Ultrasound-guided Shoulder Intraarticular Ozone Injection Versus Pulsed Radiofrequency Application for Shoulder Adhesive Capsulitis: A Randomized Controlled Trial.

Background: A diseased shoulder due to pain, stiffness, or weakness negatively affects patients' quality of life and their ability to carry out activities of daily living. Adhesive capsulitis is a disease characterized by shoulder pain and global limitation of movement in the shoulder joint. Many interventions have been proposed for the treatment of primary adhesive capsulitis. The current study compares the effect of ultrasound-guided intraarticular injection of ozone versus steroid versus intraarticular application of pulsed radiofrequency.

Objectives: The primary outcome of the current study was to compare the improvement in the Visual Analog Scale (VAS) after the 3 treatment modalities. The secondary outcomes included functional improvement measured by the Shoulder Pain and Disability Index (SPADI) and level of inflammatory biomarkers measured by serum intercellular adhesion molecule (ICAM-1) and high-sensitivity C-reactive protein(hs-CRP).

Study Design: The current study is a prospective, double blinded, randomized controlled trial. We employed a double blinding technique for both the patients and the outcome assessors.

Setting: Our study was carried out at the Medical Research Institute, Alexandria University, Egypt, after approval of the local ethical committee (IORG0008812). The study was registered in the "clinical trials library for protocol registration and results system" with number NCT04724317.The study included 45 patients with a diagnosis of primary adhesive capsulitis.

Methods: Patients were randomly assigned to 3 equal groups: steroid group, ozone group, and pulsed radiofrequency group. Pain and global shoulder functions were assessed using the VAS at rest and with movement, range of motion (ROM), and the SPADI. Moreover, ICAM-1 and hs-CRP were measured as inflammatory markers.

Results: The results of the current study reveal that all patients in all groups have had a statistically significant improvement after their intervention regarding pain, disability, ROM, and inflammatory markers. Pairwise comparisons revealed that improvement of the VAS during movement had a statistically significant improvement starting from the second week and continuing to the fourth and eighth week. VAS during rest had a significant improvement starting from follow-up week one in the steroid group. Moreover, improvement in the ROM and SPADI scores started from the second week follow-up. Percent improvement was calculated for each group and there was a statistically significant difference between groups in VAS at rest and ROM in the pulsed radiofrequency group compared to the steroid group.Regarding inflammatory markers, both ICAM-1 and hs-CRP had a significant improvement after all 3 interventions with no statistically significant difference among the groups.

Limitations: This study is a single-center study. A shortage of previously published data, and heterogeneity in the published methodology of the 3 interventions limited our discussion data for comparison with the previous literature.

Conclusion: Ultrasound-guided shoulder joint intraarticular injection of steroid, ozone, or pulsed radiofrequency application all result in a significant improvement in pain, disability, and ROM in primary adhesive capsulitis. They can be used as an effective treatment modality for this condition. Comparing groups statistically, the pulsed radiofrequency group had a more delayed, but statistically better long-term improvement compared to the other 2 groups.