Knee OsteoarthritisNCT05537077
Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis
A study testing Prolotherapy, Home based exercise program and Hotpack therapy in people with Knee Osteoarthritis, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to compare the efficacy of %5, %10 and %20 concentration dextrose prolotherapy (DPT) treatments in patients with primary knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Prolotherapy, Home based exercise program and Hotpack therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Mar 2021
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40-70 years,
- Knee pain for more than three months,
- Diagnosed with primary knee OA according to ACR clinical/radiological diagnostic criteria and Kellgren-Lawrence stage II-III.
Who cannot join
- Total knee replacement
- Rheumatological diseases, systemic infection, and malignancy
- Pregnancy or breastfeeding
- Taking a nonsteroidal anti-inflammatory drug (NSAID) in the last week, taking steroid drugs in the last month
- Undergoing anticoagulant or immunosuppressive therapy
- Knee injection in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Medicine
Erzurum, 25240
About this study
Official title: Comparison of Effectiveness of Dextrose Prolotherapy Treatment With Different Concentrations in Patients With Knee Osteoarthritis
In this study, the investigators aimed to compare the efficacy of %5, %10 and %20 concentration dextrose prolotherapy (DPT) treatments in patients with primary knee osteoarthritis (OA). In this prospective, randomized, controlled, single-blind study, 128 patients who met the inclusion criteria were recruited and divided into four groups. Thirty patients from each group completed the study. %5 DPT was applied to Group 1, %10 to Group 2, and %20 to Group 3 in combination with home exercise program and hotpack therapy. Group 4 was given home exercise program and hotpack therapy. Groups were evaluated with VAS (Visual Analog Scale), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), knee ROM (Range of Motion), and Timed up and go test (TUG) parameters. DPT groups were evaluated in terms of side effects.
- Conditions
- Knee Osteoarthritis
- Being tested
- Prolotherapy, Home based exercise program, Hotpack therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyOther
DPT was applied as a total of 3 sessions at 0, 3 and 6 weeks. In each session, intra-articular 5 ml and periarticular 10 ml dextrose injections were administered to the knee. Periarticular injection was applied to 10 points as 1 ml in each region. The regions were determined as medial and lateral coronary ligaments, proximal and distal medial and lateral collateral ligaments, pes anserinus region, proximal and distal patellar tendon, quadriceps tendon attachment area.
Home based exercise programOther
Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.
Hotpack therapyOther
Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | %5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1. Receives: Other: Prolotherapy; Other: Home based exercise program; Other: Hotpack therapy |
| Group 2 | Active comparator | %10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2. Receives: Other: Prolotherapy; Other: Home based exercise program; Other: Hotpack therapy |
| Group 3 | Active comparator | %20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3. Receives: Other: Prolotherapy; Other: Home based exercise program; Other: Hotpack therapy |
| Group 4 | Active comparator | Hotpack therapy and home based exercise program was applied to group 4. Receives: Other: Home based exercise program; Other: Hotpack therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS)
VAS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result.
Measured: Pre-intervention, sixth week, twelfth week.
Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
WOMAC; It consists of three subcategories: pain, stiffness, and physical function difficulty. A score of 20 for pain, 8 for stiffness, 68 for physical function difficulty, and a total of 96 points can be obtained. An increase in the score is interpreted as more pain, stiffness and loss of function.
Measured: Pre-intervention, sixth week, twelfth week.
Change in Knee Joint Range of Motion
Knee flexion in the prone position and knee extension in the supine position were measured actively and passively with a goniometer.
Measured: Pre-intervention, sixth week, twelfth week.
Change in The Timed "Up & Go" Test
In this test, balance, walking speed and functional capacity are evaluated. Patients who complete the test in less than 10 seconds are considered independent.
Measured: Pre-intervention, sixth week, twelfth week.
Secondary outcomes (1)
Change in Short Form 36 (SF-36)
SF-36 used for determining quality of life. It consists of eight sub-parameters such as physical functioning, role physical, mental health, role emotional, bodily pain, social functioning, vitality and general health and a total of 36 questions. Each parameter is scored between 0 and 100. Higher scores mean a better outcome.
Measured: Pre-intervention, twelfth week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish League Against Rheumatism
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Uğur ÖZTÜRK, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537077
- Sponsor's protocol ID
- TRASD-MUO-TEZ
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wee 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 34046305Sert AT, Sen EI, Esmaeilzadeh S, Ozcan E. The Effects of Dextrose Prolotherapy in Symptomatic Knee Osteoarthritis: A Randomized Controlled Study. J Altern Complement Med. 2020 May;26(5):409-417. doi: 10.1089/acm.2019.0335. Epub 2020 Mar 30.
PubMed 32223554Ozturk 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Dextrose Prolotherapy Treatment With Different Concentrations in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05537077
- Acronym / sponsor ID
- TRASD-MUO-TEZ
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Turkish League Against RheumatismUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Sep 2022 (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.
In this study, the investigators aimed to compare the efficacy of %5, %10 and %20 concentration dextrose prolotherapy (DPT) treatments in patients with primary knee osteoarthritis (OA). In this prospective, randomized, controlled, single-blind study, 128 patients who met the inclusion criteria were recruited and divided into four groups. Thirty patients from each group completed the study. %5 DPT was applied to Group 1, %10 to Group 2, and %20 to Group 3 in combination with home exercise program and hotpack therapy. Group 4 was given home exercise program and hotpack therapy. Groups were evaluated with VAS (Visual Analog Scale), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), knee ROM (Range of Motion), and Timed up and go test (TUG) parameters. DPT groups were evaluated in terms of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Prolotherapy, Other: Home based exercise program, Other: Hotpack therapy%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1. |
| Group 2 | Active comparator | Other: Prolotherapy, Other: Home based exercise program, Other: Hotpack therapy%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2. |
| Group 3 | Active comparator | Other: Prolotherapy, Other: Home based exercise program, Other: Hotpack therapy%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3. |
| Group 4 | Active comparator | Other: Home based exercise program, Other: Hotpack therapyHotpack therapy and home based exercise program was applied to group 4. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 40-70 years,
- Knee pain for more than three months,
- Diagnosed with primary knee OA according to ACR clinical/radiological diagnostic criteria and Kellgren-Lawrence stage II-III.
Key exclusion criteria (6 listed)
- Total knee replacement
- Rheumatological diseases, systemic infection, and malignancy
- Pregnancy or breastfeeding
- Taking a nonsteroidal anti-inflammatory drug (NSAID) in the last week, taking steroid drugs in the last month
- Undergoing anticoagulant or immunosuppressive therapy
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 |
|---|---|---|
| ProlotherapyDPT was applied as a total of 3 sessions at 0, 3 and 6 weeks. In each session, intra-articular 5 ml and periarticular 10 ml dextrose injections were administered to the knee. Periarticular injection was applied to 10 points as 1 ml in each region. The regions were determined as medial and lateral coronary ligaments, proximal and distal medial and lateral collateral ligaments, pes anserinus region, proximal and distal patellar tendon, quadriceps tendon attachment area. | Other | Group 1, Group 2, Group 3 |
| Home based exercise programKnee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks. | Other | Group 1, Group 2, Group 3, Group 4 |
| Hotpack therapyHotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Change in Visual Analog Scale (VAS)
Time frame: Pre-intervention, sixth week, twelfth week.
VAS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result.
Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
Time frame: Pre-intervention, sixth week, twelfth week.
WOMAC; It consists of three subcategories: pain, stiffness, and physical function difficulty. A score of 20 for pain, 8 for stiffness, 68 for physical function difficulty, and a total of 96 points can be obtained. An increase in the score is interpreted as more pain, stiffness and loss of function.
Change in Knee Joint Range of Motion
Time frame: Pre-intervention, sixth week, twelfth week.
Knee flexion in the prone position and knee extension in the supine position were measured actively and passively with a goniometer.
Change in The Timed "Up & Go" Test
Time frame: Pre-intervention, sixth week, twelfth week.
In this test, balance, walking speed and functional capacity are evaluated. Patients who complete the test in less than 10 seconds are considered independent.
1 secondary outcome
Change in Short Form 36 (SF-36)
Time frame: Pre-intervention, twelfth week.
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 13 Sep 2022.
- 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 32223554Sert AT, Sen EI, Esmaeilzadeh S, Ozcan E. The Effects of Dextrose Prolotherapy in Symptomatic Knee Osteoarthritis: A Randomized Controlled Study. J Altern Complement Med. 2020 May;26(5):409-417. doi: 10.1089/acm.2019.0335. Epub 2020 Mar 30.
- Derived from this study: 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: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Home based exercise program and Hotpack therapy in people with Knee Osteoarthritis, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 13 Sep 2022. 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 Turkey (Türkiye). 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?
Change in Visual Analog Scale (VAS) (time frame: Pre-intervention, sixth week, twelfth week.). The study lists 4 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 NCT05537077, which also lists 3 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 13 Sep 2022.