NCT05827367

Brief Summary

  1. 1.To compare effect of high power pain threshold ultrasound versus myofascial release technique on pain pressure threshold over the medial calcaneal tuberosity of the involved heel in treating of chronic planter fasciitis patients
  2. 2.To compare effect of high power pain threshold ultrasound versus myofascial release technique on pain intensity in treating of chronic planter fasciitis patients.
  3. 3.To compare effect of high power pain threshold ultrasound versus myofascial release technique on ankle disability function in treating of chronic planter fasciitis patients.
  4. 4.To compare effect of high power pain threshold ultrasound versus myofascial release technique on ankle active dorsiflexion range of motionin treating of chronic planter fasciitis patients.
  5. 5.To compare effect of high power pain threshold ultrasound versus myofascial release technique on walk endurance. In treating of chronic planter fasciitis patients.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

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

February 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

February 27, 2023

Last Update Submit

May 1, 2023

Conditions

Keywords

high power pain thershold ultrasoundPlanter fasciitisMyofascial release

Outcome Measures

Primary Outcomes (1)

  • pain pressure threshold

    pain pressure threshold over the medial calcaneal tuberosity of the involved heel will be measured by pressure algometer.

    Change at pain pressure thershold through 4 weeks

Secondary Outcomes (1)

  • Pain intensity at first step after prolonged setting

    Change at pain intensity through 4 weeks

Other Outcomes (3)

  • Disability function of ankle joint

    Change at disability function of ankle through 4 weeks

  • Ankle joint dorsi flexion

    Change at ankle dorsi flexion through 4 weeks

  • Walk endurance

    Change at walk endurance through 4 weeks

Study Arms (3)

high power pain thershold ultrasound

EXPERIMENTAL

Patients will reseiv high power pain ultrasound ,intrinsic muscle strength and plantar fascia streatching

Device: UltrasoundOther: Strength and stretching

myofascial release

EXPERIMENTAL

Plantar fascia myofascial release,gastrocnmias Myofascial release ,soluse myofascial release,foot interstice muscle strength and plantar fascia streatching

Other: Myofascial release techniqueOther: Strength and stretching

control arm

PLACEBO COMPARATOR

Plantar fascia stretching and foot interstice muscle strength

Other: Strength and stretching

Interventions

The high-power pain threshold ultrasound (HPPTUS) In this technique, "which be applied in continuous mode with intensity from t0.5 to 2 watt/cm to elicit pain threshold the US probe was kept motionless, and the intensity progressively increased until the maximum level of pain patient can endure was selected, it was maintained on this level for 3 to 4 seconds and then decreased to half intensity for 15 seconds the treatment process was repeated three times.

high power pain thershold ultrasound

Plantar fascia myofascial release Soluse muscle myofascial release Gastrocnmias muscle myofascial release

myofascial release

Plantar fascia stretching Interstice foot muscles strengthing

control armhigh power pain thershold ultrasoundmyofascial release

Eligibility Criteria

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

You may qualify if:

  • Patients with history of plantar fasciitis more than three months ago
  • Patient's age ranged between 40-60 years old
  • Patients with body mass index (MBI)\<30kg/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 disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

UltrasonographyMyofascial Release Therapy

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • doaa rafat, Lecturer

    Cairo University

    STUDY DIRECTOR
  • amaal hassan, Professor

    Cairo University

    STUDY DIRECTOR
  • mohammed kaddah, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

menna ali mohammed tolba, B.sc. In Physicaltherapy

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

February 27, 2023

First Posted

April 25, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05