Knee Osteoarthritis (Knee OA), Knee Arthritis, Osteoarthritis
Conditions
Brief summary
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.
Detailed description
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
Interventions
OTHERBolster Foam Roll Training
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.
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).
Sponsors
Lahore University of Biological and Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This will be a single-blinded study where the outcome assessor will be kept completely blinded to the participants' group allocation. Due to the visible nature of the feedback tools (gauge versus foam), the intervention administrators and the patients cannot be blinded
Intervention model description
This is a randomized clinical trial utilizing a two-arm parallel group design. Participants will be randomly assigned in a 1:1 ratio to receive either Pressure Biofeedback training or Bolster Foam Roll training
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity assessed via Numeric Pain Rating Scale (NPRS) | Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12) | 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 |
| Functional Status and Quality of Life assessed via WOMAC Index | Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12) | 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 |
| Quadriceps Muscle Activation assessed via Modified Sphygmomanometer Test (MST) | Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12) | 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 |
Countries
Pakistan
Contacts
CONTACTSahar Fatima, Sidra Principal Investigator
CONTACTDr. Shoaib Waqas Waqas
PRINCIPAL_INVESTIGATORWHO
Lahore University of Biological and Applied Sciences
Outcome results
None listed