Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
Primary Purpose
Plantar Fasciitis
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy 1
Extracorporeal shock wave therapy 2
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of plantar fasciitis
- having at least one Gastrosoleus trigger point concomitantly.
- having no response to conservative treatments for at least 3 months
- willingness to participate
Exclusion Criteria:
- Dysfunction of the knee or ankle
- Neurologic abnormalities
- Bleeding tendency (hereditary or acquired)
- Nerve entrapment syndrome
- A previous operation on the heel
- Pregnancy
- Evidences of Infection in lower limbs
- A medical History of tumor
- previous local corticosteroid injection within 12 weeks
Sites / Locations
- Department of Rehabilitation, Alzahra Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Extracorporeal shock wave therapy 1
Extracorporeal shock wave therapy 2
Arm Description
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 , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01786057
First Posted
February 1, 2013
Last Updated
February 5, 2013
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01786057
Brief Title
Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
Official Title
The Effect of Extracorporeal Shock Wave Therapy (ESWT)of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extracorporeal shock wave therapy 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Extracorporeal shock wave therapy 2
Arm Type
Placebo Comparator
Arm Description
Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal shock wave therapy 1
Intervention Description
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
Intervention Name(s)
Extracorporeal shock wave therapy 2
Intervention Description
Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals
Primary Outcome Measure Information:
Title
Change from baseline in pain severity after 3 weeks
Description
The pain score (100 mm Visual Analogue Score ) is evaluated before the first session and 4 weeks after the last session.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in pain degree after 2 months.
Description
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.
Time Frame
Up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of plantar fasciitis
having at least one Gastrosoleus trigger point concomitantly.
having no response to conservative treatments for at least 3 months
willingness to participate
Exclusion Criteria:
Dysfunction of the knee or ankle
Neurologic abnormalities
Bleeding tendency (hereditary or acquired)
Nerve entrapment syndrome
A previous operation on the heel
Pregnancy
Evidences of Infection in lower limbs
A medical History of tumor
previous local corticosteroid injection within 12 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farnaz Dehghan, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation, Alzahra Hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
16556754
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. doi: 10.1177/0363546505281811.
Results Reference
result
PubMed Identifier
21255460
Citation
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.
Results Reference
result
PubMed Identifier
22349369
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.
Results Reference
result
PubMed Identifier
11991474
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. doi: 10.1177/107110070202300402.
Results Reference
result
Learn more about this trial
Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
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