Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis

NCT07171840 | Completed Phase 3

• 1 other identifier: OZTHUMB
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thumb Osteoarthritis

Keywords

oxygen-ozone; thumb splint; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  1, 3, 6 months

Secondary Outcomes (3)

• Visual Analogic Scale (VAS)

  1, 3, 6 months

• Grip strength test

  1,3,6 months

• Tip pinch strength test

  1, 3, 6 months

Study Arms (2)

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.

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.

Device: thumb splint

Interventions

10 cc of oxygen-ozone plus thumb splint DRUG

Oxygene-Ozone therapy plus splint therapy

ozone plus thumb splint

thumb splint DEVICE

thermoplastic splint

only thumb splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 15, 2025
• Study Start: May 1, 2021
• Primary Completion: July 23, 2022
• Study Completion: December 23, 2022
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

IT (1)