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

NCT07731737 | Recruiting

• 1 other identifier: UBAS/ERB/26/04/017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis (Knee OA); Knee Arthritis, Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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

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

• 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

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

• 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

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

Study Arms (2)

Pressure Biofeedback Training

EXPERIMENTAL

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

Other: pressure Biofeedback Training

Bolster Foam Feedback Training

ACTIVE COMPARATOR

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

Other: Bolster Foam Roll Training

Interventions

pressure Biofeedback Training OTHER

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).

Pressure Biofeedback Training

Bolster Foam Roll Training OTHER

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.

Bolster Foam Feedback Training

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

Lahore University of Biological and Applied Sciences

Lahore, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• WHO

  Lahore University of Biological and Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahar Fatima, Sidra Principal Investigator

CONTACT

+923271202200; sahar.fatima@ubas.edu.pk

Dr. Shoaib Waqas Waqas

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

PA (1)