Plantar FascitisNCT05059054
Effectiveness of Strengthening Exercise Program Compare With Foot Orthoses in Patients With Plantar Heel Pain
A study testing Strengthening exercise and Insole (CFO) group in people with Plantar Fascitis and Fasciitis, Plantar, Chronic, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fascitis, Fasciitis, Plantar, Chronic
- What is being tested?
- Strengthening exercise and Insole (CFO) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Mahidol University
Nakhon Pathom, 73170
Suthasinee Thong-On, PhD, (+66)855533681, suthasinee.tho@mahidol.ac.th
Pavinee Harutaichun, PhD, (+66)993596356, pavinee.har@mahidol.ac.th
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Plantar Fascitis, Fasciitis, Plantar, Chronic
- Being tested
- Strengthening exercise, Insole (CFO) group
- Keywords
- Plantar Fasciitis, Strength Training, Foot Orthosis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening exerciseOther
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)
Insole (CFO) groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening group | Experimental | Strengthening exercise Receives: Other: Strengthening exercise |
| Insole group | Active comparator | Insole application Receives: Other: Insole (CFO) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: End of 3rd month
Secondary outcomes (4)
Foot Function Score
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.
Measured: baseline, end of 1st month, end of 2nd month, and end of 3rd month
Plantar Fascia Thickness
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.
Measured: baseline, end of 1st month, end of 2nd month, and end of 3rd month
Gait assessment
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.
Measured: baseline, end of 1st month, end of 2nd month, and end of 3rd month
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".
Measured: baseline, end of 1st month, and end of 2nd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Apr 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between the exercise program and insole program.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suthasinee Thong-On, PhD, Principal investigator, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059054
- Sponsor's protocol ID
- 2020/285.2109
- Status last verified
- Mar 2023
- First submitted
- 21 Jun 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of the data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Strengthening Exercise Program Compare With Foot Orthoses in Patients With Plantar Heel Pain
- ClinicalTrials.gov ID
- NCT05059054
- Acronym / sponsor ID
- 2020/285.2109
- Conditions
- Plantar Fascitis, Fasciitis, Plantar, Chronic
- Keywords
- Plantar Fasciitis, Strength Training, Foot Orthosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison between the exercise program and insole program.
| Arm | Type | Receives |
|---|---|---|
| Strengthening group | Experimental | Other: Strengthening exerciseStrengthening exercise |
| Insole group | Active comparator | Other: Insole (CFO) groupInsole application |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Reaching the specific criteria of PHP including (15)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening exerciseStrengthening 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) | Other | Strengthening group |
| Insole (CFO) groupThe 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. | Other | Insole group |
Primary outcome
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".
4 secondary outcomes
Foot Function Score
Time frame: baseline, end of 1st month, end of 2nd month, and end of 3rd month
Plantar Fascia Thickness
Time frame: baseline, end of 1st month, end of 2nd month, and end of 3rd month
Gait assessment
Time frame: baseline, end of 1st month, end of 2nd month, and end of 3rd month
Pain at Worst
Time frame: baseline, end of 1st month, and end of 2nd month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No. No sharing of the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suthasinee Thong-On, PhD principal investigator
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening exercise and Insole (CFO) group in people with Plantar Fascitis and Fasciitis, Plantar, Chronic, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suthasinee Thong-On, PhD ((+66)855533681, suthasinee.tho@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at Worst (time frame: End of 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.