NCT01786057

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

9 months

First QC Date

February 1, 2013

Last Update Submit

February 5, 2013

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change from baseline in pain degree after 2 months.

    Up to 2 months

Study Arms (2)

Extracorporeal shock wave therapy 1

ACTIVE COMPARATOR

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 2

PLACEBO COMPARATOR

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

Interventions

Extracorporeal shock wave therapy 1PROCEDURE

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 1
Extracorporeal shock wave therapy 2PROCEDURE

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

Extracorporeal shock wave therapy 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation, Alzahra Hospital

Isfahan, Isfahan, Iran

Location

Related Publications (4)

  • 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.

    PMID: 16556754RESULT

  • 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.

    PMID: 21255460RESULT

  • 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.

    PMID: 22349369RESULT

  • 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.

    PMID: 11991474RESULT

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Farnaz Dehghan, MD

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 7, 2013

Study Start

November 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

IR(1)