- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07243392
Effects of Steroid, Dextrose Prolotherapy, and Platelet-Rich Plasma Injections in Knee Joint OA Patients
A Comparative Study on Effects of Steroid, Dextrose Prolotherapy, and Platelet-Rich Plasma Injections to Lessen Pain in Knee Osteoarthritis Patients
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shahid Sarwar, PhD Scholar
- Phone Number: 00923002647738
- Email: shahidsarwar.phdscholar@lincoln.edu.my
Study Contact Backup
- Name: Sana Atta, MS
- Phone Number: 00923095402052
- Email: sanaatta33@gmail.com
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 64200
- Health Sciences
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Contact:
- Sana Atta, MS
- Phone Number: 00923095402052
- Email: sanaatta33@gmail.com
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Contact:
- Shahid Sarwar, PhD Scholar
- Phone Number: 00923002647738
- Email: Shahid_sarwar99@yahoo.comshahidsarwar.phdscholar@lincoln.edu.my
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Principal Investigator:
- Shahid Sarwar, PhD Scholar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intra articular steroid injection
Participants will receive intra-articular injections of corticosteroid such as methylprednisolone in order to reduce inflammation and manage pain.
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Participants will receive intra-articular injections of corticosteroid such as methylprednisolone in order to reduce inflammation and manage pain.
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Experimental: 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.
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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.
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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NPRS
Time Frame: 9 months
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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.
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9 months
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WOMAC
Time Frame: 9 months
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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:
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9 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shahid Sarwar, Lincolin university college Malaysia
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUC/CPGS/FOS/20250318/006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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