Plantar FascitisNCT06456944
Effect of Selected Rehabilitation Program in Patients With Plantar Fasciitis
A study testing stretching exercises, ultrasound and rigid tape in people with Plantar Fascitis and Plantar Fasciitis, Chronic, run by Horus University at 2 sites in Egypt.
Trial summary
This study will be done to investigate the effect of the selected rehabilitation program for PF on plantar fascia thickness, clinical outcomes such as pain, foot function, dorsiflexion ROM and pressure pain threshold and alignment such as rearfoot eversion angle and foot posture index in patients with PF. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Plantar Fascitis, Plantar Fasciitis, Chronic, Heel Pain Syndrome
- What is being tested?
- stretching exercises, ultrasound and rigid tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jun 2024to 15 Apr 2025
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing
- Pain with palpation of the proximal insertion of the plantar fascia
- Positive windlass test
- flat foot posture utilizing the foot posture index
- age range from 40 to 60 years
Who cannot join
- tarsal tunnel syndrome
- atrophy of the fat pad.
- diabetic patients or patients with rheumatoid arthritis
- corticosteroid injection over the last sex months
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
Damietta, 34518
out-patient clinic, Faculty of Physical Therapy, Horus university
Damietta
About this study
Official title: Effect of Selected Rehabilitation Program on Pain, Function, and Plantar Fascia Thickness in Patients With Plantar Fasciitis
This study will be done to investigate the effect of the selected rehabilitation program for PF on plantar fascia thickness, clinical outcomes such as pain, foot function, dorsiflexion ROM and pressure pain threshold and alignment such as rearfoot eversion angle and foot posture index in patients with PF.
Read the detailed description
Plantar fasciitis (PF), which constitutes approximately 15% of all foot disorders, is the most prevalent cause of heel pain. It is a long-term degenerative process that is impacted by subtalar pronation and pes planus. One million US patients saw primary care physicians with PF between 1995 and 2000. There is not enough data to determine the best physical therapy management techniques for individuals with heel pain, despite the existence of multiple successful treatment approaches. this study investigated at how a mechanically based rehabilitation program affected patients with PF in terms of foot alignment, plantar fascia thickness, pain, pressure pain threshold, ROM and foot function. The approach included strengthening the plantar intrinsic muscles of the foot, plantar fascia specific stretching and Achilles tendon stretching, and passively correcting the pathomechanics of the foot by low dye tapping and high load resistance exercise for Achilles tendon and windlass mechanism
- Being tested
- stretching exercises, ultrasound, rigid tape, mobilization, myofascial release
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stretching exercisesOther
stretching exercises of the plantar fascia, gastrocnemius and soleus
ultrasoundDevice
therapeutic ultrasound upon the most painful point on the medial calcaneal tubercle. The parameters involved a pulsed mode (duty cycle 50%) using an intensity of 1.5 W/cm2 and a 1 MHz of frequency for 5 minutes
rigid tapeOther
low-dye tapping will be done to provide mechanical correction to plantar fascia and medial longitudinal arch
mobilizationOther
mobilization techniques for the talocrural joint in weight bearing and non-bearing positions and subtalar joint
myofascial releaseOther
deep tissue release of the plantar fascia and flexor hallucis longus in a stretched position of the plantar fascia
strengthening exerciseOther
strengthening exercise of the plantar intrinsic muscles using short foot exercise and strengthening of the Achilles tendon and windlass mechanism using unilateral heel raise exercises
| Study group | Role | What they receive |
|---|---|---|
| selected rehabilitation program | Experimental | involves 24 patients and will be given the selected rehabilitation program involving (self-stretching exercise, mobilization of the ankle and subtalar, rigid tape and unilateral heel raising exercise 3 times per week for 8 weeks. Receives: Other: stretching exercises; Other: rigid tape; Other: mobilization; Other: strengthening exercise |
| traditional program | Experimental | involves 24 patients and will be given the traditional program involving (self-stretching exercise, mobilization of the ankle and subtalar, plantar fascial release and ultrasonic therapy 3 times per week for 8 weeks. Receives: Other: stretching exercises; Device: ultrasound; Other: mobilization; Other: myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in pain intensity
VAS is typically composed of a 100 mm horizontal line attached to two opposed labels, the left end marked "no pain" and the right end marked "worst possible pain. Patients were marked a score on the scale by a vertical line that exactly refer to their pain
Measured: At baseline and following 8 weeks
Secondary outcomes (6)
Assessing the change in foot posture
using the foot posture index. It is a clinical measure of foot posture, either supinated or pronated, using 6 items for assessment of foot and scoring of each item from -2 to +2
Measured: At baseline and following 8 weeks
Assessing the change in foot function
The Arabic version of the foot function index (FFI) is a widely used self-reporting measure used to assess the impact of foot pathology on pain, disability, and activity limitation. It is a reliable and sensitive outcome measure for patients with foot and ankle disorders. The FFI's subscale scores range from 0% to 100%, with higher scores indicating lower function and a poorer quality of life.
Measured: At baseline and following 8 weeks
Assessing the change in plantar fascia thickness
using the ultrasound, participants were positioned in a prone position with relaxed arms and legs, and measurements were taken with the ankle joint in neutral or slightly dorsi-flexion. Electro-conductive gel was applied to the US transducer and plantar surface of foot before imaging. The transducer was placed longitudinally on the calcaneus surface to obtain a clear image of the plantar fascia.
Measured: At baseline and following 8 weeks
Assessing the change in rear foot angle
using kinovea motion analysis software, the rearfoot (calcaneus) angle is measured as the angle between the bisection of the lower one-third of the leg and the bisection of the calcaneus. The MLA is classified as: normal arch 2-8°, low arch ≥ 8.1° and high arch ≤ 1.9.
Measured: At baseline and following 8 weeks
Assessing the change in range of motion
The bubble inclinometer is used to measure the angle of the tibia relative to the floor during active ankle dorsiflexion, while the patient lunges forward with their heel on the ground and knee in line with the second toe.
Measured: At baseline and following 8 weeks
Assessing the change in pressure pain threshold
the pressure algometer is utilized to measure the pressure pain threshold (PPT), The patient lay supine, in a relaxed position, with his feet hanging over the edge of the bed with no pressure on the heel. PPT is measured by laying the patient supine with feet hanging over the bed, without pressure on the heel. PPT is determined by applying pressure to the skin until the patient experiences pain.
Measured: At baseline and following 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Jun 2024
- Primary completion15 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ramadan Ibraheem Ramadan, Horus University
- Investigators
- Mohamed Ramadan Ibraheem, Assistant lecturer, Principal investigator, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456944
- Sponsor's protocol ID
- Mohamed PHD
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibraheem MR, El-Moneim MAA, Ibrahim MM. The effect of multimodal rehabilitation program on pain, functional outcomes, and plantar fascia thickness in patients with plantar fasciitis: a randomized controlled trial. BMC Musculoskelet Disord. 2026 Feb 20;27(1):168. doi: 10.1186/s12891-026-09562-x.
PubMed 41715005
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selected Rehabilitation Program on Pain, Function, and Plantar Fascia Thickness in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06456944
- Acronym / sponsor ID
- Mohamed PHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 13 Jun 2024 (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.
This study will be done to investigate the effect of the selected rehabilitation program for PF on plantar fascia thickness, clinical outcomes such as pain, foot function, dorsiflexion ROM and pressure pain threshold and alignment such as rearfoot eversion angle and foot posture index in patients with PF.
Detailed description
Plantar fasciitis (PF), which constitutes approximately 15% of all foot disorders, is the most prevalent cause of heel pain. It is a long-term degenerative process that is impacted by subtalar pronation and pes planus. One million US patients saw primary care physicians with PF between 1995 and 2000. There is not enough data to determine the best physical therapy management techniques for individuals with heel pain, despite the existence of multiple successful treatment approaches. this study investigated at how a mechanically based rehabilitation program affected patients with PF in terms of foot alignment, plantar fascia thickness, pain, pressure pain threshold, ROM and foot function. The approach included strengthening the plantar intrinsic muscles of the foot, plantar fascia specific stretching and Achilles tendon stretching, and passively correcting the pathomechanics of the foot by low dye tapping and high load resistance exercise for Achilles tendon and windlass mechanism
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selected rehabilitation program | Experimental | Other: stretching exercises, Other: rigid tape, Other: mobilization, Other: strengthening exerciseinvolves 24 patients and will be given the selected rehabilitation program involving (self-stretching exercise, mobilization of the ankle and subtalar, rigid tape and unilateral heel raising exercise 3 times per week for 8 weeks. |
| traditional program | Experimental | Other: stretching exercises, Device: ultrasound, Other: mobilization, Other: myofascial releaseinvolves 24 patients and will be given the traditional program involving (self-stretching exercise, mobilization of the ankle and subtalar, plantar fascial release and ultrasonic therapy 3 times per week for 8 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing
- Pain with palpation of the proximal insertion of the plantar fascia
- Positive windlass test
- flat foot posture utilizing the foot posture index
- age range from 40 to 60 years
Key exclusion criteria (4 listed)
- tarsal tunnel syndrome
- atrophy of the fat pad.
- diabetic patients or patients with rheumatoid arthritis
- corticosteroid injection over the last sex months
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 |
|---|---|---|
| stretching exercisesstretching exercises of the plantar fascia, gastrocnemius and soleus | Other | selected rehabilitation program, traditional program |
| ultrasoundtherapeutic ultrasound upon the most painful point on the medial calcaneal tubercle. The parameters involved a pulsed mode (duty cycle 50%) using an intensity of 1.5 W/cm2 and a 1 MHz of frequency for 5 minutes | Device | traditional program |
| rigid tapelow-dye tapping will be done to provide mechanical correction to plantar fascia and medial longitudinal arch | Other | selected rehabilitation program |
| mobilizationmobilization techniques for the talocrural joint in weight bearing and non-bearing positions and subtalar joint | Other | selected rehabilitation program, traditional program |
| myofascial releasedeep tissue release of the plantar fascia and flexor hallucis longus in a stretched position of the plantar fascia | Other | traditional program |
| strengthening exercisestrengthening exercise of the plantar intrinsic muscles using short foot exercise and strengthening of the Achilles tendon and windlass mechanism using unilateral heel raise exercises | Other | selected rehabilitation program |
Primary outcome
Assessing the change in pain intensity
Time frame: At baseline and following 8 weeks
VAS is typically composed of a 100 mm horizontal line attached to two opposed labels, the left end marked "no pain" and the right end marked "worst possible pain. Patients were marked a score on the scale by a vertical line that exactly refer to their pain
6 secondary outcomes
Assessing the change in foot posture
Time frame: At baseline and following 8 weeks
Assessing the change in foot function
Time frame: At baseline and following 8 weeks
Assessing the change in plantar fascia thickness
Time frame: At baseline and following 8 weeks
Assessing the change in rear foot angle
Time frame: At baseline and following 8 weeks
Assessing the change in range of motion
Time frame: At baseline and following 8 weeks
Assessing the change in pressure pain threshold
Time frame: At baseline and following 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 41715005Ibraheem MR, El-Moneim MAA, Ibrahim MM. The effect of multimodal rehabilitation program on pain, functional outcomes, and plantar fascia thickness in patients with plantar fasciitis: a randomized controlled trial. BMC Musculoskelet Disord. 2026 Feb 20;27(1):168. doi: 10.1186/s12891-026-09562-x.
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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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.
Mohamed Ramadan Ibraheem, Assistant lecturer principal investigator
Horus University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stretching exercises, ultrasound and rigid tape in people with Plantar Fascitis and Plantar Fasciitis, Chronic, run by Horus University at 2 sites in Egypt.
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 4 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: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in pain intensity (time frame: At baseline and following 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456944, which also lists 1 linked publication.
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 22 Jul 2025.