Effects of Steroid, Dextrose Prolotherapy, and Platelet-Rich Plasma Injections in Knee Joint OA Patients

Lincoln University College

Status: Not yet enrolling

Conditions: Knee Osteoarthritis

Treatments: Procedure: Intra articular steroid injection; Procedure: Intra articular PRP; Other: Intra articular dextrose prolotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07243392

LUC/CPGS/FOS/20250318/006

Details and patient eligibility

About

The novelty of thisstudy lies in its comparative assessment of three latest intra-articular injection therapies including steroid injections, dextrose prolotherapy, and PRP, for knee OA associated impairments, with a focus on long-term efficacy and safety profile. While prior studies may have assessed one or two of these treatments individually therefore this protocol is systematically designed.

Full description

Osteo Arthritis (OA) is one of the chronic, Degenerative Joint Disease (DJD) categorized by the progressive loss of articular cartilage, leading to persistent joint pain, stiffness in the joints along with reduced mobility.

Knee OA has been documented as one of the principal causes of disability across the globe, with significantly higher incidence rate owing to physical trauma to joint, advancing age, obesity, and sedentary lifestyles etc. Management strategies for knee OA include following options, conservative management that include physiotherapy, adjunct therapies, pharmacological options and eventually surgical intervention such as knee replacements. Within the last few years, lots of focus has been placed on application of intra-articular injections for the knee joint which are reportedly found very effective in managing symptoms and altering the course of the disease without being too invasive. Among these, Corticosteroid Injections, Dextrose Prolotherapy and Platelet-Rich Plasma (PRP) injections stand out as the most common for the knee joint, each with its own unique mode of action and varying degree of effectiveness.

Corticosteroid intra-articular injections are known to be one of the most effective treatments. These injections provide relief in pain to joint inflammation targeting the synovial membrane through very potent anti-inflammatories injected directly into the joint.

Primary benefit of these injections is the speed of recovery with which pain is lessened and function of joint back to normal. A troublesome point of this approach is the pain relief time which is limited only a few weeks.

Literature has shown that excessive administration of corticosteroid intra-articular injections has resulted in the degradation of cartilage and narrowing of articular space, which could be antecedent to OA progression. As demonstrated in a randomized clinical trial, patients who were exposed to intra-articular triamcinolone at three-month intervals for a two-year period, experienced more cartilage volume loss over time, compared to placebo group participants highlighting the need for caution in regard to corticosteroids in the treatment of knee OA.

Dextrose prolotherapy is defined as a self augmenting injection therapy in w Dextrose prolotherapy is a unique approach with improvements in pain and function that persist over time, however, this approach likely takes a longer time for relief as compared to that of corticosteroids. Advantage of this therapeutic modality with PRP injections is that they are both anti inflammatory and regenerative in nature and thus, they provide both immediate and prolonged advantages excluding any significant risk to the patient.

Enrollment: 72 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Inclusion criteria include patients aged 40-80 years, diagnosed with knee OA having Kellgren- Lawrence grades 2-4(Gelber, 2024) having history of persistent knee pain from at least last six months -

Patients Exclusion reporting with history of recent knee surgery, patients suffering from inflammatory joint diseases for example rheumatoid arthritis, having any active body infection, diabetic patients with de ranged HbA1c, pregnant and breast-feeding females will be excluded.:

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups

Intra articular steroid injection

Experimental group

Description:

Participants will receive intra-articular injections of corticosteroid such as methylprednisolone in order to reduce inflammation and manage pain.

Treatment:

Procedure: Intra articular steroid injection

Intra articular PRP

Experimental group

Description:

Participants will receive PRP, derived from the own blood of patient, which will be processed in laboratory to concentrate platelets containing growth factors to provide support in tissue repair.

Treatment:

Procedure: Intra articular PRP

Intra articular dextrose prolotherapy

Experimental group

Description:

Participants will receive dextrose prolotherapy injections, in which a hypertonic dextrose solution that is typically 25% will be injected into the knee joint in order to stimulate joint tissue regeneration.

Treatment:

Other: Intra articular dextrose prolotherapy