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

Plantar Fasciitis Clinical Trial

Official title:

The Effect of Extracorporeal Shock Wave Therapy (ESWT)of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01786057
• Other study ID #: 13914022
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: February 1, 2013
• Last updated: February 5, 2013
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: February 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Procedure:
• 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 , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Rehabilitation, Alzahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (4)

Cotchett MP, Landorf KB, Munteanu SE, Raspovic A. Effectiveness of trigger point dry needling for plantar heel pain: study protocol for a randomised controlled trial. J Foot Ankle Res. 2011 Jan 23;4:5. doi: 10.1186/1757-1146-4-5. — View Citation

Gleitz M, Hornig K. [Trigger points - Diagnosis and treatment concepts with special reference to extracorporeal shockwaves]. Orthopade. 2012 Feb;41(2):113-25. doi: 10.1007/s00132-011-1860-0. German. — View Citation

Ogden JA, Alvarez RG, Marlow M. Shockwave therapy for chronic proximal plantar fasciitis: a meta-analysis. Foot Ankle Int. 2002 Apr;23(4):301-8. — View Citation

Wang CJ, Wang FS, Yang KD, Weng LH, Ko JY. Long-term results of extracorporeal shockwave treatment for plantar fasciitis. Am J Sports Med. 2006 Apr;34(4):592-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain severity after 3 weeks	The pain score (100 mm Visual Analogue Score ) is evaluated before the first session and 4 weeks after the last session.	Up to 4 weeks	No
Secondary	Change from baseline in pain degree after 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.	Up to 2 months	No