Clinical Trials Logo

Clinical Trial Summary

Plantar heel pain (PHP), normally known as plantar fasciitis, is a common encountered musculoskeletal problem in the foot that can cause activities limitation, difficulty, and discomfort especially while standing and walking. It involves pain and inflammation of the plantar fascia, which runs across the bottom of the foot and connects the heel bone to toes. Approximately 10% of the American population have inferior heel pain in their lifetime, and 80% in these patients were diagnosed as the PHP. According to Sullivan's study, they identified the musculoskeletal factors in PHP and found that the ankle evertors, peroneus brevis and longus muscles, and toe flexors, flexor hallucis longus and brevis muscles, flexor digitorum longus and brevis muscles were weaker than the normal. Moreover, previous studies reported that the patients with PHP frequently have weakness of the tibialis posterior muscle. Since the presence of PHP involved with the deviation of lower-extremity biomechanics, foot orthoses have been the common intervention used as a part of the conservative treatment. The previous cadaveric study provided helpful information regarding the mechanism of foot orthoses; the researchers explained that foot orthoses could reduce plantar fascia strain during stance phase by lifting the medial longitudinal arch and decreasing abnormal foot pronation. Therefore, custom-fitted orthoses should be used to provide individual comfort, maintain the height of medial longitudinal arch, and also protect the excessive tensile strain of the plantar fascia. Therefore, the present study interested to compare the effectiveness of home based strengthening exercise program and the low-cost CFO on pain intensity, foot function, and lower-extremity biomechanics during walking in patients with PHP.


Clinical Trial Description

PHP can be presented with a high prevalence in both athletic and non-athletic populations. Diagnosis of the PHP based on patients' history and physical examination. To obtain the correct diagnosis of the PHP, subjective and objective physical examinations should be performed. PHP is believed that it occurs from the excessive cumulative strain of the plantar fascia enthesis or the insertion of the plantar fascia. This excessive strain resulted in repetitive microtrauma or inflammatory condition. Sullivan in 2015, studied musculoskeletal and activity factors that associated with PHP. The results showed that the impairments in patients with PHP have a high association with high body mass index (BMI), decrease in ankle dorsiflexion range of motion (ROM), and weakness of ankle evertors and toe flexors muscles. Therefore, these factors may have a high chance to induce the recurrence of PHP. The PHP management could be approached either surgical or non-surgical treatment. The previous studies showed conflict and fewer evidences ineffectiveness of the treatment for PHP. Moreover, approximately 18 - 50% of patients with PHP who received conservative treatment still presenting their symptoms and pain in 2 years after diagnosis and 30% have recurrent PHP. From the above-mentioned review, there are few studies investigating the effect of strengthening exercise for the foot and ankle muscles on PHP. The weakness of foot and ankle muscles may lead to recurrent symptoms of PHP due to insufficient muscle function, co-contraction of muscles, and foot joints position during walking. Thus, peroneus brevis and longus muscles, tibialis posterior muscles, flexor hallucis longus and brevis muscles, flexor digitorum longus and brevis muscles should be strengthening. As described in American clinical practice guideline, customized foot orthoses (CFO) could be used to provide short-term management (3 months) for pain reduction and foot function improvement. Among all conservative options, CFO is routinely used in clinical practice and widely recommended. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05059054
Study type Interventional
Source Mahidol University
Contact Suthasinee Thong-On, PhD
Phone (+66)855533681
Email [email protected]
Status Recruiting
Phase N/A
Start date April 1, 2021
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04423900 - Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain N/A
Completed NCT04204824 - Ultrasound Treatment in the Management of Plantar Fasciitis N/A
Completed NCT04162262 - Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment N/A
Not yet recruiting NCT05071365 - Early Access to Virtual Resources for the Self-management of Plantar Fasciitis N/A
Completed NCT03246087 - Acupuncture for Plantar Fasciosis in the Primary Care Setting N/A
Recruiting NCT04175288 - The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis N/A
Completed NCT03731897 - Evaluation of the Efficacy of Prolotherapy Treatment in Patients With Plantar Fasciitis: a Randomized Double-blind Study N/A
Not yet recruiting NCT05066919 - Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study N/A
Recruiting NCT04967703 - Physiotherapy Protocols in Treating Plantar Fasciitis N/A
Active, not recruiting NCT03231150 - Plantar Fasciitis Randomized Clinical Control Trial N/A
Recruiting NCT03472989 - Plantar Fasciopathy and the Effectiveness of Radial Extracorporeal Shockwave Therapy, Physical Training or Usual Care N/A
Completed NCT04993105 - Effects of Graston Assisted Soft Tissue Mobilization in Patients With Chronic Plantar Fasciitis. N/A
Recruiting NCT04332471 - Shockwave Therapy for Plantar Fasciitis RCT N/A
Active, not recruiting NCT04243343 - Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis N/A
Completed NCT03918434 - Efficacy of a Locoregional Anesthesia Technique During Shock Wave Therapy
Recruiting NCT04894383 - Plantar Fasciitis and the Use of Orthotics as Treatment N/A
Recruiting NCT03367468 - Conservative Therapy Interventions in Plantar Fasciitis N/A
Recruiting NCT04029389 - Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection in Recalcitrant Plantar Fasciitis Treatment N/A
Completed NCT03857334 - Efficacy of Platelet Rich Plasma in Plantar Fasciitis N/A
Completed NCT03873961 - Effect of HILT vs LLLT in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis N/A