- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07676058
Comparative Effects of Myofascial Release and Instrument Assisted Soft Tissue Moblization in Pregnant Women With Plantar Fasciitis (MFR-IASM-PF)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Montiha Azeem, MSPTN
- Numéro de téléphone: 03479717317
- E-mail: muntahaazeem9@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Fatima Altaf, MSPTWH
- Numéro de téléphone: 03363228431
- E-mail: fatimaaltaf24@yahoo.com
Lieux d'étude
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recrutement
- University of Lahore teaching hospital, Lahore
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Contact:
- Montiha Azeem, MSPTN
- Numéro de téléphone: 03479717317
- E-mail: muntahaazeem9@gmail.com
-
Contact:
- Fatima Altaf, MSPTWH
- Numéro de téléphone: 03363228431
- E-mail: fatimaaltaf24@yahoo.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain Intensity Assessed by Numerical Pain Rating Scale (NPRS)
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Fatima Altaf, MSPTWH, The University of Lahore, Lahore
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 70106611
Informations sur les médicaments et les dispositifs, documents d'étude
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