الفهرس 
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Abstract
Diseased shoulder due to pain, stiffness, or weakness negatively affects patients’ quality of life and their ability to carry out their daily activities. Adhesive capsulitis, first described in 1872, is defined as “a condition of varying severity characterized by a gradual development of global limitation of active and passive shoulder motion where radiographic findings other than osteopenia are absent” (D’Orsi et al., 2012; Neviaser & Neviaser, 2011). The estimated incidence of adhesive capsulitis is 2 – 5 % of the total population once per lifetime (Kingston et al., 2018). Bilateral shoulder joint affection can occur in 20-30 % of cases (Date & Rahman, 2020).
Stages of adhesive capsulitis are theoretically classified according to the clinical presentation and the arthroscopic appearance. In the first stage, patients complain of pain increasing at night with preserved ROM. The second stage is characterized by stiffness with mild loss of axillary fold while the third stage is characterized by a profound global loss of ROM with progressive loss of axillary fold. Stage four is characterized by persistent stiffness with minimal pain which indicates relief of synovitis (Date & Rahman, 2020; Neviaser & Neviaser, 2011).
Diagnosis of adhesive capsulitis depends on the exclusion of all other pathologies of the painful stiff shoulder joint (Le et al., 2017). External rotation is usually the first affected movement. During active shoulder joint movement, pain is worse during capsule stretch at the end of motion. Passive joint movements are limited with firm endpoints in the late stages of the disease (Le et al., 2017).
Radiologically, plain x-ray films are usually negative except for osteopenia that may be present secondary to joint disuse (Neviaser & Neviaser, 2011). Magnetic resonance imaging (MRI) may be positive for capsular thickening, peri-capsular inflammatory changes, or decreased glenohumeral joint space (Le et al., 2017). Dynamic sonographic examination may reveal capsular thickening or limited supraspinatus ligament sliding movement.
Treatment options include non-operative and operative modalities. Non-operative options include physical therapy, pharmacological therapy, and intra-articular or extra-articular injection. Operative modalities are manipulation under anaesthesia and arthroscopic or open capsulotomy.
Our study aimed to evaluate the efficacy of ultrasound-guided shoulder intra-articular ozone injection versus pulsed radiofrequency application compared to intra-articular steroid injection (as the gold standard) in patients with idiopathic adhesive capsulitis. The primary outcome was the improvement in the visual analogue scale (VAS) as a pain indicator. The secondary outcomes include functional improvement (Shoulder Pain and Disability Index) and level of inflammatory biomarkers (serum Intercellular Adhesion Molecule -1 and high-sensitivity C-Reactive Protein).
A prospective randomized controlled double-blinded trial was conducted at the Medical Research Institute – Alexandria University after approval of the local ethical committee. The study was registered as a randomized controlled double-blinded study in the “clinical trials library for protocol registration and results system” with registration number NCT04724317.
Inclusion criteria included both genders, aged from 30 to 65 years who had primary shoulder adhesive capsulitis, with a history of inadequate response to a trial of conservative therapy for at least four weeks. Exclusion criteria included any patients with secondary adhesive capsulitis, central post-stroke neuropathic pain, rheumatoid arthritis, current shoulder fracture or trauma, local tumour at shoulder region, reported coagulopathy, or allergy to used medications.
Interventions were carried out using posterior approach for US-guided shoulder injection with identification of the humeral head, joint capsule, labarum, glenoid, infraspinatus, and deltoid muscles. Needle paths from inferomedial to superolateral targeting subcapsular endpoint for injection adjacent to the labarum.
Patients were categorized into three equal groups. In the steroid group, 15 patients were treated with an intra-articular injection of 5 ml of bupivacaine 0.125% added to triamcinolone 40 mg. In the ozone group, 15 patients were treated with an intra-articular injection of 5 ml of bupivacaine 0.125% followed by an injection of 10 ml of oxygen-ozone mixture (15 μg/ml). In the PRF group, 15 patients were treated with shoulder intra-articular injection of 5 ml of bupivacaine 0.125% followed by two cycles of intra-articular pulsed radiofrequency application each extended for 2 minutes (Ozyuvaci et al., 2011).
All participants were treated as day-case patients and were observed in the pain department for 2 hours after therapy. VAS, ROM, and any complications were recorded before discharge. Follow-up visits were planned at weeks 1, 2, 4, and 8 in which reassessment was done for VASr, VASm, SPADI, and ROM. A blood sample for ICAM-1 and hs-CRP was taken during the last follow-up visit.
In the current study, VASr and VASm scores showed nearly the same pattern of improvement starting within each group from the second week and extending throughout the following period of follow-up. The exception was in the steroid group which showed a more rapid effect with a significant improvement starting from the first week of follow-up. This exception can be explained by the rapid anti-inflammatory effect of intra-articular steroid injection.
Inter-group comparisons regarding VASr and VASm scores at different times of follow-up showed a significant difference at week eight, with the greatest improvement in the PRF group compared to the other two groups. This indicates a more delayed improvement in the PRF group that can be explained by its immune modulatory effect. Overall percentage improvement in VASm had no statistical difference among the studied groups using post-hoc test. Conversely, the percentage improvement in VASr showed a significant improvement in PRF compared to the steroid group. This improvement can be explained by the neuro-modulatory effect of the PRF affecting the C-fibres nerve endings of the joint capsule that initiate the resting baseline pain sensation.
Regarding ROM, the present study had a significant improvement starting from the second week and extending to the fourth and eighth weeks of follow-up. Comparing the three studied groups, there was a significant difference at weeks two, four, and eight between groups with greater improvement in the PRF group, followed by the ozone group, followed by the steroid group. In this study, we emphasize that improvement was progressive, and ROM median value was improving in PRF and ozone groups across the time of assessment.
In the current study, both components of the SPADI showed a significant improvement in second, fourth, and eighth weeks of follow-up. Serum ICAM-1 and hs-CRP, as biological markers for adhesive capsulitis, have a significant improvement after the interventions.