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

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

Tracking Information

• First Submitted Date: June 17, 2023
• First Posted Date: June 27, 2023
• Last Update Posted Date: June 27, 2023
• Estimated Study Start Date: July 1, 2023
• Estimated Primary Completion Date: February 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2023)

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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 17, 2023)

• 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
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Plantar Fascitis

Intervention

• 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.

Study Arms

• Experimental: Gastrocnemius Stretching Group
  Patients will receive ultrasound therapy, fascia strengthening exercises, and gastrocnemius stretching exercises.
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 17, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2024
• Estimated Primary Completion Date: February 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05920551
• Other Study ID Numbers: 012/7080002023
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mohamed Magdy ElMeligie, Ahram Canadian University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ahram Canadian University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Amal Fawzy, Ph.d; Faculty of Physical Therapy, Ahram Canadian University

• PRS Account: Ahram Canadian University
• Verification Date: June 2023