Chronic Plantar FasciitisNCT06712329
Chronic Plantar Fasciitis: Which is More Effective? Prolotherapy/Extracorporeal Shock Wave Therapy?
A study testing extracorporeal shock wave therapy and Prolotherapy in people with Chronic Plantar Fasciitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of this prospective study was to compare the effects of ESWT (extracorporeal shock wave therapy ) and prolotherapy on pain and foot function in patients with chronic plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Plantar Fasciitis
- What is being tested?
- extracorporeal shock wave therapy and Prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 19 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants must be aged between 18 and 75 years
- they must have experienced heel pain for a period of at least three months
- they must exhibit pain and tenderness upon palpation of the medial aspect of the calcaneal tuberosity with the ankle in full dorsiflexion
- they must have demonstrated no response to conservative treatment for a minimum of three months.
- In cases where symptoms were present on both sides, the more prominent side was included.
Who cannot join
- Inflammatory rheumatic disease
- Dermatological lesion on the heel
- Pregnancy
- Infection
- Malignancy
- Coagulopathy
Show all 11Show fewer
- Pacemaker
- Peripheral circulatory disorder
- A neurological disorder, such as radiculopathy or polyneuropathy
- Previous ESWT, dextrose prolotherapy, or surgical procedure to the heel region
- A local corticosteroid injection or oral corticosteroids in the last six weeks.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Şehir Hastanesi Bilkent
Ankara, çankaya, 06530
About this study
The primary objective of this prospective study was to compare the effects of ESWT (extracorporeal shock wave therapy ) and prolotherapy on pain and foot function in patients with chronic plantar fasciitis. In addition, the study was to investigate the changes in plantar pressure distribution and plantar fascia thickness measured by ultrasonography after ESWT and prolotherapy.
The fundamental questions that investigators want to answer are as follows:
[question 1]:Do ESWT and prolotherapy improve pain and foot function in patients with chronic plantar fasciitis? [question 2]:Do ESWT and prolotherapy change plantar pressure distribution and plantar fascia thickness in patients with chronic plantar fasciitis?
Read the detailed description
Chronic plantar fasciitis is a prevalent musculoskeletal disorder that results in discomfort and impaired functionality within the plantar surface of the foot. In instances where conservative treatment proves ineffective, it can complicate the management of the condition. Two invasive treatment options, namely extracorporeal shock wave therapy (ESWT) and prolotherapy, are available for the management of plantar fasciitis, with the objective of providing pain and functional improvement. The objective of this study was to compare the effects of ESWT and prolotherapy on pain, foot function, plantar fascia thickness and plantar pressure distribution in patients with chronic plantar fasciitis.
A total of 70 patients who did not respond to conservative treatment were included in this prospective, randomised controlled study. Following a clinical and ultrasonographic evaluation, the patients were randomly assigned to one of two groups. The study population was divided into two groups: the ESWT group (n = 36) and the prolotherapy group (n = 34). In the ESWT group, a total of 1800 to 2000 focused shock waves (0.15-0.25 mJ/mm² sessions with a frequency of 3-4 Hz) were applied. The prolotherapy group was administered a 3-ml injection of a 15% dextrose solution. The ESWT and prolotherapy treatments were administered in a total of three sessions, with two-week intervals between each session. The efficacy of the treatment was evaluated using a number of different measures, including the Visual Analogue Scale (VAS), the Foot and Ankle Ability Measurement (FAAM), the thickness of the plantar fascia and the distribution of plantar pressure. The evaluations were conducted at the outset of the study, at the six-week mark, and at the 12-week mark following the final intervention.
- Conditions
- Chronic Plantar Fasciitis
- Being tested
- extracorporeal shock wave therapy, Prolotherapy
- Keywords
- prolotherapy, extracorporeal shock wave therapy, plantar pressure distribution, plantar fascia thickness
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock wave therapyOther
Also called eswt
ESWT (Inceler Medical, Modus Focused ESWT, Turkey) was conducted by a single investigator in accordance with a standardised protocol. The patients were positioned prone on the examination table, with the affected limb placed in a supported position. The focused shockwave was applied in a circular motion along the insertion site of the plantar fascia and over the plantar fascia itself. The participants received 1,800 to 2,000 focused shock waves (0.15-0.25 mJ/mm² session with a frequency of 3-4 Hz). The frequency of the pulses was increased in a gradual manner, in accordance with the maximum tolerable degree of pain for each patient. A minimum dose of 1,000 mJ/mm² was administered. The ESWT was conducted in three sessions, with a two-week interval between each session.
ProlotherapyOther
Also called dextrose prolotherapy
The solution employed for dextrose prolotherapy comprised 1.5 ml of 30% dextrose and 1.5 ml of 0.9% isotonic sodium chloride solution, resulting in a total of 3 ml of 15% dextrose solution. . All procedures were conducted by the same investigator. A dextrose solution was infused into the centre and around the damaged area using a peppering technique. Following the procedure, patients were advised to remain in a supine position with their feet restrained for a period of 15 minutes.. Prolotherapy was repeated on three occasions, with each session occurring at a two-week interval
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal shock wave therapy group | Experimental | In the ESWT group, a total of 1800 to 2000 focused shock waves (0.15-0.25 mJ/mm² sessions with a frequency of 3-4 Hz) were applied Receives: Other: extracorporeal shock wave therapy |
| Prolotherapy Group | Experimental | The prolotherapy group was administered a 3-ml injection of a 15% dextrose solution. Receives: Other: Prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale(VAS)
The Visual Analogue Scale (VAS) was employed to evaluate the general perception of pain and the pain experienced at the first step upon rising. The scale ranges from 0 to 10, with a score of 0 indicating no pain and a score of 10 indicating the most severe pain imaginable
Measured: baseline - 6th week-12th week
Secondary outcomes (3)
Foot and Ankle Ability Measure (FAAM)
The Foot and Ankle Ability Measure (FAAM) was developed to assess the physical function of individuals with foot pathology. FAAM is a self-administered questionnaire consisting of 29 items, 21 of which pertain to activities of daily living (ADL) and 8 to sports. Each item of the FAAM is scored on a 5-point Likert scale with 4 points representing no difficulty at all; 3 points, slight difficulty; 2 points, moderate difficulty; 1 point, extreme difficulty; and 0 points, unable to do. The sixth option is not applicable if patients feel that this item does not concern them. If all items are answered, the ADL and sports subscales have a maximum score of 84 and 32, respectively. The obtained scores are transformed to percentages by dividing them with the maximum potential score and then multiplying the result by 100. A high score in both categories is indicative of a high level of physical functioning
Measured: baseline - 6th week-12th week
Thickness of the plantar fascia
A high-resolution ultrasound (5-13 MHz linear transducer, LOGIQ 9; GE Healthcare, China) was employed to ascertain the thickness of the plantar fascia. Ultrasonography measurements were conducted by the same individual, who has over five years of experience in this field. The participants were positioned in a prone manner with their ankles maintained in a neutral position. The thickness was measured in a vertical direction, commencing from the hyperechogenic border of the calcaneus bone and continuing until it reached the lower hyperechogenic edge of the plantar fascia. An average of three plantar fascia thickness measurements were taken at each assessment to minimise potential errors. The plantar fascia thickness was evaluated by a physiatrist who was unaware of the treatment groups
Measured: baseline - 6th week-12th week
Plantar pressure distribution
All participants underwent a static plantar pressure distribution assessment utilising the Formetric 4D system (DIERS MedicalSystems, Germany). In the test, each participant was required to stand on the platform, barefoot, with their feet side by side and facing forward for a period of five seconds. The parameters subjected to analysis were hindfoot plantar pressure (percent) and forefoot plantar pressure (percent)
Measured: baseline - 6th week-12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Oct 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
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 Ankara City Hospital BilkentThe 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
- 1. Inceler Medical, Modus Focused ESWT 2. 15% dextrose solution injection
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Ukbe Baykut, Ankara City Hospital Bilkent
- Investigators
- Ayşe U Baykut, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712329
- Sponsor's protocol ID
- ACHBİLKENTAUBAYKUT001
- Status last verified
- Dec 2024
- First submitted
- 16 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Plantar Fasciitis: Which is More Effective? Prolotherapy/Extracorporeal Shock Wave Therapy?
- ClinicalTrials.gov ID
- NCT06712329
- Acronym / sponsor ID
- ACHBİLKENTAUBAYKUT001
- Conditions
- Chronic Plantar Fasciitis
- Keywords
- prolotherapy, extracorporeal shock wave therapy, plantar pressure distribution, plantar fascia thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 2 Dec 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.
The primary objective of this prospective study was to compare the effects of ESWT (extracorporeal shock wave therapy ) and prolotherapy on pain and foot function in patients with chronic plantar fasciitis. In addition, the study was to investigate the changes in plantar pressure distribution and plantar fascia thickness measured by ultrasonography after ESWT and prolotherapy.
The fundamental questions that investigators want to answer are as follows:
[question 1]:Do ESWT and prolotherapy improve pain and foot function in patients with chronic plantar fasciitis? [question 2]:Do ESWT and prolotherapy change plantar pressure distribution and plantar fascia thickness in patients with chronic plantar fasciitis?
Detailed description
Chronic plantar fasciitis is a prevalent musculoskeletal disorder that results in discomfort and impaired functionality within the plantar surface of the foot. In instances where conservative treatment proves ineffective, it can complicate the management of the condition. Two invasive treatment options, namely extracorporeal shock wave therapy (ESWT) and prolotherapy, are available for the management of plantar fasciitis, with the objective of providing pain and functional improvement. The objective of this study was to compare the effects of ESWT and prolotherapy on pain, foot function, plantar fascia thickness and plantar pressure distribution in patients with chronic plantar fasciitis.
A total of 70 patients who did not respond to conservative treatment were included in this prospective, randomised controlled study. Following a clinical and ultrasonographic evaluation, the patients were randomly assigned to one of two groups. The study population was divided into two groups: the ESWT group (n = 36) and the prolotherapy group (n = 34). In the ESWT group, a total of 1800 to 2000 focused shock waves (0.15-0.25 mJ/mm² sessions with a frequency of 3-4 Hz) were applied. The prolotherapy group was administered a 3-ml injection of a 15% dextrose solution. The ESWT and prolotherapy treatments were administered in a total of three sessions, with two-week intervals between each session. The efficacy of the treatment was evaluated using a number of different measures, including the Visual Analogue Scale (VAS), the Foot and Ankle Ability Measurement (FAAM), the thickness of the plantar fascia and the distribution of plantar pressure. The evaluations were conducted at the outset of the study, at the six-week mark, and at the 12-week mark following the final intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Inceler Medical, Modus Focused ESWT 2. 15% dextrose solution injection
| Arm | Type | Receives |
|---|---|---|
| extracorporeal shock wave therapy group | Experimental | Other: extracorporeal shock wave therapyIn the ESWT group, a total of 1800 to 2000 focused shock waves (0.15-0.25 mJ/mm² sessions with a frequency of 3-4 Hz) were applied |
| Prolotherapy Group | Experimental | Other: ProlotherapyThe prolotherapy group was administered a 3-ml injection of a 15% dextrose solution. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- participants must be aged between 18 and 75 years
- they must have experienced heel pain for a period of at least three months
- they must exhibit pain and tenderness upon palpation of the medial aspect of the calcaneal tuberosity with the ankle in full dorsiflexion
- they must have demonstrated no response to conservative treatment for a minimum of three months.
- In cases where symptoms were present on both sides, the more prominent side was included.
Key exclusion criteria (11 listed)
- Inflammatory rheumatic disease
- Dermatological lesion on the heel
- Pregnancy
- Infection
- Malignancy
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 |
|---|---|---|
| extracorporeal shock wave therapyAlso: eswtESWT (Inceler Medical, Modus Focused ESWT, Turkey) was conducted by a single investigator in accordance with a standardised protocol. The patients were positioned prone on the examination table, with the affected limb placed in a supported position. The focused shockwave was applied in a circular motion along the insertion site of the plantar fascia and over the plantar fascia itself. The participants received 1,800 to 2,000 focused shock waves (0.15-0.25 mJ/mm² session with a frequency of 3-4 Hz). The frequency of the pulses was increased in a gradual manner, in accordance with the maximum tolerable degree of pain for each patient. A minimum dose of 1,000 mJ/mm² was administered. The ESWT was conducted in three sessions, with a two-week interval between each session. | Other | extracorporeal shock wave therapy group |
| ProlotherapyAlso: dextrose prolotherapyThe solution employed for dextrose prolotherapy comprised 1.5 ml of 30% dextrose and 1.5 ml of 0.9% isotonic sodium chloride solution, resulting in a total of 3 ml of 15% dextrose solution. . All procedures were conducted by the same investigator. A dextrose solution was infused into the centre and around the damaged area using a peppering technique. Following the procedure, patients were advised to remain in a supine position with their feet restrained for a period of 15 minutes.. Prolotherapy was repeated on three occasions, with each session occurring at a two-week interval | Other | Prolotherapy Group |
Primary outcome
Visual Analogue Scale(VAS)
Time frame: baseline - 6th week-12th week
The Visual Analogue Scale (VAS) was employed to evaluate the general perception of pain and the pain experienced at the first step upon rising. The scale ranges from 0 to 10, with a score of 0 indicating no pain and a score of 10 indicating the most severe pain imaginable
3 secondary outcomes
Foot and Ankle Ability Measure (FAAM)
Time frame: baseline - 6th week-12th week
Thickness of the plantar fascia
Time frame: baseline - 6th week-12th week
Plantar pressure distribution
Time frame: baseline - 6th week-12th week
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 27 Dec 2024.
- Pub MedLink provided by the sponsor.
- Individual participant dataSharing planned: No. all collected IPD
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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.
Ayşe U Baykut principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shock wave therapy and Prolotherapy in people with Chronic Plantar Fasciitis, run by Ankara City Hospital Bilkent 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 5 inclusion and 11 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 27 Dec 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 Analogue Scale(VAS) (time frame: baseline - 6th week-12th week). 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 Dec 2024.