Effects of Pressure Biofeedback Training Versus Bolster Foam Roll Training for Pain, Muscles Activation, and Quality of Life Among Knee Osteoarthritis Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorLahore University of Biological and Applied Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient diagnosis with Grade II knee Osteoarthritis.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • pressure Biofeedback Training

    Other intervention

    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).

  • Bolster Foam Roll Training

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Pressure Biofeedback TrainingExperimental treatment 1 intervention
Group B: Bolster Foam Feedback TrainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity assessed via Numeric Pain Rating Scale (NPRS)

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

Time frame
Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
2

Functional Status and Quality of Life assessed via WOMAC Index

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

Time frame
Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
3

Quadriceps Muscle Activation assessed via Modified Sphygmomanometer Test (MST)

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

Time frame
Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)

Secondary outcomes

Other outcomes

Sponsors and contacts

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