Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis

Phase 2

• Conditions: Plantar Fasciitis
• Interventions: Procedure: Extracorporeal shock wave therapy 1; Procedure: Extracorporeal shock wave therapy 2

• Registration Number: NCT01786057
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

Plantar fasciitis is one of the most common causes of heel pain. This study will be performed in the purpose of determination the effects of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis

Detailed Description

Plantar fasciitis is the most common cause of inferior heel pain, A great variety of therapies have been reported for the treatment of plantar fasciitis including extracorporeal shock wave therapy. Gastrosoleus muscle dysfunction is one of the most common contributing factors to this disease .Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there is lack of high-quality studies demonstrating the efficacy of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis , this study will be performed to examine the effect of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis

Study Timeline

• Study Start: 2012-11
• Status Verified: 2013-02
• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-05
• Last Update Submitted: 2013-02-05
• Study First Posted: 2013-02-07
• Last Update Posted: 2013-02-07
• Primary Completion: 2013-08
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. clinical diagnosis of plantar fasciitis
2. having at least one Gastrosoleus trigger point concomitantly.
3. having no response to conservative treatments for at least 3 months
4. willingness to participate

Exclusion Criteria

1. Dysfunction of the knee or ankle
2. Neurologic abnormalities
3. Bleeding tendency (hereditary or acquired)
4. Nerve entrapment syndrome
5. A previous operation on the heel
6. Pregnancy
7. Evidences of Infection in lower limbs
8. A medical History of tumor
9. previous local corticosteroid injection within 12 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal shock wave therapy 1	Extracorporeal shock wave therapy 1	Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region and (400 shock waves/session of 0.2 mJ/mm2 per each trigger point) for gastrosoleus trigger points , 3 sessions at weekly intervals
Extracorporeal shock wave therapy 2	Extracorporeal shock wave therapy 2	Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain severity after 3 weeks	Up to 4 weeks	The pain score (100 mm Visual Analogue Score ) is evaluated before the first session and 4 weeks after the last session.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in pain degree after 2 months.	Up to 2 months	The pain score (100 mm Visual Analogue Score ) and the modified criteria of the Roles and Maudsley score are evaluated at baseline and then 2 months after therapy.

Trial Locations

Locations (1)

Department of Rehabilitation, Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of