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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01786057
Recruitment Status : Unknown
Verified February 2013 by Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE February 1, 2013
First Posted Date  ICMJE February 7, 2013
Last Update Posted Date February 7, 2013
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
Change from baseline in pain severity after 3 weeks [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
Change from baseline in pain degree after 2 months. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
Official Title  ICMJE The Effect of Extracorporeal Shock Wave Therapy (ESWT)of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plantar Fasciitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: 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: Procedure: Extracorporeal shock wave therapy 1
  • Placebo Comparator: 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: Procedure: Extracorporeal shock wave therapy 2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 5, 2013)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01786057
Other Study ID Numbers  ICMJE 13914022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Farnaz Dehghan, MD Isfahan University of Medical Sciences
PRS Account Isfahan University of Medical Sciences
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP