Protocol summary

Study aim
The aim of this study is to evaluate and compare the effects of fish oil supplementation and strengthening exercises on pain relief, joint function, inflammation, and overall quality of life in individuals with osteoarthritis.
Design
Pragmatic, community based, parallel group, double blinded, randomized controlled trial. Total 95 patients will be enrolled. Patients who met our inclusion criteria will be randomized into three groups.
Settings and conduct
Muhammad physical therapy clinic and rehabilitation center, Multan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Clinically diagnosed knee OA (Grade II–III, based on the Kellgren-Lawrence scale),moderate pain severity (VAS score 4–6 at baseline),able to perform exercises and follow instructions. Exclusion criteria: Severe OA requiring surgery, allergies to fish oil or vegetarian individuals unwilling to consume fish products, current use of omega-3 supplements or structured physical therapy for OA,significant comorbid conditions (e.g., rheumatoid arthritis, uncontrolled diabetes, cardiovascular diseases).
Intervention groups
Group 1: Fish oil supplementation ( 1,000 mg fish oil capsule taken twice daily for 12 weeks.) Group 2:Strengthening exercises (Isometric Contractions: Static quadriceps contraction held for 5–10 seconds, repeated 10–15 times per session. Isotonic Strengthening exercise: Partial squats and leg raises with incremental resistance over time) Group 3:Combined intervention (Fish oil + Strengthening exercises)
Main outcome variables
Knee X rays; Western Ontario and McMaster Universities Osteoarthritis Index scale; Numeric Pain Rating Scale; Pain Catastrophizing Scale; Knee Range of Motion (goniometry); Knee injury outcome (KOOS); Muscle strength (dynamometer); Quality of life (SF-36); C-reactive protein; Interleukin-6

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N10
Registration date: 2024-12-21, 1403/10/01
Registration timing: retrospective

Last update: 2024-12-21, 1403/10/01
Update count: 0
Registration date
2024-12-21, 1403/10/01
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
2024-01-07, 1402/10/17
Expected recruitment end date
2024-04-07, 1403/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fish Oil Supplementation vs Knee Strengthening Exercises: A Comparative Study in Knee Osteoarthritis Management
Public title
Fish Oil Supplementation vs Knee Strengthening Exercises: Knee Osteoarthritis Management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinically diagnosed knee OA (Grade II–III, based on the Kellgren-Lawrence scale). - - Moderate pain severity Able to perform exercises and follow instructions
Exclusion criteria:
Severe OA requiring surgery Allergies to fish oil or vegetarian individuals unwilling to consume fish products. Current use of omega-3 supplements or structured physical therapy for OA Significant comorbid conditions (e.g., rheumatoid arthritis, uncontrolled diabetes, cardiovascular diseases).
Age
From 40 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 95
Randomization (investigator's opinion)
Randomized
Randomization description
This randomization will be done by computer-generated numbers to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Bosan Road
City
Multan
Postal code
66000
Approval date
2024-12-03, 1403/09/13
Ethics committee reference number
MIMAS/67/26/IAK

Health conditions studied

1

Description of health condition studied
Knee osteroarthritis
ICD-10 code
M19.0
ICD-10 code description
Primary osteoarthritis of other joints

Primary outcomes

1

Description
Osteophytes
Timepoint
12 weeks
Method of measurement
Knee Xray

2

Description
Pain, stiffness and ADLs
Timepoint
12 weeks
Method of measurement
NPRS and WOMAC Scale

3

Description
Knee ROM
Timepoint
12 Weeks
Method of measurement
Goniometry

Secondary outcomes

1

Description
Knee injury outcome
Timepoint
12 weeks
Method of measurement
Knee injury outcome score (KOOS)

2

Description
Quality of life
Timepoint
12 weeks
Method of measurement
SF-36

Intervention groups

1

Description
Group A: Fish Oil Supplementation, Dosage: 1,000 mg fish oil capsule taken twice daily for 12 weeks.
Category
Treatment - Drugs

2

Description
Group B: Strengthening Exercises, Supervised physiotherapy sessions three times a week for the first four weeks., Home-based exercises with detailed written and visual instructions for the remaining eight weeks. - Exercise program:Isometric Contractions:Static quadriceps contraction held for 5–10 seconds, repeated 10–15 times per session. Isotonic Strengthening:** Partial squats and leg raises with incremental resistance over time.
Category
Rehabilitation

3

Description
Group C: Combined Intervention, Participants will receive both fish oil supplementation and strengthening exercises as per the respective protocols.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad Rehabilitation Centre, Multan
Full name of responsible person
Komal Ammar Bukhari
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
komalbukhari608@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Qurat-Ul-Ain
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
qain0635@gmail.com
Grant name
Student Fund
Grant code / Reference number
MIMAS/09/10/Amna
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Proportion provided by this source
70
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
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
Maliha Khalid Khan
Position
med_doctor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
Email
malihatareen1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture Multan
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
Old shuja Abad road Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Amna Iftikhar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 300 6325074
Email
iftikharamna61@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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