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Completed

NCT Number: NCT05951322

Extra Corporeal Shock Wave Versus Phonophoresis in Sub Acromial Impingement Syndrome.

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.

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Key information

Conditions

Sub Acromial Impingement Syndrome

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shockwave therapy

Device

Radial extracorporeal shock wave device, it is serial number (1107394), medispec and connected to electrical supply 115/220 A C frequency.

Phonophoresis

Device

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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.

  2. 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

  1. Functional disability

    Time frame: Baseline

    It was assessed by using the shoulder pain and disability index (SPADI) which is a valid and reliable index for measuring shoulder pain and disability. It consists of two parts, part one which assesses pain and part two which assesses functional disability. Scores were calculated as follow, in part one pain scores in all questions were added, and the mean value was chosen. In part two functional score of all questions were added and the mean value was chosen for the purpose of data analysis. Final score for each part was statistically analyzed separately.

  2. Functional disability

    Time frame: 6 weeks

    It was assessed by using the shoulder pain and disability index (SPADI) which is a valid and reliable index for measuring shoulder pain and disability. It consists of two parts, part one which assesses pain and part two which assesses functional disability. Scores were calculated as follow, in part one pain scores in all questions were added, and the mean value was chosen. In part two functional score of all questions were added and the mean value was chosen for the purpose of data analysis. Final score for each part was statistically analyzed separately.

  3. Range of motion

    Time frame: Baseline

    In this study the shoulder flexion, abduction and internal rotation were measured by using(Model 01129 Guymon goniometer). It is an electrogoniometer which eliminates the need of manually score each measurement by storing the information internally, it reduces time. It measure any joint angle quickly and accurately. It has range of 0 to 360 and stores up to 80 data points. The validity and reliability of electrogoniometer for shoulder assessment was tested and well documented.

  4. Range of motion

    Time frame: 6 weeks

    In this study the shoulder flexion, abduction and internal rotation were measured by using(Model 01129 Guymon goniometer). It is an electrogoniometer which eliminates the need of manually score each measurement by storing the information internally, it reduces time. It measure any joint angle quickly and accurately. It has range of 0 to 360 and stores up to 80 data points. The validity and reliability of electrogoniometer for shoulder assessment was tested and well documented.

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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