- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Punjab Province
-
Lahore, Punjab Province, Pákistán, 54000
- Johar pain relief center ,Lahore
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain by numeric pain rating scale
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Range of motion by universal goniometer
Časové okno: 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.
|
Baseline, 6th week and 12th week post intervention.
|
|
Functional disability by WOMAC index
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GIU/REC/26-32
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .