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Knee OsteoarthritisNCT04598126

Patient Education Manual on Patients With Knee Osteoarthritis.

A study testing Traditional physical therapy and patient education manual +traditional physical therapy in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Traditional physical therapy and patient education manual +traditional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 sitePakistan
Study dates
30 Dec 2019to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Idiopathic knee OA-I, II, \&III

Who cannot join

  • Post Traumatic OA Knees
  • Ligament instability
  • Condromalacia patellae
  • Knee replacements
  • Cognitive impairment
  • Rheumatoid arthritis
  • Meniscus injury

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Rehabilitation department CMH(Combined military hospital)

    Sialkot, Punjab Province

Other trials in Pakistan

About this study

Official title: Effects of Patient Education Manual on Pain, Range of Motion and Function in Patient With Knee Osteoarthritis

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

Read the 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.

Being tested
Traditional physical therapy, patient education manual +traditional physical therapy
Keywords
Patient education manual, Knee O.A, Pain, ROM
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional physical therapyOther

    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 therapyOther

    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/

Study groups in NCT04598126
Study groupRoleWhat they receive
Traditional physical therapyActive comparatorTraditional physical therapy
Receives: Other: Traditional physical therapy
patient education manual +traditional physical therapyExperimentalPatient education manual +traditional physical therapy
Receives: Other: patient education manual +traditional physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]).

    Measured: 4th day

Secondary outcomes (1)

  1. 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.

    Measured: 4th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start30 Dec 2019
  3. Primary completion30 Aug 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04598126
Sponsor's protocol ID
REC/RCRS/20/1005 Samiah Sarwar
Status last verified
Oct 2020
First submitted
19 Oct 2020
Last updated
28 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22356003

  • 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.

    PubMed 29035179

  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

    PubMed 20699159

  • 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.

    PubMed 19303469

  • 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.

    PubMed 28808025

  • 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.

    PubMed 26619838

  • 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.

    PubMed 27746495

  • 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.

    PubMed 21266638

  • 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.

    PubMed 16121763

  • 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.

    PubMed 26795974

  • 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.

    PubMed 10197166

  • 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.

    PubMed 26308705

  • Sharma L. Local factors in osteoarthritis. Curr Opin Rheumatol. 2001 Sep;13(5):441-6. doi: 10.1097/00002281-200109000-00017.

    PubMed 11604602

Questions about this trial

What is this clinical trial studying?

A study testing Traditional physical therapy and patient education manual +traditional physical therapy in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale(VAS) (time frame: 4th day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04598126, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.

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Clinical Trial NCT04598126 | AzTrials