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Effect of Prolotherapy in Knee Osteoarthritis.

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Prolotherapy with 25% Dextrose
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring primary knee osteoarthritis,, prolotherapy,, musculoskeletal ultrasound

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III)
  • consent obtained

Exclusion Criteria:

  • Severe Knee osteoarthritis (KL grade IV)
  • Causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases.
  • received oral or systemic steroids 1 month prior to the procedure
  • received intra-articular steroids or hyaluronic acid 1 month prior to the procedure
  • BMI >45Kg/m2

Sites / Locations

  • Alexandria University, Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

G1 patients receive prolotherapy

Arm Description

Intra and extra articular dextrose 25%

Outcomes

Primary Outcome Measures

Pain, Stiffness and Physical function
whether prolotherapy improves physical function by Western Ontario and McMaster University (WOMAC) index and VAS in patients with primary knee osteoarthritis

Secondary Outcome Measures

Cartilage thickness
whether an increase in cartilage thickness could be detected by the musculoskeletal ultrasound following prolotherapy
Safety and Tolerability
safety and tolerability will be assessed using patient satisfaction Likeret 5 point scale

Full Information

First Posted
November 21, 2019
Last Updated
March 31, 2023
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT04178304
Brief Title
Effect of Prolotherapy in Knee Osteoarthritis.
Official Title
Effect of Prolotherapy in Knee Osteoarthritis: Clinical and Ultrasonographic Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: intra-articular injection and extra-articular injections of 25% dextrose. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically . Aim: Determine whether prolotherapy improves pain. stiffness and function of symptomatic knee osteoarthritis and determine ultrasonographic changes before and after prolotherapy.
Detailed Description
Sixty knees with primary knee osteoarthritis will be included in the study, clinical assessment will be done, then plain X-ray for the affected knee (s), followed by musculoskeletal ultrasound assessment will be done. The intervention: a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose. Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
primary knee osteoarthritis,, prolotherapy,, musculoskeletal ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sixty knees with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: 1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done. 2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose. Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. Follow up will be done at 24 weeks after the last injection both clinically and ultrasounographicly.
Masking
None (Open Label)
Masking Description
the Assessor doing the musculoskeletal ultrasound will be masked to the radiographic grading of knee osteoarthritis, the clinical condition and the improvement following prolotgerapy.
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1 patients receive prolotherapy
Arm Type
Experimental
Arm Description
Intra and extra articular dextrose 25%
Intervention Type
Drug
Intervention Name(s)
Prolotherapy with 25% Dextrose
Other Intervention Name(s)
25% dextrose intra and extra-articilar injection
Intervention Description
Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose
Primary Outcome Measure Information:
Title
Pain, Stiffness and Physical function
Description
whether prolotherapy improves physical function by Western Ontario and McMaster University (WOMAC) index and VAS in patients with primary knee osteoarthritis
Time Frame
24 weeks after last injection
Secondary Outcome Measure Information:
Title
Cartilage thickness
Description
whether an increase in cartilage thickness could be detected by the musculoskeletal ultrasound following prolotherapy
Time Frame
24 weeks after last injection
Title
Safety and Tolerability
Description
safety and tolerability will be assessed using patient satisfaction Likeret 5 point scale
Time Frame
24 weeks after last injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III) consent obtained Exclusion Criteria: Early Knee osteoarthritis (KL grade I) Severe Knee osteoarthritis (KL grade IV) Causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases. received oral or systemic steroids 1 year prior to the procedure received intra-articular steroids or hyaluronic acid 1 year prior to the procedure BMI >45Kg/m2 poorly controlled diabetes mellitus, on anticoagulation therapy, history of cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yousra H Abdel-Fattah, MD
Organizational Affiliation
Alexandria University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University, Faculty of Medicine
City
Alexandria
ZIP/Postal Code
00123
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Prolotherapy in Knee Osteoarthritis.

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