NCT06493487

Brief Summary

  1. 1.To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on general pain intensity in patient with chronic plantar fasciitis.
  2. 2.To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on pain intensity at initial morning step in patient with chronic plantar fasciitis.
  3. 3.To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on pain pressure threshold in patient with chronic plantar fasciitis.
  4. 4.To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on active dorsiflexion ROM in patient with chronic plantar fasciitis.
  5. 5.To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on functional disability in patient chronic plantar fasciitis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet 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 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 10, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

June 29, 2024

Last Update Submit

July 6, 2024

Conditions

Keywords

planter fasciitisintegrated neuromuscular inhibition technique (INIT)Instrument-Assisted Soft Tissue Mobilization (IASTM)

Outcome Measures

Primary Outcomes (1)

  • general pain intensity

    general pain intensity at planter aspect of foot will be measured by Visual analog scale (VAS): a horizontal line, 100 mm in length, anchored by word descriptors at each end (0 means no pain to 10 means worth pain). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    change of general pain intensity through 4 weeks

Secondary Outcomes (1)

  • pain intensity in morning initial step

    change of pain intensity in morning initial step through 4 weeks.

Other Outcomes (3)

  • Disability function of ankle joint

    change of disability function of ankle joint through 4 weeks

  • pain pressure threshold

    change of pain pressure thershold through 4 weeks

  • active ankle dorsiflexion range of motion

    change of active ankle dorsiflexion range of motion through 4 weeks

Study Arms (3)

integrated neuromuscular inhibition technique

EXPERIMENTAL

integrated neuromuscular inhibition in addition to conventional treatment

Other: integrated neuromuscular inhibition technique

instrument assisted soft tissue mobilization

EXPERIMENTAL

instrument assisted soft tissue mobilization technique (IASTM) in addition to conventional treatment

Other: instrument assissted soft tissue mobilization

conventional treatment

PLACEBO COMPARATOR

(home education program, therapeutic ultrasound, plantar fascia stretching, intrinsic muscle strengthening of foot, Self stretching of calf muscle using a towel and Ice Massage using frozen bottle).

Other: convential treatment

Interventions

integrated neuromuscular inhibition technique for gastrocniemus muscle

integrated neuromuscular inhibition technique

instrument assissted soft tissue mobilization for calf muscle

instrument assisted soft tissue mobilization

convential treatment (home education program, therapeutic ultrasound, plantar fascia stretching, intrinsic muscle strengthening of foot, Self stretching of calf muscle using a towel and Ice Massage using frozen bottle).

conventional treatment

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with history of plantar fasciitis more than three months ago.
  • Plantar heel pain with first few steps upon walking in the morning and after prolonged rest.
  • Patient\'s Age between 40-60 years old.
  • Patient\'s Body mass index (BMI 18 to 29.9kg/m2).

You may not qualify if:

  • Patients with any prior surgery to distal tibia, fibula, ankle joint or rear foot region.
  • Presence of any red flags i.e., tumor, fracture, and heterotrophic ossification and had acute inflammatory condition at ankle-foot region were excluded from the study.
  • Deformity of foot and ankle complex and subjects with referred pain due to sciatica and other neurological disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • magda zahran, Ass.Prof

    faculty of physical therapy

    STUDY DIRECTOR
  • Fatma Amin, Professor

    faculty of physical therapy

    STUDY DIRECTOR
  • mohammed kaddah, professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

esraa khairy afify esmail, B.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2024

First Posted

July 10, 2024

Study Start

July 1, 2024

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

July 10, 2024

Record last verified: 2024-06