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

NCT ID: NCT01786057

Last Updated: 2013-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Extracorporeal shock wave therapy 1

Intervention Type PROCEDURE

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

Group Type PLACEBO_COMPARATOR

Extracorporeal shock wave therapy 2

Intervention Type PROCEDURE

Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Farnaz Dehgan Hosseinabadi

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Farnaz Dehghan, MD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Locations

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Department of Rehabilitation, Alzahra Hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

References

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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. doi: 10.1177/0363546505281811.

Reference Type RESULT
PMID: 16556754 (View on PubMed)

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.

Reference Type RESULT
PMID: 21255460 (View on PubMed)

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.

Reference Type RESULT
PMID: 22349369 (View on PubMed)

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. doi: 10.1177/107110070202300402.

Reference Type RESULT
PMID: 11991474 (View on PubMed)

Other Identifiers

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13914022

Identifier Type: -

Identifier Source: org_study_id

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