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临床试验/CTRI/2026/02/104080
CTRI/2026/02/104080尚未招募2 期

A Comparative Study between Pulsed Radiofrequency neuromodulation of three nerves of shoulder joint i.e Suprascapular, Axillary and Lateral pectoral nerve along with Glenohumeral joint hydrodistension vs Pulsed Radiofrequency neuromodulation of the Suprascapular nerve along with Glenohumeral joint hydrodistension for treatment of Adhesive Capsulitis. A Prospective Randomised Controlled trial

CENTRAL HOSPITAL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月17日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1

研究概览

简要总结

All patients in both groups will undergo shoulder radiography before the treatment, and the etiology of adhesive capsulitis documented by magnetic resonance imaging (MRI) findings and clinically.

After checking patient’s written informed consent for the procedure and NPO status, patients will be shifted to operation theatre. In the operative room, a 20 G I.V cannula will be inserted and co-loading will be done with crystalloid (RL). Monitoring will include pulse oximetry, non-invasive blood pressure, 5 lead standard electrocardiogram (ECG). All the patients in both groups will be informed about procedure, NRS and SPADI scoring system. Patients in both groups will be placed in respective lateral position (right lateral for left shoulder joint procedure and vice versa). Grounding electrode adhesive pad will be applied to another arm/forearm. Pre-scanning will be done prior to procedure.All the procedures will be done under ultrasound guidance using high frequency linear probe.Under aseptic precautions and local anesthesia (1% lignocaine), Radiopaque radiofrequency cannula (Avanos®, 22 G, 100 mm*10 mm) will be introduced. Before radiofrequency neuromodulation, further needle position will be confirmed with sensory and motor stimulation done at 50 Hz up to 0.6 V and 2 Hz up to 1.2 V respectively.

In group P1 Pulsed RF neuromodulation will be done for Suprascapular nerve at 42 degree C for 240 sec.

In group P3 Pulsed RF neuromodulation will be done for Suprascapular nerve, Lateral pectoral nerve and Axillary nerve at 42 degree C for 240 sec.

For Lateral pectoral nerve PRF, probe will be placed in transverse plane, and needle introduced in-plane approach from lateral to medial side. For Suprascapular nerve PRF, probe will be placed along spine of scapula in transverse plane and needle introduced in-plane approach. For Axillary nerve, probe was placed in coronal plane, along the long axis of humerus and needle introduced in-plane approach. This will be followed by instillation of 1 ml of a 10 ml solution containing 18 mg ropivacaine and 40 mg triamcinolone.

After Pulsed Radiofrequency neuromodulation, Hydrodistension of glenohumeral joint (25% Dextrose 20 ml + Ropivacaine 0.2% 10 ml + distilled water 10 ml) will be done using 20 G Quincke’s spinal needle in both the groups. Hydrodistension will be done in posterior approach, probe will be placed below the spine of scapula and needle introduced in-plane from lateral aspect of the probe. It will be done till the visible joint capsule distension on USG. It will be further confirmed with jet of injected fluid coming out of spinal needle hub after removal of syringe. After procedure shoulder joint movement will be done passively.

All the patients will be discharged on same day and will be reviewed after 15 days and 3 months, 6 months and 12 months. Patients will be followed up regarding pain and range of motion using NRS score, SPADI score and Goniometer.

Patients will be evaluated using a numeric rating scale (NRS) for pain, ranging from none (0) to extreme. The Shoulder Pain and Disability Index (SPADI), a 13-item scale, was used to assess improvement in shoulder function ( 0-20 : Mild pain and disability, 21-40 : Moderate, 41-60 : Severe ,61-80 : Very severe, 81-100 : Extremely severe pain and disability ). The NRS and SPADI, will be measured before the treatment and at 15 days, 1 month, 3 months, 6 months, 12 months after the treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with Chronic pain (existing for more than three months at the time of examination) in the shoulder diagnosed as Adhesive Capsulitis 2.Refractory to conservative treatment 3.Willing to give consent for study 4.The positive effect of the test blockade of the suprascapular, axillary and lateral thoracic nerves with a local anaesthetic (reduction of the pain level from the baseline according to NRS by at least 50%).

排除标准

  • 1.Red flag signs- trauma leading to fracture, dislocation, complete tear, malignancy, septic arthritis 2.Allergy to local anaesthetics, drugs 3.Localized infection at site, Fever 4.Coagulopathy 5.Pregnant females 6.Patient on pacemakers 7.Instability of the shoulder joint 8.Cervical radiculopathy.

研究者

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

Dr Krishna Poddar

CENTRAL HOSPITAL, SOUTH EASTERN RAILWAYS, GARDEN REACH, KOLKATA

研究点 (1)

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