Effects of Dextrose Prolotherapy in Patients With Knee Osteoarthritis

NCT06063356 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-01-09

No results posted yet for this study

Summary

In this prospective, randomized, controlled, single-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with chronic knee osteoarthritis.

Conditions

Interventions

PROCEDURE

Intra-articular and extra-articular Dextrose Prolotherapy injection

In the prolotherapy group, 28 patients will receive intra-articular 5 cc 25% dextrose solution (4 cc 30% dextrose + 1 cc saline) and extra-articular 10 cc 15% dextrose solution (5 cc 30% dextrose + 2.5 cc saline + 2.5 cc 1% lidocaine) in 3 sessions.Extra-articular Injection: Using a sterile syringe with a 27 gauge needle tip (Dental), the points previously found and marked with US (medial collateral ligament, lateral collateral ligament, patellar ligament and adhesion sites of coronary ligaments; pes anserine and superior patellar regions) perpendicular to the surface, using peppering technique, a total of 10 cc of 15% dextrose solution (5 cc 30% dextrose + 2.5 cc saline + 2.5 cc 1% lidocaine) will be injected in small volumes (0.5cc-1cc) at each point.Injection applications will be done at weeks 0 - 3 - 6.

PROCEDURE

Intra-articular and extra-articular Saline injection

In the saline group, 28 patients are planned to receive 3 sessions of intra-articular 5 cc saline and extra-articular 10 cc lidocaine-serum physiologic solution (5 cc saline + 5 cc 1% lidocaine).Injection applications will be done at weeks 0 - 3 - 6.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Ekin I Sen, Assoc.Prof. · Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2024-04-20
Completion
2024-06-20

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06063356 on ClinicalTrials.gov