Knee OsteoarthritisNCT05966948
HDP vs NS Intra-articular Injection Among KOA With Obese Patient
A study testing Dextrose Solution and Normal Saline in people with Knee Osteoarthritis and Obesity, run by Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia at 1 site in Indonesia.
Trial summary
The aim of this randomized controlled trial study was to compare the effect of intra-articular injection of Hypertonic Dextrose Prolotherapy (HDP) with Normal Saline (NS) in the clinical improvement of knee osteoarthritis (KOA) patients with comorbid obesity. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Knee Osteoarthritis, Obesity
- What is being tested?
- Dextrose Solution and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2023to 1 Oct 2023
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient was diagnosed with knee osteoarthritis (KOA).
- Patient was diagnosed with obesity.
Who cannot join
- Patient with a history of knee trauma.
- Patient with a history of knee surgery.
- Patient with a history of intra-articular injection before.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia
Surabaya, East Java
About this study
Official title: Hypertonic Dextrose Prolotherapy Versus Normal Saline Intra-articular Injection Among Knee Osteoarthritis With Obese Patient
The aim of this randomized controlled trial study was to compare the effect of intra-articular injection of Hypertonic Dextrose Prolotherapy (HDP) with Normal Saline (NS) in the clinical improvement of knee osteoarthritis (KOA) patients with comorbid obesity. The main questions to be answered are:
- How does the effect of HDP versus NS intra-articular injection compare to the numerical rating score (NRS) in obese KOA patients?
- How does the effect of HDP versus NS intra-articular injection compare to scores of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) in obese KOA patients?
- How does the effect of HDP versus NS intra-articular injection compare to the thickness of the femoral cartilage in obese KOA patients?
Read more
Participants who meet the inclusion and exclusion criteria will be randomized based on the order of the outpatient department each day, with odd numbers as the HDP intervention group and even numbers as NS. They received ultrasound-guided intra-articular injections on day 1 and day 30.
Researchers will compare HDP versus NS groups to see which group improves NRS, WOMAC, and femoral cartilage thickness.
Read the detailed description
This is a randomized controlled study, which recruited KOA patients with obese comorbidity who were treated at the Outpatient Department of Physical Medicine and Rehabilitation at Rumah Sakit Daerah Haji Provinsi Jawa Timur, Surabaya, Indonesia from May to August 2023. The participants were divided into two groups, including HDP versus NS injections.
Each study participant's identity including age, gender, weight, height, and BMI was recorded. Then an evaluation of the NRS, WOMAC score, and femoral cartilage thickness was carried out using ultrasound.
This study assessed using the NRS scale for pain reduction on a scale of 0 to 10 (0 means no pain, while 10 means very pain). The WOMAC Score consists of 24 questions with four scales, namely 0: none, 1: mild, 2: moderate, 3: severe, and 4: very severe. Femoral cartilage thickness scan using ultrasound with millimeter units.
- Conditions
- Knee Osteoarthritis, Obesity
- Being tested
- Dextrose Solution, Normal Saline
- Keywords
- knee osteoarthritis, obesity
- Medical subject headings
- Osteoarthritis, Knee, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose SolutionDrug
Also called Dextrose Injection
Prolotherapy is a regenerative tissue therapy that is considered efficacious for reducing the symptoms and morbidity of Knee Osteoarthritis (KOA) using hypertonic dextrose as an injectable substance. Treatment will be given two times, on day 1st and 30th day.
Normal SalineDrug
Also called Normal Saline Injection
Normal Saline will be intra-articular injected and given two times, on day 1st and 30th day.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Dextrose Prolotherapy | Experimental | This group received a Hypertonic dextrose intra articular is 25%, while extra articular 20% injection on day 1 and day 30 with same dose. Receives: Drug: Dextrose Solution |
| Normal Saline | Placebo comparator | This group received Normal Saline injection on day 1 and day 30. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. We classified from 0 to 10, where 0 is no pain and 10 is the worst pain.
Measured: Before intervention, day 1, and day 30 after intervention
Secondary outcomes (2)
WOMAC Score
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 sub-scales:
(1) Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright; (2) Stiffness (2 items): after first waking and later in the day; (3) Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
Measured: Before intervention, day 1, and day 30 after intervention
Femoral Cartilage Thickness
The ultrasound measurement of femoral cartilage thickness is divided into three sites: medial condyle, intercondylar, and lateral condyle on the right and left sides. This measurement is in millimeters units.
Measured: Before intervention, day 1, and day 30 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 May 2023
- Primary completion30 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Model description
- This study involves two arms assigned randomly for receiving different treatment. One arm for Hypertonic Dextrose Prolotherapy as intervention group and Normal Saline as control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Vivera Pane, MD, PhD, Study chair, Universitas Nahdlatul Ulama Surabaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966948
- Sponsor's protocol ID
- RSUHajiJaTimProv
- Status last verified
- Oct 2023
- First submitted
- 11 Jul 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cortez VS, Moraes WA, Taba JV, Condi A, Suzuki MO, Nascimento FSD, Pipek LZ, Mattos VC, Torsani MB, Meyer A, Hsing WT, Iuamoto LR. Comparing dextrose prolotherapy with other substances in knee osteoarthritis pain relief: A systematic review. Clinics (Sao Paulo). 2022 May 17;77:100037. doi: 10.1016/j.clinsp.2022.100037. eCollection 2022.
PubMed 35594623Topol GA, Pestalardo IG, Reeves KD, Elias F, Steinmetz NJ, Cheng AL, Rabago D. Dextrose Prolotherapy for Symptomatic Grade IV Knee Osteoarthritis: A Pilot Study of Early and Longer-Term Analgesia and Pain-Specific Cytokine Concentrations. Clin Pract. 2022 Nov 14;12(6):926-938. doi: 10.3390/clinpract12060097.
PubMed 36412676Yu T, Yan S, Chi Z, Zhu D, Cheng P, Li H, Qin S, Zhong G, Ouyang X, Chen R, Jiao L. Comparative efficacy and safety of injection therapies for knee osteoarthritis: A protocol for systematic review and Bayesian network meta analysis. Medicine (Baltimore). 2020 Nov 20;99(47):e22943. doi: 10.1097/MD.0000000000022943.
PubMed 33217798Sit RWS, Wu RWK, Rabago D, Reeves KD, Chan DCC, Yip BHK, Chung VCH, Wong SYS. Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial. Ann Fam Med. 2020 May;18(3):235-242. doi: 10.1370/afm.2520.
PubMed 32393559Pane RV, Setiyaningsih R, Widodo G, Al Hajiri AZZ, Salsabil JR. Femoral Cartilage Thickness in Knee Osteoarthritis Patients and Healthy Adults: An Ultrasound Measurement Comparison. ScientificWorldJournal. 2023 Feb 17;2023:3942802. doi: 10.1155/2023/3942802. eCollection 2023.
PubMed 36845755Akcay S, Gurel Kandemir N, Kaya T, Dogan N, Eren M. Dextrose Prolotherapy Versus Normal Saline Injection for the Treatment of Lateral Epicondylopathy: A Randomized Controlled Trial. J Altern Complement Med. 2020 Dec;26(12):1159-1168. doi: 10.1089/acm.2020.0286. Epub 2020 Sep 28.
PubMed 32990454Sit RWS, Wu RWK, Reeves KD, Rabago D, Chan DCC, Yip BHK, Chung VCH, Wong SYS. Efficacy of intra-articular hypertonic dextrose prolotherapy versus normal saline for knee osteoarthritis: a protocol for a triple-blinded randomized controlled trial. BMC Complement Altern Med. 2018 May 15;18(1):157. doi: 10.1186/s12906-018-2226-5.
PubMed 29764447Wee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug.
PubMed 34046305Chen YW, Lin YN, Chen HC, Liou TH, Liao CD, Huang SW. Effectiveness, Compliance, and Safety of Dextrose Prolotherapy for Knee Osteoarthritis: A Meta-Analysis and Metaregression of Randomized Controlled Trials. Clin Rehabil. 2022 Jun;36(6):740-752. doi: 10.1177/02692155221086213. Epub 2022 Mar 8.
PubMed 35257594Arias-Vazquez PI, Tovilla-Zarate CA, Legorreta-Ramirez BG, Burad Fonz W, Magana-Ricardez D, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML. Prolotherapy for knee osteoarthritis using hypertonic dextrose vs other interventional treatments: systematic review of clinical trials. Adv Rheumatol. 2019 Aug 19;59(1):39. doi: 10.1186/s42358-019-0083-7.
PubMed 31426856
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Dextrose Prolotherapy Versus Normal Saline Intra-articular Injection Among Knee Osteoarthritis With Obese Patient
- ClinicalTrials.gov ID
- NCT05966948
- Acronym / sponsor ID
- RSUHajiJaTimProv
- Conditions
- Knee Osteoarthritis, Obesity
- Keywords
- knee osteoarthritis, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, IndonesiaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 1 Aug 2023 (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 randomized controlled trial study was to compare the effect of intra-articular injection of Hypertonic Dextrose Prolotherapy (HDP) with Normal Saline (NS) in the clinical improvement of knee osteoarthritis (KOA) patients with comorbid obesity. The main questions to be answered are:
- How does the effect of HDP versus NS intra-articular injection compare to the numerical rating score (NRS) in obese KOA patients?
- How does the effect of HDP versus NS intra-articular injection compare to scores of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) in obese KOA patients?
- How does the effect of HDP versus NS intra-articular injection compare to the thickness of the femoral cartilage in obese KOA patients?
Participants who meet the inclusion and exclusion criteria will be randomized based on the order of the outpatient department each day, with odd numbers as the HDP intervention group and even numbers as NS. They received ultrasound-guided intra-articular injections on day 1 and day 30.
Researchers will compare HDP versus NS groups to see which group improves NRS, WOMAC, and femoral cartilage thickness.
Detailed description
This is a randomized controlled study, which recruited KOA patients with obese comorbidity who were treated at the Outpatient Department of Physical Medicine and Rehabilitation at Rumah Sakit Daerah Haji Provinsi Jawa Timur, Surabaya, Indonesia from May to August 2023. The participants were divided into two groups, including HDP versus NS injections.
Each study participant's identity including age, gender, weight, height, and BMI was recorded. Then an evaluation of the NRS, WOMAC score, and femoral cartilage thickness was carried out using ultrasound.
This study assessed using the NRS scale for pain reduction on a scale of 0 to 10 (0 means no pain, while 10 means very pain). The WOMAC Score consists of 24 questions with four scales, namely 0: none, 1: mild, 2: moderate, 3: severe, and 4: very severe. Femoral cartilage thickness scan using ultrasound with millimeter units.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study involves two arms assigned randomly for receiving different treatment. One arm for Hypertonic Dextrose Prolotherapy as intervention group and Normal Saline as control group.
| Arm | Type | Receives |
|---|---|---|
| Hypertonic Dextrose Prolotherapy | Experimental | Drug: Dextrose SolutionThis group received a Hypertonic dextrose intra articular is 25%, while extra articular 20% injection on day 1 and day 30 with same dose. |
| Normal Saline | Placebo comparator | Drug: Normal SalineThis group received Normal Saline injection on day 1 and day 30. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient was diagnosed with knee osteoarthritis (KOA).
- Patient was diagnosed with obesity.
Key exclusion criteria (3 listed)
- Patient with a history of knee trauma.
- Patient with a history of knee surgery.
- Patient with a history of intra-articular injection before.
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 |
|---|---|---|
| Dextrose SolutionAlso: Dextrose InjectionProlotherapy is a regenerative tissue therapy that is considered efficacious for reducing the symptoms and morbidity of Knee Osteoarthritis (KOA) using hypertonic dextrose as an injectable substance. Treatment will be given two times, on day 1st and 30th day. | Drug | Hypertonic Dextrose Prolotherapy |
| Normal SalineAlso: Normal Saline InjectionNormal Saline will be intra-articular injected and given two times, on day 1st and 30th day. | Drug | Normal Saline |
Primary outcome
Numeric Rating Scale
Time frame: Before intervention, day 1, and day 30 after intervention
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. We classified from 0 to 10, where 0 is no pain and 10 is the worst pain.
2 secondary outcomes
WOMAC Score
Time frame: Before intervention, day 1, and day 30 after intervention
Femoral Cartilage Thickness
Time frame: Before intervention, day 1, and day 30 after intervention
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 18 Oct 2023.
- Background: PubMed 35594623Cortez VS, Moraes WA, Taba JV, Condi A, Suzuki MO, Nascimento FSD, Pipek LZ, Mattos VC, Torsani MB, Meyer A, Hsing WT, Iuamoto LR. Comparing dextrose prolotherapy with other substances in knee osteoarthritis pain relief: A systematic review. Clinics (Sao Paulo). 2022 May 17;77:100037. doi: 10.1016/j.clinsp.2022.100037. eCollection 2022.
- Background: PubMed 36412676Topol GA, Pestalardo IG, Reeves KD, Elias F, Steinmetz NJ, Cheng AL, Rabago D. Dextrose Prolotherapy for Symptomatic Grade IV Knee Osteoarthritis: A Pilot Study of Early and Longer-Term Analgesia and Pain-Specific Cytokine Concentrations. Clin Pract. 2022 Nov 14;12(6):926-938. doi: 10.3390/clinpract12060097.
- Background: PubMed 33217798Yu T, Yan S, Chi Z, Zhu D, Cheng P, Li H, Qin S, Zhong G, Ouyang X, Chen R, Jiao L. Comparative efficacy and safety of injection therapies for knee osteoarthritis: A protocol for systematic review and Bayesian network meta analysis. Medicine (Baltimore). 2020 Nov 20;99(47):e22943. doi: 10.1097/MD.0000000000022943.
- Background: PubMed 32393559Sit RWS, Wu RWK, Rabago D, Reeves KD, Chan DCC, Yip BHK, Chung VCH, Wong SYS. Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial. Ann Fam Med. 2020 May;18(3):235-242. doi: 10.1370/afm.2520.
- Background: PubMed 36845755Pane RV, Setiyaningsih R, Widodo G, Al Hajiri AZZ, Salsabil JR. Femoral Cartilage Thickness in Knee Osteoarthritis Patients and Healthy Adults: An Ultrasound Measurement Comparison. ScientificWorldJournal. 2023 Feb 17;2023:3942802. doi: 10.1155/2023/3942802. eCollection 2023.
- Background: PubMed 32990454Akcay S, Gurel Kandemir N, Kaya T, Dogan N, Eren M. Dextrose Prolotherapy Versus Normal Saline Injection for the Treatment of Lateral Epicondylopathy: A Randomized Controlled Trial. J Altern Complement Med. 2020 Dec;26(12):1159-1168. doi: 10.1089/acm.2020.0286. Epub 2020 Sep 28.
- Background: PubMed 29764447Sit RWS, Wu RWK, Reeves KD, Rabago D, Chan DCC, Yip BHK, Chung VCH, Wong SYS. Efficacy of intra-articular hypertonic dextrose prolotherapy versus normal saline for knee osteoarthritis: a protocol for a triple-blinded randomized controlled trial. BMC Complement Altern Med. 2018 May 15;18(1):157. doi: 10.1186/s12906-018-2226-5.
- Background: PubMed 34046305Wee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug.
- Background: PubMed 35257594Chen YW, Lin YN, Chen HC, Liou TH, Liao CD, Huang SW. Effectiveness, Compliance, and Safety of Dextrose Prolotherapy for Knee Osteoarthritis: A Meta-Analysis and Metaregression of Randomized Controlled Trials. Clin Rehabil. 2022 Jun;36(6):740-752. doi: 10.1177/02692155221086213. Epub 2022 Mar 8.
- Background: PubMed 31426856Arias-Vazquez PI, Tovilla-Zarate CA, Legorreta-Ramirez BG, Burad Fonz W, Magana-Ricardez D, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML. Prolotherapy for knee osteoarthritis using hypertonic dextrose vs other interventional treatments: systematic review of clinical trials. Adv Rheumatol. 2019 Aug 19;59(1):39. doi: 10.1186/s42358-019-0083-7.
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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.
Rita Vivera Pane, MD, PhD study chair
Universitas Nahdlatul Ulama Surabaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose Solution and Normal Saline in people with Knee Osteoarthritis and Obesity, run by Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia 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 3 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 18 Oct 2023. 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. Some participants in this study may receive a placebo. 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?
Numeric Rating Scale (time frame: Before intervention, day 1, and day 30 after intervention). 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 NCT05966948, which also lists 10 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 18 Oct 2023.