跳至主要内容
临床试验/CTRI/2025/07/091074
CTRI/2025/07/091074尚未招募不适用

Pain Relief and Functional Recovery After Shoulder Manipulation Under Interscalene vs. Combined Suprascapular and Axillary Nerve Blocks in Frozen Shoulder: A Randomized non inferiority Trial

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年7月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
142
试验地点
1
主要终点
change in SPADI score after 4weeks month following

研究概览

简要总结

After obtaining approval from the Post-graduate Research Monitoring Committee and JIPMER ethics committee (human studies), and completing Clinical Trial Registry India(CTRI) registration, patients fulfilling the eligibility criteria will be recruited for the study after obtaining written informed consent. Baseline recording of SPADI score, Constant Murley Shoulder outcome score will be taken. The patients will be randomly allocated into 2 groups, Group 1 (receiving Suprascapular nerve block and axillary nerve block), Group 2 (interscalene nerve block alone) . Prior to any intervention, the patient will be assessed with Shoulder Pain and Disability score (SPADI) and Constant-Murley Shoulder outcome score. (6) . The need for pain medication will be assessed using the Medication Quantification Scale (MQS III). All standard ASA monitors including non-invasive blood pressure, pulse oximetry, ECG will be attached. Baseline hemodynamic parameters like heart rate, blood pressure and spo2 will be recorded. An appropriately sized IV cannula will be secured. Patients belonging to Group 1 will receive ultrasound guided Suprascapular nerve block and axillary nerve block. With the patient in sitting position, Suprascapular nerve will be blocked at the level of suprascapular notch with 5 ml of 0.5%Bupivacaine after identifying the suprascapular artery using doppler. Axillary nerve is blocked at the quadrilateral space with 5 ml of 0.5%Bupivacaine after identifying the posterior circumflex humeral artery. Patients belonging to group 2 will receive ultrasound guided Interscalene brachial plexus blocks with 10 ml of 0.5% Bupivacaine, with the patient in supine position and head turned slightly to the opposite side. Blocks will be performed by a person who has done at least 50 USG guided nerve blocks. After 15 minutes of giving the block, Orthopedic surgeon/ Physical therapist involved in the study will do the shoulder manipulation using Codman’s paradox method. One orthopaedic surgeon and one physical therapist have been involved in the study and the manipulation will be done by one of them. It includes three consecutive 90° rotations - elevation, swing, and descending movements. (1) Starting position: The patient hangs his or her arm along the side with the thumb pointing forward and fingers pointing toward the ground. (2) Elevation (first move): The arm is elevated 90° in the sagittal plane without rotation about the humeral shaft axis (i.e. thumb points upward and fingers point forward). (3) Swing (second move): The arm is moved 90° to the coronal plane without rotation about the humeral shaft axis (i.e. fingers now point to the right or left for the right and left shoulders, respectively). (4) Descending (third move): Finally, the arm is lowered 90° downward (i.e. fingers point to the ground). After these three rotations, the patient will notice that the thumb points to the right or left (for the right and left shoulders, respectively), which means that the arm has rotated by 90°. Patients in both groups will be given intraarticular Methylprednisolone injection 40 mg in volume of 10 ml after the shoulder manipulation.Clinician assessment Patients will be observed until the block effect wears out. Any complications will be noted and satisfactory manipulation using Likert scale will be noted. SPADI and Constant-Murley Shoulder outcome score will be noted after 4 hours of the procedure. Patients will be advised to continue physiotherapy and RoM exercises. Patients will be reviewed every week on telephone to motivate them to continue physiotherapy. After 1 month the patient will be reviewed in pain clinic to assess SPADI, Constant-Meyer Shoulder outcome score and pain medication requirement using MQS III scale will be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age 18 years to70 years.
  • ASA class 1 & 2
  • Patients diagnosed with frozen shoulder having shoulder pain and reduced range of motion for 3 months.

排除标准

  • Previous shoulder surgery
  • Interventional pain procedures for shoulder pain in the last 6 months
  • Cervical spine disease
  • Patients suspected with rotator cuff injuries
  • Bleeding disorders
  • Allergy to the local Anesthetics
  • Local site infection.

结局指标

主要结局

change in SPADI score after 4weeks month following

时间窗: SPADI score at Baseline and 4 weeks month post intervention

shoulder manipulation

时间窗: SPADI score at Baseline and 4 weeks month post intervention

次要结局

  • 1. To assess the satisfaction of the clinician performing the after 4 hr(shoulder manipulation using a Likert scale)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anjali Dutta

Jawaharlal Institute of Postgraduate Medical Education & Research

研究点 (1)

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