NCT05920551

Brief Summary

The study aims to investigate the effectiveness of gastrocnemius stretching exercises on plantar heel pain intensity, foot mobility, and function in patients with plantar fasciitis.

Trial Health

43
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

Geographic Reach
1 country

1 active site

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

June 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

June 17, 2023

Last Update Submit

June 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Plantar heel pain intensity

    Measured using a Visual Analog Scale (VAS)

    Changes in Plantar heel pain intensity at Baseline and after 4 weeks of intervention and 3 months

Secondary Outcomes (2)

  • Changes in Foot mobility

    Changes in foot mobility at Baseline and after 4 weeks of intervention and 3 months

  • Changes in Foot function

    Changes in foot function at Baseline and after 4 weeks of intervention and 3 months

Study Arms (2)

Gastrocnemius Stretching Group

EXPERIMENTAL

Patients will receive ultrasound therapy, fascia strengthening exercises, and gastrocnemius stretching exercises.

Other: Gastrocnemius Stretching ExercisesOther: Standard care

Control Group

ACTIVE COMPARATOR

Patients will receive ultrasound therapy and fascia strengthening exercises without gastrocnemius stretching exercises.

Other: Standard care

Interventions

The gastrocnemius stretching exercises will be performed by patients in the study group. These exercises will involve stretching the gastrocnemius muscle in a controlled manner to improve flexibility and reduce tension in the plantar fascia.

Gastrocnemius Stretching Group

Ultrasound therapy: A therapeutic ultrasound device will be used to apply ultrasound waves to the plantar fascia area for pain relief and to promote healing. The frequency, intensity, and duration of the ultrasound therapy will be determined by the treating physical therapist based on individual patient needs.Fascia strengthening exercises: Patients will be instructed to perform exercises targeting the intrinsic foot muscles and the plantar fascia to improve strength and function. Examples of these exercises include toe curls, towel scrunches, and arch lifts. Patients will be asked to perform these exercises daily, with the specific number of repetitions and sets determined by the physical therapist.

Control GroupGastrocnemius Stretching Group

Eligibility Criteria

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

You may qualify if:

  • Pain reproduced with palpation of the plantar fascia
  • localized and sharp but not radiating
  • worse in the initial step after and an extended period of rest
  • decreased initially after the first steps but exacerbated with increased activityat least 6 weeks
  • unresponsive conservative form of plantar fasciitis care (ie, rest, stretching, full-length silicone insole, prescription NSAIDs when taken for a period of 2 weeks)

You may not qualify if:

  • history of previous steroid injections
  • previous surgery of the foot, lumbar spine disc herniation or back injury
  • patients with rheumatic diseases (e.g., rheumatoid arthritis, spondyloarthropathy, gout disease, enthesopathy, Sjogren's syndrome, and systemic lupus erythematosus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

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
Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

First Submitted

June 17, 2023

First Posted

June 27, 2023

Study Start

July 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations