Effect of Selected Rehabilitation Program in Patients With Plantar Fasciitis

Plantar Fascitis Clinical Trial

Official title:

Effect of Selected Rehabilitation Program on Pain, Function, and Plantar Fascia Thickness in Patients With Plantar Fasciitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456944
• Other study ID #: Mohamed PHD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: June 2024
• Source: Horus University
• Contact: Mohamed Ramadan, assistant lecturer
• Phone: 01022877063
• Email: mibraheem[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be done to investigate the effect of the selected rehabilitation program for PF on plantar fascia thickness, clinical outcomes such as pain, foot function, dorsiflexion ROM and pressure pain threshold and alignment such as rearfoot eversion angle and foot posture index in patients with PF.

Description:

Plantar fasciitis (PF), which constitutes approximately 15% of all foot disorders, is the most prevalent cause of heel pain. It is a long-term degenerative process that is impacted by subtalar pronation and pes planus. One million US patients saw primary care physicians with PF between 1995 and 2000. There is not enough data to determine the best physical therapy management techniques for individuals with heel pain, despite the existence of multiple successful treatment approaches. this study investigated at how a mechanically based rehabilitation program affected patients with PF in terms of foot alignment, plantar fascia thickness, pain, pressure pain threshold, ROM and foot function. The approach included strengthening the plantar intrinsic muscles of the foot, plantar fascia specific stretching and Achilles tendon stretching, and passively correcting the pathomechanics of the foot by low dye tapping and high load resistance exercise for Achilles tendon and windlass mechanism

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: April 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing

• Pain with palpation of the proximal insertion of the plantar fascia

• Positive windlass test

• flat foot posture utilizing the foot posture index

• age range from 40 to 60 years

Exclusion Criteria:

• tarsal tunnel syndrome

• atrophy of the fat pad.

• diabetic patients or patients with rheumatoid arthritis

• corticosteroid injection over the last sex months

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Heel Pain Syndrome
• Plantar Fasciitis, Chronic
• Plantar Fascitis

Intervention

Other:
• stretching exercises
stretching exercises of the plantar fascia, gastrocnemius and soleus

Device:
• ultrasound
therapeutic ultrasound upon the most painful point on the medial calcaneal tubercle. The parameters involved a pulsed mode (duty cycle 50%) using an intensity of 1.5 W/cm2 and a 1 MHz of frequency for 5 minutes

Other:
• rigid tape
low-dye tapping will be done to provide mechanical correction to plantar fascia and medial longitudinal arch
• mobilization
mobilization techniques for the talocrural joint in weight bearing and non-bearing positions and subtalar joint
• myofascial release
deep tissue release of the plantar fascia and flexor hallucis longus in a stretched position of the plantar fascia
• strengthening exercise
strengthening exercise of the plantar intrinsic muscles using short foot exercise and strengthening of the Achilles tendon and windlass mechanism using unilateral heel raise exercises

Locations

Country	Name	City	State
Egypt	Out-Patient Clinic, Faculty of Physical Therapy, Horus University	Damietta
Egypt	Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt	Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Horus University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the change in pain intensity	VAS is typically composed of a 100 mm horizontal line attached to two opposed labels, the left end marked "no pain" and the right end marked "worst possible pain. Patients were marked a score on the scale by a vertical line that exactly refer to their pain	At baseline and following 8 weeks
Secondary	Assessing the change in foot posture	using the foot posture index. It is a clinical measure of foot posture, either supinated or pronated, using 6 items for assessment of foot and scoring of each item from -2 to +2	At baseline and following 8 weeks
Secondary	Assessing the change in foot function	The Arabic version of the foot function index (FFI) is a widely used self-reporting measure used to assess the impact of foot pathology on pain, disability, and activity limitation. It is a reliable and sensitive outcome measure for patients with foot and ankle disorders. The FFI's subscale scores range from 0% to 100%, with higher scores indicating lower function and a poorer quality of life.	At baseline and following 8 weeks
Secondary	Assessing the change in plantar fascia thickness	using the ultrasound, participants were positioned in a prone position with relaxed arms and legs, and measurements were taken with the ankle joint in neutral or slightly dorsi-flexion. Electro-conductive gel was applied to the US transducer and plantar surface of foot before imaging. The transducer was placed longitudinally on the calcaneus surface to obtain a clear image of the plantar fascia.	At baseline and following 8 weeks
Secondary	Assessing the change in rear foot angle	using kinovea motion analysis software, the rearfoot (calcaneus) angle is measured as the angle between the bisection of the lower one-third of the leg and the bisection of the calcaneus. The MLA is classified as: normal arch 2-8°, low arch = 8.1° and high arch = 1.9.	At baseline and following 8 weeks
Secondary	Assessing the change in range of motion	The bubble inclinometer is used to measure the angle of the tibia relative to the floor during active ankle dorsiflexion, while the patient lunges forward with their heel on the ground and knee in line with the second toe.	At baseline and following 8 weeks
Secondary	Assessing the change in pressure pain threshold	the pressure algometer is utilized to measure the pressure pain threshold (PPT), The patient lay supine, in a relaxed position, with his feet hanging over the edge of the bed with no pressure on the heel. PPT is measured by laying the patient supine with feet hanging over the bed, without pressure on the heel. PPT is determined by applying pressure to the skin until the patient experiences pain.	At baseline and following 8 weeks