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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Plantar Fascitis; Extracorporeal Shockwave Therapy
• Intervention / Treatment: Device: Extracorporeal shockwave therapy; Device: ultrasound

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 Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elham M El Naggar, Bachelors; Phone Number: 01007905567; Email: elhamkhairy94@gmail.com
• Study Contact Backup: Name: Sahar A Abdallah, Lecturer; Phone Number: 01112881730; Email: saharabdallah102@yaqhoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group (A) treatment group; Group (A) will receive extracorporeal shockwave therapy and (Ultrasound, stretching and strengthening exercises)	Device: 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; 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
Experimental: Group (B) traditional group; Group (B) will receive (Ultrasound, stretching and strengthening exercises)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stride length mean distance measured by (meter)	stride length (one of gait parameters) that will be assessed by using Kinovea software.	4 weeks
stride time mean time measured by (second)	stride time (other gait parameters) that will be assessed by using kinovea software	4 weeks
speed mean distance/ time measured by (meter/second)	speed (other gait parameters) that will be assessed by using kinovea software.	4 weeks
cadence mean number of steps /times.	cadence (other gait parameters) that will be assessed by using kionvea software.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot function	foot function will be assessed by foot function index. 0 mean (no pain or difficulty) that mean better outcomes to 10 (worst pain imaginable or so difficult it requires help) that mean worst outcomes.	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Amir M Saleh, Professor, Cairo University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 12, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: ESWT on planter fascitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No