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

NCT ID: NCT07243392

Last Updated: 2025-11-21

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intra articular steroid injection

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

Group Type EXPERIMENTAL

Intra articular steroid injection

Intervention Type PROCEDURE

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

Intra articular PRP

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.

Group Type EXPERIMENTAL

Intra articular PRP

Intervention Type PROCEDURE

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.

Intra articular dextrose prolotherapy

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.

Group Type EXPERIMENTAL

Intra articular dextrose prolotherapy

Intervention Type OTHER

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.

Interventions

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Intra articular steroid injection

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

Intervention Type PROCEDURE

Intra articular PRP

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.

Intervention Type PROCEDURE

Intra articular dextrose prolotherapy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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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Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lincoln University College

OTHER

Sponsor Role lead

Responsible Party

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Shahid sarwar

PhD Scholar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shahid Sarwar

Role: PRINCIPAL_INVESTIGATOR

Lincolin university college Malaysia

Locations

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Health Sciences

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Shahid Sarwar, PhD Scholar

Role: CONTACT

00923002647738

Sana Atta, MS

Role: CONTACT

00923095402052

Facility Contacts

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Shahid Sarwar, PhD Scholar

Role: primary

Sana Atta, MS

Role: backup

00923095402052

References

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Allen KD, Thoma LM, Golightly YM. Epidemiology of osteoarthritis. Osteoarthritis Cartilage. 2022 Feb;30(2):184-195. doi: 10.1016/j.joca.2021.04.020. Epub 2021 Sep 14.

Reference Type BACKGROUND
PMID: 34534661 (View on PubMed)

Arias-Vazquez PI, Tovilla-Zarate CA, Castillo-Avila RG, Legorreta-Ramirez BG, Lopez-Narvaez ML, Arcila-Novelo R, Gonzalez-Castro TB. Hypertonic Dextrose Prolotherapy, an Alternative to Intra-Articular Injections With Hyaluronic Acid in the Treatment of Knee Osteoarthritis: Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2022 Sep 1;101(9):816-825. doi: 10.1097/PHM.0000000000001918. Epub 2021 Nov 18.

Reference Type BACKGROUND
PMID: 34740224 (View on PubMed)

Avdulaj, E. (2023). Comparative Analysis of Knee Replacement Surgery who follow up by Physical Therapy and Intra-articular Steroid Injections for Obese Patients. Albanian Journal of Trauma and Emergency Surgery, 7(2), 1300-1303.

Reference Type BACKGROUND

Berrigan WA, Bailowitz Z, Park A, Reddy A, Liu R, Lansdown D. A Greater Platelet Dose May Yield Better Clinical Outcomes for Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Systematic Review. Arthroscopy. 2025 Mar;41(3):809-817.e2. doi: 10.1016/j.arthro.2024.03.018. Epub 2024 Mar 19.

Reference Type BACKGROUND
PMID: 38513880 (View on PubMed)

Cecerska-Heryc E, Goszka M, Serwin N, Roszak M, Grygorcewicz B, Heryc R, Dolegowska B. Applications of the regenerative capacity of platelets in modern medicine. Cytokine Growth Factor Rev. 2022 Apr;64:84-94. doi: 10.1016/j.cytogfr.2021.11.003. Epub 2021 Dec 2.

Reference Type BACKGROUND
PMID: 34924312 (View on PubMed)

Gupta S, Paliczak A, Delgado D. Evidence-based indications of platelet-rich plasma therapy. Expert Rev Hematol. 2021 Jan;14(1):97-108. doi: 10.1080/17474086.2021.1860002. Epub 2020 Dec 17.

Reference Type BACKGROUND
PMID: 33275468 (View on PubMed)

Ozturk MU, Baygutalp F. A comparative analysis of prolotherapy efficacy in patients with knee osteoarthritis across varied dextrose concentrations. Clin Rheumatol. 2023 Dec;42(12):3321-3331. doi: 10.1007/s10067-023-06723-4. Epub 2023 Aug 4.

Reference Type BACKGROUND
PMID: 37540383 (View on PubMed)

Other Identifiers

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LUC/CPGS/FOS/20250318/006

Identifier Type: -

Identifier Source: org_study_id

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