Plantar FascitisPFNCT06248853
Effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis
A study testing Garston technique and exercise program in people with Plantar Fascitis, run by Cairo University.
Trial summary
this study will be conducted to investigate the effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Garston technique and exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2024to 30 Apr 2024
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients that Clinically diagnosed cases of plantar fasciitis not less than 6 weeks.
- patients willing to precipitate in the study and take treatment for 6 successive weeks.
- Heel pain felt maximally over the plantar aspect of heel
- Pain in the heel on the first step in the morning
- No history of rest pain in the heel
Who cannot join
- Subjects with clinical disorders where therapeutic ultrasound is contraindicated such as infective conditions of foot, tumor, calcaneal fracture, metal implant around ankle.
- Subjects with a clinical disorder where myofascial release is contraindicated as dermatitis.
- Subjects with impaired circulation to lower extremities
- Subjects with referred pain due to sciatica and other neurological disorders.
- Arthritis
- Corticosteroids injection in heel preceding 3 months
Trial locations and contacts
No sites are listed yet.
About this study
this study will be conducted to investigate the effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis
Read the detailed description
Plantar fasciitis (PF), generally a self-limiting condition, is identified as one of the most common causes of heel pain in adults. It affects both sedentary and athletic populations .
It may be considered that PF emerges due to excessive and prolonged standing or running, which causes an acute inflammation or micro-tears, and degenerative changes plantar fascia. The persistence of these risk factors inhibits the regular repair process thus collagen degeneration occurs, causing the structural changes of the plantar fascia. Numerous interventions have been described for treatment of PF, which include: Stretching calf or plantar region which is performed with the patient stands with staggered legs facing toward a wall, with both hands stretched out .The Graston technique can break up scar tissue and restore soft tissue. The Graston technique is a type of manual therapy in which patented stainless-steel instruments are used to restore soft tissue motion by breaking up scar tissue. fifty patients with planter fasciitis will be assigned randomly to two equal groups; first one will receive graston technique in addition to exercise program, the second one will receive exercise program only for six weeks
- Conditions
- Plantar Fascitis
- Being tested
- Garston technique, exercise program
- Keywords
- graston technique, planter thickness, planter fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garston techniqueOther
the patients will receive instrumented assisted soft tissue mobilization using the Graston technique, which includes the application of a cream to the posterior calf and plantar foot from the knee to the toes to reduce friction on the skin. The Graston tools will be used to mobilize the tissues of the triceps surae and plantar foot bypassing the tools along the leg and foot
exercise programOther
the patients will receive pedaling an exercise bicycle for 5 min with minimal resistance to warm the tissues, gastrocnemius stretches performed on a step for three repetitions held for 30 sec each , plantar fascia stretching performed in a seated position for three repetitions held for 30 sec each, and foot intrinsic muscular strengthening using a short foot exercise. Ice will be offered as needed for pain management after each session in addition to home program exercise
| Study group | Role | What they receive |
|---|---|---|
| Garston technique | Experimental | the patients will receive graston technique with exercise program three times aweek for six weeks Receives: Other: Garston technique; Other: exercise program |
| exercise program | Active comparator | the patients will receive an exercise program three times a week for six weeks Receives: Other: exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
plantar thickness
Ultrasonography will be used to measure planter thickness
Measured: up to six weeks
Secondary outcomes (4)
pain intensity
Visual Analogue Scale (VAS) will be used to assess pain intensity: The VAS is a 100-mm horizontal line that may be used to quantify symptoms in a continuous fashion. Patients will instructed to indicate the intensity of their pain by marking on a line anchored by "no pain" on the left and "worst imaginable pain" on the right .
Measured: up to six weeks
pain intensity at the first step
numerical pain rating scale (NPRS) will be used to measure pain intensity at the first step. NPRS is a 10cm horizontal line t. Patients will instructed to indicate the intensity of their pain by marking on a line anchored by "no pain" on the left and "worst imaginable pain" on the right side.
Measured: up to six weeks
functional levels of foot
The Foot and Ankle Ability Measure (FAAM) questionnaire will be used to assess foot function. The FAAM is a self-reported questionnaire that comprehensively assesses the physical function of those with musculoskeletal conditions of the leg, foot, and ankle. It has a 21-item subscale for measuring the function of the individual with his or her activities of daily living (ADLs) and a ten-item subscale for measuring function with sports. The ADL subscale will be used for this study. The instrument is scored on a Likert scale from 4 to 0, with 4 representing ''no difficulty'' as going up stairs and 0 representing ''unable to do.'' The answers are then converted to a scale from 0 to 100, with a higher score representing a higher functional level.
Measured: up to six weeks
pain pressure threshold
The pressure algometer device will be used to measure pain pressure threshold
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (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 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
- Model description
- Graston technique and exercise program
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248853
- Sponsor's protocol ID
- P.T.REC/012/002947
- Acronym
- PF
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis
- ClinicalTrials.gov ID
- NCT06248853
- Acronym / sponsor ID
- PF / P.T.REC/012/002947
- Conditions
- Plantar Fascitis
- Keywords
- graston technique, planter thickness, planter fasciitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 8 Feb 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 conducted to investigate the effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis
Detailed description
Plantar fasciitis (PF), generally a self-limiting condition, is identified as one of the most common causes of heel pain in adults. It affects both sedentary and athletic populations .
It may be considered that PF emerges due to excessive and prolonged standing or running, which causes an acute inflammation or micro-tears, and degenerative changes plantar fascia. The persistence of these risk factors inhibits the regular repair process thus collagen degeneration occurs, causing the structural changes of the plantar fascia. Numerous interventions have been described for treatment of PF, which include: Stretching calf or plantar region which is performed with the patient stands with staggered legs facing toward a wall, with both hands stretched out .The Graston technique can break up scar tissue and restore soft tissue. The Graston technique is a type of manual therapy in which patented stainless-steel instruments are used to restore soft tissue motion by breaking up scar tissue. fifty patients with planter fasciitis will be assigned randomly to two equal groups; first one will receive graston technique in addition to exercise program, the second one will receive exercise program only for six weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Graston technique and exercise program
| Arm | Type | Receives |
|---|---|---|
| Garston technique | Experimental | Other: Garston technique, Other: exercise programthe patients will receive graston technique with exercise program three times aweek for six weeks |
| exercise program | Active comparator | Other: exercise programthe patients will receive an exercise program three times a week for six weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients that Clinically diagnosed cases of plantar fasciitis not less than 6 weeks.
- patients willing to precipitate in the study and take treatment for 6 successive weeks.
- Heel pain felt maximally over the plantar aspect of heel
- Pain in the heel on the first step in the morning
- No history of rest pain in the heel
Key exclusion criteria (6 listed)
- Subjects with clinical disorders where therapeutic ultrasound is contraindicated such as infective conditions of foot, tumor, calcaneal fracture, metal implant around ankle.
- Subjects with a clinical disorder where myofascial release is contraindicated as dermatitis.
- Subjects with impaired circulation to lower extremities
- Subjects with referred pain due to sciatica and other neurological disorders.
- Arthritis
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 |
|---|---|---|
| Garston techniquethe patients will receive instrumented assisted soft tissue mobilization using the Graston technique, which includes the application of a cream to the posterior calf and plantar foot from the knee to the toes to reduce friction on the skin. The Graston tools will be used to mobilize the tissues of the triceps surae and plantar foot bypassing the tools along the leg and foot | Other | Garston technique |
| exercise programthe patients will receive pedaling an exercise bicycle for 5 min with minimal resistance to warm the tissues, gastrocnemius stretches performed on a step for three repetitions held for 30 sec each , plantar fascia stretching performed in a seated position for three repetitions held for 30 sec each, and foot intrinsic muscular strengthening using a short foot exercise. Ice will be offered as needed for pain management after each session in addition to home program exercise | Other | Garston technique, exercise program |
Primary outcome
plantar thickness
Time frame: up to six weeks
Ultrasonography will be used to measure planter thickness
4 secondary outcomes
pain intensity
Time frame: up to six weeks
pain intensity at the first step
Time frame: up to six weeks
functional levels of foot
Time frame: up to six weeks
pain pressure threshold
Time frame: up to six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Garston technique and exercise program in people with Plantar Fascitis, run by Cairo University.
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 6 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 mostafa elshenawy, master (01124009013, melshenawy584@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plantar thickness (time frame: up to six weeks). 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 8 Feb 2024.