A Randomized Controlled Trial Comparing the Efficacy of Intra-articular Steroid Injection and Pericapsular Nerve Group (PENG) Block for Pain Control and Functional Outcomes in Patients Undergoing Manipulation Under Anesthesia (MUA) for Frozen Shoulder.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Pain reduction (NPRS) within 24 hours post-MUA.
研究概览
简要总结
Patients satisfying the inclusive criteria will be prepared for procedure with standard monitoring.
Randomization will be done by computer generated random number and allocation will be done by Sequentially numbered, opaque, sealed envelope (SNOSE technique), the randomization group is written on a paper and is kept in an opaque sealed envelope. The envelope is labeled with a serial number by a person who is not part of the study. The envelope will be opened, and the group will be allocated by staff nurse who is not the part of the study.The following procedure will be performed by an Anesthesiologist who has 5 years experience with Ultrasound usage.The outcomes will be recorded by the Anaesthesiologist.
Group A (Intra-articular Steroid Injection Under sterile conditions, a corticosteroid (inj Triancinolone 40mg) with 2%2ml and 0.5% Bupivacine 2ml will be injected into the pericapsular region under ultrasound guidance.
Injection will be administered immediately before the MUA procedure
Group B (PENG Block):
- The PENG block will be performed under ultrasound guidance targeting the articular branches of the shoulder joint.
- A local anaesthetic (e.g., 0.5% bupivacaine 10 mL+2% Lidocaine 10ml ) will be used, and the block will be performed prior to MUA.
Study Procedure 1. Baseline Assessment:
o Pain assessment (NPRS). o Range of motion (ROM) measurements. o Functional assessments using SPADI scores.
- Randomization: o Patients will be randomly assigned to one of the two intervention groups. o Randomization will be conducted using a computer-generated sequence.
o AllocationwillbedonebySequentiallynumbered,opaque,sealedenvelope(SNOSE technique)
o Its Superior Trial o NoBlindinginthisstudy o Withdrawncriteria:Failureofblock,patientrefusedaftertheconsentandorlossoffollow-
up the patient o Rescuecriteria:ifpatientisnotsatisfiedwiththepainrelieswillRefertotheOrtho
department for the surgical intervention. o CTRI:applied
-
Intervention: o Pericapsular steroid injection or PENG block will be administered prior to MUA.
-
Post-MUA Assessments:
o Pain: NPRS scores will be recorded at 1 hour, 6 hours, 12 hours, and 24 hours post- procedure.
o ROM: Shoulder ROM will be assessed immediately post-procedure and at follow-up visits.
o Functional outcomes: SPADI scores will be assessed at24 hrs 1 week and 1 month post- procedure.
o Duration of analgesia and any complications will be documented. 8. Outcome Measures
Primary Outcome: • Pain reduction (NPRS) within 24 hours post-MUA.
Secondary Outcomes:
- Change in shoulder ROM from baseline to post-MUA and follow-up visits.
- Functional improvement as measured by SPADI scores.
- Duration of analgesia.
- Incidence of complications or adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Candidates for MUA based on clinical evaluation and failure of conservative management Willingness to participate and provide informed consent.
排除标准
- •1.Patients with contraindications to regional anesthesia or steroid use (e.g., infections, allergy, coagulopathy).
- •Previous shoulder surgery or trauma.
- •Neurological or other musculoskeletal disorders affecting shoulder function.
- •Pregnancy or lactation.
结局指标
主要结局
Pain reduction (NPRS) within 24 hours post-MUA.
时间窗: 24 hours
次要结局
- Change in shoulder ROM from baseline to post-MUA & follow-up visits. Functional improvement as measured by SPADI scores.Duration of analgesia.(Incidence of complications or adverse effects.)
研究者
Dr Sangeeta Dhanger
Indira Gandhi Medical College & Research Institute