Effects of Pressure Biofeedback Training Versus Bolster Foam Roll Training for Pain, Muscles Activation, and Quality of Life Among Knee Osteoarthritis Patients
23. července 2026 aktualizováno: Lahore University of Biological and Applied Sciences
Effects of Pressure Biofeedback Training Versus Bolster Foam Roll Training for Pain, Muscle Activation and Quality of Life Among Knee Osteoarthritis Patients
The current study will be a single-blinded, two-arm parallel group randomized clinical trial involving 48 participants.
The trial will compare Pressure Biofeedback training with Bolster Foam Roll training.
Interventions will be delivered three times per week for eight weeks.
The primary outcomes will include pain intensity, functional status, and muscle activation.
Assessments will be conducted at baseline (week 0), mid-intervention (week 4), post-intervention (week 8), and follow-up (week 12).
The study will be conducted at the outpatient departments of Sir Ganga Ram Hospital (SGRH) and Mayo Hospital Lahore.
The hypothesis is that there is a difference between Pressure Biofeedback Training and Bolster Foam Feedback Training regarding pain reduction, muscle activation, and patient-reported quality of life compared to Bolster Foam rolling training among knee osteoarthritis patients.
Přehled studie
Postavení
Nábor
Intervence / Léčba
Detailní popis
Knee Osteoarthritis is a common degenerative joint disease that causes pain, disability, and reduced quality of life.
Grade II knee OA represents a mild but symptomatic stage where targeted rehabilitation can help slow disease progression and improve joint function.
A major challenge in these patients is Arthrogenic Muscle Inhibition (AMI), which limits rehabilitation progress by reducing the normal activation of the quadriceps muscles due to pain and swelling.
This leads to noticeable muscle weakness and difficulty performing functional movements.To counteract AMI, rehabilitation protocols integrate biofeedback mechanisms to enhance motor learning.
A foam bolster is normally used to provide tactile feedback, while a Pressure Biofeedback Unit (PBU) provides a visual target to help patients activate their muscles better.
This study will evaluate whether the addition of a quantifiable visual target (PBU) offers superior clinical efficacy over traditional tactile-based Bolster Foam feedback.A total of 48 participants will be randomly assigned in a 1:1 ratio to either Group A (Pressure Biofeedback) or Group B (Bolster Foam Feedback).
Both groups will undergo 3 supervised sessions per week for 8 weeks.
Each session will last 45 minutes and include a standard baseline conventional exercise protocol.
The groups will differ during the targeted isometric intervention phase, using either a PBU or a bolster foam for feedback.
Outcome measures will be assessed at predefined time points to evaluate changes in pain, function, and muscle activation.
Findings from this trial aim to guide clinical practice by identifying the most effective feedback method for routine rehabilitation
Typ studie
Intervenční
Zápis (Odhadovaný)
48
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Sahar Fatima, Sidra Principal Investigator
- Telefonní číslo: +923271202200
- E-mail: sahar.fatima@ubas.edu.pk
Studijní záloha kontaktů
- Jméno: Dr. Shoaib Waqas Waqas
Studijní místa
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Lahore, Pákistán, 54000
- Nábor
- Lahore University of Biological and Applied Sciences
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Kontakt:
- sahar fatima
- Telefonní číslo: 03344399403
- E-mail: sahar.fatima@ubas.edu.pk
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Patient diagnosis with Grade II knee Osteoarthritis.
Age between 45 and 65 years, encompassing the typical onset of symptomatic OA.
Both genders Male and Female are included.
Symptomatic patients meeting the following American College of Rheumatology criteria: average pain score ≥ 3 in the last week on the numerical rating scale, morning stiffness < 30 min, and joint crepitus
Exclusion Criteria:
History of knee surgery (TKA, HTO, ACLR) or arthroscopy in the affected knee within the last 6 months.
Intra-articular corticosteroid or hyaluronic acid injections within the last 3 months.
Neurological conditions affecting lower limb motor control (e.g., Stroke, Parkinson's, Radiculopathy).
Acute infection, tumor, or fracture around the knee joint.
Severe cognitive impairment or inability to follow visual/tactile cues.
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Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Pressure Biofeedback Training
Participants will receive 45-minute sessions including warm-up and conventional physiotherapy.
For targeted isometric training, participants lie supine with a Pressure Biofeedback Unit airbag under the popliteal fossa inflated to 60 mmHg.
They press the knee downward to move the dial up 20-40 mmHg, holding for 10 seconds across 3 sets of 10 repetitions
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This intervention combines a standard land-based therapeutic exercise protocol with visual feedback for targeted isometric quadriceps activation.
During a 45-minute session, participants first complete warm-up and conventional strengthening exercises (e.g., straight leg raises, hip abduction, step-ups).
For the specific isometric component, participants lie supine with a Pressure Biofeedback Unit (PBU) airbag placed under the popliteal fossa, inflated to a baseline of 60 mmHg.
They are instructed to press the knee downward to increase the dial reading by 20-40 mmHg and hold it steady for 10 seconds.
This is performed for 3 sets of 10 repetitions to counteract Arthrogenic Muscle Inhibition (AMI).
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Aktivní komparátor: Bolster Foam Feedback Training
Participants will receive the same 45-minute sessions with warm-up and conventional physiotherapy.
For targeted isometric training, participants lie supine with a firm high-density foam bolster under the knee.
They are instructed to "crush the foam" into the table to feel the resistance, holding for 10 seconds across 3 sets of 10 repetitions
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Participants will complete a 45-minute exercise session consisting of a warm-up and conventional physiotherapy exercises (straight leg raises, side-lying hip abduction, step-ups, mini-squats, and stretches).
For the targeted isometric component, participants are positioned supine with a firm high-density foam bolster placed under the knee.
They are instructed to "crush the foam" into the table to feel the physical resistance, holding the contraction for 10 seconds.
They will complete 10 repetitions across 3 sets.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pain Intensity assessed via Numeric Pain Rating Scale (NPRS)
Časové okno: Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
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Knee pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).
Participants will rate their current knee pain, as well as their worst and best pain over the last 24 hours, on an 11-point integers scale.
On this scale, 0 indicates "No pain" and 10 indicates "worst pain imaginable
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Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
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Functional Status and Quality of Life assessed via WOMAC Index
Časové okno: Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
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The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be utilized as the primary outcome measure for functional status and disease-specific quality of life.
The index comprises 24 items covering three dimensions: Pain (Score range: 0-20), Stiffness (Score range: 0-8), and Physical Function (Score range: 0-68).
Items are scored on a 5-point Likert scale (0=none to 4=Extreme), where higher aggregate scores indicate greater disability
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Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
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Quadriceps Muscle Activation assessed via Modified Sphygmomanometer Test (MST)
Časové okno: Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
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Quadriceps muscle activation will be assessed using the Modified Sphygmomanometer Test.
A cuff is placed under the popliteal fossa and inflated to a baseline of 40 mmHg.
The patient performs a Maximum Voluntary Isometric Contraction (MVIC), and the peak pressure sustained for 3 seconds is recorded.
The final outcome is the change in pressure (Peak - Baseline) calculated from the average of 3 trials
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Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: WHO, Lahore University of Biological and Applied Sciences
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. května 2026
Primární dokončení (Odhadovaný)
15. srpna 2026
Dokončení studie (Odhadovaný)
15. října 2026
Termíny zápisu do studia
První předloženo
23. července 2026
První předloženo, které splnilo kritéria kontroly kvality
23. července 2026
První zveřejněno (Aktuální)
28. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
28. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UBAS/ERB/26/04/017
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