Effect of Prolotherapy in Knee Osteoarthritis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2021-12-30

Brief Summary

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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.

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Detailed Description

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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:

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 ultrasonographically .

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

the Assessor doing the musculoskeletal ultrasound will be masked to the radiographic grading of knee osteoarthritis, the clinical condition and the improvement following prolotgerapy.

Study Groups

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G1 patients receive prolotherapy

Intra and extra articular dextrose 25%

Group Type EXPERIMENTAL

Prolotherapy with 25% Dextrose

Intervention Type DRUG

Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose

Interventions

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Prolotherapy with 25% Dextrose

Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose

Intervention Type DRUG

Other Intervention Names

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25% dextrose intra and extra-articilar injection

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No