Effects of Dextrose Prolotherapy in Patients With Knee Osteoarthritis

NCT06063356 | Unknown

• 1 other identifier: IstanbulU-2023-77979112
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain score at 1-months, 3-months and 6-months

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.

  Baseline, 1-month, 3-month, 6-month

Secondary Outcomes (7)

• Change from baseline stiffness and physical function at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline activity pain score at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline rest pain score at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline night pain score at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline quality of life at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

Study Arms (2)

Dextrose Prolotherapy

ACTIVE COMPARATOR

Intra-articular Injection: A total of 5 cc of 25% dextrose solution (4 cc of 30% dextrose + 1 cc of saline) will be administered to the patellofemoral joint space in each patient with the same technique using the supero-lateral technique using a sterile injector with a 20 gauge needle tip.

Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection; Procedure: Intra-articular and extra-articular Saline injection

Saline

ACTIVE COMPARATOR

Intra-articular Injection: Using a sterile syringe with a 20 gauge needle tip, a total of 5 cc of saline will be administered to the patellofemoral joint space in each patient with the same technique using the supero-lateral technique.

Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection; Procedure: Intra-articular and extra-articular Saline injection

Interventions

Intra-articular and extra-articular Dextrose Prolotherapy injection PROCEDURE

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.

Dextrose Prolotherapy; Saline

Intra-articular and extra-articular Saline injection PROCEDURE

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.

Dextrose Prolotherapy; Saline

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral or bilateral symptomatic knee pain resistant to conservative treatment for at least three months
• Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
• years of age
• Functional ambulation scale stage 4-5

You may not qualify if:

• Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
• Intra-articular knee injection within the last six months
• History of severe trauma to the knee within the past six months
• Concomitant severe meniscus or ligament injury, surgery applied to the knee area
• Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
• Having a bleeding disorder and / or using warfarin
• Patients with hemoglobin less than 11g/dL and platelet count of less than 150,000 platelets per microliter
• Presence of uncontrolled diabetes mellitus
• Presence of cardiac or systemic disease that may affect exercise
• The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
• Body Mass Index ≥35 kg/m²
• Allergy to local anesthetic

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ekin I Sen, Assoc.Prof.

  Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 2, 2023
• Study Start: August 15, 2023
• Primary Completion: April 20, 2024
• Study Completion: June 20, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

TU (1)