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Effectiveness of Strengthening Exercise Program Compare With Foot Orthoses in Patients With Plantar Heel Pain

Unknown statusNot applicableNCT05059054
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Effectiveness of Strengthening Exercise Program Compare With Foot Orthoses in Patients With Plantar Heel Pain
Conditions
  • Plantar Fascitis
  • Fasciitis, Plantar, Chronic
Interventions
  • Other: Strengthening exercise
  • Other: Insole (CFO) group
Sponsor
Mahidol University
Start date
2021-04-01
Primary completion
2023-09-30
Sex
All
Age range
from 18 Years to 60 Years
Results posted
No results posted in this snapshot
Countries
Thailand
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Reaching the specific criteria of PHP including (15) * A complaint of tenderness from the palpation of the medial calcaneal tubercle and the medial aspect of the proximal portion of the plantar fascia, or pain along the plantar fascia at medial longitudinal arch side * The presence of heel pain immediately during the first few steps of walking in the morning or after prolonged period of inactivity; and gradually decreased throughout the day with ordinary walking; and worsened with prolonged activity * Having the symptom of heel pain for at least 6 weeks, indicating the chronic condition (29) * Having maximum level of pain intensity during last week using visual analog scale (VAS) ranging from 3 to 6 mm Exclusion Criteria: * Having BMI more than 30 kg/m2 (40) * Having leg length difference more than 1 cm (30) * Unable to perform the exercise program * Having positive sciatica test, indicating the L5-S1 nerve root irritation * Having history of lower extremity fracture * Having history of lower extremity surgery * Having been diagnosed with gout, diabetic neuropathy, rheumatoid arthritis, systemic lupus erythematosus (SLE), cancer, infection disease and tumor

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05059054