Effects of Pressure Biofeedback Training Versus Bolster Foam Roll Training for Pain, Muscles Activation, and Quality of Life Among Knee Osteoarthritis Patients
2026년 7월 23일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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
연구 유형
중재적
등록 (추정된)
48
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sahar Fatima, Sidra Principal Investigator
- 전화번호: +923271202200
- 이메일: sahar.fatima@ubas.edu.pk
연구 연락처 백업
- 이름: Dr. Shoaib Waqas Waqas
연구 장소
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Lahore, 파키스탄, 54000
- 모병
- Lahore University of Biological and Applied Sciences
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연락하다:
- sahar fatima
- 전화번호: 03344399403
- 이메일: sahar.fatima@ubas.edu.pk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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아니
설명
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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공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain Intensity assessed via Numeric Pain Rating Scale (NPRS)
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: WHO, Lahore University of Biological and Applied Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 1일
기본 완료 (추정된)
2026년 8월 15일
연구 완료 (추정된)
2026년 10월 15일
연구 등록 날짜
최초 제출
2026년 7월 23일
QC 기준을 충족하는 최초 제출
2026년 7월 23일
처음 게시됨 (실제)
2026년 7월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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