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临床试验/NCT05951322
NCT05951322已完成3 期

The Influence of Extra Corporeal Shock Wave Versus Phonophoresis on Pain Severity and Functional Disability in Patients With Sub Acromial Impingement Syndrome. A Randomized Clinical Trial.

Prince Sattam Bin Abdulaziz University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月8日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. Activities requiring repetitive or sustained use of the arms over head often predispose the rotator cuff tendon to injury. Hence the objective of the study is to examine the influence of extra corporeal Shock wave versus phonophoresis on pain severity and functional disability in patients with sub acromial impingement syndrome.

详细描述

Background: shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. Activities requiring repetitive or sustained use of the arms over head often predispose the rotator cuff tendon to injury. Objective of the study: To examine the influence of extra corporeal Shock wave versus phonophoresis on pain severity and functional disability in patients with sub acromial impingement syndrome. Subjects and Methods: Thirty patients diagnosed as shoulder impingement syndrome stage II Neer classification due to mechanical causes. Patients were randomly distributed into two equal groups. The first group consisted of 15 patients with a mean age of 45.46 (+ 8.64) received therapeutic exercises( stretching exercise of posterior shoulder capsule and strengthening exercises of shoulder muscles) and shockwave therapy (6000 shock, 2000/session, 3 sessions, 2 weeks a part, 0.22mJ/mm2) years. The second group consisted of 15 patients with a mean age of 46.26 (+ 8.05) received same therapeutic exercises and phonophoresis (3 times per week, each other day, for 4 consecutive weeks). Patients were evaluated pretreatment and post treatment for shoulder pain severity, shoulder functional disability, shoulder flexion, abduction and internal rotation motions.

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
Single (Outcomes Assessor)

盲法说明

The outcome asseser is blinded.

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The patient reported a positive "Neer sign" and" Hawkins sign".
  • •The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and over head playing athletes).
  • •The patient reported pain with palpation of the rotator cuff tendons.
  • •The patient reported pain with resisted isometric abduction.

排除标准

  • •Frozen shoulder.
  • •Rotator cuff tear.
  • •Glenohumeral or acromioclavicular arthritis.
  • •Implented pace maker.
  • •Pregnancy

研究组 & 干预措施

Shockwave therapy

Experimental

All patients were received (ESWT) at sitting position, exposed the affected shoulder, the shoulder adducted and elbow extended and the shock wave applicator was directed in most tender point near the insertion of rotator cuff at greater tuberosity under the acromion [23].

The treatment area was prepared with a coupling gel to minimize the loss of shockwave at the interface between applicator tip and skin.

Each patient was received (6000 shocks,21000 shock/ session, 3 session 2 weeks apart, energy flux density 0.22 mJ/mm2, energy level 5-7, pulse rate 160/min., 2-3Hz)

干预措施: Shockwave therapy (Device)

Phonophoresis

Active Comparator

Pagani ultrasound apparatus 200 cosistts of multi frequency head(1 and 3 MHz), surface area 4 cm², continuous and pulsed mode, main voltages: 100-240-VAC.50/60Hz.

干预措施: Phonophoresis (Device)

结局指标

主要结局

Pain intensity

时间窗: 6 weeks

Pain assessed by (Visual analog scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10cm line with 0 (no pain) and 10 (worst pain) on the other end .Patients were asked to place a mark a long the line to denote their level of pain.

Pain intensity

时间窗: Baseline

Pain assessed by (Visual analog scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10cm line with 0 (no pain) and 10 (worst pain) on the other end .Patients were asked to place a mark a long the line to denote their level of pain.

次要结局

  • Range of motion(6 weeks)
  • Functional disability(6 weeks)
  • Functional disability(Baseline)
  • Range of motion(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gopal Nambi

Principal Investigator

Prince Sattam Bin Abdulaziz University

研究点 (1)

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