Evaluation of functional outcomes in shoulder impingement syndrome treated with arthroscopic subacromial decompression and platelet rich plasma (PRP) augmentation
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Outcome
研究概览
简要总结
Shoulder impingement results from an “inflammation and degeneration of the
anatomical structures in the region of the subacromial spaceâ€.
The subacromial space is defined by the humeral head inferiorly, the anterior edge and under surface of the
anterior third of the acromion, coracoacromial ligament, and the acromioclavicular
joint superiorly. The height of space between acromion and humeral head ranges
from 1.0 to 1.5 cm as seen on radiographs (anteroposterior view).
SIS is believed to originate from extrinsic causes, intrinsic causes, or a combination of
both. Extrinsic causes, which result in compression of the rotator cuff tendons and
surrounding tissues, include anatomical variants of the acromion, a thickened
coracoacromial ligament, subacromial bursitis, or postural abnormalities.
Intrinsic causes are associated with degeneration of the rotator cuff tendons and include agerelated
degeneration that may vary in severity according to genetic predisposition, a
deficient vascular supply, a history of intensive work or tobacco. The diagnosis of SIS
is usually based on the patient’s history and on clinical exam such as the impingement
tests.
Painful shoulders pose a substantial socioeconomic burden, accounting for 2.4% of all
primary care consultations in the UK and 4.5 million visits to physicians annually in
the USA. Subacromial pain accounts for up to 70% of all shoulder-pain problems and
can impair the ability to work or do household tasks. The incidence of shoulder
impingement syndrome (SIS) increases as the population ages.
There are 2 types of treatment for SIS: nonsurgical and surgical. The nonsurgical
treatment options that are recommended usually include exercise therapy, subacromial
corticosteroid injection, rest, nonsteroidal anti-inflammatory drugs (NSAIDs),
physical modalities (eg, therapeutic ultrasound, electrotherapy, manual therapy), and
taping.
Surgical treatment involves decompressing the subacromial space by removing the
bone spur and any involved soft tissue arthroscopically, a procedure known as
arthroscopic subacromial decompression. The indications for surgery are persistent
and severe subacromial shoulder pain combined with functional restrictions that are
resistant to conservative measures.
The use of platelet-rich plasma (PRP) as a biological solution for injuries to tendons
of the rotator cuff has achieved popularity over the past several years. PRP is blood
plasma with a high platelet concentration that, once activated, releases various growth
factors involved in the tissue repair process. Early clinical evidence suggests that
PRP improves pain and function outcomes in some tendinopathies compared to
control injection and baseline status. This could be explained by the analgesic effect
of the PRP via the Protease-activated receptors 4 (PAR4) peptides. There is some
evidence demonstrating a positive effect of PRP in tendinopathies and osteoarthritis
of the knee; however, the evidence in rotator cuff tendinopathy is limited.
In spite of increased PRP use in clinical settings, we found only 3 randomized
controlled trials that evaluated the effectiveness of PRP injection in treating rotator
cuff tendinopathy nonsurgically.
In view of advantages of autologous PRP in SIS and reduction of subacromial
impingement by arthroscopic subacromial decompression we plan to study the
evaluation of functional outcome of arthroscopic subacromial decompression and
PRP augmentation in shoulder impingement syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •The inclusion criteria will be skeletally mature patients with shoulder pain lasting for atleast 3 months with clinical diagnosis of shoulder impingement syndrome confirmed with MRI scan.
排除标准
- •Radicular pain.
- •Presence of pathologies such as frozen shoulder, calcific tendinitis, biceps subluxation, and a superior labrum anterior posterior lesion.
- •Previous shoulder surgery within last 6 months.
- •Connective tissue disorders such as rheumatoid arthritis, polymyalgia rheumatica, or fibromyalgia.
- •Full thickness rotator cuff tear on MRI.
- •Ligamentous laxity (positive sulcus test) or shoulder dislocation (positive apprehension test).
- •Prior corticosteroid injection within 3 months of the study.
- •Haemotological and bleeding diathesis.
结局指标
主要结局
Outcome
时间窗: Outcome | will be assessed during follow up period as per VAS Score, Constant Score, UCLA Score at 3 week, 3 months and 6 months
will be assessed during follow up period as per VAS Score, Constant Score, UCLA Score.
时间窗: Outcome | will be assessed during follow up period as per VAS Score, Constant Score, UCLA Score at 3 week, 3 months and 6 months
次要结局
- Any kind of skin reaction, pain and(complication will be noted during follow up period.)
研究者
Dr Raj Singh
Pt.B.D.Sharma PGIMS Rohtak, Haryana
