- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Johar pain relief center ,Lahore
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain by numeric pain rating scale
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Range of motion by universal goniometer
Tidsramme: 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.
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Functional disability by WOMAC index
Tidsramme: 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.
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Baseline, 6th week and 12th week post intervention.
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GIU/REC/26-32
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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