Comparison of The Therapeutic Effects of Ultrasound-guided Dextrose Prolotherapy Injection with Shock wave Therapy in the Treatment of Plantar Fasciitis
To compare the clinical effectiveness of local dextrose injection with shock wave for plantar fascitis
Design
A total number of 7 patients will randomly be categorized into one of the following groups, using block randomization (39 patients in each group):
Group A: Will receive ultrasound guided localized injection of 2 ml Dextrose 20% in the attachment of the plantar fascia to the calcareous bone.
Group B: Will receive 3 sessions of shock wave therapy every other day for 2000 pulse, 2 Hz with power of 0.2 mj/mm2.
Settings and conduct
This randomized control trial will be conducted in Baghiatolah Azam Hospital, Tehran, Iran. This hospital is affiliated to the Baghaiatolah university of medical sciences. Based on the nature of the interventions, blinding is not applicable for this study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 20 to 50 years; A typical history of plantar fascistic and localized tenderness in the medial side of the heel; providing informed consent for participation in the study.
Exclusion Criteria: Evidence of calcaneal fracture on x-ray; history of heel surgery; damage to Achilles tendon; inflammatory diseases; diabetes mellitus; local or systemic infections; peripheral vascular diseases; gout; blood coagulation disorders; corticosteroid injection during the last 6 months; contraindications to steroid; non-steroidal anti-inflammatory use within the last 7 days
Intervention groups
Overall, 78 patients will randomly be allocated equally into two groups
Main outcome variables
Pain intensity at the standing position; early morning pain; pain on joint movement, daily activities, climbing stairs and exercise tolerance. The outcomes are evaluated repeatedly up to 3 months after interventions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140306016865N2
Registration date:2019-07-31, 1398/05/09
Registration timing:registered_while_recruiting
Last update:2019-07-31, 1398/05/09
Update count:0
Registration date
2019-07-31, 1398/05/09
Registrant information
Name
Mahsa Asheghan
Name of organization / entity
Baqiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 8837
Email address
m_asheghan@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-31, 1398/05/09
Expected recruitment end date
2019-10-31, 1398/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Therapeutic Effects of Ultrasound-guided Dextrose Prolotherapy Injection with Shock wave Therapy in the Treatment of Plantar Fasciitis
Public title
Dextrose Prolotherapy Injection in the Plantar Fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 50 years
A typical history of plantar fascistic and localized tenderness in the medial side of the heel
providing informed consent for participation in the study.
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be categorized into one of the following groups, using block randomization:
Group A: Receive ultrasound guided localized injection of 2 ml Dextrose 20% in the attachment of the plantar fascia to the calcareous bone.
Group B: Receive 3 sessions of shock wave therapy every other day for 2000 pulse, 2 Hz with power of 0.2 mj/mm2
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baghiatolah University of Medical Sciences (BMSU)
Street address
Baghiatolah University of Medical Sciences, Mola Sadra St, Vanak SQ, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.BMSU.REC.1397.138
Health conditions studied
1
Description of health condition studied
Plantar fascial fibromatosis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Pain intensity at the standing position
Timepoint
All the outcomes were evaluated at the baseline visit and at 1 week, 1 month, and 3 months after the intervention.
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Early morning pain; pain on joint movement; daily activities; climbing stairs and exercise tolerance
Timepoint
All the outcomes were evaluated at the baseline visit and at 1 week, 1 month, and 3 months after the intervention.
Method of measurement
Visual analog scale. We also assess the ability to perform daily activities, climbing stairs and exercise tolerance with FAAM Questionnaire.
Intervention groups
1
Description
Intervention group: Will receive ultrasound guided localized injection of 2 ml Dextrose 20% in the attachment of the plantar fascia to the calcareous bone.
Category
Treatment - Drugs
2
Description
Control group: Will receive 3 sessions of shock wave therapy every other day for 2000 pulse, 2 Hz with power of 0.2 mj/mm2