Comparison of ultrasound guided local injections of dextrose and corticosteroid efficacy on pain and daily activity of patients with chronic plantar fasciitis
In this study we compare effects of dextrose and corticosteroid on pain and daily activity of patients with plantar fasciitis.Patients suffering from heel pain with a VAS( Visual Analogue Scale) more than 4 for at least two months whose history,physical exam and sonography confirm plantar faciitis are included. A history of direct trauma; systemic inflamatory or soft tissue diseases; disk herniation with S1 radiculopathy; gout; diabetes melitus;surgury or injection in fascia since 6 months ago, existence of cyst/mass in pain site; coincidence of paresthesia or numbness; coagolupathy; pregnancy; hypersensitivity to corticosteroids; infection of injection site, posterior heel pain and any treatment for the condition since 4 weeks ago are exclusion criterias. Patients will be randomized with a simple randomization method in two intervention groups. One group will be injected with 2 cc of dextrose 20% and the other with a combination of 1 cc of methylprednisolone 40 mg and 1 cc of saline 0.9%, both in plantar fascia under an ultrasound guide.Anesthesia will be induced by 1 cc of lidocain 1% and a 22 gauged needle.A resident of physical medicine and rehabilitation who is blind toward the injected drugs will evaluate the patients at the base time, 2 weeks and 8 weeks following the injection.The evaluation will be done for efficacy on pain by VAS and on daily activity by FAAM questionaire.Thickness of plantar fascia will be determined by sonography. Finally the collected data from two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041321744N1
Registration date:2015-06-01, 1394/03/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-01, 1394/03/11
Registrant information
Name
Amin Arbabi
Name of organization / entity
Iran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 7713 6756
Email address
arbabiamin0123@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Iran University Of Medical Science, Dr Eftekhar Ardebili
Expected recruitment start date
2015-06-05, 1394/03/15
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ultrasound guided local injections of dextrose and corticosteroid efficacy on pain and daily activity of patients with chronic plantar fasciitis
Public title
Effects of dextrose and corticostroid on plantar fasciitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: a history of plantar fasciitis;heel pain for more than 2 months with a VAS(visual Analogue Scale) more than 4;fascia hypoechogenisity and thickness more than 4 mm in sonography
exclusion:a history of direct trauma; positive tinnel sign; a history of systemic inflamatory or soft tissue diseases; disk herniation with S1 radiculopathy; a history of gout; diabetes melitus; a history of surgury or injection in fascia since 6 months ago, existence of cyst/mass in pain site; coincidence of paresthesia or numbness; coagolupathy; pregnancy; hypersensitivity to corticosteroids; infection of injection site, posterior heel pain; any treatment for the condition since 4 weeks ago; patients who receive physiotherapy, splint, Ionophoresis and shockwave during 2 months after injection
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University Of Medical Sience
Street address
Iran University Of Medical Science, Hemmat Freeway, next to Milad Hospital
City
Tehran
Postal code
Approval date
2014-09-03, 1393/06/12
Ethics committee reference number
105/2741/د/93
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
XIII
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Pain
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Visual Analog Scale(VAS)
2
Description
Daily living and sport activity
Timepoint
before injection,2 weeks and 8 weeks after injection
Method of measurement
FAAM questionaire
Secondary outcomes
1
Description
Thickness of plantar fascia
Timepoint
before injection, 2 weeks and 8 weeks after injection
Method of measurement
sonography
Intervention groups
1
Description
First intervention group: injection 0f a combination of 1 cc methylprednisolone 40 mg and 1 cc salin 0.9%
Category
Treatment - Drugs
2
Description
Second intervention group: injection of 2 cc of dextrose 20%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Amin Arbabi
Street address
Valiasr square, Behafarin Avenue, Firoozgar hospita, Physical medicine and rehabilitation wardl
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University Of Medical Science
Full name of responsible person
Dr Eftekhar Ardebili
Street address
Next to Milad hospital, Hemmat Autobahn
City
Tehran
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 of Iran University Of Medical Science