AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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.

Elham M El Naggar, Bachelors contact

01007905567

elhamkhairy94@gmail.com

Sahar A Abdallah, Lecturer contact

01112881730

saharabdallah102@yaqhoo.com

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.

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 groups in NCT06310122
Study groupRoleWhat they receive
Group (A) treatment groupExperimentalGroup (A) will receive extracorporeal shockwave therapy and (Ultrasound, stretching and strengthening exercises)
Receives: Device: Extracorporeal shockwave therapy; Device: ultrasound
Group (B) traditional groupExperimentalGroup (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.

  1. Stride length mean distance measured by (meter)

    stride length (one of gait parameters) that will be assessed by using Kinovea software.

    Measured: 4 weeks

  2. stride time mean time measured by (second)

    stride time (other gait parameters) that will be assessed by using kinovea software

    Measured: 4 weeks

  3. speed mean distance/ time measured by (meter/second)

    speed (other gait parameters) that will be assessed by using kinovea software.

    Measured: 4 weeks

  4. cadence mean number of steps /times.

    cadence (other gait parameters) that will be assessed by using kionvea software.

    Measured: 4 weeks

Secondary outcomes (1)
  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.

  1. First posted15 Mar 2024
  2. Study start12 Mar 2024 (estimated)
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion30 Mar 2025 (estimated)

Resources

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)
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 35097359
  • Greve 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 19219314
  • Lai 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in