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Patient Education Manual on Patients With Knee Osteoarthritis.

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Traditional physical therapy
patient education manual +traditional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Patient education manual, Knee O.A, Pain, ROM

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation department CMH(Combined military hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional physical therapy

patient education manual +traditional physical therapy

Arm Description

Traditional physical therapy

Patient education manual +traditional physical therapy

Outcomes

Primary Outcome Measures

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]).

Secondary Outcome Measures

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.

Full Information

First Posted
October 19, 2020
Last Updated
October 26, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04598126
Brief Title
Patient Education Manual on Patients With Knee Osteoarthritis.
Official Title
Effects of Patient Education Manual on Pain, Range of Motion and Function in Patient With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Patient education manual, Knee O.A, Pain, ROM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional physical therapy
Arm Type
Active Comparator
Arm Description
Traditional physical therapy
Arm Title
patient education manual +traditional physical therapy
Arm Type
Experimental
Arm Description
Patient education manual +traditional physical therapy
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy
Intervention Description
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/
Intervention Type
Other
Intervention Name(s)
patient education manual +traditional physical therapy
Intervention Description
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/
Primary Outcome Measure Information:
Title
Visual analogue scale(VAS)
Description
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]).
Time Frame
4th day
Secondary Outcome Measure Information:
Title
WOMAC osteoarthritis index
Description
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.
Time Frame
4th day
Other Pre-specified Outcome Measures:
Title
ROM Knee flexion ( Flexion Rt)
Description
Changes from the Baseline ROM range of Motion of knee flexion was taken with the Help of Goniometer
Time Frame
4th day
Title
ROM Knee flexion ( Flexion Lt)
Description
Changes from the Baseline ROM range of Motion of knee flexion was taken with the Help of Goniometer
Time Frame
4th day
Title
ROM knee Extension ( extension Rt)
Description
Changes from the Baseline ROM range of Motion of knee extension was taken with the Help of Goniometer
Time Frame
4th day
Title
ROM knee extension ( extension Lt)
Description
Changes from the Baseline ROM range of Motion of knee extension was taken with the Help of Goniometer
Time Frame
4th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil Ur-Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation department CMH(Combined military hospital)
City
Sialkot
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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22356003
Citation
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Patient Education Manual on Patients With Knee Osteoarthritis.

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