NCT07487753

Brief Summary

This study compares instrument-assisted soft tissue mobilization (IASTM) and foam roller therapy in individuals with plantar fasciitis. Both groups receive structured exercises. The study evaluates changes in pain, ankle dorsiflexion range of motion, and functional ability after treatment to determine which intervention is more effective for improving symptoms and physical function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 11, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

Plantar FasciitisInstrument-Assisted Soft Tissue Mobilization (IASTM)Foam RollingPain ReductionFunctional Improvement

Outcome Measures

Primary Outcomes (4)

  • Pain intensity measured using the Numeric Pain Rating Scale (NPRS)

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).

    Pre (baseline) and Post (4 weeks)

  • Ankle dorsiflexion range of motion measured in degrees using a goniometer

    Ankle range of motion will be measured in degrees using a universal goniometer.

    Pre (baseline) and Post (4 weeks)

  • Health-related quality of life measured using the Short Form-36 (SF-36) questionnaire

    Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire, which evaluates physical and mental health domains. Each domain is scored separately and then transformed to a 0-100 scale, where higher scores indicate better health status and quality of life.

    Pre (baseline) and Post (4 weeks)

  • Foot pain and disability measured using the Foot Function Index (FFI)

    Foot function and disability related to plantar fasciitis were measured using the Foot Function Index (FFI) questionnaire. Each item of the Foot Function Index (FFI) is rated on a Visual Analog Scale (VAS) from 0 to 10, where 0 indicates no pain or difficulty and 10 indicates the worst pain or extreme difficulty. Scores for the answered items in each subscale are summed and divided by the maximum possible score for that subscale, and the result is multiplied by 100 to obtain a percentage score (FFI Score = Sum of item scores / Maximum possible score × 100). The scores range from 0% to 100%, where 0% represents no pain or disability and 100% represents maximum pain and disability. Higher scores indicate greater pain, functional limitation, and disability related to foot problems. A total FFI score can be calculated by averaging the three subscale scores: Pain, Disability, and Activity Limitation.

    Pre (baseline) and Post (4 weeks)

Study Arms (2)

1

EXPERIMENTAL

IASTM + Exercise

Other: Instrument-Assisted Soft Tissue Mobilization (IASTM)

2

ACTIVE COMPARATOR

Foam Roller + Exercise

Other: Foam Roller Therapy

Interventions

Instrument-assisted soft tissue mobilization applied to the plantar fascia and surrounding soft tissues to improve tissue mobility and reduce pain.

1

Self-myofascial release using a foam roller applied to the plantar fascia region to reduce pain and improve flexibility.

2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45 years
  • Pain on palpation at the medial tuberosity of the calcaneus
  • Pain during the first steps in the morning that decreases after walking
  • Symptoms present for more than one month

You may not qualify if:

  • History of foot surgery
  • Inflammatory rheumatic disease
  • Previous steroid injection
  • Radiculopathy affecting the lower limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRIIRS

Faridabad, Haryana, 121004, India

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 23, 2026

Study Start

April 15, 2025

Primary Completion

June 15, 2025

Study Completion

June 30, 2025

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared due to institutional and ethical restrictions related to participant confidentiality and consent agreements. However, summarized data supporting the findings of this study are available from the corresponding author upon reasonable request.

Locations