NCT06165926

Hypertonic Dextrose Injection and Physical Therapy for Frozen Shoulder

Efficacy of Intra-Articular Hypertonic Dextrose Injection and Physical Therapy for Frozen Shoulder: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of our study is to investigate whether the combination of hypertonic dextrose injection and shoulder joint hydrodilation, in conjunction with physical therapy, can effectively enhance shoulder joint pain relief, improve range of motion, and enhance daily life functionality in patients with frozen shoulder.

Detailed description

Frozen shoulder (FS), also known as adhesive capsulitis, is a common shoulder ailment, with an annual incidence of approximately 2.4 individuals per 100,000, accounting for about 2% of the total population. The onset of symptoms is predominant in individuals aged forty to sixty years, presenting as persistent restrictions in shoulder joint mobility accompanied by shoulder joint pain. While the detailed mechanisms underlying frozen shoulder remain unclear, arthroscopic examination of the shoulder joint reveals thickening and contraction of the shoulder joint capsule, adhesion with the humeral head, and a reduction in joint cavity volume, particularly in the folds of the axillary recess of the joint capsule and its surrounding areas. These changes contribute to restricted shoulder joint mobility in individuals with frozen shoulder. Additionally, research suggests that in cases of severe inflammation, certain cytokines and growth factors drive fibroblasts to replace normal tissue through repair and remodeling responses. This excessive fibrosis and the loss of normal collagen remodeling response further contribute to the development of frozen shoulder. The meta-analysis published in JAMA Network in 2020 highlighted the significance of medium to long-term physical therapy in facilitating subsequent improvements in range of motion and functionality for patients with adhesive capsulitis, also known as frozen shoulder. Moreover, numerous studies suggest that combining intra-articular injections with shoulder joint capsular distension procedures, such as hydrodilatation, can enhance shoulder joint function and mobility. Prolotherapy is a non-surgical regenerative injection therapy involving the injection of a solution into painful or degenerated areas. The injected proliferants induce a local inflammatory response, triggering the release of growth factors and stimulating fibroblasts and collagen-producing cells. This process mimics the natural healing mechanisms of the body, promoting cellular tissue growth through a beneficial inflammatory response. In clinical practice, the most commonly utilized solution for prolotherapy is the hypertonic dextrose with concentrations ranging from 15% to 25%. Concentrations exceeding 10% are generally considered to induce local inflammation, thereby triggering a cascade of reparative effects. Although there have been numerous studies on shoulder joint capsular distension procedures in the past, the injected solutions often consisted of corticosteroids and saline. In clinical observations, the use of hypertonic dextrose injection combined with shoulder joint capsular distension appears to offer improved outcomes in terms of pain relief and joint angle progression in patients with adhesive capsulitis. However, there is currently no research investigating the effectiveness of hypertonic dextrose injection combined with shoulder joint capsular distension for treating frozen shoulder. Therefore, this study represents the first exploration of whether the use of hypertonic dextrose injection combined with shoulder joint hydrodilatation and physical therapy is more effective than the conventional approach using saline injection combined with physical therapy in the treatment of frozen shoulder.

Conditions

• Frozen Shoulder

Interventions

Type	Name	Description
DRUG	15% hypertonic dextrose	The solution is prepared with 3 ml of 50% Dextrose, 1 ml of 2% xylocaine, and 6 ml of normal saline. The ultrasound-guided injection of 15% hypertonic dextrose is performed at the first week. Subsequent ultrasound-guided shoulder joint injection treatment with hypertonic dextrose is performed at the fourth weeks. A total of 2 sessions of hypertonic dextrose injections are performed.
DRUG	Normal saline	The solution is prepared with 1 ml of 2% xylocaine + 9 ml of normal saline. The ultrasound-guided injection of Normal saline(0.9%) is performed at the first week. Subsequent ultrasound-guided shoulder joint injection treatment with Normal saline is performed at the fourth weeks. A total of 2 sessions of Normal saline injections are performed.
OTHER	physical therapy	Under the guidance and supervision of a physical therapist, the patient undergoes physical therapy sessions twice a week for a total duration of 8 weeks. Each session lasts approximately 30 minutes and includes joint activities, stretching, and muscle-strengthening exercises.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-30
• Completion: 2024-12-31
• First posted: 2023-12-12
• Last updated: 2023-12-12