Plantar FascitisNCT06310122
Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Planter Fascitis
A study testing Extracorporeal shockwave therapy and ultrasound in people with Plantar Fascitis and Extracorporeal Shockwave Therapy, run by Cairo University.
Trial summary
The purpose of this study is : to determine the effect of extracorporeal shockwave on pain intensity in patients with plantar fasciitis. to determine the effect of extracorporeal shockwave on foot function in patients with plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Plantar Fascitis, Extracorporeal Shockwave Therapy
- What is being tested?
- Extracorporeal shockwave therapy and ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2024to 30 Mar 2025
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- - 52 female patient with chronic planter fasciitis.
- Patient,s age will be (18 - 40) , all of them are diagnosed with planter fasciitis will be recruited for the study.
- BMI will be (18 - 40 kg/m2).
- Unilateral chronic planter fasciitis.
- Symptoms of pf pain lasted more than 3 months.
- Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs:
Show all 11Show fewer
- Pain in the morning or after sitting a long time.
- Local pain where the fascia attaches to the heel.
- Increasing pain with extended walking or standing for more than 15 minutes.
- History of 6 months of unsuccessful conservative treatment.
- Therapy free period of at least 4 weeks before referral.
Who cannot join
- Patients will exclude from this study if their pain due to:
- Bilateral plantar fasciitis.
- Dysfunction of foot or ankle (for example, instability).
- Arthrosis or arthritis of the foot.
- Infections or tumors of the lower extremity.
- Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome).
Show all 15Show fewer
- Vascular abnormality (for example, severe varicosities, chronic ischemia).
- Operative treatment of the heel spur.
- Hemorrhagic disorders and anticoagulant therapy.
- Pregnancy.
- Diabetes.
- Trauma.
- previous surgery.
- Inflammation disease.
- Rheumatoid arthritis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Plantar Fascitis
The purpose of this study is :
- to determine the effect of extracorporeal shockwave on pain intensity in patients with plantar fasciitis.
- to determine the effect of extracorporeal shockwave on foot function in patients with plantar fasciitis.
- to determine the effect of extracorporeal shockwave on gait parameters in patients with plantar fasciitis
Read the detailed description
Plantar fasciitis with an accompanying heel spur is very burdensome and difficult to treat disease. It most often arises as a result of degenerative changes of the proximal plantar fascia and the tissues surrounding the aponeurosis, occurring due to continuous irritation of the area and resulting micro-injuries. The main symptom of plantar fasciitis is pain in the heel area; this worsens over time, increasingly occurring upon loading and eventually, even at rest. Redness and swelling are also observed in the heel. The risk of the disease is increased by being overweight, working a job that requires long periods of standing, lifting heavy objects.
About 85% to 90% of patients do not need to undergo surgery, and 80% of patient do not experience pain relapse after conservative treatments. Minimally invasive treatments commonly used for treating PF are extracorporeal shockwave therapy (ESWT), corticosteroid (CS)injections, platelet-rich plasma (PRP) injections, botulinum toxin (BTX), acupuncture, dry needling and prolotherapy.
Conservative treatment options for PF include rest, weight loss, non-steroidal anti-inflammatory drugs, physical therapies (ultrasound therapy, low-energy, and laser therapy), plantar fascia and calf muscle strengthening and stretching exercises. If symptoms persist, second-option treatment is usually local corticosteroid injections. However, despite providing a good effect in terms of pain reduction, corticosteroids have proven to damage the fascial tissue, thus increasing the risk of further degeneration and eventual rupture. To avoid this complication, Extracorporeal shock wave therapy (ESWT) is a treatment recommendation for patients with chronic PF recalcitrant to other conservative treatment.
Extracorporeal shockwave therapy (ESWT) is a physical therapy that generates three-dimensional pressure pulses, lasting microseconds and reaching peek pressures of 35-120 MPa, and has effects depending on intensity, pulse cycle and shockwave (SW) modality. We have two modalities of SW therapy: focused shockwave (FSW) and radial shockwave (RSW). FSW is documented as a possible alternative to the surgical approach: it focuses on a small area (2 to 8 mm) and penetrates at a selected depth, having effects that depend on the energy delivered to the focal area; that is why it is important to know the energy flux density (EFD), which is considered the "dose" of SW administered.
RSW produces SW that are transmitted radially and do not have penetrating effects on tissue, acting superficially. They are frequently used in soft-tissue pathologies and, recently, also in plantar fasciitis. As this physical therapy is widely used for the treatment of plantar fasciitis. The mechanism of ESWT is not completely clear. However, it is speculated that ESWT may produce a reflexive analgesic effect by inducing excitability of the axon and destroying unmyelinated sensory fibers.
Due to the negligible side effects, which only relate to minor referred pain during ESWT sessions and minor hematoma, this therapy represents a safe, advantageous, and well-tolerated approach without surgical risks or severe complications. Therefore, the use of ESWT has gained increasing popularity for treating different musculoskeletal disorders. These encompass tendinopathies (both calcifying and non-calcifying), plantar fasciitis (PF), lateral epicondylitis ("tennis elbow"), greater trochanteric pain syndrome, bone nonunion fractures, and joint diseases including avascular necrosis.
The extracorporeal shock wave produces a treatment effect by passing through muscle and adipose tissue and releasing energy at the border of the bone due to the difference in impedance. Therefore, ESWT improves the clinical condition of the plantar fascia. Thus, the benefits of ESWT may be fundamentally more difficult to achieve in patients with pain throughout the entire plantar fascia when the ESWT target site is far from the enthesis of the calcaneus. Furthermore, the investigators speculate that the ESWT effect may be insufficient in patients with degeneration of the plantar fascia itself.
- Conditions
- Plantar Fascitis, Extracorporeal Shockwave Therapy
- Being tested
- Extracorporeal shockwave therapy, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapyDevice
Devices used to improve foot function pain and gait pattern
Patients will be placed in prone position, therapist locate the point of maximum tenderness. treatment area will be prepared with coupling gel to minimize the loss of shockwave therapy at the interface between applicator tip and skin. Each patient will receive 2000 impulses ,3 bar energy,15mm depth applicator at frequency (10 HZ) per session / week for 4 weeks
ultrasoundDevice
Devices used to improve foot function pain and gait pattern
Participants in the study group will be treated with 5 minutes of therapeutic ultrasound at a frequency of 1 MHz and continuous current at a pulse intensity of 1.8 W/cm2 (when the sensitivity level was too high and the procedure hurt the patient, the therapist reduced the intensity . 3 sessions /week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group (A) treatment group | Experimental | Group (A) will receive extracorporeal shockwave therapy and (Ultrasound, stretching and strengthening exercises) Receives: Device: Extracorporeal shockwave therapy; Device: ultrasound |
| Group (B) traditional group | Experimental | Group (B) will receive (Ultrasound, stretching and strengthening exercises) Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride length mean distance measured by (meter)
stride length (one of gait parameters) that will be assessed by using Kinovea software.
Measured: 4 weeks
stride time mean time measured by (second)
stride time (other gait parameters) that will be assessed by using kinovea software
Measured: 4 weeks
speed mean distance/ time measured by (meter/second)
speed (other gait parameters) that will be assessed by using kinovea software.
Measured: 4 weeks
cadence mean number of steps /times.
cadence (other gait parameters) that will be assessed by using kionvea software.
Measured: 4 weeks
Secondary outcomes (1)
pain intensity level.
pain intensity will be assessed by visual analogue scale. 0 mean (no pain) that mean better outcomes to 10 that mean (unbearable pain) that mean worst outcomes.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start12 Mar 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Two groups : group (A) , group (B) One of them will receive traditional treatment ( ultra sound , exercises) Other one will recieve extracorporeal shockwave therapy and traditional treatment also
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Mohammed Khairy Abd El Azeem El Naggar, Cairo University
- Investigators
- Amir M Saleh, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310122
- Sponsor's protocol ID
- ESWT on planter fascitis
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan.
PubMed 35097359Greve JM, Grecco MV, Santos-Silva PR. Comparison of radial shockwaves and conventional physiotherapy for treating plantar fasciitis. Clinics (Sao Paulo). 2009;64(2):97-103. doi: 10.1590/s1807-59322009000200006.
PubMed 19219314Lai TW, Ma HL, Lee MS, Chen PM, Ku MC. Ultrasonography and clinical outcome comparison of extracorporeal shock wave therapy and corticosteroid injections for chronic plantar fasciitis: A randomized controlled trial. J Musculoskelet Neuronal Interact. 2018 Mar 1;18(1):47-54.
PubMed 29504578
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Plantar Fascitis
- ClinicalTrials.gov ID
- NCT06310122
- Acronym / sponsor ID
- ESWT on planter fascitis
- Conditions
- Plantar Fascitis, Extracorporeal Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 15 Mar 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 purpose of this study is :
- to determine the effect of extracorporeal shockwave on pain intensity in patients with plantar fasciitis.
- to determine the effect of extracorporeal shockwave on foot function in patients with plantar fasciitis.
- to determine the effect of extracorporeal shockwave on gait parameters in patients with plantar fasciitis
Detailed description
Plantar fasciitis with an accompanying heel spur is very burdensome and difficult to treat disease. It most often arises as a result of degenerative changes of the proximal plantar fascia and the tissues surrounding the aponeurosis, occurring due to continuous irritation of the area and resulting micro-injuries. The main symptom of plantar fasciitis is pain in the heel area; this worsens over time, increasingly occurring upon loading and eventually, even at rest. Redness and swelling are also observed in the heel. The risk of the disease is increased by being overweight, working a job that requires long periods of standing, lifting heavy objects.
About 85% to 90% of patients do not need to undergo surgery, and 80% of patient do not experience pain relapse after conservative treatments. Minimally invasive treatments commonly used for treating PF are extracorporeal shockwave therapy (ESWT), corticosteroid (CS)injections, platelet-rich plasma (PRP) injections, botulinum toxin (BTX), acupuncture, dry needling and prolotherapy.
Conservative treatment options for PF include rest, weight loss, non-steroidal anti-inflammatory drugs, physical therapies (ultrasound therapy, low-energy, and laser therapy), plantar fascia and calf muscle strengthening and stretching exercises. If symptoms persist, second-option treatment is usually local corticosteroid injections. However, despite providing a good effect in terms of pain reduction, corticosteroids have proven to damage the fascial tissue, thus increasing the risk of further degeneration and eventual rupture. To avoid this complication, Extracorporeal shock wave therapy (ESWT) is a treatment recommendation for patients with chronic PF recalcitrant to other conservative treatment.
Extracorporeal shockwave therapy (ESWT) is a physical therapy that generates three-dimensional pressure pulses, lasting microseconds and reaching peek pressures of 35-120 MPa, and has effects depending on intensity, pulse cycle and shockwave (SW) modality. We have two modalities of SW therapy: focused shockwave (FSW) and radial shockwave (RSW). FSW is documented as a possible alternative to the surgical approach: it focuses on a small area (2 to 8 mm) and penetrates at a selected depth, having effects that depend on the energy delivered to the focal area; that is why it is important to know the energy flux density (EFD), which is considered the "dose" of SW administered.
RSW produces SW that are transmitted radially and do not have penetrating effects on tissue, acting superficially. They are frequently used in soft-tissue pathologies and, recently, also in plantar fasciitis. As this physical therapy is widely used for the treatment of plantar fasciitis. The mechanism of ESWT is not completely clear. However, it is speculated that ESWT may produce a reflexive analgesic effect by inducing excitability of the axon and destroying unmyelinated sensory fibers.
Due to the negligible side effects, which only relate to minor referred pain during ESWT sessions and minor hematoma, this therapy represents a safe, advantageous, and well-tolerated approach without surgical risks or severe complications. Therefore, the use of ESWT has gained increasing popularity for treating different musculoskeletal disorders. These encompass tendinopathies (both calcifying and non-calcifying), plantar fasciitis (PF), lateral epicondylitis ("tennis elbow"), greater trochanteric pain syndrome, bone nonunion fractures, and joint diseases including avascular necrosis.
The extracorporeal shock wave produces a treatment effect by passing through muscle and adipose tissue and releasing energy at the border of the bone due to the difference in impedance. Therefore, ESWT improves the clinical condition of the plantar fascia. Thus, the benefits of ESWT may be fundamentally more difficult to achieve in patients with pain throughout the entire plantar fascia when the ESWT target site is far from the enthesis of the calcaneus. Furthermore, the investigators speculate that the ESWT effect may be insufficient in patients with degeneration of the plantar fascia itself.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups : group (A) , group (B) One of them will receive traditional treatment ( ultra sound , exercises) Other one will recieve extracorporeal shockwave therapy and traditional treatment also
| Arm | Type | Receives |
|---|---|---|
| Group (A) treatment group | Experimental | Device: Extracorporeal shockwave therapy, Device: ultrasoundGroup (A) will receive extracorporeal shockwave therapy and (Ultrasound, stretching and strengthening exercises) |
| Group (B) traditional group | Experimental | Device: ultrasoundGroup (B) will receive (Ultrasound, stretching and strengthening exercises) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- - 52 female patient with chronic planter fasciitis.
- Patient,s age will be (18 - 40) , all of them are diagnosed with planter fasciitis will be recruited for the study.
- BMI will be (18 - 40 kg/m2).
- Unilateral chronic planter fasciitis.
- Symptoms of pf pain lasted more than 3 months.
Key exclusion criteria (15 listed)
- Bilateral plantar fasciitis.
- Dysfunction of foot or ankle (for example, instability).
- Arthrosis or arthritis of the foot.
- Infections or tumors of the lower extremity.
- Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome).
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 shockwave therapyDevices used to improve foot function pain and gait pattern Patients will be placed in prone position, therapist locate the point of maximum tenderness. treatment area will be prepared with coupling gel to minimize the loss of shockwave therapy at the interface between applicator tip and skin. Each patient will receive 2000 impulses ,3 bar energy,15mm depth applicator at frequency (10 HZ) per session / week for 4 weeks | Device | Group (A) treatment group |
| ultrasoundDevices used to improve foot function pain and gait pattern Participants in the study group will be treated with 5 minutes of therapeutic ultrasound at a frequency of 1 MHz and continuous current at a pulse intensity of 1.8 W/cm2 (when the sensitivity level was too high and the procedure hurt the patient, the therapist reduced the intensity . 3 sessions /week for 4 weeks | Device | Group (A) treatment group, Group (B) traditional group |
Primary outcome
Stride length mean distance measured by (meter)
Time frame: 4 weeks
stride length (one of gait parameters) that will be assessed by using Kinovea software.
stride time mean time measured by (second)
Time frame: 4 weeks
stride time (other gait parameters) that will be assessed by using kinovea software
speed mean distance/ time measured by (meter/second)
Time frame: 4 weeks
speed (other gait parameters) that will be assessed by using kinovea software.
cadence mean number of steps /times.
Time frame: 4 weeks
cadence (other gait parameters) that will be assessed by using kionvea software.
1 secondary outcome
pain intensity level.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 35097359Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan.
- Background: PubMed 19219314Greve JM, Grecco MV, Santos-Silva PR. Comparison of radial shockwaves and conventional physiotherapy for treating plantar fasciitis. Clinics (Sao Paulo). 2009;64(2):97-103. doi: 10.1590/s1807-59322009000200006.
- Background: PubMed 29504578Lai TW, Ma HL, Lee MS, Chen PM, Ku MC. Ultrasonography and clinical outcome comparison of extracorporeal shock wave therapy and corticosteroid injections for chronic plantar fasciitis: A randomized controlled trial. J Musculoskelet Neuronal Interact. 2018 Mar 1;18(1):47-54.
- Individual participant dataSharing planned: No
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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.
Amir M Saleh, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave therapy and ultrasound in people with Plantar Fascitis and Extracorporeal Shockwave Therapy, 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 11 inclusion and 15 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 15 Mar 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 Elham M El Naggar, Bachelors (01007905567, elhamkhairy94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride length mean distance measured by (meter) (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 NCT06310122, which also lists 3 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 15 Mar 2024.