- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07593599
Comparing the Effects of Macquarie Injury Management Group Protocol and Targeted Knee Exercise Program on Pain, Range of Motion and Functional Disability in Patients With Grade II Knee Osteoarthritis
Comparative Effects of Macquarie Injury Management Group Protocol and Targeted Knee Exercise Program on Pain, Range of Motion and Functional Disability in Patients With Grade II Knee Osteoarthritis
The goal of this clinical trial is to learn if the macquire injury management group protocol and targeted knee exercise program works to treat knee osteoarthritis grade 2.This clinical trial compares the effects of macquire injury management group protocol and targeted knee exercise program on pain and range of motion and functional disability in patients with knee osteoarthritis grade 2.Adults with knee osteoarthritis grade 2 were included in this study. A total of 84 participants were divided into two groups with 42 patients in each group.
One group received macquire injury management group protocol and the other group received targeted knee exercise program. Pain was assessed using the numeric pain rating scale and functional disability was measured using WOMAC index. Range of motion was also evaluated before and after treatment by universal goniometer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA), the most prevalent type of arthritis, is the foremost cause of disability. Knee OA mainly affects the synovial membrane, bones, and cartilage of the joint. The synovial membrane is a smooth lining that protects the joint. Conservative management through manual therapy is widely used, but comparative effectiveness of different techniques remains unclear. This randomized clinical trial was designed to compare the effects of macquire injury management group protocol and targeted knee exercise program on pain and range of motion and functional disability in patients with knee osteoarthritis grade 2.A total of 84 participants diagnosed with knee osteoarthritis grade 2 were recruited . All the screened and willing participants were randomly allocated to two groups by lottery method with 42 patients in each group. (Group A: Experimental group /MIMG group, Group B: Comparative Group / CK group) .Group A received macquire injury management group protocol . The MIMG Knee Protocol is known for its emphasis on soft tissue mobilization. The patients were made to lie down in a supine position and their knee joints were in an extended position during the treatment. In order to perform the soft tissue mobilization, the physiotherapist gently worked on the soft tissues of the knee joint for about two to three minutes using both his hands. In addition to the manual treatment method, the patients also underwent 45 minutes of physical therapy exercises . Group B received targeted knee exercise program , was aimed at improving the strength, proprioception, and stability of the knee joint. It comprised of progressively increasing knee exercises for the quadriceps (for example, straight leg raises and terminal knee extensions), hip abductors, and hamstrings. In addition to these exercises, there were also exercises to increase the stability of the joint by means of proprioceptive exercises involving single leg standing and dynamic stability exercises. Functional exercises including sit-to-stand and step up were also included. The intervention period lasted for 12 weeks with 3 sessions per week. Outcome measures were assessed at baseline and post-intervention.
Pain was assessed using the numeric pain rating scale and functional disability was measured using WOMAC index. Range of motion was also evaluated before and after treatment by universal goniometer. The primary objective of this study is To determine the effects of Macquire Injury Management Group protocol and Targeted Knee Exercise Program on Pain, Range of Motion and Functional Disability in Patients with Grade II Knee Osteoarthritis. The findings will help clinicians select the most effective manual therapy approach for managing Grade II Knee Osteoarthritis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Johar pain relief center ,Lahore
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both female and male subjects aged between 40 to 60 year
- Diagnosed knee osteoarthritis, Grade II by Kellegren Lawrence.
Exclusion Criteria:
- Any surgical procedure done for lower extremity
- Any infection
- Post traumatic knee stiffness
- Secondary knee osteoarthritis
- Peripheral vascular disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: macquire injury management group Protocol (MIMG )
The macquire injury management group Protocol is known for its emphasis on soft tissue mobilization.
The patients were made to lie down in a supine position and their knee joints were in an extended position during the treatment.
In order to perform the soft tissue mobilization, the physiotherapist gently worked on the soft tissues of the knee joint for about two to three minutes using both his hands.
In addition to the manual treatment method, the patients also underwent 45 minutes of physical therapy exercises
|
The patients were made to lie down in a supine position and their knee joints were in an extended position during the treatment.
In order to perform the soft tissue mobilization, the physiotherapist gently worked on the soft tissues of the knee joint for about two to three minutes using both his hands.
In addition to the manual treatment method, the patients also underwent 45 minutes of physical therapy exercises
|
|
Active Comparator: Targeted knee exercise program
targeted knee exercise program , was aimed at improving the strength, proprioception, and stability of the knee joint.
It comprised of progressively increasing knee exercises for the quadriceps (for example, straight leg raises and terminal knee extensions), hip abductors, and hamstrings.
In addition to these exercises, there were also exercises to increase the stability of the joint by means of proprioceptive exercises involving single leg standing and dynamic stability exercises.
Functional exercises including sit-to-stand and step up were also included.
The intervention period lasted for 12 weeks with 3 sessions per week.
|
It comprised of progressively increasing knee exercises for the quadriceps (for example, straight leg raises and terminal knee extensions), hip abductors, and hamstrings.
In addition to these exercises, there were also exercises to increase the stability of the joint by means of proprioceptive exercises involving single leg standing and dynamic stability exercises.
Functional exercises including sit-to-stand and step up were also included.
The intervention period lasted for 12 weeks with 3 sessions per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain by numeric pain rating scale
Time Frame: Baseline , 6th week and 12th week post intervention
|
The level of pain was assessed using the Numeric Pain Rating Scale (NPRS), which is a simple and widely used tool for evaluating pain intensity.
In this scale, individuals are asked to rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain.
Based on the categorization by Fiddiyanti et al. (2024), pain scores ranging from 1-3 are considered mild pain, 4-6 indicate moderate pain, and 7-10 represent severe pain.
This scale provides a quick and reliable measure of a person's subjective pain experience.
|
Baseline , 6th week and 12th week post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion by universal goniometer
Time Frame: Baseline, 6th week and 12th week post intervention.
|
Range of motion was measured by Universal goniometer (UG) is commonly used as a standard method to evaluate Range of motion (ROM) as part of joint motions.
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Baseline, 6th week and 12th week post intervention.
|
|
Functional disability by WOMAC index
Time Frame: Baseline, 6th week and 12th week post intervention.
|
Functional disability was measured by WOMAC index, is a scale consisting of 24 items in 3 domains.
Pain- 5 items, Stiffness -2 items, Physical function- 17 items.
Total score ranges from 0 to 96.
Each item is scored 0(none), 1(mild), 2(moderate), 3(severe) and 4(extreme).
Average of the score is obtained by dividing the total score with 96 and multiplying with 100.
|
Baseline, 6th week and 12th week post intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIU/REC/26-32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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