跳至主要内容
临床试验/CTRI/2025/12/099099
CTRI/2025/12/099099尚未招募Phase 3 4

Arthroscopic Subacromial decompression vs conservative management in subacromial impingement- A prospective comparative study

SHIVANAND S1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

Subacromial impingement syndrome (SAIS) is one of the most common causes of shoulder pain, accounting for nearly 44–65% of shoulder disorders. It occurs due to compression of the rotator cuff tendons beneath the acromion, leading to inflammation and bursitis. While both conservative treatment and arthroscopic subacromial decompression (ASD) are widely used, there is ongoing debate regarding which approach offers superior functional outcomes.

Aim:

To compare the functional outcomes of arthroscopic subacromial decompression versus conservative management in patients with subacromial impingement.

Study Design:

A prospective randomized controlled trial conducted among adults aged 20–60 years diagnosed clinically and radiologically with subacromial impingement. A total of 60 patients were randomized into two equal groups: one receiving arthroscopic decompression and the other undergoing conservative management (physiotherapy, anti-inflammatory medication, subacromial injections).

Methodology:

Block randomization was employed. Functional outcomes were assessed at 3 weeks, 6 weeks, 3 months, and 6 months using the Constant Score, American Shoulder and Elbow Surgeons (ASES) Score, and SF-36 questionnaire.

Inclusion and exclusion criteria ensured homogeneity and eliminated confounding factors such as rotator cuff tears, arthritis, or prior shoulder surgery.

Ethical Considerations:

Ethical approval was obtained, and informed consent was secured from all participants. Confidentiality and the right to withdraw at any stage were ensured.

Expected Outcomes:

It is hypothesized that arthroscopic subacromial decompression will provide better pain relief, improved range of motion, and superior functional recovery compared to conservative management, though both methods have individual merits.

Significance:

This study aims to provide evidence-based clarity on the optimal management strategy for subacromial impingement, guiding clinicians toward more effective, patient-centered treatment decisions.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • 60yrs Clinical and Radiological diagnosis of subacromial impingement. Neer subacromial impingement classification types 1– 3 Shoulder pain for more than 6 months.

排除标准

  • Radiographic features suggestive of osteoarthritis Presence of total rotator cuff rupture Previous history of surgery to the affected shoulder.
  • Previous history of fracture to the affected shoulder.
  • Calcification exceeding 2cm in the rotator cuff tendons.
  • Any neurological or spinal disorder or uncontrolled Diabetes Mellitus.

研究者

发起方
SHIVANAND S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

SHIVANAND S

SRM MEDICAL COLLEGE AND RESEARCH CENTRE, SRM UNIVERSITY

研究点 (1)

Loading locations...

相似试验