Effects of Pressure Biofeedback Training Versus Bolster Foam Roll Training for Pain, Muscles Activation, and Quality of Life Among Knee Osteoarthritis Patients
2026年7月23日 更新者：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.
調査の概要
状態
募集
詳細な説明
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
研究の種類
介入
入学 (推定)
48
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sahar Fatima, Sidra Principal Investigator
- 電話番号：+923271202200
- メール：sahar.fatima@ubas.edu.pk
研究連絡先のバックアップ
- 名前：Dr. Shoaib Waqas Waqas
研究場所
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Lahore、パキスタン、54000
- 募集
- Lahore University of Biological and Applied Sciences
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コンタクト：
- sahar fatima
- 電話番号：03344399403
- メール：sahar.fatima@ubas.edu.pk
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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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研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Intensity assessed via Numeric Pain Rating Scale (NPRS)
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：WHO、Lahore University of Biological and Applied Sciences
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月1日
一次修了 (推定)
2026年8月15日
研究の完了 (推定)
2026年10月15日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年7月23日
最初の投稿 (実際)
2026年7月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月28日
QC基準を満たした最後の更新が送信されました
2026年7月23日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。