Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy
2026年6月12日 更新者：Dr. Javier Bonastre Férez、Universidad Europea de Valencia
Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy
Chronic refractory plantar fasciopathy is a common musculoskeletal condition that can cause persistent heel pain and functional limitations despite conservative treatment. When symptoms do not improve, patients often face the decision between continuing non-surgical management or undergoing surgery. However, direct comparative evidence between these treatment strategies is limited.
This multicenter controlled trial aims to compare the effectiveness of a multimodal conservative intervention consisting of manual therapy and ultrasound-guided percutaneous neuromodulation with endoscopic plantar fascial release followed by standard postoperative rehabilitation in adults with chronic refractory plantar fasciopathy.
A total of 120 participants will be allocated to treatment groups according to their informed treatment preference within a shared decision-making process. The primary outcome will be the change in the Foot Function Index (FFI) after 6 weeks. Secondary outcomes include pain intensity, health-related quality of life, treatment adherence, adverse events, and exploratory neurophysiological measures. The results are expected to provide evidence to support clinical decision-making and optimize the management of patients with chronic refractory plantar fasciopathy.
調査の概要
状態
まだ募集していません
詳細な説明
Chronic refractory plantar fasciopathy is one of the most common causes of persistent heel pain and is associated with substantial disability, reduced quality of life, and limitations in daily and occupational activities. Although most patients respond to conservative management, a subgroup continues to experience symptoms despite prolonged treatment and may be considered for surgical intervention. However, evidence directly comparing optimized multimodal conservative care with surgical management remains limited.
This multicenter, non-randomized controlled trial has been designed to evaluate the comparative effectiveness of these two therapeutic strategies under real-world clinical conditions. Participants will be allocated to treatment groups according to their informed treatment preference following a standardized shared decision-making process.
The experimental group will receive a 6-week multimodal conservative intervention consisting of manual therapy techniques and ultrasound-guided percutaneous neuromodulation delivered in 12 supervised sessions. The control group will undergo endoscopic plantar fascial release followed by a standardized postoperative rehabilitation program.
The primary outcome measure is the change in the Foot Function Index (FFI) at 6 weeks after treatment initiation. Secondary outcomes include pain intensity measured using the Visual Analog Scale (VAS), health-related quality of life assessed with the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), treatment adherence, adverse events, and exploratory neurophysiological assessment through electromyography.
To minimize the effects of treatment selection bias inherent to the non-randomized design, analyses will include adjusted analysis of covariance (ANCOVA) and inverse probability of treatment weighting (IPTW). The findings of this study are expected to provide clinically relevant evidence to support shared decision-making and optimize treatment selection for patients with chronic refractory plantar fasciopathy.
研究の種類
介入
入学 (推定)
120
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：Javier Bonastre Férez, PhD
- 電話番号：+34644120315
- メール：javier.bonastre@universidadeuropea.es
研究場所
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Valencia
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Valencia、Valencia、スペイン、46010
- European University of Valencia
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コンタクト：
- Javier Bonastre Férez, PhD
- 電話番号：+34644120315
- メール：javier.bonastre@universidadeuropea.es
-
-
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:
- Adults aged 30 to 65 years.
- Diagnosis of chronic refractory plantar fasciopathy with symptom duration greater than 6 months.
- Failure of at least two previous conservative treatments, each lasting at least 12 weeks.
- Foot Function Index (FFI) total score ≥45 points.
- Resting pain intensity ≥4/10 on the Visual Analog Scale (VAS).
- Plantar fascia thickness ≥4 mm at the calcaneal insertion confirmed by ultrasound.
- Ability to provide written informed consent and comply with study procedures.
Exclusion Criteria:
- Previous foot surgery on the affected side.
- Calcaneal stress fracture.
- Glycated hemoglobin (HbA1c) >7.5%.
- Inability or unwillingness to comply with study procedures or follow-up assessments.
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：非ランダム化
- 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：Multimodal Conservative Intervention
Participants assigned to this arm will receive a 6-week multimodal conservative intervention consisting of manual therapy techniques combined with ultrasound-guided percutaneous neuromodulation, delivered in 12 supervised sessions (2 sessions per week).
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A 6-week multimodal conservative treatment including manual therapy techniques (gastrocnemius stretching, transverse friction massage, and tibial nerve neurodynamic mobilization) combined with ultrasound-guided percutaneous neuromodulation of the posterior tibial nerve using low-frequency electrical stimulation.
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アクティブコンパレータ：Surgical Management
Participants assigned to this arm will undergo endoscopic plantar fascial release followed by a standardized postoperative rehabilitation program, including manual therapy during the rehabilitation period.
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Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.
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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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Change in Foot Function Index (FFI) total score
時間枠：Baseline and 6 weeks
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The primary outcome is the change in the total Foot Function Index (FFI) score from baseline to 6 weeks after treatment initiation.
The FFI is a validated patient-reported outcome measure assessing pain and functional disability related to foot disorders.
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Baseline and 6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in pain intensity measured by the Visual Analog Scale (VAS)
時間枠：Baseline, 3 weeks, 6 weeks, and 12 weeks
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Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
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Baseline, 3 weeks, 6 weeks, and 12 weeks
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Change in health-related quality of life assessed by the EQ-5D-5L
時間枠：Baseline, 6 weeks, and 12 weeks
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Health-related quality of life will be evaluated using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
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Baseline, 6 weeks, and 12 weeks
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Treatment adherence
時間枠：During the 6-week intervention period
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Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants.
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During the 6-week intervention period
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Incidence of adverse events
時間枠：From baseline through 12 weeks
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Adverse events will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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From baseline through 12 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Tibial nerve sensory conduction velocity assessed by electromyography
時間枠：Baseline and 12 weeks
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Exploratory neurophysiological assessment of tibial nerve sensory conduction velocity measured by electromyography to investigate potential changes associated with the interventions.
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Baseline and 12 weeks
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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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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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12月1日
一次修了 (推定)
2027年9月1日
研究の完了 (推定)
2028年1月1日
試験登録日
最初に提出
2026年6月12日
QC基準を満たした最初の提出物
2026年6月12日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月12日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- UEV-PF-MTPNM-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
At the time of study registration, no final decision has been made regarding the sharing of individual participant data (IPD).
Any future data sharing will be considered in accordance with institutional policies, ethical approvals, participant consent, and applicable data protection regulations.
If data sharing is approved, only de-identified data will be made available.
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