Rajiv GandhiUniversityof Health Sciences,
Karnataka, Bangalore
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the Candidate & Address / ROHAN DEO SHAMB-302, Archit Vrindavan, Gangapur Road, Sector-c, Anandvalli, Nasik-422013
2. / Name of the Institution / K.T.G COLLEGE OF PHYSIOTHERAPY
Hegganahalli Cross, Vishwaneedam Post,
Sunkadakatte Via Magadi Road,
Bangalore – 560091
3. / Course of Study & Subject / MASTERS OF PHYSIOTHERAPY
(Musculoskeletal Disorders and Sports)
4. / Date of Admission to the Course / 14/06/2012
5 / Title of the Topic:
“EFFECTIVENESS OF DIFFERENT RATIOS OF PULSED ULTRASOUND FOR SUBJECTS WITH OSTEOARTHRITIS OF KNEE.”
6 / Brief Resume of the Intended Work:
6.1 Need of the Study:
Osteoarthritis (OA) is a common and important cause of pain and disability in elderly adults.8
osteoarthritis is characterized by erosion of articular cartilage, either primary or secondary to trauma or other conditions. which becomes soft, frayed, and thinned with eburnation of subchondral bone, and outgrowths of marginal osteophytes seen with pain and loss of function, it mainly affects weight-bearing joints and it is common in elderly people.1
In ageneral practice setting. 1% of people aged over 45 years have a currently-recorded clinical diagnosisof knee osteoarthritis; 5% will have had the clinical diagnosis made at some point. Acommunity-based cohort study showed that radiological features of knee osteoarthritis were verycommon. 13% of women aged 45–65 years developed new knee osteophytes - an incidence of3% per year.8
One in four people aged over 55 years have knee pain and by the age of 65 years 30% of men and 40% of women have radiographic changes of knee osteoarthritis.3
The treatment of osteoarthritis of knee joint is completely depends on the alleviation of pain. Non steroidal anti inflammatory drugs (NSAID) mainly use for the treating pain and stiffness with osteoarthritis of knee joint.2
Physiotherapy is a non- pharmacological intervention for osteoarthritis of knee joint. physiotherapy involves different modalities such as short wave diathermy, transcutaneous electrical nerve stimulation (TENS), Hot packs, Ultrasound and Exercises.4.
Therapeutic ultrasound is one of the modality suggested for the management of pain and loss of function due to osteoarthritis.6 It is a form of mechanical energy consisting of high frequency vibration that can be continuous or pulsed.10 Pulsed ultrasound produced non thermal effect and is used for reduction of inflammation, whereas continuous ultrasound generates thermal effect.7,10 Therapeutic ultrasound is also reputed to reduce edema, relieve pain and accelerate tissue repair.7 The results of a number of placebo-controlled studies suggest that therapeutic ultrasound is useful for reducing pain and disability in osteoarthritis of knee.4
Several studies have done before for pulsed ultrasound on osteoarthritis of knee on duty cycle of 1:4(ratio 1:4 ) found that pulsed ultrasound (ratio 1:4) is effective in pain relief and improving function for the subjects with osteoarthritis of knee.1,7,10,11
F. Tascioglu evaluated the effectiveness of continuous and pulsed ultrasound therapy over placebo without applying any other physical therapy agent for knee osteoarthritis.1 In their study they found that pulsed ultrasound therapy is a safe and effective treatment modality of pain relief and improving function in patients with knee osteoarthritis.1 However the study was limited to evaluate the different dosage and forms of pulsed ultrasound application for osteoarthritis of knee.
Knowing the different ratios of pulsed ultrasound such as 1:2 and 1:4 for OA knee is clinically beneficial to decide the dosometry.1,10
There are no studies found in the literature on effectiveness of different pulsed ratio for osteoarthritis knee. Therefore there is a need to study the effect of different ratio such as 1:2 and 1:4 of pulsed ultrasound on improving pain and function ability for osteoarthritis of knee.
Hence,the present study is aiming to study the effectiveness of different ratios such as 1:2 and 1:4 duty cycle of pulsed ultrasound for subjects with osteoarthritis of knee on pain and functional ability.
Research Question:
Does the ratio of 1:2 duty cyclesand ratio 1:4 duty cycle of pulsed ultrasound therapy will have an effect on improving pain and function for subjects with osteoarthritis knee?
Hypothesis
Null Hypothesis:
Duty cycle of 1:2 ratio or duty cycle 1:4 ratio of pulsed ultrasound will not have a significant effect on improving pain and function in subjects with osteoarthritis knee.
Alternate Hypothesis:
Duty cycle of 1:2 ratio or duty cycle 1:4 ratio of pulsed ultrasound will have a significant effect on improving pain and function in subjects with osteoarthritis knee.
6.2 Review of Literatures:
Osteoarthritis :
F Tascioglu , S Kuzgun et. al (2010): studied short term effectiveness of continuous ultrasound verses pulsed ultrasound verses placebo physiotherapy in ninety patients for the duration of five sessions in a week for two weeks with bilateral knee osteoarthritis. In their study they found that there was significant decreases in pain and improving function in group who received pulsed ultrasound at ratio of 1:4than the group who received the continuous and placebo ultrasound in osteoarthritis of knee.
Cetin N, et. al.(2008):in this comparative study between hot packs, short wave diathermy, ultrasound, TENS, isokinetic strength,on pain and functional status in women with OA knees. They found that Hot pack with a transcutaneous electrical nerve stimulator or short-wave diathermy has the best outcome on improving the pain and functional status for osteoarthritis of knee.
Felson DT, Zhang et. al. (1995):studied incidence and natural history of OA in the thirty elderly patients. In this study they have stated that there were one thousand four hundred thirty eight subjects amoung thousand elderly person with OA knee. The new onset of knee OA is frequent and is more common in women than men. However, among the elderly, age may not affect new disease occurrence or progression.
Ultrasound
Rutjes AW , et. al.(2010): studied done on therapeutic ultra sound for osteoarthritis of knee and hip, five groups trail is made two with continuous ultrasound, two pulsed ultrasound, one with pulsed and continuous ultrasound. Here they have found that both pulsed and continuous ultrasound as the active treatment to reduce the pain in osteoarthritis of knee joint.
Huang Mh, et. al.(2005): studied Preliminaryresults of integrated therapy for patients with
knee osteoarthritis. Total one hundred forty patient of OA divided into four groups 1. Isokinetic ex. 2. Isokinetic ex. And pulsed ultrasound 3.isokinetic ex. Pulsed ultrasound and intraarticular hyaluronan therapy 4. Control group. Here they have found that each group had increased the muscle peak torque and significant reduction in pain. Only in group two and three increase in range of motion is observed.
It proves that pulsed ultrasound with isokinetic exercise treatment increase in range of motion and reduction in pain.
Lennart D. Johns et. al.(2002) : studiedNonthermal Effects of Therapeutic Ultrasound: The Frequency Resonance Hypothesis .A possible mechanical mechanism by which treatment with non-thermal levels of ultrasound stimulates therapeutic effects. The concept of the absorption of ultrasonic energy by enzymatic proteins leading to changes in the enzymes activity is not novel. However, recent reports demonstrating that ultrasound affects enzyme activity and possibly gene regulation provide a probable molecular mechanism of ultrasound's nonthermal therapeutic action. The results gives better understanding of ultrasound's mechanical mechanism for how and when ultrasound should be employed as a therapeutic modality.
Valma J Robertson and Kerry G Baker(2001):- in this review on therapeutic ultrasound ofeffectivenessstudy. Different types of dosage and forms of application is used to check effectiveness of continuous ultrasound, pulsed ultrasound, placebo ultrasound on Epicondylagia, Surgical extraction third molar, Perineal trauma, Breast engorgement ,Osteoarthritis of knee, Shoulder pain, Pressure Ulcers ,Carpal tunnel syndrome, Calcific tendinitis. Here they have found that the pulsed ultrasound is more effective compared with other form of treatment.
Outcome measures :
Salaffi F, et. al. (2003): in this study The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index is a tested questionnaire to assess symptoms and physical functional disability in patients with OA of the knee and the hip. They tested WOMAC for its metric properties in 304 patients with OA of the knee. The result shows that WOMAC is a reliable and valid instrument for evaluating the severity of OA of the knee, with metric properties in agreement with the original, widely used version.12
Max Zusman(1986) carried out the study on reliability and validity of Visual Analogue scale. According this study it is important to recognize that measures such as VAS provide little or no insight in to the basis or prognosis of different pain producing disorder. Nevertheless the foregoing suggest that for many types of clinical study VAS is reliable, convenient, inexpensive and readily analyzed method of measuring pain intensity.136.3 Objectives of the Study:
- To find the effect of ratio 1:2 duty cycle by measure pain and function using pre and post intervention
- To find the effect of ratio 1:4 duty cycle by measure pain and function using pre and post intervention
- To compare the effectiveness of improvement on pain and function between the ratio of 1:2 and1:4.
7.
8. / Material and Methods:
7.1Study Design:
Experimental study design with two groups Group A (duty cycle 1:2), Group B (duty cycle 1:4).
7.2 Methodology:
Study Subject:
Subjects with bilateral knee osteoarthritis.
Sample Size:
The study will be carried on 30 subjects. (15 subject in Group A- duty cycle 1:2 and 15 subjects in Group B - duty cycle 1:4).
Study setting and source of data:
The study will be carried in KTG Hospital, Bangalore and other rehabilitation centers.
Sampling Method:
Simple random sampling method.
Study Duration:
5 sessions in a week for 3 weeks.
Sample Selection:
Inclusion Criteria:
1.American college of rheumatology criteria for classification and reporting of osteoarthritis of knee joint. ( age:- > 50yrs., stiffness < 30 min. , crepitus , Bony tenderness, bony enlargements , no palpable warmth ) for clinical criteria ( study suggest that knee pain plus any 3 criteria should be there for the finding of osteoarthritis of knee joint. )15
2.Mild to Moderate OA knee based on percentage of WOMAC score.
3.Both male and females.
4.Age group between 45to 55 years.
5.Subjects who willing to participate.
6.BMI range between 20 to 25.15
7.History of Bilateral Knee Osteoarthritis from last two years.1
UExclusion Criteria:
- OA of the hip.1
- OA involvement of the foot joints.1
- Serious concomitant systemic diseases.1
- Intra articular fluid effusion.1
- Lower limb arthoplasty.1
- Intra articular corticosteroid or hyaluronic acid injection during the last 6 months.1
- None of the patient who undergone knee surgery.
- Osteoarthritis of knee with deformity.
- Couch with pillow.
- Ultra sound machine ( Delsonic Ultrasoinc Therapy Unit), with gel.
- Assessment performa .
- Pen and paper.
- Visual analogue scale (VAS) to measure intensity of pain(Annexure – 2).
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for function. (Annexure-3).
- Ethical clearance:
- Subject who meets the inclusion criteria will be assigned into randomization method.
- All the subjects fulfilling the inclusion and exclusion criteria will be informed about the study and a written consent (Annexure–1) will be taken. Subjects are randomly allocated to either Group A( duty cycle 1:2) or Group B(duty cycle 1:4) in to two groups of fifteen. Thirty pieces of paper were used, with fifteen pieces having the words “Group A” written on them, and fifteen having the words “Group B” written on them. All the pieces of paper were tightly folded and placed in a box. After shaking the box thoroughly, piece of paper will be withdrawn, each piece of paper individual and wrote the group name on list that corresponded with patient number from one to thirty.
Group B: Pulsed ultrasound with duty cycle 1:4 ratio.
- Pre-test evaluation
Procedure of Intervention for Group A
Pulsed ultrasound (duty cycle 1:2)
The treatment willapply to both sides ofthe knee. No physiotherapy was given priorto ultrasound treatment in any of thegroups.In group A (pulsed ultrasound ratio 1:2),The ultrasound equipment will set at a frequency of 1 MHz and a intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:2. With the 5-cm. diameter head applicator for 10 min per session (Delsonic ultrasonic therapy unit, Mumbai,India ) The patients were inthe supine position and an acoustic gel thatdid not contain any pharmacologicallyactive substance will applied. Ultrasoundwas then applied to the superomedial andlateral parts of the knee in circularmovements with the probe at right angles toensure maximum absorption of the energy. Intervention will be given for five times a week for three weeks.
Procedure of Intervention for Group B
pulsed ultrasound (pulsed mode cycle 1:4) :-
The treatment willbe applied to both sides ofthe knee. No physiotherapy was given priorto ultrasound treatment in any of thegroups. In group B (pulsed ultrasound ratio 1:4), The ultrasound equipment willbe set at a frequency of 1 MHz and a intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4. With the 5-cm. diameter head applicator for 10 min per session (Delsonic ultrasonic therapy unit, Mumbai, India) The patients were inthe supine position and an acoustic gel thatdid not contain any pharmacologicallyactive substance will be applied. Ultrasound was then applied to the superomedial andlateral parts of the knee in circularmovements with the probe at right angles toensure maximum absorption of the energy. Intervention will be given for five times a week for three weeks.
Post-test evaluation
Post intervention measurement such as pain and function will be measured after three weeks of intervention. The pre intervention and post intervention measurement variable will be used for analysis.
Statistical test
- Statistical analysis will be performed by using SPSS software for window (version 16) and p-value will be set as 0.05.
- Descriptive statistics and chi-square test will be used to analyse the base line data for demographic data.
- Unpaired t-test and Wilcoxon signed ranked test will be used to find the significance of parameters.
- Independent t-test and Mann-Whitney U test will be used to analysis the variables between the groups.
As the study includes human subject ethical clearance is obtained from ethical committee of K.T.G. Collage of Physiotherapy, Bangalore as per the ethical guidelines for bio medical research on human subjects, 2000ICMR, New Delhi. Also a written consent will be taken from each subject who participates in this study.
List of references:
- F tascioglu, S kuzgun, O armagan and G ogutler. Short-term Effectiveness of Ultrasound Therapy in Knee Osteoarthritis. 2010; 1233 – 1242 [first published online as 38(4) 4] 1233
- John d. Bradley, kemith d brandt, barry p. kati. Comparison of an ant inflammatory dose of ibuprofen an analgesic dose of ibuprofen and acetaminophen in the treatment of patient with osteoarthritis of knee joint .1991/vol.325no. Available from:
- T E McAlindon, C Cooper, J R Kirwan, P A Dieppe.Determinants of disability in osteoarthritis of the knee joint.Annals of the Rheumatic Diseases 1993; 52: 258-262.
- cetin, Nuri MD; Aytar, Aydan PT, MSc; Atalay, Ayce MD; Akman, Mahmut Nafiz MD. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. Available from :
- Prof David Scott# and Anna Kowalczyk . osteoarthritis of knee. Clin Evid (Online). 2007: 1121. Published online 2007 September 1.PMCID: PMC2943785
- Dilek Durmus, Yeim Akyol, Samsun, Turkey. Effects of Therapeutic Ultrasound on Pain, Disability, Walking Performance, Quality of Life, and Depression in Patients with Chronic Low Back Pain: A Randomized, Placebo Controlled Trial. Year –2010, May;30(7):901-10. Epub 2009 Jul 31.
- Rutjes AWS, Nuesch E, Sterchi R, Juni P Therapeutic ultrasound for osteoarthritis of the knee or hip. 2010 coharan publisher.
- P. Turner,1 J. H. Barl Beliefs About the Causes of Osteoarthritis Among Primary Care Patients Arthritis & Rheumatism Vol. 57, No. 2, March 15, 2007, pp 267–271 DOI 10.1002/art.22537© 2007, available from
- Valma J Robertson and Kerry G Baker:- A Review of Therapeutic Ultrasound: Effectiveness studies. phister. 2001; 81:1339-1350 available from
- MAO-Hsiung Huang, Rei-Cheng Yang. et. al.. Preliminary Results of Integrated Therapy for Patients With Knee Osteoarthritis Arthritis & Rheumatism (Arthritis Care & Research) Vol. 53, No. 6, December 15, 2005, pp 812–820 DOI 10.1002/art.21590 © 2005. Available from :
- Salaffi f , leardini g, canesi bet. al.- reliability and validity of the western Ontario and mc master universities (WOMAC) osteoarthritis Index in Italian patient with osteoarthritis of knee joint. Osteoarthritis Cartilage. 2003 Aug;11(8):551-60.
- Felson DT, Zhang Y, Hannan MTet. al.The incidence and natural history of knee osteoarthritis in the elderly. The Framingham osteoarthritis study. Boston University School of Medicine, Arthritis Center, MA 02118, USA : 38(10):1500-5.
- Max Zusmancarried out the study on reliability and validity of Visual Analogue scale. australian journal of physiotherapy. Vol.32, no4, 1986.
- Falconer j, Hayes kw, Chang Rw : Effect of ultrasound on mobility in osteoarthritis of the knee. (Arthritis care) ref. 1992;5:29 - 35
- Williams A, McHale j, Bowdith M, et. al.: Effect of 1 Mhz ultrasound on electrical pain threshold perception in humans. Ultrasound med Bio 1987; 13: 249 -258.
- Bitton R: The economic burden of osteoarthritis Am.j Manag Care 2009; 15(8):S230-S235.
9 / Signature of Candidate
10 / Remarks of the Guide
11. / Name and Designation of
11.1 Guide : CHITRA. K
11.2 Signature
11.3 Co-Guide :
11.4 Signature
11.5Head of Department :
11.6Signature
12. / 12.1Remarks of the Chairman & Principal
12.2Signature
ANNEXURE -1
CONSENT FORM
I Rohan Deo Sham. have explained to...... (Subject name) ...... the purpose of the research, the procedures required, and the possible risks and benefits to the best of my ability.
......
InvestigatorSignature Date
College:
Place:
CONSENT TO PARTICIPATE IN THE STUDY
Purpose of Research
I...... (Subject name)...... have been informed that this study is for EFFECTIVENESS OF DIFFERENT RATIOS OF PULSED ULTRASOUND IN SUBJECT WITH OSTEOARTHRITIS OF KNEE. Both approaches/technique are acceptable physiotherapy intervention for this problem. This study will help physiotherapy better understand the use of Effectiveness of different ratios of pulsed ultrasound in subject with osteoarthritis of knee.
Procedure
I understand that I will be examined for pain and functional disability for my muscles involved in knee joint.
I am aware that in addition to ordinary care received. The Physiotherapy examination consists of Visual Analogue Scale and WOMAC Scale. I have been asked to undergo these tests at the beginning of the study and after the study.
Risk and Discomforts
I understand that I may experience some pain or discomfort during the examination or during my treatment . This is mainly the result of my condition, and the procedures of this study are not expected to exaggerate these feelings which are associated with the usual course of treatment.
Benefits
I understand that my participation in the study will have no direct benefit to me other than potential benefit of the treatment which is planned to reduce my pain and increase my knee function. The major potential benefit is to find out which treatment program is more effective.
Confidentiality
I understand that the information produced by this study will became part of my research record and will be subject to the confidentiality and privacy regulation, but will be stored in the investigator’s research file.
If the data are used for publication in the literature or for the teaching purpose, no names will be used, and other identifiers, such as photographs and audio or videotapes, will be used with my special written permission.
Refusal or Withdrawal of Participation
I understand that my participation is voluntary and that I may refuse to participate or may withdraw consent and discontinue participation in the study at any time without prejudice to my present or future care at the Hospital. I also understand that Mr. Rohan Deo Sham. may terminate my participation in this study at any time after she explained the reasons for doing so.
I confirmed that Mr. Rohan Deo Sham. has explained to me the purpose of the research, the study procedures that I will undergo, and the possible risks and discomforts as well as benefits that I may experience. Alternatives to my participation in the study have also been discussed. I have read and I understand this consent form. Therefore, I agree to give my consent to participate as a subject in this research project.
......
Participant Signature Date
......
Witness to Signature Date
ANNEXURE - 2
Visual Analog Scale (VAS):
VAS is presented as 10cm line.
No pain at one end and worst imaginable pain at other end.
Patient is asked to mark a 100mm line to indicate pain intensity.
I------I
No Pain Pain as bad as it could possibly be
If used as a graphic rating scale, a 10 cm baseline is recommended
A 10 cm baseline is recommended for VAS scale.
ANNEXURE 3
The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
Overview:
The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications.
Pain:
(1) walking
(2) stair climbing
(3) nocturnal
(4) rest
(5) weight bearing
Stiffness:
(1) morning stiffness
(2) stiffness occurring later in the day
Physical function:
(1) descending stairs
(2) ascending stairs
(3) rising from sitting
(4) standing
(5) bending to floor
(6) walking on flat
(7) getting in or out of car
(8) going shopping
(9) putting on socks
(10) rising from bed
(11) taking off socks
(12) lying in bed
(13) sitting
(14) sitting
(15) getting on or off toilet
(16) heavy domestic duties
(17) light domestic duties
While the index was being developed performance of social functions and the status of emotional function were also included. These were not included in the final instrument.
Social function:
(1) leisure activities
(2) community events
(3) church attendance
(4) with spouse
(5) with family
(6) with friends
(7) with others
Emotional function:
(1) anxiety
(2) irritability
(3) frustration
(4) depression
(5) relaxation
(6) insomnia
(7) boredom
(8) loneliness
(9) stress
(10) well-being
Scoring and Interpretation
Response Points
None 0
Slight 1
Moderate 2
Severe 3
Extreme 4
Alternatively a visual analogue scale (VAS) may be used ranging from 0 to 10.
score = SUM(points for relevant items)
average score = (total score) / (number of items)
Interpretation:
• minimum total score: 0
• maximum total score: 96
• minimum pain subscore: 0
• maximum pain subscore: 20
• minimum stiffness subscore: 0
• maximum stiffness subscore: 8
• minimum physical function subscore: 0
• maximum physical function subscore: 68
1