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

• ClinicalTrials.gov Identifier: NCT05059054
• Recruitment Status: Recruiting
• First Posted: September 28, 2021
• Last Update Posted: October 7, 2021
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Mahidol University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Plantar Fascitis; Fasciitis, Plantar, Chronic	Other: Strengthening exercise; Other: Insole (CFO) group	Not Applicable

Detailed 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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Comparison between the exercise program and insole program.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Strengthening Exercise Program Compare With Foot Orthoses in Patients With Plantar Heel Pain
• Actual Study Start Date: April 1, 2021
• Estimated Primary Completion Date: April 30, 2022
• Estimated Study Completion Date: September 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Strengthening group; Strengthening exercise	Other: Strengthening exercise; 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.; Toe curl exercise (toe flexors strengthening); Ankle evertor exercise (peroneal strengthening); Ankle invertor exercise (tibialis posterior strengthening); Heel raise exercise (high-load strength training)
Active Comparator: Insole group; Insole application	Other: Insole (CFO) group; 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.

Outcome Measures

Primary Outcome Measures :

1. Pain at Worst [ Time Frame: End of 3rd month ]
   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".

Secondary Outcome Measures :

1. Foot Function Score [ Time Frame: baseline, end of 1st month, end of 2nd month, and end of 3rd month ]
   The Foot Function Index (FFI) is a self-rating questionnaire that reflexes the foot health via pain and function (45-47). It consists of the 23 questions of the difficulty level and pain during performing foot function with the visual analogue scale for each question. The score ranges from 0-230 and minimum score represents a good condition of foot pain and function. This study used the Thai version of FFI that translated forward and backward from the English version.
2. Plantar Fascia Thickness [ Time Frame: baseline, end of 1st month, end of 2nd month, and end of 3rd month ]
   Plantar fascia thickness was assessed by using a portable digital Ultrasound (US) diagnosis imaging system, D-6600 (Mindray, China) with a 10 MHz wideband linear array probe, operate by the researcher. Test-retest reliability was proved and showed excellent reliability at ICC 0.969 (Appendix I). To evaluate the plantar fascia thickness, scan depth was set at 4 cm (48, 49). The researcher assessed the thickness on the symptomatic foot of the participants or the most painful side in patients with bilateral PHP.
3. Gait assessment [ Time Frame: baseline, end of 1st month, end of 2nd month, and end of 3rd month ]
   Gait assessment will be performed at the motion analysis research laboratory of the Faculty of Physical Therapy, Mahidol University. This laboratory consists of an eight-camera motion analysis system (Motion Analysis Corporation, Santa Rosa, CA, USA) with a sample rate of 120 Hz. The cameras are synchronized with three force transducers (Bertec force plate, Columbus, OH, USA), which are set to have a sample rate of 1200 Hz on a 10-meter walkway. The software for the motion analysis system is CORTEX version 2.5 with three major functions consisting of calibration of capture volume, tracking and identifying marker locations in calibrated 3D space, and post-processing tools for tracking, editing, and preparing data for other packages. Marker histories and analog signals are smoothed with a 6th order, low-pass Butterworth filter at 5 Hz and 50 Hz, respectively.
4. Pain at Worst [ Time Frame: baseline, end of 1st month, and end of 2nd month ]
   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".

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Suthasinee Thong-On, PhD; (+66)855533681; suthasinee.tho@mahidol.ac.th

Contact: Pavinee Harutaichun, PhD; (+66)993596356; pavinee.har@mahidol.ac.th

Locations

Thailand

Faculty of Physical Therapy, Mahidol University; Recruiting

Nakhon Pathom, Thailand, 73170

Contact: Suthasinee Thong-On, PhD (+66)855533681 suthasinee.tho@mahidol.ac.th

Contact: Pavinee Harutaichun, PhD (+66)993596356 pavinee.har@mahidol.ac.th

Sponsors and Collaborators

Mahidol University

Investigators

• Principal Investigator: Suthasinee Thong-On, PhD; Dr.

More Information

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT05059054
• Other Study ID Numbers: 2020/285.2109
• First Posted: September 28, 2021
• Last Update Posted: October 7, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No sharing of the data.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mahidol University:

Plantar Fasciitis; Strength Training; Foot Orthosis

Additional relevant MeSH terms:

Fasciitis; Fasciitis, Plantar; Musculoskeletal Diseases; Foot Diseases