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Clinical Trials/NCT05951322
NCT05951322
Completed
Phase 3

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 site in 1 country30 target enrollmentJanuary 8, 2023

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Sub Acromial Impingement Syndrome
Sponsor
Prince Sattam Bin Abdulaziz University
Enrollment
30
Locations
1
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2023
End Date
June 8, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gopal Nambi

Principal Investigator

Prince Sattam Bin Abdulaziz University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Pain intensity

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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