Chronic Plantar FasciitisNCT07070245
Comparing Instrument Assisted Soft Tissue Mobilization With Positional Release Technique for Plantar Fasciitis Pain and Range of Motion
A study testing Instrument assisted soft tissue mobilization, Positional release and Exercises in people with Chronic Plantar Fasciitis and Heel Pain, run by Doaa Said Mohamed Ibrahim at 1 site in Egypt.
Trial summary
Chronic plantar fasciitis (CPF) is the most common cause of chronic heel pain in adults, affecting both young active patients and older, more sedentary individuals. It results from chronic overload of the plantar fascia. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Plantar Fasciitis, Heel Pain, Plantar Fascia Inflammation
- What is being tested?
- Instrument assisted soft tissue mobilization, Positional release and Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically diagnosed cases of plantar fasciitis not less than 3 months.
- Heel pain felt maximally over plantar aspect of heel.
- Pain in the heel on the first step in the morning.
- Their age ranging from 30 to 50 years
Who cannot join
- Subjects can't tolerate close physical contact (Kotwalkar et al., 2019).
- Athletes.
- Subjects with skin infections (Kotwalkar et al., 2019).
- Subjects with recent fracture with incomplete bony union (Rowlett et al., 2018).
- Subjects with acute inflammatory or infectious process (Rowlett et al., 2018).
- Subjects with hematoma (Rowlett et al., 2018).
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- Subjects with osteoporosis (Looney et al., 2011).
- Subjects with foot deformity (Kotwalkar et al., 2019).
- Subjects that take medications that may increase blood clotting (Kotwalkar et al., 2019).
- Surgery to the ankle or foot (Looney et al., 2011).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Chronic plantar fasciitis (CPF) is the most common cause of chronic heel pain in adults, affecting both young active patients and older, more sedentary individuals. It results from chronic overload of the plantar fascia. This overload may be due to overuse, as seen in runners and military personnel, or due to excessive loading in individuals with obesity (body mass index >30), sedentary lifestyles, or occupations that require prolonged standing.
- Being tested
- Instrument assisted soft tissue mobilization, Positional release, Exercises
- Keywords
- Instrument assisted soft tissue mobilization, Chronic plantar fasciitis, Positional release technique
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument assisted soft tissue mobilizationProcedure or surgery
The treatment protocol will be two sessions. given per week for 4 weeks.
Positional releaseProcedure or surgery
The treatment protocol will be two sessions. given per week for 4 weeks.
ExercisesProcedure or surgery
The treatment protocol will be two sessions. given per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Positional release technique | Experimental | Positional release technique in addition to exercises in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise (study group) The treatment protocol will be two sessions. given per week for 4 weeks. Receives: Procedure: Positional release |
| Traditional exercises (control group) | Experimental | Traditional exercises (control group), traditional exercises in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise The treatment protocol will be two sessions.
given per week for 4 weeks. Receives: Procedure: Exercises |
| Instrument assisted soft tissue mobilization | Experimental | Instrument-assisted soft tissue mobilization in addition to exercises (study group) in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise Receives: Procedure: Instrument assisted soft tissue mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity level assessed by Numeric Pain Rating Scale (NPRS)
Pain intensity level assessed by Numeric Pain Rating Scale. A scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Baseline and after 8 sessions (approximately 4 weeks)
Range of motion
A digital goniometer is used for the assessment of ankle dorsiflexion, plantar flexion range of motion, and knee flexion range of motion.
Measured: Baseline and after 8 sessions (approximately 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start22 Jun 2025
- Primary completion22 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
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 Chronic Plantar FasciitisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doaa Said Mohamed Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Doaa Said Mohamed Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070245
- Sponsor's protocol ID
- No:P.T.REC/012/005492
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and limitations in data-sharing agreements.
Publications
Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
PubMed 18524985
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Instrument Assisted Soft Tissue Mobilization With Positional Release Technique for Plantar Fasciitis Pain and Range of Motion
- ClinicalTrials.gov ID
- NCT07070245
- Acronym / sponsor ID
- No:P.T.REC/012/005492
- Keywords
- Instrument assisted soft tissue mobilization, Chronic plantar fasciitis, Positional release technique
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Doaa Said Mohamed IbrahimUniversity, hospital or other
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 22 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 17 Jul 2025 (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.
Chronic plantar fasciitis (CPF) is the most common cause of chronic heel pain in adults, affecting both young active patients and older, more sedentary individuals. It results from chronic overload of the plantar fascia. This overload may be due to overuse, as seen in runners and military personnel, or due to excessive loading in individuals with obesity (body mass index >30), sedentary lifestyles, or occupations that require prolonged standing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positional release technique | Experimental | Procedure: Positional releasePositional release technique in addition to exercises in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise (study group) The treatment protocol will be two sessions. given per week for 4 weeks. |
| Traditional exercises (control group) | Experimental | Procedure: ExercisesTraditional exercises (control group), traditional exercises in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise The treatment protocol will be two sessions. given per week for 4 weeks. |
| Instrument assisted soft tissue mobilization | Experimental | Procedure: Instrument assisted soft tissue mobilizationInstrument-assisted soft tissue mobilization in addition to exercises (study group) in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinically diagnosed cases of plantar fasciitis not less than 3 months.
- Heel pain felt maximally over plantar aspect of heel.
- Pain in the heel on the first step in the morning.
- Their age ranging from 30 to 50 years
Key exclusion criteria (10 listed)
- Subjects can't tolerate close physical contact (Kotwalkar et al., 2019).
- Athletes.
- Subjects with skin infections (Kotwalkar et al., 2019).
- Subjects with recent fracture with incomplete bony union (Rowlett et al., 2018).
- Subjects with acute inflammatory or infectious process (Rowlett et al., 2018).
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 |
|---|---|---|
| Instrument assisted soft tissue mobilizationThe treatment protocol will be two sessions. given per week for 4 weeks. | Procedure or surgery | Instrument assisted soft tissue mobilization |
| Positional releaseThe treatment protocol will be two sessions. given per week for 4 weeks. | Procedure or surgery | Positional release technique |
| ExercisesThe treatment protocol will be two sessions. given per week for 4 weeks. | Procedure or surgery | Traditional exercises (control group) |
Primary outcome
Pain intensity level assessed by Numeric Pain Rating Scale (NPRS)
Time frame: Baseline and after 8 sessions (approximately 4 weeks)
Pain intensity level assessed by Numeric Pain Rating Scale. A scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Range of motion
Time frame: Baseline and after 8 sessions (approximately 4 weeks)
A digital goniometer is used for the assessment of ankle dorsiflexion, plantar flexion range of motion, and knee flexion range of motion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 18524985Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and limitations in data-sharing agreements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument assisted soft tissue mobilization, Positional release and Exercises in people with Chronic Plantar Fasciitis and Heel Pain, run by Doaa Said Mohamed Ibrahim at 1 site 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 4 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 17 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain intensity level assessed by Numeric Pain Rating Scale (NPRS) (time frame: Baseline and after 8 sessions (approximately 4 weeks)). The study lists 2 primary outcomes in all. 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 NCT07070245, 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 17 Jul 2025.