Plantar FasciitisNCT06174142
Comparing Two Protocols of Shock Wave Therapy for Patients With Plantar Fasciitis
A study testing High-Frequency ESWT and Low-Frequency ESWT Group in people with Plantar Fasciitis, run by University of Sharjah.
Trial summary
The goal of this clinical trial is to compare the efficacy of two distinct shock wave therapy protocols and their impact on improving function and reducing pain in individuals with plantar fasciitis, a common cause of heel pain that affects millions worldwide. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- High-Frequency ESWT and Low-Frequency ESWT Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 25 Jan 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
- The participants should present with unilateral pain
- The participants' age will be ranged from 20-50 years old.
- The participants should have the pain from for at least 6 weeks.
- Moderate disability as assessed by the foot function index (FFI)
- The Body Mass Index (BMI) should be normal.
- The participants should have pronated feet (6-9 on the foot posture index)
Who cannot join
- History of surgery or fracture
- History of corticosteroid injection within 6 months
- Unable to follow or understand the instructions
- High BMI
- Severe foot pronation (+10 on the foot posture index)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial Comparing Two Protocols of Shock Wave Therapy for Patients With Plantar Fasciitis
The goal of this clinical trial is to compare the efficacy of two distinct shock wave therapy protocols and their impact on improving function and reducing pain in individuals with plantar fasciitis, a common cause of heel pain that affects millions worldwide.
The key questions the study aims to address are:
Read more
How effective is each shock wave therapy protocol in enhancing functional ability without pain in patients with plantar fasciitis? Does either protocol offer a significant benefit over the other in terms of pain relief and functional improvement after a course of six treatment sessions?
Participants will be randomly assigned to one of three groups and will engage in the study as follows:
Undergo six sessions of shock wave therapy with parameters specific to their assigned group.
Complete questionnaires assessing foot function and pain levels. Participate in evaluations before, during, and after the treatment to monitor their progress.
The three groups in the comparison are as follows:
Group A will receive shock wave therapy at a higher frequency and specific intensity, with a set number of impulses.
Group B will undergo therapy with a different frequency and intensity level but will receive the same number of impulses.
Group C, the control group, will receive a sham therapy, mirroring the treatment experience without the therapeutic effects to serve as a baseline for comparison.
The study is anticipated to delineate a more effective protocol for treating plantar fasciitis with shock wave therapy. The findings may contribute to enhanced treatment guidelines, potentially resulting in faster recovery times for patients. The participation of individuals in this research will offer valuable insights that could inform future therapeutic strategies for managing plantar fasciitis
Read the detailed description
This randomized controlled trial is designed to evaluate the efficacy of two distinct shock wave therapy protocols in treating plantar fasciitis, a condition that causes heel pain and can severely impact daily activities. The aim is to discern which protocol is more effective at improving functional abilities and reducing pain.
Plantar fasciitis typically manifests as a sharp pain at the bottom of the heel, often affecting individuals who engage in high-impact activities such as running. With the variability in treatment approaches, shock wave therapy has been recognized as a promising, non-invasive treatment method. The study seeks to address the current gaps in research by identifying the most beneficial treatment parameters of shock wave therapy.
Participants will be randomly allocated to one of three groups:
Group A will receive shock wave therapy with high-frequency settings. Group B will receive shock wave therapy with low-frequency settings but higher intensity.
Group C will serve as a control group, receiving sham shock wave therapy to provide a baseline for comparison.
All groups will partake in a consistent regimen of physical therapy exercises, ensuring that any differences in outcomes are attributable to the shock wave therapy parameters. The inclusion of these exercises is crucial as they contribute to recovery by stretching and strengthening the affected area.
To maintain the integrity of the trial, participants will be blinded to the shock wave therapy parameters they receive, thereby reducing potential bias. The study will feature comprehensive assessments at various points: before the intervention, halfway through the sessions, upon completion of the therapy, and during a follow-up phase to assess the durability of the effects.
The trial is anticipated to yield significant insights into the effectiveness of different shock wave therapy protocols, which will be instrumental in developing more refined treatment guidelines. Ultimately, these findings could enhance the quality of life for individuals with plantar fasciitis and guide clinical practice for the treatment of associated heel pain.
- Conditions
- Plantar Fasciitis
- Being tested
- High-Frequency ESWT, Low-Frequency ESWT Group, Sham ESWT Control Group
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency ESWTDevice
Participants will receive extracorporeal shock wave therapy at a frequency of 15 Hz and intensity/pressure level 3, with a total of 1800 impulses per session. This intervention will be conducted once per week for six weeks, alongside a standard physical therapy regimen
Low-Frequency ESWT GroupDevice
"Participants will be treated with extracorporeal shock wave therapy at a frequency of 10 Hz and intensity/pressure level 4, also with a total of 1800 impulses per session. This protocol will be delivered weekly for six sessions, accompanied by standardized physical therapy exercises."
Sham ESWT Control GroupDevice
"Participants in this control group will undergo a sham ESWT procedure that mimics the treatment experience without actual therapeutic effects, ensuring the blinding of participants. This sham therapy will be scheduled once a week for six weeks, in conjunction with the same physical therapy program as the other groups."
| Study group | Role | What they receive |
|---|---|---|
| High-Frequency ESWT Group | Experimental | This arm will receive extracorporeal shockwave therapy (ESWT) with a higher frequency setting of 15 Hz and an intensity/pressure of level 3. Participants will receive a total of 1800 impulses per session for 6 sessions, with one session per week, alongside a selected physical therapy program. Receives: Device: High-Frequency ESWT |
| Low-Frequency ESWT Group | Experimental | Experimental Receives: Device: Low-Frequency ESWT Group |
| Sham ESWT Control Group | Sham comparator | Participants in the control group will undergo a sham shockwave therapy protocol, which simulates ESWT treatment without actual therapeutic effects, to serve as a comparison for the active treatments. They will also engage in the same physical therapy program as the other two arms. Receives: Device: Sham ESWT Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Evaluate the decrease in heel pain as measured by the Visual Analog Scale (VAS).
Measured: Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).
Secondary outcomes (1)
Functional Improvement
Measure the change in foot function using the Foot Function Index (FFI).
Measured: Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion5 Jan 2024 (estimated)
- Study completion25 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies 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
- This randomized trial compares two shock wave therapy protocols in plantar fasciitis treatment against a sham control. Group A receives high-frequency therapy (15 Hz, intensity level 3), Group B low-frequency (10 Hz, intensity level 4), and Group C a sham treatment, all alongside physical therapy. The goal is to evaluate pain reduction and functional improvement after six sessions, with follow-up assessments to gauge effect durability.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Alkalbani, University of Sharjah
- Investigators
- Fatima Alkalbani, Bsc, Principal investigator, PRS User
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174142
- Sponsor's protocol ID
- FAlkalbani
- Status last verified
- Dec 2023
- First submitted
- 9 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data collected during this trial outside of the study team and the immediate research purposes outlined in the protocol. Data sharing decisions will be revisited upon study completion and publication of results, considering participant consent, data sensitivity, and ethical considerations
Publications
Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004 May;25(5):303-10. doi: 10.1177/107110070402500505.
PubMed 15134610Dunn JE, Link CL, Felson DT, Crincoli MG, Keysor JJ, McKinlay JB. Prevalence of foot and ankle conditions in a multiethnic community sample of older adults. Am J Epidemiol. 2004 Mar 1;159(5):491-8. doi: 10.1093/aje/kwh071.
PubMed 14977645Petraglia F, Ramazzina I, Costantino C. Plantar fasciitis in athletes: diagnostic and treatment strategies. A systematic review. Muscles Ligaments Tendons J. 2017 May 10;7(1):107-118. doi: 10.11138/mltj/2017.7.1.107. eCollection 2017 Jan-Mar.
PubMed 28717618Leao RG, Azuma MM, Ambrosio GHC, Faloppa F, Takimoto ES, Tamaoki MJS. Effectiveness of shockwave therapy in the treatment of plantar fasciitis. Acta Ortop Bras. 2020 Jan-Feb;28(1):7-11. doi: 10.1590/1413-785220202801227402.
PubMed 32095104Xu D, Jiang W, Huang D, Hu X, Wang Y, Li H, Zhou S, Gan K, Ma W. Comparison Between Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection for Plantar Fasciitis. Foot Ankle Int. 2020 Feb;41(2):200-205. doi: 10.1177/1071100719891111. Epub 2019 Nov 19.
PubMed 31744313Luffy L, Grosel J, Thomas R, So E. Plantar fasciitis: A review of treatments. JAAPA. 2018 Jan;31(1):20-24. doi: 10.1097/01.JAA.0000527695.76041.99.
PubMed 29227320Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.
PubMed 24626080Thompson JV, Saini SS, Reb CW, Daniel JN. Diagnosis and management of plantar fasciitis. J Am Osteopath Assoc. 2014 Dec;114(12):900-6. doi: 10.7556/jaoa.2014.177.
PubMed 25429080Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.
PubMed 12756315Gollwitzer H, Saxena A, DiDomenico LA, Galli L, Bouche RT, Caminear DS, Fullem B, Vester JC, Horn C, Banke IJ, Burgkart R, Gerdesmeyer L. Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: a randomized, controlled multicenter study. J Bone Joint Surg Am. 2015 May 6;97(9):701-8. doi: 10.2106/JBJS.M.01331.
PubMed 25948515Rompe JD, Decking J, Schoellner C, Nafe B. Shock wave application for chronic plantar fasciitis in running athletes. A prospective, randomized, placebo-controlled trial. Am J Sports Med. 2003 Mar-Apr;31(2):268-75. doi: 10.1177/03635465030310021901.
PubMed 12642264Garrett TR, Neibert PJ. The effectiveness of a gastrocnemius-soleus stretching program as a therapeutic treatment of plantar fasciitis. J Sport Rehabil. 2013 Nov;22(4):308-12. doi: 10.1123/jsr.22.4.308. Epub 2013 May 22.
PubMed 23752554Thong-On S, Bovonsunthonchai S, Vachalathiti R, Intiravoranont W, Suwannarat S, Smith R. Effects of Strengthening and Stretching Exercises on the Temporospatial Gait Parameters in Patients With Plantar Fasciitis: A Randomized Controlled Trial. Ann Rehabil Med. 2019 Dec;43(6):662-676. doi: 10.5535/arm.2019.43.6.662. Epub 2019 Dec 31.
PubMed 31918529Cheing GL, Chang H. Extracorporeal shock wave therapy. J Orthop Sports Phys Ther. 2003 Jun;33(6):337-43. doi: 10.2519/jospt.2003.33.6.337. No abstract available.
PubMed 12839209Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
PubMed 2037861
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Two Protocols of Shock Wave Therapy for Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06174142
- Acronym / sponsor ID
- FAlkalbani
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 5 Jan 2024 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 18 Dec 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 the efficacy of two distinct shock wave therapy protocols and their impact on improving function and reducing pain in individuals with plantar fasciitis, a common cause of heel pain that affects millions worldwide.
The key questions the study aims to address are:
How effective is each shock wave therapy protocol in enhancing functional ability without pain in patients with plantar fasciitis? Does either protocol offer a significant benefit over the other in terms of pain relief and functional improvement after a course of six treatment sessions?
Participants will be randomly assigned to one of three groups and will engage in the study as follows:
Undergo six sessions of shock wave therapy with parameters specific to their assigned group.
Complete questionnaires assessing foot function and pain levels. Participate in evaluations before, during, and after the treatment to monitor their progress.
The three groups in the comparison are as follows:
Group A will receive shock wave therapy at a higher frequency and specific intensity, with a set number of impulses.
Group B will undergo therapy with a different frequency and intensity level but will receive the same number of impulses.
Group C, the control group, will receive a sham therapy, mirroring the treatment experience without the therapeutic effects to serve as a baseline for comparison.
The study is anticipated to delineate a more effective protocol for treating plantar fasciitis with shock wave therapy. The findings may contribute to enhanced treatment guidelines, potentially resulting in faster recovery times for patients. The participation of individuals in this research will offer valuable insights that could inform future therapeutic strategies for managing plantar fasciitis
Detailed description
This randomized controlled trial is designed to evaluate the efficacy of two distinct shock wave therapy protocols in treating plantar fasciitis, a condition that causes heel pain and can severely impact daily activities. The aim is to discern which protocol is more effective at improving functional abilities and reducing pain.
Plantar fasciitis typically manifests as a sharp pain at the bottom of the heel, often affecting individuals who engage in high-impact activities such as running. With the variability in treatment approaches, shock wave therapy has been recognized as a promising, non-invasive treatment method. The study seeks to address the current gaps in research by identifying the most beneficial treatment parameters of shock wave therapy.
Participants will be randomly allocated to one of three groups:
Group A will receive shock wave therapy with high-frequency settings. Group B will receive shock wave therapy with low-frequency settings but higher intensity.
Group C will serve as a control group, receiving sham shock wave therapy to provide a baseline for comparison.
All groups will partake in a consistent regimen of physical therapy exercises, ensuring that any differences in outcomes are attributable to the shock wave therapy parameters. The inclusion of these exercises is crucial as they contribute to recovery by stretching and strengthening the affected area.
To maintain the integrity of the trial, participants will be blinded to the shock wave therapy parameters they receive, thereby reducing potential bias. The study will feature comprehensive assessments at various points: before the intervention, halfway through the sessions, upon completion of the therapy, and during a follow-up phase to assess the durability of the effects.
The trial is anticipated to yield significant insights into the effectiveness of different shock wave therapy protocols, which will be instrumental in developing more refined treatment guidelines. Ultimately, these findings could enhance the quality of life for individuals with plantar fasciitis and guide clinical practice for the treatment of associated heel pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This randomized trial compares two shock wave therapy protocols in plantar fasciitis treatment against a sham control. Group A receives high-frequency therapy (15 Hz, intensity level 3), Group B low-frequency (10 Hz, intensity level 4), and Group C a sham treatment, all alongside physical therapy. The goal is to evaluate pain reduction and functional improvement after six sessions, with follow-up assessments to gauge effect durability.
| Arm | Type | Receives |
|---|---|---|
| High-Frequency ESWT Group | Experimental | Device: High-Frequency ESWTThis arm will receive extracorporeal shockwave therapy (ESWT) with a higher frequency setting of 15 Hz and an intensity/pressure of level 3. Participants will receive a total of 1800 impulses per session for 6 sessions, with one session per week, alongside a selected physical therapy program. |
| Low-Frequency ESWT Group | Experimental | Device: Low-Frequency ESWT GroupExperimental |
| Sham ESWT Control Group | Sham comparator | Device: Sham ESWT Control GroupParticipants in the control group will undergo a sham shockwave therapy protocol, which simulates ESWT treatment without actual therapeutic effects, to serve as a comparison for the active treatments. They will also engage in the same physical therapy program as the other two arms. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The participants should present with unilateral pain
- The participants' age will be ranged from 20-50 years old.
- The participants should have the pain from for at least 6 weeks.
- Moderate disability as assessed by the foot function index (FFI)
- The Body Mass Index (BMI) should be normal.
Key exclusion criteria (5 listed)
- History of surgery or fracture
- History of corticosteroid injection within 6 months
- Unable to follow or understand the instructions
- High BMI
- Severe foot pronation (+10 on the foot posture index)
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 |
|---|---|---|
| High-Frequency ESWTParticipants will receive extracorporeal shock wave therapy at a frequency of 15 Hz and intensity/pressure level 3, with a total of 1800 impulses per session. This intervention will be conducted once per week for six weeks, alongside a standard physical therapy regimen | Device | High-Frequency ESWT Group |
| Low-Frequency ESWT Group"Participants will be treated with extracorporeal shock wave therapy at a frequency of 10 Hz and intensity/pressure level 4, also with a total of 1800 impulses per session. This protocol will be delivered weekly for six sessions, accompanied by standardized physical therapy exercises." | Device | Low-Frequency ESWT Group |
| Sham ESWT Control Group"Participants in this control group will undergo a sham ESWT procedure that mimics the treatment experience without actual therapeutic effects, ensuring the blinding of participants. This sham therapy will be scheduled once a week for six weeks, in conjunction with the same physical therapy program as the other groups." | Device | Sham ESWT Control Group |
Primary outcome
Pain Reduction
Time frame: Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).
Evaluate the decrease in heel pain as measured by the Visual Analog Scale (VAS).
1 secondary outcome
Functional Improvement
Time frame: Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Background: PubMed 15134610Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004 May;25(5):303-10. doi: 10.1177/107110070402500505.
- Background: PubMed 14977645Dunn JE, Link CL, Felson DT, Crincoli MG, Keysor JJ, McKinlay JB. Prevalence of foot and ankle conditions in a multiethnic community sample of older adults. Am J Epidemiol. 2004 Mar 1;159(5):491-8. doi: 10.1093/aje/kwh071.
- Background: PubMed 28717618Petraglia F, Ramazzina I, Costantino C. Plantar fasciitis in athletes: diagnostic and treatment strategies. A systematic review. Muscles Ligaments Tendons J. 2017 May 10;7(1):107-118. doi: 10.11138/mltj/2017.7.1.107. eCollection 2017 Jan-Mar.
- Background: PubMed 32095104Leao RG, Azuma MM, Ambrosio GHC, Faloppa F, Takimoto ES, Tamaoki MJS. Effectiveness of shockwave therapy in the treatment of plantar fasciitis. Acta Ortop Bras. 2020 Jan-Feb;28(1):7-11. doi: 10.1590/1413-785220202801227402.
- Background: PubMed 31744313Xu D, Jiang W, Huang D, Hu X, Wang Y, Li H, Zhou S, Gan K, Ma W. Comparison Between Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection for Plantar Fasciitis. Foot Ankle Int. 2020 Feb;41(2):200-205. doi: 10.1177/1071100719891111. Epub 2019 Nov 19.
- Background: PubMed 29227320Luffy L, Grosel J, Thomas R, So E. Plantar fasciitis: A review of treatments. JAAPA. 2018 Jan;31(1):20-24. doi: 10.1097/01.JAA.0000527695.76041.99.
- Background: PubMed 24626080Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.
- Background: PubMed 25429080Thompson JV, Saini SS, Reb CW, Daniel JN. Diagnosis and management of plantar fasciitis. J Am Osteopath Assoc. 2014 Dec;114(12):900-6. doi: 10.7556/jaoa.2014.177.
- Background: PubMed 12756315Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.
- Background: PubMed 25948515Gollwitzer H, Saxena A, DiDomenico LA, Galli L, Bouche RT, Caminear DS, Fullem B, Vester JC, Horn C, Banke IJ, Burgkart R, Gerdesmeyer L. Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: a randomized, controlled multicenter study. J Bone Joint Surg Am. 2015 May 6;97(9):701-8. doi: 10.2106/JBJS.M.01331.
- Background: PubMed 12642264Rompe JD, Decking J, Schoellner C, Nafe B. Shock wave application for chronic plantar fasciitis in running athletes. A prospective, randomized, placebo-controlled trial. Am J Sports Med. 2003 Mar-Apr;31(2):268-75. doi: 10.1177/03635465030310021901.
- Background: PubMed 23752554Garrett TR, Neibert PJ. The effectiveness of a gastrocnemius-soleus stretching program as a therapeutic treatment of plantar fasciitis. J Sport Rehabil. 2013 Nov;22(4):308-12. doi: 10.1123/jsr.22.4.308. Epub 2013 May 22.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data collected during this trial outside of the study team and the immediate research purposes outlined in the protocol. Data sharing decisions will be revisited upon study completion and publication of results, considering participant consent, data sensitivity, and ethical considerations
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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.
Fatima Alkalbani, Bsc principal investigator
PRS User
Questions about this trial
What is this clinical trial studying?
A study testing High-Frequency ESWT and Low-Frequency ESWT Group in people with Plantar Fasciitis, run by University of Sharjah.
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 6 inclusion and 5 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 18 Dec 2023. 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. Some participants in this study may receive a placebo. 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 Fatima Alkalbani, Bsc (971507132332, fatimaalkalbani1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction (time frame: Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06174142, which also lists 18 linked publications.
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 18 Dec 2023.