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

July 23, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Dr. Shoaib Waqas Waqas

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • Recruiting
        • Lahore University of Biological and Applied Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Other: pressure Biofeedback Training
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).
Active Comparator: 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
Other: Bolster 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity assessed via Numeric Pain Rating Scale (NPRS)
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lahore University of Biological and Applied Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: WHO, Lahore University of Biological and Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UBAS/ERB/26/04/017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings