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

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ClinicalTrials.gov Identifier: NCT05920551
Recruitment Status : Recruiting
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Magdy ElMeligie, Ahram Canadian University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plantar Fascitis Other: Gastrocnemius Stretching Exercises Other: Standard care Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis: A Randomised Controlled Trial
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: Gastrocnemius Stretching Group
Patients will receive ultrasound therapy, fascia strengthening exercises, and gastrocnemius stretching exercises.
 Other: Gastrocnemius Stretching Exercises
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.

Other: Standard care
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.
Active Comparator: Control Group
Patients will receive ultrasound therapy and fascia strengthening exercises without gastrocnemius stretching exercises.
 Other: Standard care
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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Plantar heel pain intensity [ Time Frame: Changes in Plantar heel pain intensity at Baseline and after 4 weeks of intervention and 3 months ]
    Measured using a Visual Analog Scale (VAS)


Secondary Outcome Measures :
  1. Changes in Foot mobility [ Time Frame: Changes in foot mobility at Baseline and after 4 weeks of intervention and 3 months ]
    Measured using an inversion/eversion device

  2. Changes in Foot function [ Time Frame: Changes in foot function at Baseline and after 4 weeks of intervention and 3 months ]
    Measured using the Foot and Ankle Ability Measure (FAAM)


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pain reproduced with palpation of the plantar fascia
  2. localized and sharp but not radiating
  3. worse in the initial step after and an extended period of rest
  4. decreased initially after the first steps but exacerbated with increased activityat least 6 weeks
  5. 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:

  1. history of previous steroid injections
  2. previous surgery of the foot, lumbar spine disc herniation or back injury
  3. patients with rheumatic diseases (e.g., rheumatoid arthritis, spondyloarthropathy, gout disease, enthesopathy, Sjogren's syndrome, and systemic lupus erythematosus)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920551


Contacts
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Contact: Mohamed M ElMeligie, Ph.d +201064442032 mohamed.elmeligie@acu.edu.eg

Locations
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Egypt
Outpatient clinic of faculty of physical therapy, Ahram Canadian University Recruiting
Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
Contact: Mohamed M ElMeligie, Ph.d    01064442032    mohamed.elmeligie@acu.edu.eg   
Sponsors and Collaborators
Ahram Canadian University
Investigators
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Study Director: Amal Fawzy, Ph.d Faculty of Physical Therapy, Ahram Canadian University
More Information
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Responsible Party: Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier: NCT05920551    
Other Study ID Numbers: 012/7080002023
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases