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Comparison Between Foot Segment Mulligan Mobilization and Ilium Mulligan Mobilization in Treatment Patellofemoral Pain Patients With Flatfeet: a Randomized Controlled Comparative Study (PFP)

2026年9月2日 更新者:Labib Mousa Labib Ghali、Cairo University

Targeting the Lower-Limb Kinetic Chain in Patellofemoral Pain: A Randomized Comparison of Foot and Ilium Mulligan Mobilization Combined With Hip-Knee Focused Exercises

This three-arm, parallel-group randomized controlled trial will investigate the comparative effects of adding Mulligan foot-segment mobilization or Mulligan ilium mobilization to a standardized hip-knee focused exercise program in patients with patellofemoral pain and foot pronation. The study will compare these interventions with hip-knee focused exercises alone over a 4-weeks intervention period. The primary outcomes will be pain intensity and functional status, while secondary outcomes will include lower-limb muscle strength, dynamic knee valgus, pelvic tilt angle, and foot pronation.

調査の概要

詳細な説明

Patellofemoral pain is a common musculoskeletal condition characterized by pain around or behind the patella that is aggravated by activities such as squatting, stair negotiation, running, and prolonged sitting. Although local knee impairments may contribute to symptoms, factors throughout the lower-limb kinetic chain may also influence patellofemoral mechanics and clinical presentation.

Foot pronation may alter lower-limb biomechanics during weight-bearing activities and may contribute to changes in tibial and femoral movement. Proximal factors, including pelvic alignment and dynamic knee valgus, may also influence lower-limb loading and patellofemoral joint mechanics. Exercise therapy targeting the hip and knee is commonly used for the management of patellofemoral pain; however, it may not fully address kinetic-chain impairments in patients presenting with concomitant foot pronation.

This study will evaluate whether adding Mulligan mobilization directed toward either the distal foot segment or the proximal ilium/pelvic segment provides additional clinical and biomechanical benefits when combined with a standardized hip- and knee-focused exercise program.

Participants with patellofemoral pain and clinically relevant foot pronation will be screened according to predefined eligibility criteria and randomly allocated to one of three parallel groups:

Foot Mulligan Mobilization Group: Participants will receive standardized hip- knee focused therapeutic exercises combined with Mulligan mobilization directed toward the foot segment.

Ilium Mulligan Mobilization Group: Participants will receive the same standardized hip- knee focused therapeutic exercises combined with Mulligan mobilization directed toward the ilium/pelvic segment.

Control Group: Participants will receive the standardized hip- knee focused therapeutic exercise program alone.

The intervention period will last 4 weeks. Outcome measures will be assessed at baseline and immediately after completion of the intervention.

The primary outcomes will be pain intensity, assessed using the Visual Analogue Scale (VAS), and functional status, assessed using the Anterior Knee Pain Scale (AKPS). Secondary outcomes will include hip and knee muscle strength assessed using a handheld dynamometer, dynamic knee valgus assessed using photogrammetric analysis and Kinovea motion-analysis software, pelvic tilt angle assessed using a PALM/pelvic inclinometer, and foot posture assessed using the Foot Posture Index (FPI).

The study will primarily examine changes over time and differences among the three treatment groups, with particular attention to the group-by-time interaction. Appropriate statistical analyses will be performed based on the distribution and characteristics of the collected data, with statistical significance set at p < 0.05.

The study aims to determine whether targeting the distal or proximal segment of the lower-limb kinetic chain provides greater additional benefit when combined with hip-knee focused exercises in patients with patellofemoral pain and foot pronation.

研究の種類

介入

入学 (推定)

90

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

研究連絡先のバックアップ

  • 名前:Samah H Nagib, PhD
  • 電話番号:00962 776671425
  • メール:s.nagib@zuj.edu.jo

研究場所

      • Amman、ヨルダン、11733
        • Al-Zaytoonah University of Jordan
        • コンタクト:

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Age of the subjects between 18-35 years
  2. BMI was from 18.5 to ≤ 29.5 Kg/m² .
  3. Anterior or retro patellar knee pain for at least 6 weeks duration.
  4. Foot posture index score from +6 to + 12.
  5. Sagittal plane innominate tilt angle more than 8 degrees.
  6. Pain elicited at least by two of the following four screening tests; (i) isometric muscle contraction with slight bent knee,(ii) palpation of the patella, (iii) patellar compression against the femoral bone (iv) active resisted knee extension.
  7. Pain provoked by at least two of the following activities: running, walking, hopping, squatting, stair negotiation, kneeling, or prolonged sitting

Exclusion Criteria:

  1. Meniscal or other intra-articular pathologic conditions; cruciate or collateral ligament involvement.
  2. A history of traumatic patellar subluxation or dislocation..
  3. Previous surgery in the knee, ankle and hip joints.
  4. Knee, ankle and hip joints osteoarthritis.
  5. Taking non-steroidal anti-inflammatory drugs or corticosteroids within 24 hours before the test.
  6. History of brain injury or vestibular disorder within the last 6 months.
  7. Pregnant female.

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Group A: Foot segment Milligan mobilization group
mobilization with movement for talonavicular and talocrural joint + Hip-knee focused exercises

Mobilization with movement of the foot segment First, a dorsal glide of the talonavicular joint will be combined with plantarflexion and inversion of the foot.

Second, a posterior glide of the talocrural joint will be applied in combination with the corresponding active ankle dorsiflexion.

Both mobilization techniques will be applied for 10 repetitions/ 3 sets

他の名前:
  • Mulligan mobilization of the foot segment

Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle.

The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators.

The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.

他の名前:
  • conventional hip-knee focused exercises
実験的:Group B: Ilium Milligan mobilization group
mobilization with movement of ilium + Hip-knee focused exercises

Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle.

The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators.

The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.

他の名前:
  • conventional hip-knee focused exercises
the patients will be in prone position with their hands at shoulder level, and the therapist will stand on the opposite side of the mobilized ilium. The therapist will stabilize the sacrum with the medial aspect of one hand, place the fingers of the other hand under the anterior superior iliac spine, and then will pull the ilium in posterior translation and rotation in relation to the sacrum. Next, the patient will be asked to perform 10 pain-free press-ups by extending the elbows. The mobilization included 3 sets with 10 repetitions for each set and a 30-s rest in between.
アクティブコンパレータ:Group C: Control group
Hip-knee focused exercises only

Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle.

The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators.

The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.

他の名前:
  • conventional hip-knee focused exercises

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
Function measured by Anterior Knee Pain Scale
時間枠:baseline and after 4 weeks
Anterior Knee Pain Scale (AKPS) It is a self-administered, weighted questionnaire that examines 13 different items including pain and functionality and a maximum score of 100 points, with higher scores indicating better lower extremity function. It documents response to six activities associated specifically with AKPS (walking, running, jumping, climbing stairs, squatting and sitting for prolonged period with knee bent). This scale has demonstrated high test-retest reliability and is considered a good and valid detector for significant changes after treatment of patients with PFPS.
baseline and after 4 weeks
Pain measured by Numeric pain rating scale (NPRS)
時間枠:baseline and after 4 weeks
Numeric pain rating scale (NPRS) The numeric pain rating scale ranges from 0 to 10 points, where 0 represents no pain and 10 represents the worst possible suffering. Its ICC which measures the reliability of test-retests, has been 0.76, indicating that it is a reliable measure of pain intensity.
baseline and after 4 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Muscle strength by hand-held dynamometer
時間枠:baseline and after 4 weeks

This device is valid and reliable in assessment of muscle strength during the dynamic movement and also during the isometric contraction of the muscles with intra-rater correlation coefficient (ICC ≥0.75).

It used to assess the isometric muscle strength of hip and knee joint in patient with PFPS by using a calibrated Nicholas hand-held dynamometer (Lafayette Instrument Company, Lafayette, IN, USA) which characterized by good to excellent interrater and intra-rater reliability

baseline and after 4 weeks
Pelvic tilt angle by Palpation Meter device (PALM)
時間枠:baseline and after 4 weeks
Palpation meter (PALM) is a pelvic leveling tool that blends inclinometer and caliper functions, it's made by performance Attainment Associates (Performance Attainment Associates, 3600 LaBore, Suite 6, Saint Paul, MN 55110 - 4144 USA). It's developed to measure pelvic torsion, pelvic tilting and leg length discrepancy (LLD). The body of the PALM contains a bubble level in a semi-circular arc with one-degree graduations that range from zero degree to thirty degrees on either side of the midline. The caliper arms are placed in bony landmarks and the degree of deviation from horizontal is read from the inclinometer. Interclass correlation coefficient suggests that intratester reliability was high for frontal plane measure (0.84) and sagittal plane measures (0.98) and intertester reliability was high for sagittal plane measures (0.89) but moderate for frontal plane measures (0.65).
baseline and after 4 weeks
foot pronation by Foot Posture Index (FPI)
時間枠:baseline and after 4 weeks

It is a clinical tool that measures foot posture in multiple planes and anatomical segments. Its correlation coefficient showed excellent intra-rater reliability (ICC = 0.89-0.96) which indicates a very good FPI-6 reliability in the foot assessment. The FPI-6 is a valid cheap non-invasive instrument which in a fast and simple way allows one to conduct a comprehensive evaluation of many parameters of the foot's construction without the need to apply complex and time-consuming measurement methods.

Foot posture index determined either the foot was pronated or not based on the scores of its six items (talar head palpation curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment). Each of the six items of FPI-6 was evaluated on a scale from -2 to +2. The neutral position of the foot is classified as 0, a positive score is foot pronation and negative score is foot supination

baseline and after 4 weeks

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。

スポンサー

捜査官

  • 主任研究者:Labib M Ghali, PhD、Cairo University
  • スタディチェア:Samah H Nagib, PhD、Al-Zaytoonah University of Jordan

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 (推定)

2026年10月1日

一次修了 (推定)

2027年11月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年9月2日

QC基準を満たした最初の提出物

2026年9月2日

最初の投稿 (実際)

2026年9月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月8日

QC基準を満たした最後の更新が送信されました

2026年9月2日

最終確認日

2026年8月1日

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