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

Sponsor

Ahram Canadian University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05920551

Collaborator

(none)

Enrollment

Location

Arms

7.1

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fascitis	Other: Gastrocnemius Stretching Exercises Other: Standard care	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Changes in Plantar heel pain intensity [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

Changes in Foot mobility [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 [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

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al Ḩayy Ath Thāmin	Giza	Egypt	3221405

Sponsors and Collaborators

Ahram Canadian University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fasciitis

Fasciitis, Plantar

Study Results

No Results Posted as of Jun 27, 2023