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临床试验/CTRI/2017/08/009550
CTRI/2017/08/009550已完成4 期

A comparative study on efficacy of suprascapular nerve block versus subacromial steroid injection in shoulder impingement syndrome.

IPGMER SSKM Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年8月22日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Shoulder Pain And Disability Index (SPADI)

研究概览

简要总结

Shoulder impingement syndrome is the encroachment of acromion, coraco acromial ligament, coracoid process or acromio-clavicular joint on the rotator cuff muscles. It is the most common musculoskeletal pathology of shoulder joint leading to PM&R OPD visit. Inadequate early treatment leads to progressive stiffness due to pain ultimately leading to adhesive capsulitis. A “pain-less movement-more pain†vicious cycle goes on causing significant difficulty in activities of daily livings (ADL).

Early interruption of the progression of the pathology and symptoms by early diagnosis, short courses of NSAIDs, and a complete stepwise rehabilitation programme for shoulder joint is desired. To hasten the improvement, early intervention or use of modality has a definite positive role. Deep heat modalities like ultrasonic therapy(UST) improves local oedema, helps to get rid of pain producing substances & improves symptoms as well as the pathology.

Intraarticular corticosteroid injection by sub-acromion approach is an age-old treatment procedure for impingement syndrome. But it has shown mixed results mostly in some external impingement variants. It should be avoided in even minute tear in cuff tendons & where joint space decompression is required as some studies as well as textbooks suggested a small chance of progression of partial tear into a complete one after misplaced corticosteroid injection directly in the cuff tendon.

For the last a few years, selective nerve block is been established as one of most feasible and effective intervention in regional painful conditions. Because the degree of neural blockade depends on the drug’s potency and the amount that reaches the nerve fibers, a nerve block can be effective only if it is injected at the the point nearest the nerve. Interestingly most of the afferent supply around the shoulder is by suprascapular nerve, which can be approached from skin, being easily guided by the anatomical landmarks.

So, suprascapular nerve block is effective for managing acute or chronic pain at shoulder. It is a valuable adjunctive therapy in impingement syndrome because it creates a pain-free window period that facilitates therapeutic exercises and restores activities by relieving pain. Among various nerve block techniques, suprascapular nerve block is an effective, feasible, simple, and practical method for the management of shoulder pain following impingement syndrome.

In our study we would try to compare the efficacies of suprascapular nerve block and subacromial steroid injection in patients with shoulder pain due to impingement syndrome. Not many studies have been done to compare the effects of both these accepted methods of treating shoulder pain.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • (1) Clinically suggestive and USG and/or MRI confirming Neer Stage I & II impingement.
  • (2) Not sufficiently responding to conservative treatment over 8weeks.
  • (3) Aged 20 to 60 years.
  • (4) Pain defined as a score of 5 points or more on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain).
  • (5) Patient mentally sound enough to communicate and participate in the study and can understand the parameters well.

排除标准

  • USG showing Rotator cuff tear.
  • Bleeding or clotting disorders.
  • Patients refusing intervention or participation.
  • The presence of another obvious associated cause for the pain (i.e., Primary osteoarthritis of glenohumeral joint, fracture, radiculopathy, myofascial pain, central neuropathic pain)
  • Severe motor weakness (muscle power of deltoid less than grade 2 on the manual muscle test).
  • Patients with Post myocardial infarction, Post stroke, Post mastectomy, prolonged immobilization.
  • The presence of an unstable medical condition or a known uncontrolled systemic disease, including cancer, diabetes, rheumatoid arthritis, endocrine disease, major depression, schizophrenia, & patients with persistent very high level of ESR & CRP.
  • Patients with contraindications of steroid injections i.e. overlying soft tissue sepsis, bacteraemia, anatomic inaccessibility, uncooperative patient, uncontrolled bleeding diathesis etc.
  • Patients who got intra-articular injection in shoulder within last six months.

结局指标

主要结局

Shoulder Pain And Disability Index (SPADI)

时间窗: At baseline, Postprocedure 2 weeks, 4 weeks & 12weeks.

次要结局

  • Pain (VAS) score (0 to 10)(At baseline, Postprocedure 2 weeks, 4 weeks & 12weeks.)

研究者

发起方
IPGMER SSKM Hospital
申办方类型
Government medical college

研究点 (1)

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