Knee OsteoarthritisNCT07243392
Effects of Steroid, Dextrose Prolotherapy, and Platelet-Rich Plasma Injections in Knee Joint OA Patients
A study testing Intra articular steroid injection, Intra articular PRP and Intra articular dextrose prolotherapy in people with Knee Osteoarthritis, run by Lincoln University College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intra articular steroid injection, Intra articular PRP and Intra articular dextrose prolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.:
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Health Sciences
Lahore, Punjab Province, 64200
Shahid Sarwar, PhD Scholar, 00923002647738, Shahid_sarwar99@yahoo.comshahidsarwar.phdscholar@lincoln.edu.my
Sana Atta, MS, 00923095402052, sanaatta33@gmail.com
About this study
Official title: A Comparative Study on Effects of Steroid, Dextrose Prolotherapy, and Platelet-Rich Plasma Injections to Lessen Pain in Knee Osteoarthritis Patients
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intra articular steroid injection, Intra articular PRP, Intra articular dextrose prolotherapy
- Keywords
- Osteoarthristis, Osteoarthritis, Knee, pain, steroids, Platelet-Rich Plasma, Injections, Intra-Articular, Regenerative Medicine., Prolotherapy
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra articular steroid injectionProcedure or surgery
Participants will receive intra-articular injections of corticosteroid such as methylprednisolone in order to reduce inflammation and manage pain.
Intra articular PRPProcedure or surgery
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 prolotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra articular steroid injection | Experimental | Participants will receive intra-articular injections of corticosteroid such as methylprednisolone in order to reduce inflammation and manage pain. Receives: 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. Receives: 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. Receives: Other: Intra articular dextrose prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start28 Nov 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lincoln University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahid sarwar, Lincoln University College
- Investigators
- Shahid Sarwar, Principal investigator, Lincolin university college Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243392
- Sponsor's protocol ID
- LUC/CPGS/FOS/20250318/006
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34534661Arias-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.
PubMed 34740224Avdulaj, 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.
PubMed 38513880Cecerska-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.
PubMed 34924312Gupta 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.
PubMed 33275468Ozturk 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.
PubMed 37540383
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Effects of Steroid, Dextrose Prolotherapy, and Platelet-Rich Plasma Injections to Lessen Pain in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT07243392
- Acronym / sponsor ID
- LUC/CPGS/FOS/20250318/006
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthristis, Osteoarthritis, Knee, pain, steroids, Platelet-Rich Plasma, Injections, Intra-Articular, Regenerative Medicine., Prolotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Lincoln University CollegeUniversity, hospital or other
- Study start
- 28 Nov 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra articular steroid injection | Experimental | Procedure: Intra articular steroid injectionParticipants will receive intra-articular injections of corticosteroid such as methylprednisolone in order to reduce inflammation and manage pain. |
| Intra articular PRP | Experimental | Procedure: Intra articular PRPParticipants 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 | Experimental | Other: Intra articular dextrose prolotherapyParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra articular steroid injectionParticipants will receive intra-articular injections of corticosteroid such as methylprednisolone in order to reduce inflammation and manage pain. | Procedure or surgery | Intra articular steroid injection |
| Intra articular PRPParticipants 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 or surgery | Intra articular PRP |
| Intra articular dextrose prolotherapyParticipants 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 |
Primary outcome
NPRS
Time frame: 9 months
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.
WOMAC
Time frame: 9 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 34534661Allen 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.
- Background: PubMed 34740224Arias-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.
- BackgroundAvdulaj, 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: PubMed 38513880Berrigan 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.
- Background: PubMed 34924312Cecerska-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.
- Background: PubMed 33275468Gupta 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.
- Background: PubMed 37540383Ozturk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shahid Sarwar principal investigator
Lincolin university college Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra articular steroid injection, Intra articular PRP and Intra articular dextrose prolotherapy in people with Knee Osteoarthritis, run by Lincoln University College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahid Sarwar, PhD Scholar (00923002647738, shahidsarwar.phdscholar@lincoln.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07243392, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.