NCT07676058

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 23, 2026

Last Update Submit

July 5, 2026

Conditions

Keywords

Plantar FasciitisMyofascial ReleaseInstrument-Assisted Soft Tissue Mobilization

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Assessed by Numerical Pain Rating Scale (NPRS)

    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)

Study Arms (2)

Myofascial Release (MFR) Group

EXPERIMENTAL

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.

Procedure: Myofascial Release (MFR)

Instrument-Assisted Soft Tissue Mobilization (IASTM) Group

EXPERIMENTAL

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.

Procedure: Instrument-Assisted Soft Tissue Mobilization (IASTM)

Interventions

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.

Myofascial Release (MFR) Group

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.

Instrument-Assisted Soft Tissue Mobilization (IASTM) Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales only
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Fatima Altaf, MSPTWH

    The University of Lahore, Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Altaf, MSPTWH

CONTACT

Montiha Azeem, MSPTN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 30, 2026

Study Start

June 30, 2026

Primary Completion

July 30, 2026

Study Completion

July 31, 2026

Last Updated

July 8, 2026

Record last verified: 2026-06

Locations