Ultrasound Guided Shoulder Intra-Articular Ozone Injection Versus Pulsed Radiofrequency Application for Shoulder Adhesive Capsulitis
Condition: Adhesive Capsulitis; Shoulder Pain
MeSH terms: Shoulder Pain; Bursitis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of the ultrasound guided shoulder
      intra-articular Ozone injection versus pulsed radiofrequency application in patients with
      shoulder adhesive capsulitis.

        -  Primary Outcome :

           - Pain score using visual analogue scale during rest (VASr) and movement (VASm).

        -  Secondary Outcome :

             -  Quality of life using Shoulder Pain and Disability Index (SPADI). It assesses the
                overall functionality of the shoulder joint.

             -  Levels of serum ICAM -1, and serum high sensitive C-reactive protein (hs-CRP) are
                compared before and after treatment intervention.
    

Detailed description: 
      After approval of the local ethical committee of Medical Research Institute - Alexandria
      University (IORG0008812), an informed written consent will be taken from all patients
      participating in the study. The study will be carried out on 45 adult patients (15 per group)
      of either gender, aged from 30 to 65 years. Eligible patients are those who were diagnosed
      with primary shoulder adhesive capsulitis according to the previously mentioned diagnostic
      criteria, with history of inadequate response to a trial of conservative therapy (NSAIDs and
      physiotherapy) for at least four weeks.

      Patients will be assigned into three equal groups using computerized random blocks method:

        1. Steroid Group (S): [15 patients] Control group treated with intra-articular injection of
           5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance.

        2. Ozone Group (O3): [15 patients] Patients will be treated with intra-articular injection
           of 5 ml of Bupivacaine 0.125% followed by injection of 10 ml of Oxygen-Ozone mixture (15
           μg/ml) under the ultrasound guidance.

        3. Pulsed radiofrequency Group (PRF): [15 patients] Patients will be treated with shoulder
           intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed
           radiofrequency application under the ultrasound guidance.

      Patients' Evaluation and Preparation:

      Patients' preparation starts with pre-intervention evaluation visit. Proper history taking
      and clinical examination will be carried out. Documentation of the range of motion and VAS
      score will be done after proper explanation. Patients will be asked to fill a SPADI score
      form.

      Laboratory investigations will include complete blood count (CBC), prothrombin time (PT), and
      international normalized ratio (INR).

      Baseline serum ICAM-1 level and hs-CRP level will be measured using 5 ml of patient's venous
      blood.

      Patients will be asked to sign a consent form to participate in the study. Participants will
      be admitted to pain management ward. Random assignment will be carried out using computerized
      random blocks with variable block size.

      All interventions will be carried out in the operating theatre (OR) for proper monitoring and
      sterilization procedures. A 20 G intravenous (IV) cannula will be inserted for all patients
      in the OR. Basic monitoring will be applied; continuous electrocardiogram (ECG) monitoring,
      arterial Oxygen saturation (SPO2) monitoring, and non-invasive blood pressure (NIBP)
      monitoring.

      Intervention Methodology:

        1. Group S:

           Patients will be put in lateral semi-prone position with the affected shoulder facing
           up. Shoulder space will be opened by arm internal rotation and adduction across the
           chest. Under sterile conditions and proper draping of the affected shoulder, scanning
           will start using Sonosite® M- turbo™ ultrasound machine. A high frequency linear probe
           (7-14 MHz) will be put parallel and just inferior to spine of the scapula.
           Identification of humeral head, joint capsule, labrum, glenoid, and infraspinatus and
           deltoid muscles should be available in one image to avoid wrong needle positioning. The
           in-plane posterior approach for intra-articular injection will be used (Furman et al.,
           2017). Needle insertion (22 Gauge, 5 cm length) approach from inferomedial to
           superolateral direction towards the humeral head. The targeted needle path should avoid
           labrum puncture. The end point for injection is subcapsular and adjacent to the labrum.

           After confirmation of proper needle position, 5 ml of Bupivacaine 0.125% will be
           injected added to triamcinolone 40 mg (Babaei-Ghazani et al., 2019).

        2. Group O3:

           Under the previously described position and scanning technique, intra-articular
           injection of 5 ml of Bupivacaine 0.125% followed by 10 ml of Oxygen-Ozone mixture (15
           μg/ml) will be done (Noori-Zadeh et al., 2019).

        3. Group PRF:

      Under the previously described position and scanning technique, 5 ml of Bupivacaine 0.125%
      will be directly injected. Following, Intra-articular PRF will be applied with a 10 cm
      neurotherm needle with 10 mm active tip for 4 minutes to the glenohumeral joint (Ozyuvaci et
      al., 2011).

      Post-Procedure Assessment:

      All participants will be treated as day-case patients and will be observed in the recovery
      ward for 2 h after therapy. VAS, shoulder joint ROM, and any complication (e.g., hematoma
      formation, vasovagal attack, etc.) will be recorded before discharge.

      Follow-up visits will be planned for all participants at week 1, 2, 4, 8 post-intervention.
      During these visits, reassessment will be done for VASr, VASm, SPADI score, and ROM.

        -  Pain score Using visual analogue scale during rest (VASr) and movement (VASm), pain will
           be categorized as mild (0-3), moderate (4-6), or severe (7-10). Improved pain score is
           considered significant when there is a categorical improvement in pain level.

        -  Quality of life Using Shoulder Pain and Disability Index (SPADI), improvement in quality
           of life is considered significant when there is 10% reduction in the final index.

      During the last follow-up visit, samples for serum ICAM-1 and highly sensitive CRP levels
      will be obtained.

      Statistical Analysis:

      Data will be analyzed using descriptive statistical methods as well as comparison of the
      qualitative and quantitative data. Presentation will be carried out in the form of proper
      tables and graphical presentation.
    

Intervention name(s): Steroid Group; Ozone Group; PRF Group
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Ultrasound guided shoulder intra-articular steroid injection; Ultrasound guided shoulder intra-articular Ozone injection; Ultrasound guided shoulder intra-articular pulsed radiofrequency application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adhesive capsulitis; soulder pain; triamcinolone; ozone; pulsed radiofrequency