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

NCT05059054 | Unknown

• 1 other identifier: 2020/285.2109
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Fascitis; Fasciitis, Plantar, Chronic

Keywords

Plantar Fasciitis; Strength Training; Foot Orthosis

Outcome Measures

Primary Outcomes (1)

• Pain at Worst

  The participants were asked about pain at the worst in the past week. Visual analogue scale (VAS) was used for the participants to rate the pain on the paper with the 10 centimeters (cm) line. Left and right ends of the line demonstrate "no pain with 0 score" and "worst pain ever with 10 scores".

  End of 3rd month

Secondary Outcomes (4)

• Foot Function Score

  baseline, end of 1st month, end of 2nd month, and end of 3rd month

• Plantar Fascia Thickness

  baseline, end of 1st month, end of 2nd month, and end of 3rd month

• Gait assessment

  baseline, end of 1st month, end of 2nd month, and end of 3rd month

• Pain at Worst

  baseline, end of 1st month, and end of 2nd month

Study Arms (2)

Strengthening group

EXPERIMENTAL

Strengthening exercise

Other: Strengthening exercise

Insole group

ACTIVE COMPARATOR

Insole application

Other: Insole (CFO) group

Interventions

Strengthening exercise OTHER

Strengthening exercise program Participants performed this protocol at home for 3 times per day. The participants progress their exercise based on the achievement of the previous level of each exercise protocol. The physical therapist recorded the level of each exercise for each participant during eight times of treatment. Total time for this section is approximately 30 minutes. Detail of the strengthening exercise is in the following. 1. Toe curl exercise (toe flexors strengthening) 2. Ankle evertor exercise (peroneal strengthening) 3. Ankle invertor exercise (tibialis posterior strengthening) 4. Heel raise exercise (high-load strength training)

Strengthening group

Insole (CFO) group OTHER

The CFO insole group The participants will receive the foot assessment before making the CFO for each participant. The 3-quarter-length CFO will be made from thermoplastic material (rigid foot orthoses) which consists of four layers i.e. two layers of 0.5-mm polyvinyl chloride (PVC) and one layer of 1.5-mm thick fiber to increase strength of foot orthoses in the bottom layers as well as one layer of 1.2-mm genuine leather in the upper layer to increase comfort. The participants will be asked to use the CFO in daily life during weight-bearing activities.

Insole group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Nakhon Pathom, 73170, Thailand

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Suthasinee Thong-On, PhD

  Dr.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suthasinee Thong-On, PhD

CONTACT

(+66)855533681; suthasinee.tho@mahidol.ac.th

Pavinee Harutaichun, PhD

CONTACT

(+66)993596356; pavinee.har@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between the exercise program and insole program.

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: September 28, 2021
• Study Start: April 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)