Ultrasound Guided Shoulder Intra-Articular Ozone Injection Versus Pulsed Radiofrequency Application for Shoulder Adhesive Capsulitis - A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain score, using Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 30 to 65 years
- •Either gender
- •Diagnosed with Adhesive Capsulitis
- •Inadequate response for conservative therapy (NSAIDs and physiotherapy) for four weeks
排除标准
- •Patients diagnosed with central post-stroke neuropathic pain
- •Patients with documented rheumatoid arthritis
- •Patients with current shoulder fracture or trauma
- •Known causes for secondary adhesive capsulitis (e.g., diabetes)
- •Patients with local tumor at shoulder region
- •Patients with local skin infection over shoulder region
- •Patients with reported coagulopathy
- •Patients with allergy to LA
研究组 & 干预措施
Steroid Group
shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance
干预措施: Steroid Group (Procedure)
Ozone Group
shoulder 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
干预措施: Ozone Group (Procedure)
PRF Group
shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed radiofrequency application under the ultrasound guidance
干预措施: PRF Group (Procedure)
结局指标
主要结局
Pain score, using Visual Analogue Scale (VAS)
时间窗: Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.
Visual analogue scale during rest (VASr) and movement (VASm), pain will be categorized as mild (0-3), moderate (4-6), or severe (7-10). Change in pain score is considered significant when there is a categorical shift in pain level.
次要结局
- Systemic inflammatory markers, using serum High Sensitive C Reactive Protein (hs-CRP) level.(Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).)
- Systemic inflammatory markers, using serum Intracellular Adhesion Molecule (ICAM 1) level.(Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).)
- QOL improvement, using Shoulder Pain And Disability Index (SPADI)(Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.)
研究者
Ahmed Foula
Principal Investigator
Alexandria University