NCT05754697

Brief Summary

The goal of this clinical trial\] is to compare between the effect of instrument assisted soft tissue mobilization and positional release technique in patients with chronic plantar fasciitis The main question\[s\] it aims to answer are:

  1. 1.Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on pain pressure threshold in patients with chronic plantar fasciitis?
  2. 2.Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on foot function level in patients with chronic plantar fasciitis?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

First Submitted

Initial submission to the registry

January 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

January 28, 2023

Last Update Submit

September 26, 2023

Conditions

Chronic Plantar Fasciitis

Keywords

Positional release techniqueInstrument assisted soft tissue mobilization

Outcome Measures

Primary Outcomes (1)

  • Pressure Algometer (Change in pain pressure threshold)

    Change in pain pressure threshold as assessed using pressure algometer on medial plantar process, with the unit of measurement in kg/cm². Change in pain pressure threshold as assessed using pressure algometer on gastrocnemius muscle, with the unit of measurement in kg/cm². Change in pain pressure threshold as assessed using pressure algometer on soleus muscle, with the unit of measurement in kg/cm². Change in pain pressure threshold as assessed using pressure algometer over the posteromedial aspect of the calcaneus , with the unit of measurement in kg/cm².

    Pre-intervention and immediately after intervention

Secondary Outcomes (1)

  • The Arabic Version of Foot and Ankle Ability Measure

    Pre-intervention and immediately after intervention

Study Arms (3)

instrument assisted soft tissue mobilization in addition to traditional treatment

EXPERIMENTAL

study group

Other: Instrument assisted soft tissue mobilization in addition to traditional treatment

positional release technique in addition to traditional treatment

EXPERIMENTAL

study group

Other: Positional release technique in addition to traditional treatment

traditional treatment

ACTIVE COMPARATOR

control group

Other: Traditional treatment

Interventions

Instrument assisted soft tissue mobilization in addition to traditional treatmentOTHER

The treatment protocol will be two sessions will be given per week for 4 weeks.

instrument assisted soft tissue mobilization in addition to traditional treatment
Positional release technique in addition to traditional treatmentOTHER

The treatment protocol will be two sessions will be given per week for 4 weeks.

positional release technique in addition to traditional treatment
Traditional treatmentOTHER

The treatment protocol will be two sessions will be given per week for 4 weeks.

traditional treatment

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically diagnosed cases of plantar fasciitis not less than 3 months.
  • Heel pain felt maximally over plantar aspect of heel.
  • Pain in the heel on the first step in the morning.
  • Their age ranging from 30-50 years.
  • Body mass index range from (18.5 to 24.9 kg/m2).

You may not qualify if:

  • Subjects can't tolerate close physical contact.
  • Athletes.
  • Subjects with skin infections.
  • Subjects with recent fracture with incomplete bony union.
  • Subjects with acute inflammatory or infectious process.
  • Subjects with hematoma.
  • Subjects with osteoporosis.
  • Subjects with foot deformity.
  • Subjects that take medications that may increase blood clotting.
  • Surgery to the ankle or foot.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Clinic

Port Said, Egypt

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Doaa Ibrahim

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 28, 2023

First Posted

March 6, 2023

Study Start

March 15, 2023

Primary Completion

June 15, 2023

Study Completion

July 30, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)