Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients .
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- change of range of motion from base line
研究概览
简要总结
Atotal of 150 consecutive patients with chronic supraspinatous tendinopathy were invited to participate in the study .patients were recruited from the out patient clinic of rheumatology and rehabilitation department,Mansoura university hospital
a. perineural injection therapy group (subcutaneous prolotherapy) This group included 30 patients aged from 18 to 60 years Deep prolotherapy injection group The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine. The pathological area of the supraspinatous tendon was identified and graded using ultrasound pathology rating scale guided by ultrasonography (Simens Acuson p300 machine) Proper preparation with antiseptic solution of skin overlying the point of injection .
详细描述
Baseline Evaluation
All patients were subjected to the following:
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Thorough History Taking
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Personal history: collected data include: age, sex, marital status, handedness, special habits and the current occupation.
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Complaint in the patient's own words.
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Present History he current symptoms, mode of onset, duration, , factors that may aggravate or relieve pain Characters of pain (dull aching,sharp pain ,burning sensation ,parasthesia). Distribution of pain . Review of systems: symptoms related to rheumatic conditions in particular conditions with predilection for shoulder joint affection.
Symptoms suggestive of medical disorders e.g. diabetes mellitus or thyroid dysfunction. 4. Past History Previous significant trauma(direct or occupational) orsugery to shoulder. Previous steroid injection to the shoulder. Previous injection of any type of regenerative medicine (as prp) 2. Thorough General Examination
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 20 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with supraspinatous tendinopathy
排除标准
- •Shoulder joint instability omplete rotator cuff tear Adhesive capsulitis Septic arthritis Malignancy Coagulopathy Connective tissue diseases Spondyloarthropathies Previous corticosteroid injection in the last six months. Previous other forms of regenerative injection therapy (e.g prp injection therapy) in the last six mo
研究组 & 干预措施
perineural injection group
perineural injection therapy group (subcutaneous prolotherapy) This group included 30 patients aged from 18 to 60 years
Buffered glucose preparation :
2.4 ml of Na Bicarbonate 8.4% are mixed with 500ml dextrose 5%.
Patients received 8 weekly injection sessions at sites of chronic constriction injurey of the following nerves :
Suprascapular nerve..
干预措施: subctaneous perineural injection (Other)
deepprolotherapy group
Deep prolotherapy injection group The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine. The pathological area of the supraspinatous tendon was identified and graded using ultrasound pathology rating scale guided by ultrasonography (Simens Acuson p300 machine) Proper preparation with antiseptic solution of skin overlying the point of injection .
干预措施: deep prolotherapy (Other)
结局指标
主要结局
change of range of motion from base line
时间窗: immediately before injection,2 monthes after injection,3 monthes after injection
III.Examination of passive and active range of motion using goniometer based on the description of norkin and white as following * Abduction ;170 * Adduction :50 * Flexion :165 * Extension:60 * Internal rotation at 90 abduction :70 * External rotation at 90 abduction :100
change of pain from baseline
时间窗: immediately before injection,2 monthes after injection,3 monthes after injection
The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain
次要结局
- change of function from base line(immediately before injection,2 monthes after injection,3 monthes after injection)