Protocol summary

Study aim
To assess the effectiveness of proprioceptive and therapeutic exercises on pain, stiffness and physical functioning among the patients with knee osteoarthritis.
Design
A Randomized control Trial with parallel group design of 54 patients, enrolled between August 2022 and October 2022, and followed for one month.
Settings and conduct
District head quarter hospital Mandi Baha ud Din and City hospital Jalal pur Jattan. The participants were chosen through lottery method (single blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 45-60 years old patients diagnosed of knee osteoarthritis. Exclusion criteria: Patients with diagnosed osteoporosis, history of traumatic injury and surgery of knee joint (within last 6 months) and Patients of knee osteoarthritis with recommended surgery of knee.
Intervention groups
After 20 minutes of local heating Group A received proprioceptive exercises. Exercises included One leg balance: every patient stood on the affected leg with upright posture with hip and knee flexion on the other leg and ankle joint were off from the surface. Two repetitions of this position were held for 1 minute followed by rest for 10 to 20 seconds. Blind advanced one leg balance: This was the same as the one leg stance except that the patient was commanded to completely close his/her eyes during the exercise. Group B was treated with therapeutic exercises. Straight leg raise (SLR), pillow squeeze, heel raise, and quadriceps setting. The exercises were done in three sets of 5 repetitions with a 3-min rest between the Each patient was treated four times a week for a period of 4 weeks. Pre-treatment, 2nd week and 4th week pain intensity, joint stiffness and physical difficulties were assessed by using Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire.
Main outcome variables
Pain, Stiffness and Physical Functioning

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201021049094N3
Registration date: 2022-12-17, 1401/09/26
Registration timing: retrospective

Last update: 2022-12-17, 1401/09/26
Update count: 0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Raheela Kousar
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 53 3589155
Email address
raheelasaleem10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-09, 1401/05/18
Expected recruitment end date
2022-12-09, 1401/09/18
Actual recruitment start date
2022-08-09, 1401/05/18
Actual recruitment end date
2022-12-09, 1401/09/18
Trial completion date
2022-12-10, 1401/09/19
Scientific title
Effectiveness of proprioceptive and therapeutic exercises on pain, stiffness and functional disability among the patients with knee osteoarthritis
Public title
Effectiveness of proprioceptive and therapeutic exercises on pain, stiffness and functional disability among the patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
45-60 years old patients diagnosed of knee osteoarthritis
Exclusion criteria:
Patients with diagnosed osteoporosis History of traumatic injury and surgery of knee joint (within last 6 months) History of central or peripheral neuropathy Patients of knee osteoarthritis with recommended surgery of knee Patients with active synovitis
Age
From 45 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
Sample size
Target sample size: 54
Actual sample size reached: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by lottery method. Allocation concealment through sealed envelope. In a bowl we put closed slips of group A and group B. Participants fulfilling inclusion criteria will randomly pick up groups and then allocated through sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
the patients were blind about their exercise group as they were not known ethier they were the member of Group A or Group B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of University of Lahore
Street address
University of Lahore, chenab campus adjacent to chenab bridge, Gujrat.
City
Gujrat
Postal code
50700
Approval date
2022-08-16, 1401/05/25
Ethics committee reference number
REG/GRT/22/AHS-85

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis: Knee OA is the most common form of arthritis related to functional disabilities in middle-aged and older adults. Clinically complaints of pain, decreased muscle strength, joint instability, joint stiffness, and proprioceptive deficits are exhibited by patients with degenerative knee OA, all of which lead to a decline or loss of function.
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Pain
Timepoint
Before intervention and 2, 4 weeks after intervention.
Method of measurement
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire

2

Description
Stiffness
Timepoint
Before intervention and 2, 4 weeks after intervention.
Method of measurement
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire

3

Description
Physical Functioning
Timepoint
Before intervention and 2, 4 weeks after intervention.
Method of measurement
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: Proprioceptive Exercises (baseline: heating therapy)
Category
Rehabilitation

2

Description
Intervention group B: Therapeutic Exercises (base line: heating therapy)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
D.H.Q hospital M.B.Din (Physical Therapy Department)
Full name of responsible person
Nosheen Sultan
Street address
D.H.Q hospital, old block jail road, M.B.Din
City
Mandi Baha ud Din
Postal code
50400
Phone
+92 349 9740755
Email
Nosheensultan1957@gmail.com

2

Recruitment center
Name of recruitment center
City hospital Jalal pur Jattan (Physical Therapy Department)
Full name of responsible person
Nosheen Sultan
Street address
City hospital tanda chok Jalal pur Jattan
City
Gujrat
Postal code
50780
Phone
+92 349 9740755
Email
Nosheensultan1957@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Self
Full name of responsible person
Nosheen Sultan
Street address
Heigherwala khurd, Tehsil: Phalia Distt: Mandi baha ud Din.
City
PAHRIANWALI ADD
Postal code
50300
Phone
+92 349 9740755
Email
Nosheensultan1957@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Self
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
University of Lahore Chenab campus Gujrat
Full name of responsible person
Nosheen Sultan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Heigherwala khurd, via pahrianwali tehsil: phalia Distt: M.B.Din.
City
Mandi Baha ud Din
Province
Punjab
Postal code
50300
Phone
+92 349 9740755
Email
Nosheensultan1957@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Nosheen Sultan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Heigherwala khurd, via Pahrianwali Tehsil: Phalia Distt: M.B.Din.
City
Mandi Baha ud Din
Province
Punjab
Postal code
50300
Phone
+92 349 9740755
Email
Nosheensultan1957@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Lahore, Chenab Campus Gujrat.
Full name of responsible person
Nosheen Sultan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Heigherwala khurd, via Pahrianwali tehsil: Phalia Distt: M.B.Din.
City
Mandi Baha ud Din.
Province
Punjab
Postal code
50300
Phone
+92 349 9740755
Email
nosheensultan1957@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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