Rajiv Gandhi University of Health Sciences, Karnataka Bangalore

ANNEXURE II

1. Name of the candidate and address (in block letters)

AKSHATA G. DORKADI DR. M. V. SHETTY COLLEGE OF PHYSIOTHERAPYVIDYANAGAR, KAVOORMANGALORE-575013

2. Name of the Institution DR. M. V. SHETTY COLLEGE OF PHYSIOTHERAPY

3. Course of study and subject MASTER OF PHYSIOTHERAPYMUSCULOSKELETAL DISORDERS AND SPORTS PHYSIOTHERAPY

4. Date of admission of course 22nd May, 2010

5. Title of the topic A COMPARATIVE STUDY BETWEEN THE EFFECTIVENESS OF MAITLAND’S MANUAL THERAPY WITH CORE STABILITY AND CORE STABILITYY ALONE IN PATIENTS WITH MECHANICAL LOW BACK PAIN

6. BRIEF RESUME OF THE INTENDED WORK:

6.1) INTRODUCTION AND NEED OF THE STUDY:

Mechanical low back pain is a common musculoskeletal symptom that may be either acute or chronic. It may be caused by a variety of diseases and disorders that affect the lumbar spine1. Mechanical low back pain is a symptom that affects 80% of the general population at some point in life with sufficient severity to cause absence from work. For individuals younger than 45 years, mechanical LBP represents the most common cause of disability and is generally associated with a work related injury2. For individuals older than 45 years, mechanical LBP is the third most

common cause of disability, and a careful history and physical examination are vital to evaluation, treatment and management3.

Patients with mechanical low back pain undergo a variety of therapeutic interventions such as manual therapy, muscle stretching and muscle strengthening exercises, NSAIDs, Corticosteroid injections, low level laser therapy, TENS, Short Wave Diathermy, Interferential Therapy, Taping Techniques and McKenzie Exercises4,5,6,7.

Many studies have been performed on Manual Therapy proving beneficial for reducing pain and increasing function for mechanical low back pain. Its a clinical approach utilizing skilled, specific hands on techniques, including but not limited to manipulation/ mobilization, used by the physical therapist to diagnose and treat soft tissues and joint structures for the purpose of modulating pain; increasing Range of Motion (ROM); reducing or eliminating soft tissue inflammation; inducing relaxation; improving contractile and non-contractile tissue repair, extensibility, and or stability; facilitating movement; and improving function8. It has been proclaimed that various national guidelines for LBP treatment in primary care are fairly consistent, but discrepancies were emphasized with regard to exercise and spinal manipulation9.

Core strengthening has become a major trend in the rehabilitation of patients suffering with lower back pain. Core stabilization exercises have become a major focus in spinal rehabilitation as well as in prophylactic care such as sports injury prevention, the therapeutic evidences in terms of postural control variables were not well documented. Training methods for developing and maintaining core stability includes Pilates, Exercise Ball or Pilates Ball10,11,12.

The word LASER is an acronym or “Light Amplification by Stimulated Emission of Radiation”. The Low Level Laser Therapy principle is based on the principle of stimulated emission. The biological effects of Low Level Laser Therapy includes 1) Growth by cellular biostimulation 2) the anti-inflammatory effects 3) the analgesic effect. Low Level Laser Therapy radiation can act on two levels, the moderation of the pain message and the stimulation of morphinomimetic effect production. Many studies have been to show Low Level Laser Therapy to be effective in reducing pain and improving function in mechanical low back pain13.

But there is lack of evidence regarding the comparative effect of Manual Therapy along with Low Level Laser Therapy versus Low Level Laser Therapy alone, in bringing up better outcome measure on patients with Mechanical low back pain. Both groups will also receive core stability exercises as a treatment protocol.

Need of the study:

Recent studies states that manual therapy shows a significant effect in pain reduction and improvement of function in patients with mechanical low back pain.

A recent study was done on core stability exercises as an intervention for mechanical low back pain which demonstrated significant improvements in patients with low back pain10,11,12. Previous studies proved that Low Level Laser Therapy has proved effective in treating patients with Mechanical Low Back Pain13.

But there is lack of evidence revealing comparative effectiveness of Manual Therapy in combination with core stability and Low Level Laser Therapy versus core stability and Low Level Laser Therapy, in patients with Mechanical Low back pain, so there is a need to find out the comparative effectiveness of both the interventions.

Research Question:

Whether the combined effect of Manual Therapy in combination with core stability and Low Level Laser Therapy will be effective in treating patients with mechanical low back pain as compared to core stability and Low Level Laser Therapy?

Hypothesis:

Null hypothesis:

There will be no significant difference in pain and function following Manual Therapy in combination with core stability and Low Level Laser Therapy when compared to core stability and Low Level Laser Therapy in patients with Mechanical low back pain.

Alternate Hypothesis:

There will be significant difference in pain and function following Manual Therapy in combination with core stability and Low Level Laser Therapy when compared to core stability and Low Level Laser Therapy in patients with Mechanical low back pain.

6.2) REVIEW OF LITERATURE:

Gert Bronfort et al, 2010 has conducted a study on the effectiveness of Spinal Manipulation/mobilization and concluded that it is effective in adults for: acute, subacute and chronic low back pain; cervicogenic headache; cervigogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and cervical and thoracic manipulation/mobilization is effective for acute/subacute neck pain14.

Bogefeldt et al-2008 found manual therapy and advice to stay active was more effective than advice to stay active alone for reducing sick leave and improving return to work at 10 weeks for acute LBP. The study had a low risk of bias15.

Ferreira et al-2007 found spinal manipulation was superior to general exercise for

function and perceived effect at eight weeks in chronic LBP patients, but no differences were noted between groups at six and 12 months16.

Mohseni-Bandpei et al-2006 showed that patients receiving manipulation/exercise for chronic LBP reported greater improvement compared with those receiving ultrasound/exercise at both the end of the treatment period and at 6-month follow-up17.

Koumantakis GA et al-2005 performed a study and concluded that trunk muscle stabilization training reduced pain and increased function as compared to general exercises in patients with low back pain18.

Dr. Craig W. Martin-2008 concluded in his study that the application of Low Level Laser Therapy was effective in reducing pain and improving the function in patients with low back pain19.

Morshedi Hadi et al-2009 performed a study on Low Level Laser Therapy (LLLT) for chronic low back pain (LBP) and concluded that a statistical significant difference was found in pain during movement in favor of laser treatment; a statistical significant difference in favor of laser treatment for patient-assessed global disease activity with laser compared to pacebo; and else evaluated the effectiveness of laser treatment in vertebrae L4, L5 and S1 and the fasciae, sacral ligaments and Ilium and astronomies muscles20.

Gholamreza Esmaeeli Djavid-2007 studied the effect of Low level laser therapy combined with exercise and found to be more beneficial than exercise alone in a long term goal in reducing pain and increasing lumbar range of motion21.

Ramprasad Muthukrishnan-2009 studied the differential effects of core stabilization regime and conventional physiotherapy regime on postural control parameters during perturbation in patients with movement and control impairment chronic low back pain and concluded that core stability exercise group demonstrated significant improvements after intervention in ground reaction forces indicating changes in load transfer patterns during perturbation22.

Boonstra AM et al-2008 carried out a study to determine the Reliability and Validity of the Visual Analogue Scale for disability in patients with chronic musculoskeletal pain and they conducted that reliability of the VAS for disability is moderated to good and a strong correlation with the VAS for pain23.

Julie M Fritz et al-2001 conducted a study to determine the validity of a global rating of change as a reflection of meaningful change in patient status and to compare the measurement properties of a modified Oswestry low back pain disability questionnaire and the quebec pain disability scale. The modified Oswestry low back pain disability questionnaire demonstrated superior measurement properties compared with the QUE with higher levels of test retest reliability and

7.

responsiveness compared with QUE24.

6.3) OBJECTIVES OF THE STUDY:

1. To find out whether the application of Manual Therapy in combination with core stability exercises and Low Level Laser Therapy can reduce the pain and improve the function in patients with mechanical low back pain.

2. To find out whether the application of Core stability exercises and low Level Laser Therapy can reduce the pain and improve the function in patients with mechanical low back pain.

3. To compare the efficacy of Manual Therapy in combination with core stability exercises and Low Level Laser Therapy Versus Core stability exercises and low Level Laser Therapy, to reduce pain and improve function in patients with mechanical low back pain.

MATERIALS AND METHODS:

7.1) Study Design:

Experimental Design (Comparative study)

7.2) Source of Data:

Mechanical low back pain patients referred by a physician/orthopaedician for physiotherapy in and around Mangalore.

7.2 (I) Definition of Study Subjects:

A sample size of 50 patients in the age group of 20 – 40 years with 25 in each of the two groups will be there for the study.

7.2 (II) Inclusion and Exclusion Criteria:

Inclusion Criteria:

Patients with mechanical low back pain that lasted for 3 weeks but less than 6 months.

Both Males and Females. Age from 20 to 40 years.

Exclusion Criteria:

Nerve root irritation Scoliosis Recent myocardial infarction Spondylosis Spondylolisthesis Pregnant females of more than 1 year postpartum. Osteoporosis

7.2(III) Study Sampling Design, Method and Size:

Sample design:

Purposive random sampling

Sample size:

50 patients fulfilling the inclusion and exclusion criteria.

7.2(IV) Follow Up:

Post test will be conducted immediately after the intervention.

7.2(V) Parameters used for comparison and statistical analysis used:

Collective data will be analyzed by Wilcozon signed rank test, Manwitney U test.

7.2(VI) Duration of study:

The study will be conducted over a duration of 12 months.

7.2(VII) Methodology:

50 symptomatic individuals fulfilling the inclusion and exclusion criterias will be selected and randomly divided into two groups i.e. Group A and Group B, each group consisting 25 members. Informed consent will be obtained from them.

Pre test will be conducted on Group A and Group B by Visual-Analogue Scale for pain and by Oswestry Disability Questionnaire for function.

GROUP A: Manual Therapy and Core Stability Exercises with Low Level Laser Therapy.

MANUAL THERAPY:

Procedure:

1. ANTERIOR GLIDE USING SPINOUS PROCESSES: The patient lies in prone lying. The lumbar spine is placed in midrange in relation to forward/backward bending, side bending and rotation. The therapist is at the patient’s side facing the lumbar spine. The mobilizing hand is positioned with the heel of the hand or the thumb over the guiding hand. The guiding hand is positioned with the thumb or the middle finger over the spinous processbeing mobilized. The mobilizing hand glides the spinous process anteriorly as the patient exhales. The guiding hand controls the position of the mobilizing hand.

2. LATERA GLIDE USING SPINOUS PROCESSES: The patient lies in prone lying. The lumbar spine is placed in midrange in relation to forward/backward bending, side bending and rotation. The therapist is at the patient’s side facing the lumbar spine. The stabilizing hand is positioned with the thumb or the anterior surface of the pisiform on the lateral surface of the spinous process of the more inferior vertebra. The mobilizing hand is positioned with the thumb on the medial (ulnar) surface of the pisiform on the lateral surface of the spinous process of the more superior vertebra opposite to the side of the stabilizing hand. The stabilizing hand holds the more inferior vertebra in position. The mobilizing hand glides the more superior spinous process towards the contralateral side as the patient relaxes.

3. ANTERIOR GLIDE USING THE TRANSVERSE PROCESSES: The patient is in prone. The lumbar spine is placed in midrange in relation to forward/backward bending, side bending and rotation. The therapist is at the patient’s side facing the lumbar spine. The stabilizing hand is positioned with the thumb or the anterior surface of the pisiform on the transverse process of the more inferior vertebra. The mobilizing hand is positioned with the thumb or the anterior surface of the pisiform on the transverse process of the more superior vertebra opposite to the side of the stabilizing hand. The stabilizing hand holds the more inferior vertebra in position. The mobilizing hand glides the more superior transverse process in an direction as the patient exhales.

4. ROTATION GLIDE: The patient is lying on the side not being treated with the arm resting over the therapist’s mobilizing arm. The lumbar spine is placed in midrange in relation to forward/backward bending, side bending, and rotation. The therapist is at the side of the treatment table facing the patient’s anterior trunk. A pillow can be used to separate the patient’s chest from the therapist. The therapist locks the more inferior vertebrae by bringing the patient’s knees towards the chest to the extent that the motion segment below the one being mobilized is fully flexed, but the motion segment being mobilized has not yet moved. The therapist next locks the more superior vertebrae by rotating the upper trunk away from the therapist to the extent that the motion segment

above the one being mobilized is fully rotated but the motion segment being mobilized is not yet moved. One hand is positioned with the middle finger on the lower lateral surface of the spinous process of the more inferior vertebra and the forearm on the patient’s pelvis. The other hand is positioned with the thumb on the upper lateral surface of the spinous process of the more superior vertebra and the forearm of the elbow anterior and medial to the patient’s shoulder. The therapist’s hand on the more inferior vertebra glides the spinous process upward as the forearm rotates the pelvis forward and the patient exhales. The therapist’s hand on the more superior vertebra simultaneously glides the spinous process downward as the forearm rotates the upper trunk backward25.

CORE STABILITY EXERCISES:

Procedure:

The core stability exercises include three levels.Level I: Lower stomach to spine, Leg movements, Abdominal controlled curls, Bridging and wall squats (Each exercises will be repeated 10 to 15 times).

Level II: Heel slides, Controlled roll ups, Hundreds, Single leg bridging and modified Plank (Each exercises will be repeated 10 to 15 times).

Level III: Advanced roll ups, Hundreds plus, Front plank, Side plank and Lunges (Each exercises will be repeated 10 to 15 times).

Duration of a single session will be 30 to 40 minutes22.

LOW LEVEL LASER THERAPY:

It will be used with parameters such as Infrared Diode Laser (904nm), maximum power - 60 W, peak power pulse - 27 W, pulse frequency – 1280 Hz, average point region: 2-8 J, dose point: 3-4 J, total energy density – 24 J/cm2. Scanning method will be used with appropriate Amplitude, Frequency and Position of the Beam.

TECHNIQUE OF APPLICATION: The parameters will be taken same as above with patients treated for 3 minutes. The patients will be explained about the laser technique and need for improvement in pain. The patient will be positioned in prone lying, so that the patient is relaxed and comfortable and also the affected part will be well exposed. The rest of the parts will be covered with bed sheets. The therapist will be standing at the bed side. Both the therapist and the patient will wear protective goggles for safety and to preserve blinding of the therapist or the patient26,27.

8.

GROUP B: Core Stability Exercises and Low Level Laser Therapy .

CORE STABILITY EXERCISES:

The treatment will be the same as given for Group A.

LOW LEVEL LASER THERAPY:

The treatment will be the same as given for Group A

Post test will be done on Group A and Group B by Visual-Analogue Scale for pain and by Oswestry Disability Questionnaire for function.

The results will be recorded and analysed.

7.3) Does the study require any investigations to be conducted on patients or other human or animal? If so, please describe briefly.

YES. Visual-Analogue Scale- Pain Assessment.Oswestry Disability Questionnaire-Functional Assessment.

7.4) Has ethical clearance been obtained from your institution in case of 7.3. YES

LIST OF REFERENCES:

1. Biering-Sorensen F. A prospective study of low back pain in a general population. I. Occurrence, recurrence and aeitiology. Scand J. Rehabil Med 1983; 15:71-9.

2. Carey TS, Garrett J, Jackman A, et al. The outcomes and cost of cares for acute low back pain among patients seen by primary care practitioners, chiropractors and orthopaedic surgeons. The North Carolina Back Pian Project. N Engl J Med 1995; 333:913-7.

3. Cassidy JD, Carroll L J, Cote P. The Saskatchewan health and back pain survey. The prevalence of low back pain and related disability in Saskatchewan adults. Spine 1998; 23:1860-6.

4. Abenhaim L, Rossignol M, Valat JP et al. The role of activity in the therapeutic management of back pain. Report of the International Paris Task Force on Back

Pain. Spine 2000;25:1S-33S.

5. Faas A. Exercises: which ones are worth trying, for which patients, and when? Spine 1996; 21:2874-8.

6. Koes BW, Assendelft WJ, van der Heijden GJ et al. Spine manipulation and mobilization for back and neck pain: a blinded review. Br Med J 1991; 303; 1298-303.

7. Koes BW, Bouter LM, Beckerman H, et al. Physiotherapy exercises and back pain: a blinded review. Be Med J 1991; 302; 1572-6.

8. American academy of orthopedic manual physical therapy (aaompt) and american physical association (apta).

9. Koes BW, van Tulder MW, Ostelo R, et al. Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine 2001; 26:2504-13.

10. Ferreira PH, Ferreira ML, Christopher GM, Herbert RD, Kathryn R. Specific stabilization exercises for spinal and pelvic apin: a systemic review. Aust J Physiother. 2006; 52:70-88.

11. O’ Sullivan PB Twomey L, Allison GT. Altered abdominal muscle recruitment in patients with chronic back pain following a specific exercise intervention. J Orthop Sports Phys Ther. 1998; 27:114-24.

12. Cairns, Mindy C, Foster, Nadine E, Wright, Chris. Randomized Controlled Trial of Specific Spinal Stabilization Exercises and Conventional Physiotherapy for Recurrent Low Back Pain. Spine. 2006;31: E670-E681. doi: 10.1097/01.brs.0000232787.71928.5d.

13. Information of Laser therapy. Electrocare Manual.

14. Gert Bronfort, Mitch Haas, Roni Evans, Bret Leininger and Jay Triano. Effectiveness of manual therapies: the UK evidence report. J Chiropractic and Osteopathy. 2010; 18:3.

15. Bogefeldt J, Grunnesjo MI, Svardsudd K, Blomberg S. Sick leave reduction from a comprehensive manual therapy programme for low back pain: the Gotland Low Back Pain Study. Clin Rehabil 2008; 22:529-541.

16. Ferreira ML, Ferreira PH, Latimer J, Herbert RD, Hodges PW, Jennings MD. Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: randomized controlled trial. Pain 2007; 131:31-37.

17. Mohseni-Bandpei MA, Critchley J, Staunton T. A prospective randomized controlled trial of spinal manipulation and ultrasound in the treatment of chronic low back pain. Physiotherapy 2006; 92:34-42.

18. Koumantakis GA, Watson PJ, Oldham JA. Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain. Phys Ther. 2005;85:209-225.

19. Dr. Craig W. Martin. Effectiveness of low level laser therapy in treating various conditions: a rapid review. worksafeBC Evidence-Based Practice Group 2008.

20. Morshedi Hadi, Safari Variani Ali, Mohammadi Zeiydi Isa, Banafsheh Mohammadi Zeidi. Low Level Laser Therapy (LLLT) for Chronic Low Back Pian. European Journal of Scientific Research 2009;1450:216.

21. Gholamreza Esmaeeli Djavid, Ramin Mehrdad, Mohammad Ghasemi, Hormoz Hasan-Aadeh, Akbar Sotoodeh-Manesh and Gholmreza Pouryaghoub. In chronic low back pain, low level laser therapy combined with exercise is more beneficial than exercise alone in the long term: a randomized trail. Aust J Physiother. 2007;53:155-60.

22. Ramprasad Muthukrishnan, Shweta D Shenoy, Sandhu S Jaspal, Shankara Nellikunja and Svetlana Fernandes. The differential effects of core stabilization exercise regime and conventional physiotherapy regime on postural control parameters during perturbation in patients with movement and control impairemetn chronic low back pain. 2009.

23. Boonstra AM, Schiphorst Preuper HR, Reneman MF. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008;31 (2):165-9.

24. Julie M Fritz and James J Irrgang A. Comparison of a Modified Low Back Pain Disability Questionnaire and the Quebec Pain Disability Scale. Physical therapy 2001; vole81, No.2:776-778.

25. Susan L. Edmond. Joint Mobilization/ Manipulation. Second Edition. Page no. 297-311.

26. Information on Laser Therapy. Electrocare Manual.

27. Hormoz et al. In chronic low back pain, Low Level Laser therapy combined with exercise alone in the long term: a randomized trial. Australian Journal 2007; 53(3): 155-160.