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Comparison of the Efficacy of Ultrasound-Guided Dextrose Prolotherapy (PrT) and Platelet-Rich Plasma (PRP) Injections in Adult Patients with Chronic Ankle Pain Following Ankle Sprain.

Protocol summary

Study aim
Comparing the effectiveness of ultrasound-guided dextrose prolotherapy injection and platelet-rich plasma (PRP) in adult patients with chronic ankle pain following sprain.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized (block randomization method with a block size of 3), phase 3 on 60 patients.
Settings and conduct
Patients who referred to the PM&R clinic are selected based on the inclusion criteria. Informed consent is obtained and the prepared questionnaires are filled. Patients will be randomly divided into 3 groups (control, PRP and dextrose prolotherapy injections). Blinding method is used in this study. All syringes are prepared in similar shapes and each syringe and patient will be given a code. All injections (intra-articular and peri-articular) are performed under ultrasound guidance and sterile conditions. Patients are evaluated 4 and 12 weeks later and the questionnaires are filled again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients with complaints of chronic ankle pain due to lateral sprain and chronic ankle ligament damage who have not responded to conservative treatments. Exclusion criteria: Patients with a history of underlying disease, recent ankle fracture or infection, surgery or injection in the ankle area, patients with accompanying ankle injury, use of anticoagulants, and a history of allergic reaction to dextrose or lidocaine injection.
Intervention groups
In the first group, single injection of PRP is performed around the damaged ligament and inside the ankle joint. In the second group, single injection of dextrose prolotherapy is performed around the damaged ligament and inside the ankle joint. In the third group (control), single injection of normal saline is performed around the injured ligament and inside the ankle joint.
Main outcome variables
Pain, Function, Alignment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231025059859N1
Registration date: 2024-06-07, 1403/03/18
Registration timing: prospective

Last update: 2024-06-07, 1403/03/18
Update count: 0
Registration date
2024-06-07, 1403/03/18
Registrant information
Name
Maryam Cheraghali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4612 5762
Email address
mcheraghali71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Ultrasound-Guided Dextrose Prolotherapy (PrT) and Platelet-Rich Plasma (PRP) Injections in Adult Patients with Chronic Ankle Pain Following Ankle Sprain.
Public title
Effect of Dextrose Prolotherapy and Platelet-Rich Plasma Injections on Chronic Pain after Ankle Sprain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult Patients (18 Years and Older). Patient with Complaints of Chronic Ankle Pain (for 12 Weeks or More) due to Lateral Sprain and Chronic Ankle Ligament Damage Who Have Not Responded to Conservative Treatments.
Exclusion criteria:
Patients with History of Rheumatologic Disorders. Patients with History of Diabetes Mellitus. Patients with History of Recent Fractures of the Ankle Bones (Within the Last 3 Months). Patients with History of Infection Around the Ankle Joint. Patients with History of Intra-Articular or Extra-Articular Injections in the Ankle Region in the Past Year. Patients with History of Ankle Surgery. Patients who Use Anticoagulant Drugs. Patients who Had Any Previous Allergic Reaction to Dextrose or Lidocaine Injection. Patients with Accompanying Ankle Injury such as Osteochondritis Dissecans of the Talus.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To ensure balanced allocation across the three groups (two intervention, one control), a block randomization method with a block size of 3 will be employed. Microsoft Excel's randomization function will be used to generate an unbiased sequence, assigning one participant to each group within each block. Allocation concealment methods will be strictly followed to prevent knowledge of group assignment before enrollment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Normal saline, Dextrose Prolotherapy (PrT) and Platelet-Rich Plasma (PRP) syringes are prepared in the same shape and each syringe is given a code and each patient is also given a code. The participants, clinical caregiver, outcome assessor and the main researcher will not know about the syringes and the type of codes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committee of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Faculty of Medicine- Poorsina St.- Qods St.- Enghelab St.
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.280

Health conditions studied

1

Description of health condition studied
Ankle Sprain
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle

Primary outcomes

1

Description
Determination and comparison of pain.
Timepoint
Before intervention, 4 and 12 weeks after the intervention.
Method of measurement
Visual analogue scale questionnaire.

2

Description
Determination and comparison of pain.
Timepoint
Before intervention, 4 and 12 weeks after the intervention.
Method of measurement
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot questionnaire.

Secondary outcomes

1

Description
Determination and comparison of function.
Timepoint
Before intervention, 4 and 12 weeks after the intervention.
Method of measurement
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot questionnaire.

2

Description
Determination and comparison of alignment.
Timepoint
Before intervention, 4 and 12 weeks after the intervention.
Method of measurement
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot questionnaire.

Intervention groups

1

Description
First Intervention group: Platelet-rich plasma (a single injection of 4 cc of liquid containing platelets with 5 to 6 times concentration: 1.5 cc around the ligament and 2.5 cc intra-articular).
Category
Treatment - Drugs

2

Description
Second intervention group: Dextrose prolotherapy (a single injection of 4 cc of 10% dextrose solution; 2 cc of 20% dextrose with 2 cc of 2% lidocaine solution: 1.5 cc around the ligament and 2.5 cc intra-articular).
Category
Treatment - Drugs

3

Description
Control group: Normal saline (a single injection of 4 cc of 0.9% normal saline solution: 1.5 cc around the ligament and 2.5 cc intra-articular).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Maryam Cheraghali
Street address
Imam Khomeini Hospital, At the end of Keshavarz Blvd., Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2291
Fax
+98 21 6658 1625
Email
dr.mcheraghali@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbari Sari
Street address
Research and Technology Affairs Management Unit, Room 605, 6th Floor, Headquarters of Tehran University of Medical Sciences, Corner of Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3619
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Cheraghali
Position
Physical medicine and rehabilitation resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Khomeini Hospital, At the end of Keshavarz Blvd., Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2291
Email
dr.mcheraghali@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyede Zahra Emami Razavi
Position
Associate professor of physical medicine and rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Imam Khomeini Hospital, At the end of Keshavarz Blvd., Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2291
Email
zemamirazavi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Cheraghali
Position
Physical medicine and rehabilitation resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Khomeini Hospital, At the end of Keshavarz Blvd., Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2291
Email
dr.mcheraghali@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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