Medial Collateral Ligament LesionsNCT06620874
Comparison of the Efficacy of Ultrasound-Guided Injections of Saline, High-Concentration Dextrose, and Ligament Repair Agents for the Treatment of Medial Collateral Ligament Pathology in Degenerative Knee Osteoarthritis: A Randomized Double-Blind Trial.
A study testing STABHA Injection, High-Concentration Glucose Water Injection and Saline Injection in people with Medial Collateral Ligament Lesions and Knee Osteoarthritis, run by Chen Ting-an.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of STABHA, high-concentration glucose water, and saline injections in treating knee osteoarthritis with medial collateral ligament lesions. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Medial Collateral Ligament Lesions, Knee Osteoarthritis
- What is being tested?
- STABHA Injection, High-Concentration Glucose Water Injection and Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Sep 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- The patients should fulfill the following criteria:
- Age between 45 to 80 years old.
- Meet at least three of the six American College of Rheumatology (ACR) criteria, including age over 50 years, morning stiffness less than 30 minutes, crepitus in passive knee movements, bony tenderness, bony enlargement, and no palpable warmth.
- Radiologic grading of 2 or 3 according to Kellgren-Lawrence criteria.
- Evidence of medial collateral ligament (MCL) pathology with incomplete injuries (grade I or II).
- Willing to receive prolotherapy treatment.
- Willing and able to complete all follow-ups and assessments in the randomized double-blind trial.
Who cannot join
- The exclusion criteria are:
- Severe systemic disorders including cancer, uncontrolled diabetes mellitus, sepsis, or cardiopulmonary diseases.
- History of anticoagulation therapy, knee injection over the past three months.
- History of knee surgery or candidates for knee arthroplasty.
- History of intolerance to prolotherapy.
- Pregnancy.
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- Infectious arthritis, inflammatory joint diseases, joint dysplasia.
- Body Mass Index (BMI) greater than 35 kg/m2.
- Complete tear of medial collateral ligament under ultrasound.
- Fracture or other causes of knee pain instead of osteoarthritis.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to evaluate the effectiveness of STABHA, high-concentration glucose water, and saline injections in treating knee osteoarthritis with medial collateral ligament lesions. This prospective, double-blind, randomized trial will recruit 51 patients from the Shin Kong Hospital Rehabilitation Department.
The main questions it aims to answer are:
Read more
- Do STABHA or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline?
- What side effects do participants experience with these treatments?
Participants will be randomly divided into three groups: STABHA, high-concentration glucose water, and saline. In addition to routine intra-articular hyaluronic acid injections, each group will receive two ultrasound-guided injections of their assigned treatment into the medial collateral ligament of the knee, with a two-week interval. All participants will also undergo a 4-week physical therapy program.
Participants will:
- Receive two ultrasound-guided injections over two weeks.
- Undergo 4 weeks of physical therapy.
- Return for follow-up assessments at 1 and 3 months, including the WOMAC osteoarthritis index, pain score, KOOS knee outcome score, knee range of motion, and knee ultrasound examination.
- Being tested
- STABHA Injection, High-Concentration Glucose Water Injection, Saline Injection
- Keywords
- medical collateral ligament (MCL), Knee osteoarthritis, prolotherapy, STABHA, rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STABHA InjectionBiological
Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval
High-Concentration Glucose Water InjectionOther
Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval
Saline InjectionOther
Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval
| Study group | Role | What they receive |
|---|---|---|
| STABHA Injection | Experimental | Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval. Receives: Biological: STABHA Injection |
| High-Concentration Glucose Water Injection | Experimental | Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval. Receives: Other: High-Concentration Glucose Water Injection |
| Saline Injection | Placebo comparator | Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval. Receives: Other: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction Using WOMAC Osteoarthritis Index
The primary outcome will assess the change in pain scores using the WOMAC Osteoarthritis Index at baseline, 1 month, and 3 months after the treatment intervention
Measured: Baseline, 1 month, and 3 months post-intervention
Secondary outcomes (2)
Knee Range of Motion
The change in knee range of motion will be measured using a goniometer at baseline, 1 month, and 3 months after intervention
Measured: Baseline, 1 month, and 3 months post-intervention
KOOS Knee Outcome Score
The outcome will assess the change in KOOS Knee Outcome Score at baseline, 1 month, and 3 months after the treatment intervention
Measured: Baseline, 1 month, and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Collateral Ligament LesionsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Ting-an
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Ting-an, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620874
- Sponsor's protocol ID
- 20240724R
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Ultrasound-Guided Injections of Saline, High-Concentration Dextrose, and Ligament Repair Agents for the Treatment of Medial Collateral Ligament Pathology in Degenerative Knee Osteoarthritis: A Randomized Double-Blind Trial.
- ClinicalTrials.gov ID
- NCT06620874
- Acronym / sponsor ID
- 20240724R
- Keywords
- medical collateral ligament (MCL), Knee osteoarthritis, prolotherapy, STABHA, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Chen Ting-anUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 1 Oct 2024 (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 goal of this clinical trial is to evaluate the effectiveness of STABHA, high-concentration glucose water, and saline injections in treating knee osteoarthritis with medial collateral ligament lesions. This prospective, double-blind, randomized trial will recruit 51 patients from the Shin Kong Hospital Rehabilitation Department.
The main questions it aims to answer are:
- Do STABHA or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline?
- What side effects do participants experience with these treatments?
Participants will be randomly divided into three groups: STABHA, high-concentration glucose water, and saline. In addition to routine intra-articular hyaluronic acid injections, each group will receive two ultrasound-guided injections of their assigned treatment into the medial collateral ligament of the knee, with a two-week interval. All participants will also undergo a 4-week physical therapy program.
Participants will:
- Receive two ultrasound-guided injections over two weeks.
- Undergo 4 weeks of physical therapy.
- Return for follow-up assessments at 1 and 3 months, including the WOMAC osteoarthritis index, pain score, KOOS knee outcome score, knee range of motion, and knee ultrasound examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STABHA Injection | Experimental | Biological: STABHA InjectionParticipants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval. |
| High-Concentration Glucose Water Injection | Experimental | Other: High-Concentration Glucose Water InjectionParticipants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval. |
| Saline Injection | Placebo comparator | Other: Saline InjectionParticipants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -
- Age between 45 to 80 years old.
- Meet at least three of the six American College of Rheumatology (ACR) criteria, including age over 50 years, morning stiffness less than 30 minutes, crepitus in passive knee movements, bony tenderness, bony enlargement, and no palpable warmth.
- Radiologic grading of 2 or 3 according to Kellgren-Lawrence criteria.
- Evidence of medial collateral ligament (MCL) pathology with incomplete injuries (grade I or II).
Key exclusion criteria (10 listed)
- The exclusion criteria are:
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 |
|---|---|---|
| STABHA InjectionParticipants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval | Biological | STABHA Injection |
| High-Concentration Glucose Water InjectionParticipants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval | Other | High-Concentration Glucose Water Injection |
| Saline InjectionParticipants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval | Other | Saline Injection |
Primary outcome
Pain Reduction Using WOMAC Osteoarthritis Index
Time frame: Baseline, 1 month, and 3 months post-intervention
The primary outcome will assess the change in pain scores using the WOMAC Osteoarthritis Index at baseline, 1 month, and 3 months after the treatment intervention
2 secondary outcomes
Knee Range of Motion
Time frame: Baseline, 1 month, and 3 months post-intervention
KOOS Knee Outcome Score
Time frame: Baseline, 1 month, and 3 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Medial Collateral Ligament Lesions
RecruitingObservational study
Clinical-instrumental Evaluation and Assessment of Return to Sports Activity in Patients Surgically Treated for Isolated "Stener-like" Lesions of the Medial Collateral Ligament (MCL) or in the Context of Multiligament Injuries and Articular Fractures
Ligament Injury, Knee Injuries
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.
Questions about this trial
What is this clinical trial studying?
A study testing STABHA Injection, High-Concentration Glucose Water Injection and Saline Injection in people with Medial Collateral Ligament Lesions and Knee Osteoarthritis, run by Chen Ting-an.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-an Chen (+886984-166-521, phoebe19910215@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction Using WOMAC Osteoarthritis Index (time frame: Baseline, 1 month, and 3 months post-intervention). 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 1 Oct 2024.