- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04598126
Patient Education Manual on Patients With Knee Osteoarthritis.
Effects of Patient Education Manual on Pain, Range of Motion and Function in Patient With Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This RCT was conducted to see effects of patient education manual on pain, ROM and functional performance in patient of knee osteoarthritis. In this study the investigators provide an educational manual as a home plan in which they educate and guide patients about proper posture, life style modification, precautions and safety measures and home exercise in patient with knee osteoarthritis.
The investigators will divide the patients in two groups. One group was treated with the patient education manual and routine physical therapy and the other group was treated with routine physical therapy alone. After baseline assessment patient was assessed at 2nd, 4th and 6th week and then do final assessment to analyse our results on SPSS, either patient education manual is helpful in minimising there pain functional limitation and increasing their Range Of Motion. Visual analogue scale, goniometry and WOMEC was used to measure outcome regarding pain, Range of motion and functional performance in patients with knee osteoarthritis. This study was help full in the management, to improve function and to decrease status of disability in future in patients with knee osteoarthritis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Sialkot, Punjab, Pakistan
- Rehabilitation department CMH(Combined military hospital)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Idiopathic knee OA-I, II, &III
Exclusion Criteria:
- Post Traumatic OA Knees
- Ligament instability
- Condromalacia patellae
- Knee replacements
- Cognitive impairment
- Rheumatoid arthritis
- Meniscus injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional physical therapy
|
Traditional physical therapy Ultrasound posteriorly 6 mints 4 days/week hydrocollateral pack anteriorly 10 mints 4 days/week Quadriceps isometrics 10 repetitions×1 set, 4 days/week and Hamstring muscle strechings 10 repetitions×1 set, 4 days/
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Experimental: patient education manual +traditional physical therapy
Patient education manual +traditional physical therapy
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Patient educational Manual + Traditional physical therapy Ultrasound posteriorly 6 mints 4 days/week hydrocollateral pack anteriorly 10 mints 4 days/week Quadriceps isometrics 10 repetitions×1 set, 4 days/week and Hamstring muscle strechings 10 repetitions×1 set, 4 days/ |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale(VAS)
Time Frame: 4th day
|
The VAS is a unidimensional measure of pain intensity.it
is a continuous scale comprised of a horizontal (HVAS) or vertical (VAS) line, usually 10 centimeters (100 mm) in length.
the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 )[100-mm scale]).
|
4th day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WOMAC osteoarthritis index
Time Frame: 4th day
|
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
The WOMAC parameters are: 0-none,1-slight,2-moderate,3-sever,4-extreme. |
4th day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM Knee flexion ( Flexion Rt)
Time Frame: 4th day
|
Changes from the Baseline ROM range of Motion of knee flexion was taken with the Help of Goniometer
|
4th day
|
|
ROM Knee flexion ( Flexion Lt)
Time Frame: 4th day
|
Changes from the Baseline ROM range of Motion of knee flexion was taken with the Help of Goniometer
|
4th day
|
|
ROM knee Extension ( extension Rt)
Time Frame: 4th day
|
Changes from the Baseline ROM range of Motion of knee extension was taken with the Help of Goniometer
|
4th day
|
|
ROM knee extension ( extension Lt)
Time Frame: 4th day
|
Changes from the Baseline ROM range of Motion of knee extension was taken with the Help of Goniometer
|
4th day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Syed Shakil Ur-Rehman, Riphah International University
Publications and helpful links
General Publications
- Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.
- Jarvholm B, Lewold S, Malchau H, Vingard E. Age, bodyweight, smoking habits and the risk of severe osteoarthritis in the hip and knee in men. Eur J Epidemiol. 2005;20(6):537-42. doi: 10.1007/s10654-005-4263-x.
- Iqbal MN, Haidri FR, Motiani B, Mannan A. Frequency of factors associated with knee osteoarthritis. J Pak Med Assoc. 2011 Aug;61(8):786-9.
- Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
- Loeser RF. Aging and osteoarthritis: the role of chondrocyte senescence and aging changes in the cartilage matrix. Osteoarthritis Cartilage. 2009 Aug;17(8):971-9. doi: 10.1016/j.joca.2009.03.002. Epub 2009 Mar 12.
- Liaqat M, Liaqar B, Rauf R, Bashir F. Prevalence of knee osteoarthritis and quality of life in middle aged adults. International Journal of Rehabilitation Sciences (IJRS). 2018;7(02):26-8.
- Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.
- Plotnikoff R, Karunamuni N, Lytvyak E, Penfold C, Schopflocher D, Imayama I, Johnson ST, Raine K. Osteoarthritis prevalence and modifiable factors: a population study. BMC Public Health. 2015 Nov 30;15:1195. doi: 10.1186/s12889-015-2529-0.
- Pal CP, Singh P, Chaturvedi S, Pruthi KK, Vij A. Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop. 2016 Sep;50(5):518-522. doi: 10.4103/0019-5413.189608.
- Sowers M, Karvonen-Gutierrez CA, Jacobson JA, Jiang Y, Yosef M. Associations of anatomical measures from MRI with radiographically defined knee osteoarthritis score, pain, and physical functioning. J Bone Joint Surg Am. 2011 Feb 2;93(3):241-51. doi: 10.2106/JBJS.I.00667.
- Stubbs B, Aluko Y, Myint PK, Smith TO. Prevalence of depressive symptoms and anxiety in osteoarthritis: a systematic review and meta-analysis. Age Ageing. 2016 Mar;45(2):228-35. doi: 10.1093/ageing/afw001. Epub 2016 Jan 20.
- Rashan L, Hamidpour R. OsteoLuban a Novel Natural Remedy for Osteoarthritis. 2019.
- Creamer P, Lethbridge-Cejku M, Hochberg MC. Where does it hurt? Pain localization in osteoarthritis of the knee. Osteoarthritis Cartilage. 1998 Sep;6(5):318-23. doi: 10.1053/joca.1998.0130.
- Farrokhi S, Chen YF, Piva SR, Fitzgerald GK, Jeong JH, Kwoh CK. The Influence of Knee Pain Location on Symptoms, Functional Status, and Knee-related Quality of Life in Older Adults With Chronic Knee Pain: Data From the Osteoarthritis Initiative. Clin J Pain. 2016 Jun;32(6):463-70. doi: 10.1097/AJP.0000000000000291.
- Sharma L. Local factors in osteoarthritis. Curr Opin Rheumatol. 2001 Sep;13(5):441-6. doi: 10.1097/00002281-200109000-00017.
- van Tunen JAC, Peat G, Bricca A, Larsen LB, Sondergaard J, Thilsing T, Roos EM, Thorlund JB. Association of osteoarthritis risk factors with knee and hip pain in a population-based sample of 29-59 year olds in Denmark: a cross-sectional analysis. BMC Musculoskelet Disord. 2018 Aug 21;19(1):300. doi: 10.1186/s12891-018-2183-7.
- Mora JC, Przkora R, Cruz-Almeida Y. Knee osteoarthritis: pathophysiology and current treatment modalities. J Pain Res. 2018 Oct 5;11:2189-2196. doi: 10.2147/JPR.S154002. eCollection 2018.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCRS/20/1005 Samiah Sarwar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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