A PLACEBO-CONTROL EXPERIMENTAL STUDY
carried out by Mrs. Rashim Joshi of I year M.P.T. has been brought forward for scrutiny to the board members. After analyzing the objectives, subjects involved and the methodology of the project, the following conclusions were drawn. The project does not have any mental or physical harm to the subjects involved. The performance of the study procedure will not cause any injury to the subjects. The board has evaluated and confirmed that the experimenter is trained and qualified in giving the intervention and /or measuring outcome. The informed consent from the prepared formats ensures that the experimenter explains the procedure of the study to the patients, their voluntary participation is confirmed and the identification of the subjects is maintained confidential. Furthermore the findings of the study will benefit similar subjects, the profession and the society. Hence, the review board has no objections on the conduct of the study.

Chairman of Departmental Review Board

Project Guide

Principal

APPENDIX II CONSENT FORM Title: THE EFFECT OF MULLIGAN BENT LEG RAISE TECHIQUE ON SLR, PAIN AND OSWESTRY DISABILITY QUESTIONNAIRE IN SUBJECTS WITH LOW BACK PAIN- A PLACEBO-CONTROL EXPERIMENTAL STUDY. PURPOSE OF THE RESEARCH:
I __________________ have been informed that this study is carried to investigate the immediate effects of the Mulligan BLR and to check if these effects are carried out till 24hr. This study will help health professionals to treat low backache in a better way so as to prevent the disabling sequel of the same.

PROCEDURE:
I have been explained that this study includes a treatment technique and the measurements, which will be taken by goniometer and VAS scale. I am aware of the instructions told by the researcher and shall follow that.

RISK AND COMFORT:

I understand that there is no potential risk associated with this study and this study will produce no harm to me by participating. I understand that there wont be any discomfort throughout the study. I am aware that Mrs. Rashim Joshi will help me in better understanding of the procedure.

BENEFITS:

I understand that this study will help me to know better the effectiveness of this manual therapy technique and improvement in my functional status.

ALTERNATIVES:
I understand that this is a novel technique for the treatment of low backache. There are many other conventional techniques available for the management of the same.

CONFIDENTIALITY:
All the data recorded will be kept in strictest confidence. Apart from the researcher no one will ever access to the data with my and researchers permission. If the data are used for publication in the medical literature or for teaching purpose, no names will be used.

PHOTOGRAPHIC CONSENT:
Photographs and videotapes will not be used for any publication and shall not be reproduced under any circumstances without my consent.

REQUEST FOR MORE INFORMATION:

I understand that I may ask any questions about this study at any time. Mrs. Rashim Joshi is available to answer my questions and copy of this consent form will be given to me to keep for my careful reading.

REFUSAL OR WITHDRAWAL OF PARTICIPATION:

I understand that my participation in the study is voluntary and I may refuse to withdraw consent and continue participation at anytime. I also understand that Mrs. Rashim Joshi may not include me in the study at any time after she explains me the reason for doing so.

INJURY STATEMENT:
I understand that, in the unlikely event of the injury resulting directly/ indirectly from my participation in this study medical treatment will be available but no further compensation will be provided. I understand that my participation in this study and I am not waiver any of my legal rights, I explain to ______________________ the purpose of the research, the procedure required and the possible risks and benefits to the best of my ability. INVESTIGATOR: MRS. RASHIM JOSHI

_______________________ Investigator Signature Date:

I conform that Mrs. Rashim Joshi has informed me the purpose of research the study, the procedure and the possible risk and benefits I may experience. I have read and understood this consent to participate in this research project.

______________________ Subjects signature Date:

______________________

Witness Signature

Date:

APPENDIX III PROFORMA

Name: Age: Sex: Address: Group: Serial number: Date of assessment:

INCLUSION CRITERIA:

1. Is the patient having low back ache? 2. Is the age between 25- 40 years? 3. Is the SLR limitation more than 15o ?

(Y/N) (Y/N) (Y/N)

EXCLUSION CRITERIA:

1. Is the patient having lumbar canal stenosis? 2. Is the patient having sciatica symptoms? 3. Is the patient having prolapsed intervertebral disc? 4. Does the patient have any dermatomal affection or any muscular weakness as a consequence of back pain?

(Y/N) (Y/N) (Y/N)

(Y/N)

EXPERIMENTAL GROUP: IMMEDIATELY AFTER TREATMENT

BEFORE TREATMENT SLR

24hr AFTER TREATMENT

VAS SCORE

PLACEBO GROUP: IMMEDIATELY AFTER TREATMENT

BEFORE TREATMENT SLR

24hr AFTER TREATMENT

VAS SCORE

SIGNATURE OF SUBJECT:

SIGNATURE OF WITNESS:

SIGNATURE OF INVESTIGATOR:

DATE: