Chronic Plantar FasciitisNCT05754697
IASTM Versus PRT in Patients With Chronic PF
A study testing Instrument assisted soft tissue mobilization in addition to traditional treatment, Positional release technique in addition to traditional treatment and Traditional treatment in people with Chronic Plantar Fasciitis, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial] is to compare between the effect of instrument assisted soft tissue mobilization and positional release technique in patients with chronic plantar fasciitis The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Plantar Fasciitis
- What is being tested?
- Instrument assisted soft tissue mobilization in addition to traditional treatment, Positional release technique in addition to traditional treatment and Traditional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 30 Jul 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 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 30-50 years.
- Body mass index range from (18.5 to 24.9 kg/m2).
Who cannot join
- Subjects can't tolerate close physical contact.
- Athletes.
- Subjects with skin infections.
- Subjects with recent fracture with incomplete bony union.
- Subjects with acute inflammatory or infectious process.
- Subjects with hematoma.
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- Subjects with osteoporosis.
- Subjects with foot deformity.
- Subjects that take medications that may increase blood clotting.
- Surgery to the ankle or foot.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Instrument Assisted Soft Tissue Mobilization Versus Positional Release Technique in Patients With Chronic Plantar Fasciitis
The goal of this clinical trial] is to compare between the effect of instrument assisted soft tissue mobilization and positional release technique in patients with chronic plantar fasciitis
The main question[s] it aims to answer are:
- Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on pain pressure threshold in patients with chronic plantar fasciitis?
- Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on foot function level in patients with chronic plantar fasciitis?
Read the detailed description
Design of the study:
Pretest - posttest randomized controlled trial.
Subjects selection:
Sixty patients their age range from 30-50 years of both genders with chronic plantar fasciitis will participate in this study according to sample size calculation.
- Conditions
- Chronic Plantar Fasciitis
- Being tested
- Instrument assisted soft tissue mobilization in addition to traditional treatment, Positional release technique in addition to traditional treatment, Traditional treatment
- Keywords
- Positional release technique, Instrument assisted soft tissue mobilization
- 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 mobilization in addition to traditional treatmentOther
The treatment protocol will be two sessions will be given per week for 4 weeks.
Positional release technique in addition to traditional treatmentOther
The treatment protocol will be two sessions will be given per week for 4 weeks.
Traditional treatmentOther
The treatment protocol will be two sessions will be given per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| instrument assisted soft tissue mobilization in addition to traditional treatment | Experimental | study group Receives: Other: Instrument assisted soft tissue mobilization in addition to traditional treatment |
| positional release technique in addition to traditional treatment | Experimental | study group Receives: Other: Positional release technique in addition to traditional treatment |
| traditional treatment | Active comparator | control group Receives: Other: Traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Algometer (Change in pain pressure threshold)
Change in pain pressure threshold as assessed using pressure algometer on medial plantar process, with the unit of measurement in kg/cm².
Change in pain pressure threshold as assessed using pressure algometer on gastrocnemius muscle, with the unit of measurement in kg/cm².
Change in pain pressure threshold as assessed using pressure algometer on soleus muscle, with the unit of measurement in kg/cm².
Change in pain pressure threshold as assessed using pressure algometer over the posteromedial aspect of the calcaneus , with the unit of measurement in kg/cm².
Measured: Pre-intervention and immediately after intervention
Secondary outcomes (1)
The Arabic Version of Foot and Ankle Ability Measure
The foot and ankle ability measure is a reliable, responsive, and valid measure of physical function for individuals with a broad range of musculoskeletal disorders of the lower leg, foot, and ankle.
This self-report outcome instrument is available in English, German, French and Persian. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.
Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
Measured: Pre-intervention and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start15 Mar 2023
- Primary completion15 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Said Mohamed Ibrahim, Cairo University
- Investigators
- Doaa Ibrahim, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754697
- Sponsor's protocol ID
- P.T.REC/012/003841
- Status last verified
- Sep 2023
- First submitted
- 28 Jan 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrument Assisted Soft Tissue Mobilization Versus Positional Release Technique in Patients With Chronic Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05754697
- Acronym / sponsor ID
- P.T.REC/012/003841
- Conditions
- Chronic Plantar Fasciitis
- Keywords
- Positional release technique, Instrument assisted soft tissue mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 6 Mar 2023 (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.
The goal of this clinical trial] is to compare between the effect of instrument assisted soft tissue mobilization and positional release technique in patients with chronic plantar fasciitis
The main question[s] it aims to answer are:
- Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on pain pressure threshold in patients with chronic plantar fasciitis?
- Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on foot function level in patients with chronic plantar fasciitis?
Detailed description
Design of the study:
Pretest - posttest randomized controlled trial.
Subjects selection:
Sixty patients their age range from 30-50 years of both genders with chronic plantar fasciitis will participate in this study according to sample size calculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| instrument assisted soft tissue mobilization in addition to traditional treatment | Experimental | Other: Instrument assisted soft tissue mobilization in addition to traditional treatmentstudy group |
| positional release technique in addition to traditional treatment | Experimental | Other: Positional release technique in addition to traditional treatmentstudy group |
| traditional treatment | Active comparator | Other: Traditional treatmentcontrol group |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 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 30-50 years.
- Body mass index range from (18.5 to 24.9 kg/m2).
Key exclusion criteria (10 listed)
- Subjects can't tolerate close physical contact.
- Athletes.
- Subjects with skin infections.
- Subjects with recent fracture with incomplete bony union.
- Subjects with acute inflammatory or infectious process.
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 mobilization in addition to traditional treatmentThe treatment protocol will be two sessions will be given per week for 4 weeks. | Other | instrument assisted soft tissue mobilization in addition to traditional treatment |
| Positional release technique in addition to traditional treatmentThe treatment protocol will be two sessions will be given per week for 4 weeks. | Other | positional release technique in addition to traditional treatment |
| Traditional treatmentThe treatment protocol will be two sessions will be given per week for 4 weeks. | Other | traditional treatment |
Primary outcome
Pressure Algometer (Change in pain pressure threshold)
Time frame: Pre-intervention and immediately after intervention
Change in pain pressure threshold as assessed using pressure algometer on medial plantar process, with the unit of measurement in kg/cm². Change in pain pressure threshold as assessed using pressure algometer on gastrocnemius muscle, with the unit of measurement in kg/cm². Change in pain pressure threshold as assessed using pressure algometer on soleus muscle, with the unit of measurement in kg/cm². Change in pain pressure threshold as assessed using pressure algometer over the posteromedial aspect of the calcaneus , with the unit of measurement in kg/cm².
1 secondary outcome
The Arabic Version of Foot and Ankle Ability Measure
Time frame: Pre-intervention and immediately after intervention
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 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Doaa Ibrahim principal investigator
Cairo University
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 in addition to traditional treatment, Positional release technique in addition to traditional treatment and Traditional treatment in people with Chronic Plantar Fasciitis, run by Cairo University 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 5 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: finished, as of the sponsor's last update on 28 Sep 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 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?
Pressure Algometer (Change in pain pressure threshold) (time frame: Pre-intervention and immediately after intervention). 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 28 Sep 2023.