Anatomical Evaluation of Supraspinatus Through Ultrasonography and Biomechanical Measurements Following Different Combinations of Physical Therapies in Patients of Supraspinatus Tendinitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Shoulder Joint Range of Motion from 0-180 degree
研究概览
简要总结
A randomized controlled trial will be conducted to get the expected outcomes. Patients of both gender groups with unilateral shoulder pain will be selected with age range 40-60 years from Sehat medical complex and randomly allocated into four groups (Group A, B, C and D) of two different trials (Trial I and Trial II). The sample size will be 120 patients for both trials. Musculoskeletal ultrasound, goniometry, pain pressure threshold, dynamometer and functional indices will be used to measure the tendon thickness, range of motion, pain, muscle strength and function level. The group A will get BFRT, Group B will get ESWT, group c will get the combination of both and group D will be the Control group (Routine physical therapy). In Trial II the group A will get BFRT, Group B will get Eccentric Training, Group C will get combination of both A & B and group D will be control group. data will be collected at baseline, 4th week, 8th week and 12 week of interventions. For data analysis SPSS version 25 will be used. Repeated measures ANOVA will be applied to compare the quantitative data within and between the groups. Post-Hoc test Tukey and Bonferroni correction will be used. The level of significance will be set at 5% (P<0.05).
详细描述
Musculoskeletal (MSK) disorders affect 1.71 billion people globally. In Pakistan 3.7-20% people are suffering from shoulder pain and while other rotator cuff muscles have been targeted with various therapies singly, neither supraspinatus tendinitis has received its due attention nor has the effect of combination of therapies been explored on it. Additionally, using the technique of MSK ultrasound will give us an objective quantitative basis for the anatomical evaluation. The tendon dimensions and biomechanical measurements of the supraspinatus show marked and differential improvement under the influence of different combinations of physical therapies compared to any single therapy.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral shoulder pain
- •both gender group
- •two positive tests of (Neer impingement test, Hawkins-Kendy test, Empty can test),
- •shoulder pain history up to 3 months
- •not receiving any physiotherapy last 3 months.
- •not receiving pain medications (NSAIDS) for last 15 days.
排除标准
- •referred shoulder pain
- •limited shoulder ROM less then 90 degree
- •previous shoulder surgery, intra articular injection or nerve block last 6 months.
- •patient with 180 mmHg blood pressure/uncontrolled BP
- •upper limb fracture, uncontrolled diabetes, open wounds, fistula and vascular surgery.
- •pregnant woman or 6 month history of pregnancy
研究组 & 干预措施
Control Group D
Control group with routine physical therapy
干预措施: Control (Other)
Group A (Blood Flow Restriction Therapy)
4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley
干预措施: Blood flow Restriction therapy (Other)
Group B (Extracorporeal Shock wave therapy)
10 minutes shocks of 2000 J/session
干预措施: ESWT (Device)
Group C (Combination of BFRT+ESWT)
Interventional study group Combination therapy
干预措施: Blood flow Restriction therapy (Other)
Group C (Combination of BFRT+ESWT)
Interventional study group Combination therapy
干预措施: ESWT (Device)
结局指标
主要结局
Shoulder Joint Range of Motion from 0-180 degree
时间窗: 12 weeks
shoulder joint ROM will be measured by Goniometer having 360 degree or inclinometer
MSK Ultrasound for shoulder
时间窗: 12 weeks
tendon thickness in long (mm) and short axis (mm)
Shoulder Functional scale
时间窗: 12 weeks
Quick-DASH (Quick-Disability of arm shoulder and hand) functional scale, it is 11 items scale with response range 0-5 on. 0 is no disability and 100 shows severe disability. The scale have 5 response options much worse, somewhat worse, unchanged, somewhat better, much better
Shoulder Joint PAIN
时间窗: 12 WEEKS
NPRS 0-10 , 10 is the worse imaginable pain and 0 is no pain
Shoulder Muscle Strength
时间窗: 12 weeks
Manual muscle testing and Dynamometer
次要结局
未报告次要终点