Thumb OsteoarthritisPhase 3NCT07171840
Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis
A Phase 3 study testing 10 cc of oxygen-ozone plus thumb splint and thumb splint in people with Thumb Osteoarthritis, run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial summary
Osteoarthritis of trapezio-metacarpal joint (TMJ) most commonly occurs in women over 50 years old, often bilateral and it is a disabling condition presenting with pain at base of the thumb, swelling, instability, deformity and impairment of hand function with limitation in gripping and pinching objects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- 10 cc of oxygen-ozone plus thumb splint and thumb splint
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 23 Dec 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Presence of clinically observed active infection or severe inflammation in the index trapezio-metacarpal joint or skin disease/breakdown or infection in the area of the planned injection site of the index thumb joint.
- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; Human Immunodeficiency Virus (HIV), viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis.
- Diagnosed with leukaemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment.
- Disease of cervical spine, shoulder or other upper extremity joints judged by the investigator to be contributing to the pain in the index thumb joint (e.g. radiculopathy, De Quervain S., etc.).
- Untreated symptomatic injury of the index hand (e.g., acute traumatic injury, tendinopathy, nerve lesion).
- Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index thumb joint.
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- Presence of venous or lymphatic stasis in the index arm.
- Orally administered systemic steroid use within 2 weeks prior to screening
- Planned/anticipated surgery of the index hand during the study period.
- Major surgery of the index hand within 12 months prior to screening.
- Minor surgery (e.g. arthroscopy) of the index hand within 6 months prior to screening
- Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening, which, in the opinion of the investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection.
- Pregnant or nursing mothers or women planning to become pregnant during the time they will be participating in the study.
- Previously documented failed treatment with OOT or splint
- Known drug or alcohol dependence currently or within the last year.
- Use of any investigational drug or device within 30 days prior to screening.
- Use of any investigational biologics within 60 days prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis: a Randomized Controlled Clinical Trial
Osteoarthritis of trapezio-metacarpal joint (TMJ) most commonly occurs in women over 50 years old, often bilateral and it is a disabling condition presenting with pain at base of the thumb, swelling, instability, deformity and impairment of hand function with limitation in gripping and pinching objects. There are several surgical treatment options for TMJO as well as many conservative treatments such as splinting, thumb strengthening exercises, anti-inflammatory drugs and intra-articular injections. There are no currently approved TMJO treatments capable of slowing OA-related structural progression, so the main goals of the conservative treatment are to provide symptomatic relief, improve joint function, and delay surgical intervention. In recent years, the interest in the use of ozone is in constant increase especially because of the biological properties of inducing analgesia, anti-inflammatory, and antioxidant effects. Some articles have reported promising results on the effectiveness of oxygen-ozone, but the evidence is low. So, the aim of this study is to evaluate the effectiveness of intra-articular oxygen-ozone therapy (OOT) combined with thumb splint and compare it with only the splint therapy.
Read the detailed description
Osteoarthritis is a degenerative condition that causes pain, impaired function and affects daily activities. In osteoarthritis, there is the destruction of cartilage and subchondral bone, with the consequent narrowing of articular space. Several factors have been associated with the development of degenerative changes in the carpometacarpal joint (CMCJ), including increased thumb base joint laxity and greater grip strength. Trapezio-metacarpal joint (TMJ) is a disabling condition presenting with pain at base of the thumb, swelling, instability, deformity and limitation of hand function. The patient with symptomatic TMJO in its initial stages is usually treated conservatively before surgical intervention: one of the main actions of intra-articular treatments, ranging from corticosteroids to hyaluronic acid and biologic products is to reduce inflammatory distress within the joint; injection treatments are usually used alone or in combination with thumb splint in a multimodal rehabilitation approach.
In recent years, there has been a growing interest in the effects of ozone because intra-articular administration of an adequate mixture of oxygen-ozone is supposed to reduce pain, to have protective immunomodulatory effects on cartilage, and to reduce oxidative stress, thus potentially representing an alternative to other injective methods. However, is still unclear what best therapeutic protocol is in terms of ozone concentration, volume to be injected, number of injections and time between injections.
This study will compare the efficacy of OOT injection plus thumb splint to only joint splint in patients with painful unilateral thumb OA who have been unable to achieve satisfactory pain relief with previous conservative OA treatment (e.g. physical therapy, simple analgesics). This will be done using a randomized controlled trial with study subjects receiving a cycle of two injection of OOT plus thumb splint. The primary study objective is to determine whether two injections of OO and thumb splint are superior to the use of only the joint splinting in reducing pain and this is measured by the improvement in DASH score from baseline. Secondary objectives of this study are improvement in VAS Pain, Grip Strength Function and Tip Pinch Function.
During screening, potential subjects who provide informed consent will be assessed for eligibility. Screening will consist in checking the presence of inclusion and exclusion criteria, including symptomatic OA in one thumb joint from 3 months and a thumb joint radiograph showing an Eaton and Litter grade of 1 to 3 and an absence of severe osteoarthritis. Subjects will also provide demographic and medication use information. Baseline X-ray will be collected.
- Conditions
- Thumb Osteoarthritis
- Being tested
- 10 cc of oxygen-ozone plus thumb splint, thumb splint
- Keywords
- oxygen-ozone, thumb splint, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 cc of oxygen-ozone plus thumb splintDrug
Oxygene-Ozone therapy plus splint therapy
thumb splintDevice
thermoplastic splint
| Study group | Role | What they receive |
|---|---|---|
| ozone plus thumb splint | Experimental | Participant will receive an intraarticular injection of oxygen-ozone, once a week for two weeks. During procedure a clear ultrasound image is to be taken to document needle placement in the synovial space. After that, a physiotherapist will create two personalized thermoplastic splints for every patient for the stabilizing of the TMJ (one for the day that has a functional aim and one for the night with the objective of TMJ rest). The two splints will be used for 2 months. Receives: Drug: 10 cc of oxygen-ozone plus thumb splint |
| only thumb splint | Active comparator | A physiotherapist will create two personalized thermoplastic splints for every patient for the stabilizing of the TMJ (one for the day that has a functional aim and one for the night with the objective of TMJ rest). The two splints will be used for 2 months. Receives: Device: thumb splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH)
Assessment of the patient's disability; 38 questions, score range 0-100. Higher scores indicate greater severity of disability.
Measured: 1, 3, 6 months
Secondary outcomes (3)
Visual Analogic Scale (VAS)
Assessment of pain. Score range 0-10. Higher scores indicate worse pain.
Measured: 1, 3, 6 months
Grip strength test
Assessment of force. It tests muscles responsible for flexion of the metatarsals and phalanges. Changes in force are recorded by the use of a dynamometer
Measured: 1,3,6 months
Tip pinch strength test
Assessment of force. It tests muscles responsible for flexion of the fingers and adduction of the thumb. Changes in force are recorded by the use of a dynamometer
Measured: 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 May 2021
- Primary completion23 Jul 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiano Sconza, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171840
- Sponsor's protocol ID
- OZTHUMB
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07171840
- Acronym / sponsor ID
- OZTHUMB
- Conditions
- Thumb Osteoarthritis
- Keywords
- oxygen-ozone, thumb splint, osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 23 Jul 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 15 Sep 2025 (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.
Osteoarthritis of trapezio-metacarpal joint (TMJ) most commonly occurs in women over 50 years old, often bilateral and it is a disabling condition presenting with pain at base of the thumb, swelling, instability, deformity and impairment of hand function with limitation in gripping and pinching objects. There are several surgical treatment options for TMJO as well as many conservative treatments such as splinting, thumb strengthening exercises, anti-inflammatory drugs and intra-articular injections. There are no currently approved TMJO treatments capable of slowing OA-related structural progression, so the main goals of the conservative treatment are to provide symptomatic relief, improve joint function, and delay surgical intervention. In recent years, the interest in the use of ozone is in constant increase especially because of the biological properties of inducing analgesia, anti-inflammatory, and antioxidant effects. Some articles have reported promising results on the effectiveness of oxygen-ozone, but the evidence is low. So, the aim of this study is to evaluate the effectiveness of intra-articular oxygen-ozone therapy (OOT) combined with thumb splint and compare it with only the splint therapy.
Detailed description
Osteoarthritis is a degenerative condition that causes pain, impaired function and affects daily activities. In osteoarthritis, there is the destruction of cartilage and subchondral bone, with the consequent narrowing of articular space. Several factors have been associated with the development of degenerative changes in the carpometacarpal joint (CMCJ), including increased thumb base joint laxity and greater grip strength. Trapezio-metacarpal joint (TMJ) is a disabling condition presenting with pain at base of the thumb, swelling, instability, deformity and limitation of hand function. The patient with symptomatic TMJO in its initial stages is usually treated conservatively before surgical intervention: one of the main actions of intra-articular treatments, ranging from corticosteroids to hyaluronic acid and biologic products is to reduce inflammatory distress within the joint; injection treatments are usually used alone or in combination with thumb splint in a multimodal rehabilitation approach.
In recent years, there has been a growing interest in the effects of ozone because intra-articular administration of an adequate mixture of oxygen-ozone is supposed to reduce pain, to have protective immunomodulatory effects on cartilage, and to reduce oxidative stress, thus potentially representing an alternative to other injective methods. However, is still unclear what best therapeutic protocol is in terms of ozone concentration, volume to be injected, number of injections and time between injections.
This study will compare the efficacy of OOT injection plus thumb splint to only joint splint in patients with painful unilateral thumb OA who have been unable to achieve satisfactory pain relief with previous conservative OA treatment (e.g. physical therapy, simple analgesics). This will be done using a randomized controlled trial with study subjects receiving a cycle of two injection of OOT plus thumb splint. The primary study objective is to determine whether two injections of OO and thumb splint are superior to the use of only the joint splinting in reducing pain and this is measured by the improvement in DASH score from baseline. Secondary objectives of this study are improvement in VAS Pain, Grip Strength Function and Tip Pinch Function.
During screening, potential subjects who provide informed consent will be assessed for eligibility. Screening will consist in checking the presence of inclusion and exclusion criteria, including symptomatic OA in one thumb joint from 3 months and a thumb joint radiograph showing an Eaton and Litter grade of 1 to 3 and an absence of severe osteoarthritis. Subjects will also provide demographic and medication use information. Baseline X-ray will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozone plus thumb splint | Experimental | Drug: 10 cc of oxygen-ozone plus thumb splintParticipant will receive an intraarticular injection of oxygen-ozone, once a week for two weeks. During procedure a clear ultrasound image is to be taken to document needle placement in the synovial space. After that, a physiotherapist will create two personalized thermoplastic splints for every patient for the stabilizing of the TMJ (one for the day that has a functional aim and one for the night with the objective of TMJ rest). The two splints will be used for 2 months. |
| only thumb splint | Active comparator | Device: thumb splintA physiotherapist will create two personalized thermoplastic splints for every patient for the stabilizing of the TMJ (one for the day that has a functional aim and one for the night with the objective of TMJ rest). The two splints will be used for 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Presence of clinically observed active infection or severe inflammation in the index trapezio-metacarpal joint or skin disease/breakdown or infection in the area of the planned injection site of the index thumb joint.
- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; Human Immunodeficiency Virus (HIV), viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis.
- Diagnosed with leukaemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment.
- Disease of cervical spine, shoulder or other upper extremity joints judged by the investigator to be contributing to the pain in the index thumb joint (e.g. radiculopathy, De Quervain S., etc.).
- Untreated symptomatic injury of the index hand (e.g., acute traumatic injury, tendinopathy, nerve lesion).
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 |
|---|---|---|
| 10 cc of oxygen-ozone plus thumb splintOxygene-Ozone therapy plus splint therapy | Drug | ozone plus thumb splint |
| thumb splintthermoplastic splint | Device | only thumb splint |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 1, 3, 6 months
Assessment of the patient's disability; 38 questions, score range 0-100. Higher scores indicate greater severity of disability.
3 secondary outcomes
Visual Analogic Scale (VAS)
Time frame: 1, 3, 6 months
Grip strength test
Time frame: 1,3,6 months
Tip pinch strength test
Time frame: 1, 3, 6 months
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 26 Sep 2025.
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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 Phase 3 study testing 10 cc of oxygen-ozone plus thumb splint and thumb splint in people with Thumb Osteoarthritis, run by Humanitas Clinical and Research Center at 1 site in Italy.
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 0 inclusion and 17 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 26 Sep 2025. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Disabilities of the Arm, Shoulder and Hand (DASH) (time frame: 1, 3, 6 months). 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 26 Sep 2025.