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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04598126
Other study ID # REC/RCRS/20/1005 Samiah Sarwar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 30, 2019
Est. completion date September 30, 2020

Study information

Verified date October 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 were provide an educational manual as a home plan in which the investigators educate and guide patients about proper posture, life style modification, precautions and safety measures and home exercise in patient with knee osteoarthritis


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date September 30, 2020
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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/
patient education manual +traditional physical therapy
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/

Locations

Country Name City State
Pakistan Rehabilitation department CMH(Combined military hospital) Sialkot Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

Järvholm B, Lewold S, Malchau H, Vingård 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. — View Citation

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. Review. — View Citation

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.

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Rashan L, Hamidpour R. OsteoLuban a Novel Natural Remedy for Osteoarthritis. 2019.

Sharma L. Local factors in osteoarthritis. Curr Opin Rheumatol. 2001 Sep;13(5):441-6. Review. — View Citation

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. — View Citation

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. Review. — View Citation

van Tunen JAC, Peat G, Bricca A, Larsen LB, Søndergaard 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. — View Citation

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. — View Citation

Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Review. Erratum in: Clin Geriatr Med. 2013 May;29(2):ix. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other ROM Knee flexion ( Flexion Rt) Changes from the Baseline ROM range of Motion of knee flexion was taken with the Help of Goniometer 4th day
Other ROM Knee flexion ( Flexion Lt) Changes from the Baseline ROM range of Motion of knee flexion was taken with the Help of Goniometer 4th day
Other ROM knee Extension ( extension Rt) Changes from the Baseline ROM range of Motion of knee extension was taken with the Help of Goniometer 4th day
Other ROM knee extension ( extension Lt) Changes from the Baseline ROM range of Motion of knee extension was taken with the Help of Goniometer 4th day
Primary Visual analogue scale(VAS) 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 WOMAC osteoarthritis index It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
The WOMAC parameters are:
0-none,1-slight,2-moderate,3-sever,4-extreme.
4th day
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