このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Comparative Effects of Myofascial Release and Instrument Assisted Soft Tissue Moblization in Pregnant Women With Plantar Fasciitis (MFR-IASM-PF)

2026年7月5日 更新者:Fatima Altaf、University of Lahore

Plantar fasciitis is a common musculoskeletal disorder characterized by heel pain and functional limitations, which may become more pronounced during pregnancy due to weight gain, hormonal changes, and altered biomechanics. Conservative physiotherapy interventions are commonly used to manage symptoms; however, evidence regarding the comparative effectiveness of different manual therapy techniques in pregnant women remains limited.

This randomized clinical trial aims to compare the effects of Myofascial Release (MFR) and Instrument-Assisted Soft Tissue Mobilization (IASTM) on pain intensity and foot function in pregnant women diagnosed with plantar fasciitis. A total of 44 pregnant women aged 20-40 years in their second or third trimester will be recruited and randomly allocated into two treatment groups. Both groups will receive baseline treatment consisting of therapeutic ultrasound, gastrocnemius and soleus stretching exercises, tibialis anterior strengthening, and a home exercise program. In addition, Group A will receive Myofascial Release, while Group B will receive Instrument-Assisted Soft Tissue Mobilization.

The intervention will be delivered over a period of four weeks, with three supervised sessions per week. Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), while foot-related pain, disability, and functional limitations will be measured using the Foot Function Index (FFI). Outcomes will be evaluated at baseline and after completion of the intervention.

The findings of this study are expected to provide evidence regarding the most effective manual therapy approach for reducing pain and improving functional outcomes in pregnant women suffering from plantar fasciitis.

調査の概要

詳細な説明

Plantar fasciitis is one of the most prevalent causes of heel pain and is frequently associated with inflammation, microtrauma, and degeneration of the plantar fascia. During pregnancy, physiological and biomechanical changes such as increased body weight, ligamentous laxity, altered gait patterns, and shifts in the center of gravity may increase stress on the plantar fascia, thereby elevating the risk of developing plantar heel pain. These symptoms can negatively affect mobility, functional independence, and overall quality of life.

Various conservative physiotherapy interventions have been used to manage plantar fasciitis, including stretching exercises, strengthening programs, therapeutic ultrasound, and manual therapy techniques. Among manual therapy approaches, Myofascial Release (MFR) and Instrument-Assisted Soft Tissue Mobilization (IASTM) have gained increasing attention because of their potential to reduce fascial restrictions, improve tissue mobility, decrease pain, and enhance functional performance. However, limited evidence exists regarding the comparative effectiveness of these interventions specifically in pregnant women.

This study is designed as a single-blind, parallel-group, randomized clinical trial conducted at physiotherapy, orthopedic, and gynecology clinics of the University of Lahore Hospital. A total of 44 pregnant women diagnosed with plantar fasciitis will be recruited through convenience sampling and randomly assigned to one of two intervention groups.

Both groups will receive standardized baseline treatment comprising therapeutic ultrasound (1.0 MHz, 1.2 W/cm²), gastrocnemius and soleus stretching exercises, tibialis anterior strengthening exercises, and a home-based stretching program. Participants in Group A will receive Myofascial Release techniques targeting the plantar fascia, medial heel region, gastrocnemius-soleus complex, and intrinsic foot musculature. The intervention aims to reduce fascial restrictions, improve tissue extensibility, and restore normal foot biomechanics.

Participants in Group B will receive Instrument-Assisted Soft Tissue Mobilization using specialized stainless-steel instruments. Treatment will focus on the plantar fascia, calcaneal insertion, Achilles tendon, calf musculature, and intrinsic foot muscles through controlled sweeping, cross-friction, and tissue remodeling techniques designed to improve mobility and reduce adhesions.

Both intervention programs will be administered over four weeks, with three treatment sessions per week, resulting in a total of twelve supervised sessions. Each treatment session will last approximately 30 minutes. Pregnancy-specific safety precautions will be maintained throughout the intervention period, including avoidance of prolonged supine positioning, monitoring for adverse symptoms, and adjustment of treatment intensity according to participant comfort.

The primary outcome measure will be pain intensity assessed using the Numerical Pain Rating Scale (NPRS). The secondary outcome measure will be foot-related pain, disability, and functional limitation assessed using the Foot Function Index (FFI). Outcome assessments will be performed at baseline and after completion of the four-week intervention period by a blinded assessor.

The results of this trial will contribute to evidence-based physiotherapy practice by identifying the more effective manual therapy approach for managing plantar fasciitis in pregnant women, thereby assisting clinicians in optimizing treatment strategies for this unique patient population.

研究の種類

介入

入学 (推定)

44

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

研究場所

    • Punjab Province
      • Lahore、Punjab Province、パキスタン、54000
        • 募集
        • University of Lahore teaching hospital, Lahore
        • コンタクト:
        • 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:

  • Pregnant women aged 20-40 years.
  • In the second and third trimester of pregnancy (gestational weeks 12-34).
  • Clinically diagnosed with plantar fasciitis, with symptoms of heel pain at the medial calcaneal insertion of the plantar fascia.
  • The pain is most intense with the first few steps in the morning or after prolonged rest. Positive findings from a Windlass test or palpation-provoked pain indicating plantar fasciitis.

Exclusion Criteria:

  • Known foot fractures or significant foot deformities.
  • Systemic inflammatory diseases (e.g., rheumatoid arthritis) that may affect tissue healing and response to therapy.
  • Active obstetric complications that contraindicate physiotherapy.
  • Recent corticosteroid injections to the heel (<6 months prior).
  • Inability or unwillingness to comply with follow-up visits or the intervention protocol.

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
実験的:Myofascial Release (MFR) Group
Participants in this group will receive Myofascial Release (MFR) in addition to conventional physiotherapy. Conventional treatment includes therapeutic ultrasound (1.0 MHz, 1.2 W/cm²), gastrocnemius and soleus stretching exercises, tibialis anterior strengthening exercises, and a home exercise program. The MFR intervention targets the plantar fascia, medial heel region, gastrocnemius-soleus complex, and intrinsic foot muscles using sustained manual pressure and fascial mobilization techniques. Treatment will be delivered three times per week for four weeks, with each session lasting 30 minutes.
Myofascial Release (MFR) is a manual therapy technique aimed at reducing fascial restrictions, improving tissue mobility, and alleviating pain. Participants will receive MFR targeting the plantar fascia, medial calcaneal region, gastrocnemius-soleus complex, and intrinsic foot muscles. Techniques include longitudinal fascial release, thumb or knuckle gliding, sustained pressure, cross-fiber friction, deep longitudinal sweeping, and myofascial spreading. Treatment will be administered for 30 minutes per session, three times per week for four weeks (12 sessions total), in addition to conventional physiotherapy consisting of therapeutic ultrasound, stretching exercises, strengthening exercises, and a home exercise program.
実験的:Instrument-Assisted Soft Tissue Mobilization (IASTM) Group
Participants in this group will receive Instrument-Assisted Soft Tissue Mobilization (IASTM) in addition to conventional physiotherapy. Conventional treatment includes therapeutic ultrasound (1.0 MHz, 1.2 W/cm²), gastrocnemius and soleus stretching exercises, tibialis anterior strengthening exercises, and a home exercise program. IASTM will be performed using specialized stainless-steel instruments applied to the plantar fascia, calcaneal insertion, Achilles tendon, calf muscles, and intrinsic foot muscles to reduce soft tissue restrictions and improve mobility. Treatment will be delivered three times per week for four weeks, with each session lasting 30 minutes.
Instrument-Assisted Soft Tissue Mobilization (IASTM) is a manual therapy technique that utilizes specialized stainless-steel instruments to identify and treat soft tissue restrictions. Participants will receive IASTM over the plantar fascia, calcaneal insertion, Achilles tendon, gastrocnemius, soleus, and intrinsic foot muscles. Techniques include longitudinal sweeping strokes, cross-fiber strumming, edge-loading techniques, adhesion-targeting strokes, and fascial spreading. Treatment will be administered for 30 minutes per session, three times per week for four weeks (12 sessions total), in addition to conventional physiotherapy consisting of therapeutic ultrasound, stretching exercises, strengthening exercises, and a home exercise program.

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
Pain Intensity Assessed by Numerical Pain Rating Scale (NPRS)
時間枠:Baseline and Week 4 (Post-Intervention)
Pain intensity will be measured using the 11-point Numerical Pain Rating Scale (NPRS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will be asked to rate the intensity of their worst heel pain, particularly during the first steps taken in the morning. The NPRS is a valid and reliable tool for assessing pain severity in individuals with plantar fasciitis. Changes in NPRS scores will be used to evaluate the effectiveness of Myofascial Release and Instrument-Assisted Soft Tissue Mobilization in reducing plantar heel pain among pregnant women.
Baseline and Week 4 (Post-Intervention)

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:Fatima Altaf, MSPTWH、The University of Lahore, Lahore

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6月30日

一次修了 (推定)

2026年7月30日

研究の完了 (推定)

2026年7月31日

試験登録日

最初に提出

2026年6月23日

QC基準を満たした最初の提出物

2026年6月23日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年7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7月5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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。

購読する