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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05920551
Other study ID # 012/7080002023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date February 1, 2024

Study information

Verified date June 2023
Source Ahram Canadian University
Contact Mohamed M ElMeligie, Ph.d
Phone +201064442032
Email mohamed.elmeligie@acu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in Foot mobility Measured using an inversion/eversion device Changes in foot mobility at Baseline and after 4 weeks of intervention and 3 months
Secondary Changes in Foot function Measured using the Foot and Ankle Ability Measure (FAAM) Changes in foot function at Baseline and after 4 weeks of intervention and 3 months
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