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

NCT06310122 | Not Yet Recruiting

• 1 other identifier: ESWT on planter fascitis
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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

Conditions

Plantar Fascitis; Extracorporeal Shockwave Therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• pain intensity level.

  4 weeks

Other Outcomes (1)

• Foot function

  4 weeks

Study Arms (2)

Group (A) treatment group

EXPERIMENTAL

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

Device: Extracorporeal shockwave therapy; Device: ultrasound

Group (B) traditional group

EXPERIMENTAL

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

Device: ultrasound

Interventions

Extracorporeal shockwave therapy 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

Group (A) treatment group

ultrasound 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 (A) treatment group; Group (B) traditional group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• 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.

  PMID: 35097359 BACKGROUND

• 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.

  PMID: 19219314 BACKGROUND

• 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.

  PMID: 29504578 BACKGROUND

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Ultrasonography

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Amir M Saleh, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Elham M El Naggar, Bachelors

CONTACT

01007905567; elhamkhairy94@gmail.com

Sahar A Abdallah, Lecturer

CONTACT

01112881730; saharabdallah102@yaqhoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 15, 2024
• Study Start: March 12, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 30, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share