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

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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

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

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Procedure: Extracorporeal shock wave therapy 1 Procedure: Extracorporeal shock wave therapy 2 Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Extracorporeal Shock Wave Therapy (ESWT)of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
Study Start Date : November 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786057


Locations
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Iran, Islamic Republic of
Department of Rehabilitation, Alzahra Hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Farnaz Dehghan, MD Isfahan University of Medical Sciences