Plantar FascitisNCT05920551
Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis
A study testing Gastrocnemius Stretching Exercises in people with Plantar Fascitis, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
The study aims to investigate the effectiveness of gastrocnemius stretching exercises on plantar heel pain intensity, foot mobility, and function in patients with plantar fasciitis. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Gastrocnemius Stretching Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Feb 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pain reproduced with palpation of the plantar fascia
- localized and sharp but not radiating
- worse in the initial step after and an extended period of rest
- decreased initially after the first steps but exacerbated with increased activityat least 6 weeks
- unresponsive conservative form of plantar fasciitis care (ie, rest, stretching, full-length silicone insole, prescription NSAIDs when taken for a period of 2 weeks)
Who cannot join
- history of previous steroid injections
- previous surgery of the foot, lumbar spine disc herniation or back injury
- patients with rheumatic diseases (e.g., rheumatoid arthritis, spondyloarthropathy, gout disease, enthesopathy, Sjogren's syndrome, and systemic lupus erythematosus)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: Efficacy of Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis: A Randomised Controlled Trial
The study aims to investigate the effectiveness of gastrocnemius stretching exercises on plantar heel pain intensity, foot mobility, and function in patients with plantar fasciitis.
Read the detailed description
This randomized controlled trial will include patients diagnosed with plantar fasciitis. Participants will be randomly assigned to either a study group performing gastrocnemius stretches or a control group. Both groups will receive ultrasound therapy and fascia strengthening exercises. The study group will additionally perform specific gastrocnemius stretching exercises. Outcome measures will be assessed before and after 4 weeks of intervention and will include pain intensity, foot mobility using an inversion/eversion device, and function using the Foot and Ankle Ability Measure. The study hypothesizes that the study group will demonstrate greater improvements in pain, foot mobility, and function compared to the control group. The study findings could guide physical therapy interventions for patients with plantar fasciitis.
- Conditions
- Plantar Fascitis
- Being tested
- Gastrocnemius Stretching Exercises, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrocnemius Stretching ExercisesOther
The gastrocnemius stretching exercises will be performed by patients in the study group. These exercises will involve stretching the gastrocnemius muscle in a controlled manner to improve flexibility and reduce tension in the plantar fascia.
Standard careOther
Ultrasound therapy: A therapeutic ultrasound device will be used to apply ultrasound waves to the plantar fascia area for pain relief and to promote healing. The frequency, intensity, and duration of the ultrasound therapy will be determined by the treating physical therapist based on individual patient needs.Fascia strengthening exercises: Patients will be instructed to perform exercises targeting the intrinsic foot muscles and the plantar fascia to improve strength and function. Examples of these exercises include toe curls, towel scrunches, and arch lifts. Patients will be asked to perform these exercises daily, with the specific number of repetitions and sets determined by the physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Gastrocnemius Stretching Group | Experimental | Patients will receive ultrasound therapy, fascia strengthening exercises, and gastrocnemius stretching exercises. Receives: Other: Gastrocnemius Stretching Exercises; Other: Standard care |
| Control Group | Active comparator | Patients will receive ultrasound therapy and fascia strengthening exercises without gastrocnemius stretching exercises. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Plantar heel pain intensity
Measured using a Visual Analog Scale (VAS)
Measured: Changes in Plantar heel pain intensity at Baseline and after 4 weeks of intervention and 3 months
Secondary outcomes (2)
Changes in Foot mobility
Measured using an inversion/eversion device
Measured: Changes in foot mobility at Baseline and after 4 weeks of intervention and 3 months
Changes in Foot function
Measured using the Foot and Ankle Ability Measure (FAAM)
Measured: Changes in foot function at Baseline and after 4 weeks of intervention and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 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.
- 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920551
- Sponsor's protocol ID
- 012/7080002023
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05920551
- Acronym / sponsor ID
- 012/7080002023
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 27 Jun 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 study aims to investigate the effectiveness of gastrocnemius stretching exercises on plantar heel pain intensity, foot mobility, and function in patients with plantar fasciitis.
Detailed description
This randomized controlled trial will include patients diagnosed with plantar fasciitis. Participants will be randomly assigned to either a study group performing gastrocnemius stretches or a control group. Both groups will receive ultrasound therapy and fascia strengthening exercises. The study group will additionally perform specific gastrocnemius stretching exercises. Outcome measures will be assessed before and after 4 weeks of intervention and will include pain intensity, foot mobility using an inversion/eversion device, and function using the Foot and Ankle Ability Measure. The study hypothesizes that the study group will demonstrate greater improvements in pain, foot mobility, and function compared to the control group. The study findings could guide physical therapy interventions for patients with plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrocnemius Stretching Group | Experimental | Other: Gastrocnemius Stretching Exercises, Other: Standard carePatients will receive ultrasound therapy, fascia strengthening exercises, and gastrocnemius stretching exercises. |
| Control Group | Active comparator | Other: Standard carePatients will receive ultrasound therapy and fascia strengthening exercises without gastrocnemius stretching exercises. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pain reproduced with palpation of the plantar fascia
- localized and sharp but not radiating
- worse in the initial step after and an extended period of rest
- decreased initially after the first steps but exacerbated with increased activityat least 6 weeks
- unresponsive conservative form of plantar fasciitis care (ie, rest, stretching, full-length silicone insole, prescription NSAIDs when taken for a period of 2 weeks)
Key exclusion criteria (3 listed)
- history of previous steroid injections
- previous surgery of the foot, lumbar spine disc herniation or back injury
- patients with rheumatic diseases (e.g., rheumatoid arthritis, spondyloarthropathy, gout disease, enthesopathy, Sjogren's syndrome, and systemic lupus erythematosus)
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 |
|---|---|---|
| Gastrocnemius Stretching ExercisesThe gastrocnemius stretching exercises will be performed by patients in the study group. These exercises will involve stretching the gastrocnemius muscle in a controlled manner to improve flexibility and reduce tension in the plantar fascia. | Other | Gastrocnemius Stretching Group |
| Standard careUltrasound therapy: A therapeutic ultrasound device will be used to apply ultrasound waves to the plantar fascia area for pain relief and to promote healing. The frequency, intensity, and duration of the ultrasound therapy will be determined by the treating physical therapist based on individual patient needs.Fascia strengthening exercises: Patients will be instructed to perform exercises targeting the intrinsic foot muscles and the plantar fascia to improve strength and function. Examples of these exercises include toe curls, towel scrunches, and arch lifts. Patients will be asked to perform these exercises daily, with the specific number of repetitions and sets determined by the physical therapist. | Other | Control Group, Gastrocnemius Stretching Group |
Primary outcome
Changes in Plantar heel pain intensity
Time frame: Changes in Plantar heel pain intensity at Baseline and after 4 weeks of intervention and 3 months
Measured using a Visual Analog Scale (VAS)
2 secondary outcomes
Changes in Foot mobility
Time frame: Changes in foot mobility at Baseline and after 4 weeks of intervention and 3 months
Changes in Foot function
Time frame: Changes in foot function at Baseline and after 4 weeks of intervention and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Plantar Fascitis
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
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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.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian 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 Gastrocnemius Stretching Exercises in people with Plantar Fascitis, run by Ahram Canadian 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 3 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 27 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Plantar heel pain intensity (time frame: Changes in Plantar heel pain intensity at Baseline and after 4 weeks of intervention and 3 months). 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 27 Jun 2023.