History
# Registration date Revision Id
4 2024-09-19, 1403/06/29 315233
3 2023-12-12, 1402/09/21 288832
2 2023-08-30, 1402/06/08 277395
1 2023-08-29, 1402/06/07 277029
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  • General information

    empty
    Only the name of the organization sponsor/ Funding source was changed.
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Muhammad Institute of Medical and Allied Sciences, Multan
    Name of organization / entity - Persian:
    Full name of responsible person - English: Imran Ahmad Khan
    Full name of responsible person - Persian:
    Street address - English: HBL street
    Street address - Persian:
    City - English: Multan
    City - Persian:
    Province: Punjab
    Country: Pakistan
    Postal code: 66000
    Phone: +92 333 6120602
    Fax:
    Email: imranahmadkhandurrani@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Muhammad Nawaz Sharif University of Agriculture
    Name of organization / entity - Persian:
    Full name of responsible person - English: Imran Ahmad Khan
    Full name of responsible person - Persian:
    Street address - English: Agriculture Complex, Old Shuja Abad Rd,
    Street address - Persian:
    City - English: Multan
    City - Persian:
    Province: Punjab
    Country: Pakistan
    Postal code: 66000
    Phone: +92 333 6120602
    Fax:
    Email: imranahmadkhandurrani@gmail.com
    Web page address:
    08/26/2023/MIMAS
    08/26/2023/MNSUAM
    Private
    Public
    Muhammad Institute of Medical and Allied Sciences, Multan
    Muhammad Nawaz Sharif University of Agriculture
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Muhammad Institute of Medical and Allied Sciences Multan
    Name of organization / entity - Persian:
    Full name of responsible person - English: Maliha Khalid Khan
    Full name of responsible person - Persian:
    Position - English: Demonstrator
    Position - Persian:
    Latest degree: med_doctor
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hbl street, Sabsazar Multan
    Street address - Persian:
    City - English: Multan
    City - Persian:
    Province: Punjab
    Province - English: Punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 66000
    Phone: +92 333 6120602
    Mobile: +92 333 6120602
    Fax:
    Email: imran.ahmad@mnsuam.edu.pk
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Muhammad Nawaz Sharif University of Agriculture
    Name of organization / entity - Persian:
    Full name of responsible person - English: Imran Ahmad Khan
    Full name of responsible person - Persian:
    Position - English: Coordinator Department of Pharmacy
    Position - Persian:
    Latest degree: phd
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Agriculture Complex, Old Shuja Abad Rd,
    Street address - Persian:
    City - English: Multan
    City - Persian:
    Province: Punjab
    Province - English: Punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 66000
    Phone: +92 333 6120602
    Mobile: +92 333 6120602
    Fax:
    Email: imranahmadkhandurrani@gmail.com
    Web page address:

Protocol summary

Study aim
The purpose of the present study to evaluate the effects of mulligan stretching (knee extension hamstring flexibility) and proprioceptive exercises in knee OA patients and effect of exercises to relive pain, stiffness and improve range of motion and functional ability of patients suffering from knee OA.
Design
The randomized clinical trial, double-blinded study used to investigate the effect of propioceptive and mulligan exercises in knee osteoarthritis. The study will be conducted under the strict supervision of pharmacist, physiotherapist, radiologist and medical doctor.
Settings and conduct
Conducted at Muhammad physical therapy clinic and rehabilitation centre, Multan, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Age 35-65 years 2) Patients with diagnosed OA 3) Both genders 4) Patients with swelling in knee joints 5) Patients with pain in knee joints 6) Patients having difficulty in walking and climbing stairs Exclusion criteria: 1) Vascular neoplasia 2) Fibromyalgia 4) Radiculopathy 5) Neuropathy 6) Tumor 7) Joint fractures 8) Vestibular problems 9) Congenital disorders
Intervention groups
Treatment group A- Treatment regimem is distributed in 6-week period thrice per week exercise sessions lasted for 30 minutes treated with proprioceptive exercises: standing on one leg, knee flexion and extension exercises (sitting position with a chair and Thera Band), walking on heel and toes (with eyes open and closed), half squat). This will increase muscle strength thus decreasing pain and stiffness. Treatment regime distributed in 6-week period twice per week exercise sessions lasted for 15 minutes in group B treated with Mulligan stretching exercise (knee extension hamstrings flexibility). This will increase muscle strength.
Main outcome variables
Increase in ROM and functional ability, decrease in pain and inflammatory load in body.

General information

Reason for update
Only the name of the organization sponsor/ Funding source was changed.
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N2
Registration date: 2023-08-29, 1402/06/07
Registration timing: prospective

Last update: 2023-12-18, 1402/09/27
Update count: 3
Registration date
2023-08-29, 1402/06/07
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-31, 1402/06/09
Expected recruitment end date
2024-03-02, 1402/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARATIVE ANALYSIS OF MULLIGAN AND PROPRICEPTIVE EXERCISES IN KNEE OSTEOARTHRITIS
Public title
MULLIGAN AND PROPRICEPTIVE EXERCISES IN KNEE OSTEOARTHRITIS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 35-65 years Patients with diagnosed OA Both genders Patients with swelling in knee joints Patients with pain in knee joints Difficulty in walking and climbing stairs
Exclusion criteria:
Vascular neoplasia Fibromyalgia Radiculopathy Neuropathy Joint fractures Vestibular problems Congenital disorders Tumor
Age
From 35 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 84
More than 1 sample in each individual
Number of samples in each individual: 2
Samples will be taken before and after treatment
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation concealment occurs and patients will be recruited by using simple randomization through the Lottery method. lottery method carried out through sealed envelopes. Also the data analyser will be kept blind to minimize biasness
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be blinded. Participants will be unaware of the type of treatments that will be evaluated after the completion of the intervention trial. Subjects will be completely unaware of the type and effects of both interventions. And in the same way data analyser will be kept blind by not knowing about the effects and group details
Placebo
Not used
Assignment
Parallel
Other design features
Patients were assessed by radiological finding (x-ray) and by physical assessment and by monitoring of biochemical parameters

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Postal code
66000
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
MIMAS/06/26/Maliha

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis with grade 1,2 and 3
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Pain and functional disability
Timepoint
6 weeks
Method of measurement
Numerical Pain Rating Scale, Pain catastrophizing scale, The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

2

Description
Range of motion
Timepoint
6 weeks
Method of measurement
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Secondary outcomes

1

Description
Inflammatory biomarkers
Timepoint
6 weeks
Method of measurement
Complete blood count (CBC) and interleukins measurement

Intervention groups

1

Description
Intervention group: Group-A Treatment regimem is distributed in 6-week period thrice per week exercise sessions lasted for 30 minutes in group A treated with proprioceptive exercises: standing on one leg, knee flexion and extension exercises (sitting position with a chair and TheraBand), walking on heel and toes (with eyes open and closed), half squat). This will increase muscle strength thus decreasing pain and stiffness.
Category
Treatment - Other

2

Description
Intervention group: Group-B Treatment regimen distributed in 6-week period twice per week exercise sessions lasted for 15 minutes in group B treated with Mulligan stretching exercise (knee extension hamstrings flexibility). This will increase muscle strength.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad physical therapy clinic and rehabilitation center, Multan
Full name of responsible person
Maliha Khalid Khan
Street address
HBL street, near Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
malihatareen1997@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture
Full name of responsible person
Imran Ahmad Khan
Street address
Agriculture Complex, Old Shuja Abad Rd,
City
Multan
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Grant name
Student fund
Grant code / Reference number
08/26/2023/MNSUAM
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Nawaz Sharif University of Agriculture
Proportion provided by this source
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Saman Iqbal
Position
Final year student of DPT
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street, sbzazar station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
034350467357
Email
samaniqbal2019@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture
Full name of responsible person
Imran Ahmad Khan
Position
Coordinator Department of Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Agriculture Complex, Old Shuja Abad Rd,
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Maliha Khalid Khan
Position
Demonstrator
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street, bosan road Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
Email
malihatareen1997@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
The title is COMPARATIVE ANALYSIS OF MULLIGAN AND PROPRICEPTIVE EXERCISES IN KNEE OSTEOARTHRITIS.
When the data will become available and for how long
N/A
To whom data/document is available
N/A
Under which criteria data/document could be used
N/A
From where data/document is obtainable
N/A
What processes are involved for a request to access data/document
N/A
Comments
N/A
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