Intraarticular InjectionNCT07666347
Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis
A study testing Hyaluronic acid and Botulinum toxin type A in people with Intraarticular Injection and Botox, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intraarticular Injection, Botox, Hyaluronic Acid
- What is being tested?
- Hyaluronic acid and Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years.
- Both genders.
- Chronic knee osteoarthritis (KOA) according to American College of Rheumatology criteria for the diagnosis of knee osteoarthritis.
- Third or fourth grade Kellgren and Lawrence system for classification of osteoarthritis based on radiological data, it is a common method of classifying the severity of osteoarthritis (OA) using five grades according to the following sites and projections.
Who cannot join
- History of intra-articular injection within the last 6 months,
- History of surgery on the knee joint or major trauma to the lower limb causing fracture.
- Body mass index (BMI) more than 40 kg/m2.
- Medical conditions affecting the joint or lower extremity function such as severe osteoporosis, rheumatoid arthritis, collagen vascular diseases, and gout.
- Diabetic patient.
- Any contraindication to intra-articular injections for instance immunodeficiency, coagulation defect or anticoagulation therapy taking or skin infection at the site of injection.
- Hypersensitivity to Botulinum toxin or hyaluronic acid.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
About this study
This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is a widespread musculoskeletal disease and a leading cause of chronic disability. Conservative estimates state that up to 240 million people worldwide suffer from it. Knee osteoarthritis (KOA) is associated with chronic inflammation that causes persistent oxidative damage, which subsequently leads to joint degeneration.
Therefore, intra-articular (IA) therapies might be an alternative and safe treatment for these patients.
IA injection of hyaluronic acid (HA) is still a controversial treatment for knee osteoarthritis and comparative studies of HA versus more established treatments are warranted.
Botulinum toxin (BTX), produced by the bacterium Clostridium botulinum, acts on both sensory and motor neurons. Irreversible binding of BTX to presynaptic receptors of motor endplates inhibits acetylcholine release.
- Conditions
- Intraarticular Injection, Botox, Hyaluronic Acid, Knee Osteoarthritis
- Being tested
- Hyaluronic acid, Botulinum toxin type A
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly.
Patients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly.
| Study group | Role | What they receive |
|---|---|---|
| Group HA | Experimental | Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly. Receives: Drug: Hyaluronic acid |
| Group BTX | Experimental | Patients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly. Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 3 months after the interventions
Secondary outcomes (3)
Assessment of quality of life
The Short form (SF)-36 generic quality of life questionnaire, which is composed of eight domains: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects, and mental health.
Measured: 3 months after the interventions
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) which is a specific functional questionnaire that assesses pain (5 subitems), stiffness (2 items), and function (17 items).
Measured: 3 months after the interventions
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes, Pain (nine items); Symptoms (seven items); Activities of Daily Living Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Measured: 3 months after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start24 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraarticular InjectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666347
- Sponsor's protocol ID
- 36265PR78/5/26
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07666347
- Acronym / sponsor ID
- 36265PR78/5/26
- Conditions
- Intraarticular Injection, Botox, Hyaluronic Acid, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Jun 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.
This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is a widespread musculoskeletal disease and a leading cause of chronic disability. Conservative estimates state that up to 240 million people worldwide suffer from it. Knee osteoarthritis (KOA) is associated with chronic inflammation that causes persistent oxidative damage, which subsequently leads to joint degeneration.
Therefore, intra-articular (IA) therapies might be an alternative and safe treatment for these patients.
IA injection of hyaluronic acid (HA) is still a controversial treatment for knee osteoarthritis and comparative studies of HA versus more established treatments are warranted.
Botulinum toxin (BTX), produced by the bacterium Clostridium botulinum, acts on both sensory and motor neurons. Irreversible binding of BTX to presynaptic receptors of motor endplates inhibits acetylcholine release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group HA | Experimental | Drug: Hyaluronic acidPatients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly. |
| Group BTX | Experimental | Drug: Botulinum toxin type APatients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years.
- Both genders.
- Chronic knee osteoarthritis (KOA) according to American College of Rheumatology criteria for the diagnosis of knee osteoarthritis.
- Third or fourth grade Kellgren and Lawrence system for classification of osteoarthritis based on radiological data, it is a common method of classifying the severity of osteoarthritis (OA) using five grades according to the following sites and projections.
Key exclusion criteria (7 listed)
- History of intra-articular injection within the last 6 months,
- History of surgery on the knee joint or major trauma to the lower limb causing fracture.
- Body mass index (BMI) more than 40 kg/m2.
- Medical conditions affecting the joint or lower extremity function such as severe osteoporosis, rheumatoid arthritis, collagen vascular diseases, and gout.
- Diabetic patient.
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 |
|---|---|---|
| Hyaluronic acidPatients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly. | Drug | Group HA |
| Botulinum toxin type APatients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly. | Drug | Group BTX |
Primary outcome
Degree of pain
Time frame: 3 months after the interventions
Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
3 secondary outcomes
Assessment of quality of life
Time frame: 3 months after the interventions
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 3 months after the interventions
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3 months after the interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid and Botulinum toxin type A in people with Intraarticular Injection and Botox, run by Tanta University 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 4 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: looking for participants now, as of the sponsor's last update on 25 Jun 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed S ElSharkawy, MD (00201148207870, mselsharkawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 3 months after the interventions). 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 25 Jun 2026.