Knee OsteoarthritisNCT04178304
Effect of Prolotherapy in Knee Osteoarthritis.
A study testing Prolotherapy with 25% Dextrose in people with Knee Osteoarthritis, run by University of Alexandria at 1 site in Egypt.
Trial summary
Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: intra-articular injection and extra-articular injections of 25% dextrose. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Prolotherapy with 25% Dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2019to 30 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III)
- consent obtained
Who cannot join
- Early Knee osteoarthritis (KL grade I)
- Severe Knee osteoarthritis (KL grade IV)
- Causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases.
- received oral or systemic steroids 1 year prior to the procedure
- received intra-articular steroids or hyaluronic acid 1 year prior to the procedure
- BMI >45Kg/m2
- poorly controlled diabetes mellitus, on anticoagulation therapy, history of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prolotherapy in Knee Osteoarthritis: Clinical and Ultrasonographic Study.
Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: intra-articular injection and extra-articular injections of 25% dextrose. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .
Aim: Determine whether prolotherapy improves pain. stiffness and function of symptomatic knee osteoarthritis and determine ultrasonographic changes before and after prolotherapy.
Read the detailed description
Sixty knees with primary knee osteoarthritis will be included in the study, clinical assessment will be done, then plain X-ray for the affected knee (s), followed by musculoskeletal ultrasound assessment will be done.
The intervention:
- a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done.
- extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose.
- Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals.
Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .
- Conditions
- Knee Osteoarthritis
- Being tested
- Prolotherapy with 25% Dextrose
- Keywords
- primary knee osteoarthritis,, prolotherapy,, musculoskeletal ultrasound
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolotherapy with 25% DextroseDrug
Also called 25% dextrose intra and extra-articilar injection
Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose
| Study group | Role | What they receive |
|---|---|---|
| G1 patients receive prolotherapy | Experimental | Intra and extra articular dextrose 25% Receives: Drug: Prolotherapy with 25% Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Stiffness and Physical function
whether prolotherapy improves physical function by Western Ontario and McMaster University (WOMAC) index and VAS in patients with primary knee osteoarthritis
Measured: 24 weeks after last injection
Secondary outcomes (2)
Cartilage thickness
whether an increase in cartilage thickness could be detected by the musculoskeletal ultrasound following prolotherapy
Measured: 24 weeks after last injection
Safety and Tolerability
safety and tolerability will be assessed using patient satisfaction Likeret 5 point scale
Measured: 24 weeks after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start15 Dec 2019
- Primary completion30 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Sixty knees with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: 1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done. 2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose. Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. Follow up will be done at 24 weeks after the last injection both clinically and ultrasounographicly.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Hisham Abdel Fattah, University of Alexandria
- Investigators
- Yousra H Abdel-Fattah, MD, Principal investigator, Alexandria University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178304
- Sponsor's protocol ID
- 0201167
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2019
- Last updated
- 5 Apr 2023
- Results posted
- No
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolotherapy in Knee Osteoarthritis: Clinical and Ultrasonographic Study.
- ClinicalTrials.gov ID
- NCT04178304
- Acronym / sponsor ID
- 0201167
- Conditions
- Knee Osteoarthritis
- Keywords
- primary knee osteoarthritis,, prolotherapy,, musculoskeletal ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 26 Nov 2019 (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.
Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: intra-articular injection and extra-articular injections of 25% dextrose. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .
Aim: Determine whether prolotherapy improves pain. stiffness and function of symptomatic knee osteoarthritis and determine ultrasonographic changes before and after prolotherapy.
Detailed description
Sixty knees with primary knee osteoarthritis will be included in the study, clinical assessment will be done, then plain X-ray for the affected knee (s), followed by musculoskeletal ultrasound assessment will be done.
The intervention:
- a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done.
- extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose.
- Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals.
Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sixty knees with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: 1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done. 2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose. Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. Follow up will be done at 24 weeks after the last injection both clinically and ultrasounographicly.
| Arm | Type | Receives |
|---|---|---|
| G1 patients receive prolotherapy | Experimental | Drug: Prolotherapy with 25% DextroseIntra and extra articular dextrose 25% |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III)
- consent obtained
Key exclusion criteria (7 listed)
- Early Knee osteoarthritis (KL grade I)
- Severe Knee osteoarthritis (KL grade IV)
- Causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases.
- received oral or systemic steroids 1 year prior to the procedure
- received intra-articular steroids or hyaluronic acid 1 year prior to the procedure
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 with 25% DextroseAlso: 25% dextrose intra and extra-articilar injectionIntra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose | Drug | G1 patients receive prolotherapy |
Primary outcome
Pain, Stiffness and Physical function
Time frame: 24 weeks after last injection
whether prolotherapy improves physical function by Western Ontario and McMaster University (WOMAC) index and VAS in patients with primary knee osteoarthritis
2 secondary outcomes
Cartilage thickness
Time frame: 24 weeks after last injection
Safety and Tolerability
Time frame: 24 weeks after last injection
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 5 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Yousra H Abdel-Fattah, MD principal investigator
Alexandria University Faculty of Medicine
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 with 25% Dextrose in people with Knee Osteoarthritis, run by University of Alexandria at 1 site in Egypt.
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 7 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 5 Apr 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 Egypt. 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, Stiffness and Physical function (time frame: 24 weeks after last injection). 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 5 Apr 2023.