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

5 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

44

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Reclutamento
        • University of Lahore teaching hospital, Lahore
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Intensity Assessed by Numerical Pain Rating Scale (NPRS)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Fatima Altaf, MSPTWH, The University of Lahore, Lahore

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

30 luglio 2026

Completamento dello studio (Stimato)

31 luglio 2026

Date di iscrizione allo studio

Primo inviato

23 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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