Protocol summary

Summary
Objectives: evaluation effectiveness of high energy radial extra corporal shock wave therapy (ESWT) in the treatment of chronic plantar fasciitis and comparing it with local injection of corticosteroid. Design: 40 patients with complaint of heel pain for more than 2 months and diagnosis of chronic plantar fasciitis during one-year are selected. Setting and conduct: The eligible patients will be divided to 2 groups of 20 , A & B, via closed envelops method. Inclusion criteria: patients with heel pain for more than 2 months. Exclusion criteria: 1. History of systemic inflammatory diseases, 2. Infective or malignant diseases, 3. History of direct trauma with or without foot bones fracture, 4. Previous physiotherapy in the past 3 months or local steroid injection in the past 6 months, 5. Heel pain related to Achilles bursitis, 6. Presence of myofascial pain syndrome and trigger points in gastrocnemius muscle, 7. Active S1 radiculopathy. Interventions: In group A (shockwave therapy), high energy radial ESWT with energy flux intensity of 0.25 mj /mm2, 2000 impulse, 10 Hz frequency, for 5 sessions twice a week will be applied. In group B, local injection of 40 mg Triamcinolone to tender point of heel will be done only one session. Moreover, therapeutic foot insoles will be prescribed in both groups and stretching exercises for medial fascia as well as gastrocnemius muscles will be educated. Main outcome measurements: Evaluation of pain intensity is done using visual analogue scale, so that patients must have at least 20 mm pain score. Assessment of foot function will be done using foot function index. Third variable is satisfaction of treatment at the end of intervention by satisfaction rating scale. These variables will be assessed at baseline, weeks 4 and 8 after treatment and finally will be analyzed and compared between groups statistically.

General information

Acronym
ESWT: extracorporeal shock wave therapy.
IRCT registration information
IRCT registration number: IRCT201306163217N7
Registration date: 2014-03-04, 1392/12/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-04, 1392/12/13
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical medicine and rehabilitation research center, Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of high energy radial extra corporeal shock wave therapy (ESWT) versus local corticosteroid injection in the treatment of chronic plantar fasciitis, a single blinded randomized clinical trial.
Public title
Comparison of high energy radial extra corporeal shock wave therapy with local corticosteroid injection in the treatment of plantar fasciitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all of patients with chronic plantar fasciitis and heel pain and local tenderness for more than 2 months. Exclusion criteria: 1) History of systemic inflammatory diseases. 2) Infective or malignant diseases. 3) History of direct trauma with or without foot bones fracture. 4) Previous physiotherapy in the past 3 months or local steroid injection in the past 6 months. 5) Active S1 radiculopathy (which could be justify the cause of plantar fascia pain). 6) Heel pain related to Achilles bursitis. 7) Presence of myofascial pain syndrome and trigger points in gastrocnemius muscle.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be randomly divided to two groups via closed envelops method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz university of medical science committee of ethics.
Street address
3rd floor- Number 2 Central Building - Tabriz university of medical science - Golgasht Avenue
City
Tabriz
Postal code
51656
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
5/4/7049

Health conditions studied

1

Description of health condition studied
chronic plantar fascitis
ICD-10 code
M72.2
ICD-10 code description
Fibroblastic disorder, plantar fascial fibromatosis, plantar fasciitis.

Primary outcomes

1

Description
pain intensity
Timepoint
Before treatment and 4 & 8 weeks after treatment
Method of measurement
Visual Analogue Scale with 0-100mm grading.

2

Description
Daily foot functional ability
Timepoint
Before treatment and 4 & 8 weeks after treatment
Method of measurement
Questionnaire of foot function index.

3

Description
satisfaction rate
Timepoint
at the end of intervention
Method of measurement
satisfaction rating scale in according 4 grades:Excellent, good, moderate and poor.

Secondary outcomes

empty

Intervention groups

1

Description
Radial extracorporeal shock wave.Using high energy radial shock wave with energy flux intensity of 0.25mj/mm2 , 2000 impulse (4Bar ) and frequency of 10 HZ twice a week for five sessions.
Category
Treatment - Devices

2

Description
One local injection of 40 mg triamcinolone in tender point of medial zone of heel. (Amp triamhexal. made by Germany)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital of Tabriz
Full name of responsible person
Faraz Notghi
Street address
Daneshgah Ave.
City
East Azarbaijan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of medical science
Full name of responsible person
Dr. Yaghoob Salek Zamani
Street address
3rd floor- Number 2 Central Building - Tabriz University of Medical Scineces- Golgasht Avenue Tabriz
City
tabriz
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Faraz Notghi
Position
Resident of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Physical medicine and rehabilitation ward , Imam Reza Hospital ,Golgasht Ave
City
Tabriz
Postal code
51656
Phone
+98 41 1337 3967
Fax
+98 41 1337 3967
Email
faraz.notghi@yahoo.com
Web page address
_

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Fariba Eslamiyan
Position
Assistant professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
physical medicine and rehabilitation ward - Imam Reza Hospital- Golgasht Ave
City
Tabriz
Postal code
51656
Phone
+98 41 1337 3967
Fax
00
Email
eslamiyanf@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Fariba Eslamiyan
Position
Associate professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
physical medicine and rehabilitation ward- Imam Reza Hospital-Golgasht Ave.
City
Tabriz
Postal code
51656
Phone
+98 41 1337 3967
Fax
+98 41 1337 3967
Email
eslamiyanf@tbzmed.ac.ir fariba_eslamian@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...