Effect of Prolotherapy in Knee Osteoarthritis. | NCT04178304

Studies
Effect of Prolotherapy in Knee Osteoarthritis.

NCT04178304

Sponsor

University of Alexandria

Status

Completed

Last Update Posted

Apr 5, 2023Actual

Enrollment

63Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

Prolotherapy with 25% Dextrose

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2019Actual

Primary Completion Date

Oct 30, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Nov 21, 2019

First Submission Date that Met QC Criteria

Nov 24, 2019

First Posted Date

Nov 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2023

Last Update Posted Date

Apr 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yousra Hisham Abdel Fattah, Lecturer of Physical Medicine, Rheumatology and Rehabilitation, University of AlexandriaPrincipal Investigator

Lead Sponsor

University of AlexandriaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
G1 patients receive prolotherapy	Experimental	Intra and extra articular dextrose 25%	Drug: Prolotherapy with 25% Dextrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolotherapy with 25% Dextrose	Drug	Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose	G1 patients receive prolotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	24 weeks after last injection

Secondary Outcomes

Measure	Description	Time Frame
Cartilage thickness	whether an increase in cartilage thickness could be detected by the musculoskeletal ultrasound following prolotherapy	24 weeks after last injection
Safety and Tolerability

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yousra H Abdel-Fattah, MD	Alexandria University Faculty of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria University, Faculty of Medicine		Alexandria		00123	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000075527	Prolotherapy
D005947	Glucose

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D006601	Hexoses
D009005	Monosaccharides

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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 Info

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.

Who Masked

Not provided