Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Planter Fascitis

NCT ID: NCT06310122

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2025-03-30

Brief 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.
• 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.

Conditions

Plantar Fascitis; Extracorporeal Shockwave Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group (A) treatment group

Group (A) will receive extracorporeal shockwave therapy and (Ultrasound, stretching and strengthening exercises)

Group Type: EXPERIMENTAL

Extracorporeal shockwave therapy

Intervention Type: DEVICE

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

ultrasound

Intervention Type: DEVICE

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

Group (B) traditional group

Group (B) will receive (Ultrasound, stretching and strengthening exercises)

Group Type: EXPERIMENTAL

ultrasound

Intervention Type: DEVICE

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

Interventions

Extracorporeal shockwave therapy

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

Intervention Type: DEVICE

ultrasound

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• - 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:

• 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.

Exclusion Criteria

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).
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Elham Mohammed Khairy Abd El Azeem El Naggar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir M Saleh, Professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Elham M El Naggar, Bachelors

Role: CONTACT

elhamkhairy94@gmail.com

01007905567

Sahar A Abdallah, Lecturer

Role: CONTACT

saharabdallah102@yaqhoo.com

01112881730

References

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.

Reference Type: BACKGROUND

PMID: 35097359 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19219314 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29504578 (View on PubMed)

Other Identifiers

ESWT on planter fascitis

Identifier Type: -

Identifier Source: org_study_id