Plantar FascitisESWTNCT06685172
Comparison of the Acute Effects of Focused and Radial ESWT on Pain and Balance Performance in Individuals With Plantar Fasciitis: A Randomized Clinical Trial
A study testing f-ESWT and r-ESWT in people with Plantar Fascitis and Pain, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 63 months
- Conditions the study is for
- Plantar Fascitis, Pain
- What is being tested?
- f-ESWT and r-ESWT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Aug 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 18 to 63 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- unilateral or bilateral tenderness in the medial tubercle of calcaneus and heel pain in the first few steps in the morning, which gets worse with increased activity, absence of any known systemic disease, absence of any surgical procedure to lower extremity, absence of any treatment for PF in the last 6 months, 18-65 years, and consent to participate in the study.
Who cannot join
- pregnancy, pacemaker, receiving anticoagulant therapy, uncontrolled cardiovascular disease, tumor, acute infection, nerve root compression, local dermatological or neurological problems, diabetes mellitus, taking anti-inflammatory drugs during treatment, or incomplete follow-up.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Gulhane Faculty of Medicine
Ankara, 06018
About this study
This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis.
Read the detailed description
This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis. The study included 40 individuals (27 females and 13 males) aged between 18 and 63 years, presenting with plantar fasciitis (PF). Extracorporeal shockwave therapy (ESWT) was administered once a week for four weeks. The participants were randomly assigned to two groups (f-ESWT and r-ESWT). Pain levels were assessed using the Visual Analogue Scale, while Static and Dynamic Balance were evaluated using the Biodex Balance System.
- Conditions
- Plantar Fascitis, Pain
- Being tested
- f-ESWT, r-ESWT
- Keywords
- Balance, pain, plantar fasciitis, stability
- Medical subject headings
- Pain, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
f-ESWTOther
In the f-ESWT group, a total of 8 Hz, 0.28 mJ/mm2, and 2000 pulses were applied while in the r-ESWT group, a total of 8 Hz, 1.8 bar, and 2000 pulses were applied
r-ESWTOther
In the f-ESWT group, a total of 8 Hz, 0.28 mJ/mm2, and 2000 pulses were applied while in the r-ESWT group, a total of 8 Hz, 1.8 bar, and 2000 pulses were applied
| Study group | Role | What they receive |
|---|---|---|
| f-ESWT Group | Active comparator | Twenty patients with plantar fasciitis received f-ESWT treatment once a week for four weeks. Receives: Other: f-ESWT |
| r-ESWT Group | Active comparator | Twenty patients with plantar fasciitis received r-ESWT treatment once a week for four weeks. Receives: Other: r-ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) was used to determine the intensity of pain in patients with PF, and Biodex Balance System device (Biodex Balance System SD, 2009 USA) was used to assess balance performance.
The Visual Analogue Scale (VAS) was employed to ascertain the intensity of pain experienced by the affected/more affected extremities. The Biodex Balance System device (Biodex Balance System SD, 2009 USA) was used to assess balance performance.
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Dec 2023
- Primary completion15 Jul 2024
- Study completion15 Aug 2024
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
- Model description
- A total of 40 patients with plantar fasciitis were randomly assigned to focal-ESWT treatment (n= 20) or radial-ESWT treatment (n= 20).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğba Kocahan, Gulhane Training and Research Hospital
- Investigators
- Aydan Örsçelik, Associate Professor MD, Study chair, Health Sciences University, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685172
- Sponsor's protocol ID
- 2023/285
- Other IDs
- Health Sciences University
- Acronym
- ESWT
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared after publication as an article
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Acute Effects of Focused and Radial ESWT on Pain and Balance Performance in Individuals With Plantar Fasciitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06685172
- Acronym / sponsor ID
- ESWT / 2023/285
- Conditions
- Plantar Fascitis, Pain
- Keywords
- Balance, pain, plantar fasciitis, stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 12 Nov 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 aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis.
Detailed description
This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis. The study included 40 individuals (27 females and 13 males) aged between 18 and 63 years, presenting with plantar fasciitis (PF). Extracorporeal shockwave therapy (ESWT) was administered once a week for four weeks. The participants were randomly assigned to two groups (f-ESWT and r-ESWT). Pain levels were assessed using the Visual Analogue Scale, while Static and Dynamic Balance were evaluated using the Biodex Balance System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 40 patients with plantar fasciitis were randomly assigned to focal-ESWT treatment (n= 20) or radial-ESWT treatment (n= 20).
| Arm | Type | Receives |
|---|---|---|
| f-ESWT Group | Active comparator | Other: f-ESWTTwenty patients with plantar fasciitis received f-ESWT treatment once a week for four weeks. |
| r-ESWT Group | Active comparator | Other: r-ESWTTwenty patients with plantar fasciitis received r-ESWT treatment once a week for four weeks. |
Who may qualify
- Ages
- 18 to 63 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- unilateral or bilateral tenderness in the medial tubercle of calcaneus and heel pain in the first few steps in the morning, which gets worse with increased activity, absence of any known systemic disease, absence of any surgical procedure to lower extremity, absence of any treatment for PF in the last 6 months, 18-65 years, and consent to participate in the study.
Key exclusion criteria (1 listed)
- pregnancy, pacemaker, receiving anticoagulant therapy, uncontrolled cardiovascular disease, tumor, acute infection, nerve root compression, local dermatological or neurological problems, diabetes mellitus, taking anti-inflammatory drugs during treatment, or incomplete follow-up.
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 |
|---|---|---|
| f-ESWTIn the f-ESWT group, a total of 8 Hz, 0.28 mJ/mm2, and 2000 pulses were applied while in the r-ESWT group, a total of 8 Hz, 1.8 bar, and 2000 pulses were applied | Other | f-ESWT Group |
| r-ESWTIn the f-ESWT group, a total of 8 Hz, 0.28 mJ/mm2, and 2000 pulses were applied while in the r-ESWT group, a total of 8 Hz, 1.8 bar, and 2000 pulses were applied | Other | r-ESWT Group |
Primary outcome
Visual Analog Scale (VAS) was used to determine the intensity of pain in patients with PF, and Biodex Balance System device (Biodex Balance System SD, 2009 USA) was used to assess balance performance.
Time frame: Baseline and 5 weeks
The Visual Analogue Scale (VAS) was employed to ascertain the intensity of pain experienced by the affected/more affected extremities. The Biodex Balance System device (Biodex Balance System SD, 2009 USA) was used to assess balance performance.
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 12 Nov 2024.
- Individual participant dataSharing planned: Yes. Data can be shared after publication as an article
Related trials for Plantar Fascitis
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Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
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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
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
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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.
Aydan Örsçelik, Associate Professor MD study chair
Health Sciences University, Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing f-ESWT and r-ESWT in people with Plantar Fascitis and Pain, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 12 Nov 2024. 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 Turkey (Türkiye). 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?
Visual Analog Scale (VAS) was used to determine the intensity of pain in patients with PF, and Biodex Balance System device (Biodex Balance System SD, 2009 USA) was used to assess balance performance. (time frame: Baseline and 5 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 12 Nov 2024.