ProlotherapyNCT07355712
Combined Effect of Prolotherapy and Personalized Physical Activity on Knee Osteoarthritis Progression
A study testing Prolotherapy Only, Prolotherapy and Personalized Physical Activity Program in people with Prolotherapy, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
The aim of this clinical trial is to assess whether prolotherapy combined with personal physical activity is effective in managing pain (measured using the VAS and WOMAC scales) and improving the quality of life in participants with Grade 2 Knee Osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Prolotherapy
- What is being tested?
- Prolotherapy Only, Prolotherapy and Personalized Physical Activity Program
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Jul 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years with primary knee osteoarthritis (OA) diagnosed by ultrasonography who provided written informed consent.
- Participants were required to be cooperative and capable of complying with the study protocol
Who cannot join
- A history of traumatic knee arthritis
- Knee OA associated with trauma, fracture, ankylosing spondylitis, or septic arthritis
- Major comorbidities significantly impairing quality of life (e.g., cancer, heart failure, renal failure, stroke)
- Use of NSAIDs or systemic steroids within 1 week
- Intra-articular corticosteroid injection within 2 months; or current use of injectable or hormonal contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effect of Prolotherapy and Personalized Physical Activity on Knee Osteoarthritis Progression, Impact on IL-1β, MMP-3 Biomarkers and Clinical Outcomes
The aim of this clinical trial is to assess whether prolotherapy combined with personal physical activity is effective in managing pain (measured using the VAS and WOMAC scales) and improving the quality of life in participants with Grade 2 Knee Osteoarthritis (OA).
This trial will also measure the levels of IL-1β and MMP-3 in the participants. The primary research questions are:
Read more
- Does prolotherapy combined with personal physical activity reduce pain levels and improve clinical outcomes in participants with knee OA compared to those receiving prolotherapy ?
- How does this intervention affect the levels of IL-1β and MMP-3 in participants?
Researchers will compare prolotherapy combined with personal physical activity to prolotherapy alone to determine its impact on clinical outcomes and changes in biomarkers in patients with knee OA.
Read the detailed description
The objective of this clinical trial is to evaluate the levels of IL-1β and MMP-3, clinical outcomes related to pain (measured using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)), as well as the quality of life in participants with knee osteoarthritis (OA) who are treated with pain management through prolotherapy combined with personalized physical activity. This trial aims to develop a complementary therapy or an alternative treatment option that is cost-effective, accessible, and potentially more affordable for the broader population.
Study Design/Methods:
This study will utilize a Randomized Controlled Trial (RCT) design with pre- and post-test assessments.
Group/Arm :
- Experimental Group (Prolotherapy and Personalized Physical Activity Program)
- Active Comparator/Control (Prolotherapy only)
Intervention :
- Experimental Group: using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine and physical therapy starting 2 days post-injection with guidance of trained professionals and exercise educational videos (10 repetitions per session, 3 sessions per day, 3 days per week)
- Active Comparator Group: using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine
Measurement :
- The primary outcome will be a clinical assessment measured using theWOMAC questionnaire and VAS
- The secondary outcome will be biomarker data of IL-1 Beta and MMP-3 measured with ELISA using kits from ABclonal, IL-1Beta (Cat. No. RK00001, Lot No. 9680034260724) and MMP-3 (Cat. No. RK00308, Lot No. 9680000230724).
Data Analysis Plan:
The data will be analyzed using the Kappa Test, Univariate Analysis, and Bivariate Analysis (Independent T-Test, Paired T-Test, Wilcoxon Test, Chi-Square, Spearman and Pearson Correlation Tests, and ANCOVA).
Anticipated Outcomes:
- Low risk of allergies
- Reduction in pain levels in participants
- Improvement in functional outcomes of participants
Risk and Benefit:
Risks:
- Possible side effects or complications, such as allergic reactions or infections, may occur during the study.
Benefits:
- This study seeks to identify a new and effective alternative therapy and complementary treatment that is more affordable and widely accessible. It is expected to provide significant pain relief, functional improvements, and enhanced quality of life for patients suffering from knee osteoarthritis
- Conditions
- Prolotherapy
- Being tested
- Prolotherapy Only, Prolotherapy, Personalized Physical Activity Program
- Keywords
- Knee Osteoarthritides, Prolotherapy, physical activity, interleukin-1beta, matrix Metalloproteinase 3
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolotherapy OnlyProcedure or surgery
This arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine
ProlotherapyCombination product
This arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine
Personalized Physical Activity ProgramOther
A physical therapy program starting 2 day post-injection with guidance of trained professionals and exercise educational videos supplementation (10 repetitions per session, 3 sessions per day, 3 days per week)
| Study group | Role | What they receive |
|---|---|---|
| Prolotherapy + Personalized Physical Activity Program | Experimental | This arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine and physical therapy starting 2 day post-injection with guidance of trained professionals and exercise educational videos supplementation (10 repetitions per session, 3 sessions per day, 3 days per week) Receives: Combination Product: Prolotherapy; Other: Personalized Physical Activity Program |
| Prolotherapy Only | Active comparator | This arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine Receives: Procedure: Prolotherapy Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Functional Capacity
The primary outcome measure for this study is pain dan functional capacity using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC Questionnaire consist of 3 subscales (pain, stiffness, and physical function). Pain subscale can be scored between 0-20 points, stiffness subscale can be scored between 0-8 points, and physical function subscales can be scored between 0-68 points. Those points can be interpreted better if its low and worser if it high in total (0-24 points for mild, 25-48 points for moderate, and 49-72 points for severe)
Measured: 6 week
Secondary outcomes (3)
Concentration of IL-1 Beta and MMP-3
Biomarker such IL-1 Beta and MMP-3 were measured by ELISA using kits from ABclonal (Cat. No. RK00001, Lot No. 9680034260724 for IL-1 Beta) and (Cat. No. RK00001, Lot No. 9680034260724 for MMP-3)
Measured: 6 week
Pain with Visual Analog Scale
VAS Questionnaire points will be between 0 (no pain) and 100 (severe intolerable pain)
Measured: 6 weeks
Quality of Life with EQ-5D-5L
EQ-5D-5L Indonesian value set will have 5 segments (mobility, looking after myself, doing usual activities, pain and discomfort, feeling worried, sad, or unhappy), each segments will have 0-5 points The points can be interpret as if the higher the points, the better quality of life will be
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start10 Jul 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlotherapyStudies 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
- Single group
- Model description
- All participants receive the same intervention (prolotherapy combined with physical activity or prolotherapy alone) within the study
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Medicine, Gadjah Mada University, Universitas Islam Indonesia
- Responsible party
- Principal investigator, muhammad yusuf hisam, Gadjah Mada University
- Investigators
- muhammad yusuf hisam MYH Hisam, MD, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355712
- Sponsor's protocol ID
- KE/FK/1000/EC/2024
- Other IDs
- s3 fkkmk ugm
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Prolotherapy and Personalized Physical Activity on Knee Osteoarthritis Progression, Impact on IL-1β, MMP-3 Biomarkers and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07355712
- Acronym / sponsor ID
- KE/FK/1000/EC/2024
- Conditions
- Prolotherapy
- Keywords
- Knee Osteoarthritides, Prolotherapy, physical activity, interleukin-1beta, matrix Metalloproteinase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- Faculty of Medicine, Gadjah Mada University, Universitas Islam Indonesia
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 21 Jan 2026 (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 aim of this clinical trial is to assess whether prolotherapy combined with personal physical activity is effective in managing pain (measured using the VAS and WOMAC scales) and improving the quality of life in participants with Grade 2 Knee Osteoarthritis (OA).
This trial will also measure the levels of IL-1β and MMP-3 in the participants. The primary research questions are:
- Does prolotherapy combined with personal physical activity reduce pain levels and improve clinical outcomes in participants with knee OA compared to those receiving prolotherapy ?
- How does this intervention affect the levels of IL-1β and MMP-3 in participants?
Researchers will compare prolotherapy combined with personal physical activity to prolotherapy alone to determine its impact on clinical outcomes and changes in biomarkers in patients with knee OA.
Detailed description
The objective of this clinical trial is to evaluate the levels of IL-1β and MMP-3, clinical outcomes related to pain (measured using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)), as well as the quality of life in participants with knee osteoarthritis (OA) who are treated with pain management through prolotherapy combined with personalized physical activity. This trial aims to develop a complementary therapy or an alternative treatment option that is cost-effective, accessible, and potentially more affordable for the broader population.
Study Design/Methods:
This study will utilize a Randomized Controlled Trial (RCT) design with pre- and post-test assessments.
Group/Arm :
- Experimental Group (Prolotherapy and Personalized Physical Activity Program)
- Active Comparator/Control (Prolotherapy only)
Intervention :
- Experimental Group: using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine and physical therapy starting 2 days post-injection with guidance of trained professionals and exercise educational videos (10 repetitions per session, 3 sessions per day, 3 days per week)
- Active Comparator Group: using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine
Measurement :
- The primary outcome will be a clinical assessment measured using theWOMAC questionnaire and VAS
- The secondary outcome will be biomarker data of IL-1 Beta and MMP-3 measured with ELISA using kits from ABclonal, IL-1Beta (Cat. No. RK00001, Lot No. 9680034260724) and MMP-3 (Cat. No. RK00308, Lot No. 9680000230724).
Data Analysis Plan:
The data will be analyzed using the Kappa Test, Univariate Analysis, and Bivariate Analysis (Independent T-Test, Paired T-Test, Wilcoxon Test, Chi-Square, Spearman and Pearson Correlation Tests, and ANCOVA).
Anticipated Outcomes:
- Low risk of allergies
- Reduction in pain levels in participants
- Improvement in functional outcomes of participants
Risk and Benefit:
Risks:
- Possible side effects or complications, such as allergic reactions or infections, may occur during the study.
Benefits:
- This study seeks to identify a new and effective alternative therapy and complementary treatment that is more affordable and widely accessible. It is expected to provide significant pain relief, functional improvements, and enhanced quality of life for patients suffering from knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants receive the same intervention (prolotherapy combined with physical activity or prolotherapy alone) within the study
| Arm | Type | Receives |
|---|---|---|
| Prolotherapy + Personalized Physical Activity Program | Experimental | Combination Product: Prolotherapy, Other: Personalized Physical Activity ProgramThis arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine and physical therapy starting 2 day post-injection with guidance of trained professionals and exercise educational videos supplementation (10 repetitions per session, 3 sessions per day, 3 days per week) |
| Prolotherapy Only | Active comparator | Procedure: Prolotherapy OnlyThis arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years with primary knee osteoarthritis (OA) diagnosed by ultrasonography who provided written informed consent.
- Participants were required to be cooperative and capable of complying with the study protocol
Key exclusion criteria (5 listed)
- A history of traumatic knee arthritis
- Knee OA associated with trauma, fracture, ankylosing spondylitis, or septic arthritis
- Major comorbidities significantly impairing quality of life (e.g., cancer, heart failure, renal failure, stroke)
- Use of NSAIDs or systemic steroids within 1 week
- Intra-articular corticosteroid injection within 2 months; or current use of injectable or hormonal contraception.
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 |
|---|---|---|
| Prolotherapy OnlyThis arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine | Procedure or surgery | Prolotherapy Only |
| ProlotherapyThis arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine | Combination product | Prolotherapy + Personalized Physical Activity Program |
| Personalized Physical Activity ProgramA physical therapy program starting 2 day post-injection with guidance of trained professionals and exercise educational videos supplementation (10 repetitions per session, 3 sessions per day, 3 days per week) | Other | Prolotherapy + Personalized Physical Activity Program |
Primary outcome
Pain and Functional Capacity
Time frame: 6 week
The primary outcome measure for this study is pain dan functional capacity using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) WOMAC Questionnaire consist of 3 subscales (pain, stiffness, and physical function). Pain subscale can be scored between 0-20 points, stiffness subscale can be scored between 0-8 points, and physical function subscales can be scored between 0-68 points. Those points can be interpreted better if its low and worser if it high in total (0-24 points for mild, 25-48 points for moderate, and 49-72 points for severe)
3 secondary outcomes
Concentration of IL-1 Beta and MMP-3
Time frame: 6 week
Pain with Visual Analog Scale
Time frame: 6 weeks
Quality of Life with EQ-5D-5L
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Regenerative Medicine for Joint Hypermobility and Instability
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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. This study is not recruiting at the moment.
muhammad yusuf hisam MYH Hisam, MD principal investigator
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolotherapy Only, Prolotherapy and Personalized Physical Activity Program in people with Prolotherapy, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 21 Jan 2026. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Functional Capacity (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.