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

NCT07243392 | Not Yet Recruiting

• 1 other identifier: LUC/CPGS/FOS/20250318/006
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthristis; Osteoarthritis, Knee; pain; steroids; Platelet-Rich Plasma; Injections, Intra-Articular; Regenerative Medicine.; Prolotherapy

Outcome Measures

Primary Outcomes (2)

• NPRS

  The Numeric Pain Rating Scale (NPRS) is a validated, self-reported measure used to assess pain intensity. Participants rate their current knee pain on a scale from 0 to 10, where 0 indicates "no pain" and 10 represents "worst imaginable pain." NPRS scores will be recorded at baseline and at designated follow-up intervals to evaluate the effectiveness of steroid, dextrose prolotherapy, and platelet-rich plasma injections in reducing pain among patients with knee osteoarthritis.

  9 months

• WOMAC

  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated, disease-specific, self-administered questionnaire used to assess pain, stiffness, and physical function in patients with knee and hip osteoarthritis. It consists of 24 items divided into three subscales: * Pain (5 items) * Stiffness (2 items) * Physical Function (17 items) Each item is rated on a Likert scale (0-4) or VAS (0-100 mm) depending on the version used. Higher scores indicate greater pain, stiffness, or functional limitation. WOMAC scores will be recorded at baseline and follow-up intervals to evaluate treatment efficacy across steroid, dextrose prolotherapy, and platelet-rich plasma injection groups.

  9 months

Study Arms (3)

Intra articular steroid injection

EXPERIMENTAL

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

Procedure: Intra articular steroid injection

Intra articular PRP

EXPERIMENTAL

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.

Procedure: Intra articular PRP

Intra articular dextrose prolotherapy

EXPERIMENTAL

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.

Other: Intra articular dextrose prolotherapy

Interventions

Intra articular steroid injection PROCEDURE

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

Intra articular steroid injection

Intra articular PRP 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 PRP

Intra articular dextrose prolotherapy 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.

Intra articular dextrose prolotherapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Lincoln University College: lead

Study Sites (1)

Health Sciences

Lahore, Punjab Province, 64200, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 34534661 BACKGROUND

• 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.

  PMID: 34740224 BACKGROUND

• 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.

  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.

  PMID: 38513880 BACKGROUND

• 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.

  PMID: 34924312 BACKGROUND

• 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.

  PMID: 33275468 BACKGROUND

• 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.

  PMID: 37540383 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shahid Sarwar

  Lincolin university college Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahid Sarwar, PhD Scholar

CONTACT

00923002647738; shahidsarwar.phdscholar@lincoln.edu.my

Sana Atta, MS

CONTACT

00923095402052; sanaatta33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Scholar

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)