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Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Gastrocnemius Stretching Exercises
Standard care
Sponsored by
Ahram Canadian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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)

Sites / Locations

  • Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gastrocnemius Stretching Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in Plantar heel pain intensity
Measured using a Visual Analog Scale (VAS)

Secondary Outcome Measures

Changes in Foot mobility
Measured using an inversion/eversion device
Changes in Foot function
Measured using the Foot and Ankle Ability Measure (FAAM)

Full Information

First Posted
June 17, 2023
Last Updated
June 17, 2023
Sponsor
Ahram Canadian University
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1. Study Identification

Unique Protocol Identification Number
NCT05920551
Brief Title
Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis
Official Title
Efficacy of Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This randomized controlled trial will include patients diagnosed with plantar fasciitis. Participants will be randomly assigned to either a study group performing gastrocnemius stretches or a control group. Both groups will receive ultrasound therapy and fascia strengthening exercises. The study group will additionally perform specific gastrocnemius stretching exercises. Outcome measures will be assessed before and after 4 weeks of intervention and will include pain intensity, foot mobility using an inversion/eversion device, and function using the Foot and Ankle Ability Measure. The study hypothesizes that the study group will demonstrate greater improvements in pain, foot mobility, and function compared to the control group. The study findings could guide physical therapy interventions for patients with plantar fasciitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastrocnemius Stretching Group
Arm Type
Experimental
Arm Description
Patients will receive ultrasound therapy, fascia strengthening exercises, and gastrocnemius stretching exercises.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients will receive ultrasound therapy and fascia strengthening exercises without gastrocnemius stretching exercises.
Intervention Type
Other
Intervention Name(s)
Gastrocnemius Stretching Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Plantar heel pain intensity
Description
Measured using a Visual Analog Scale (VAS)
Time Frame
Changes in Plantar heel pain intensity at Baseline and after 4 weeks of intervention and 3 months
Secondary Outcome Measure Information:
Title
Changes in Foot mobility
Description
Measured using an inversion/eversion device
Time Frame
Changes in foot mobility at Baseline and after 4 weeks of intervention and 3 months
Title
Changes in Foot function
Description
Measured using the Foot and Ankle Ability Measure (FAAM)
Time Frame
Changes in foot function at Baseline and after 4 weeks of intervention and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis

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