search
Back to results

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

Primary Purpose

Sub Acromial Impingement Syndrome

Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Shockwave therapy
Phonophoresis
Sponsored by
Prince Sattam Bin Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sub Acromial Impingement Syndrome focused on measuring Extra corporeal shock wave, phonophoresis, sub acromial impingement syndrome

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Gopal Nambi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shockwave therapy

Phonophoresis

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Pain intensity
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
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 Outcome Measures

Functional disability
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.
Functional disability
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.
Range of motion
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.
Range of motion
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.

Full Information

First Posted
June 9, 2023
Last Updated
July 10, 2023
Sponsor
Prince Sattam Bin Abdulaziz University
search

1. Study Identification

Unique Protocol Identification Number
NCT05951322
Brief Title
Extra Corporeal Shock Wave Versus Phonophoresis in Sub Acromial Impingement Syndrome.
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 8, 2023 (Actual)
Primary Completion Date
June 8, 2023 (Actual)
Study Completion Date
June 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sub Acromial Impingement Syndrome
Keywords
Extra corporeal shock wave, phonophoresis, sub acromial impingement syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants were identified and recruited over 5-month period. Thirty-six patients diagnosed clinically with shoulder impingement syndrome (according to location of trigger points at rotator cuff muscles and aggravation of pain with overhead activities) were randomly assigned in two groups.
Masking
Outcomes Assessor
Masking Description
The outcome asseser is blinded.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shockwave therapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Phonophoresis
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Shockwave therapy
Intervention Description
Radial extracorporeal shock wave device, it is serial number (1107394), medispec and connected to electrical supply 115/220 A C frequency.
Intervention Type
Device
Intervention Name(s)
Phonophoresis
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
Baseline
Title
Pain intensity
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Functional disability
Description
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.
Time Frame
Baseline
Title
Functional disability
Description
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.
Time Frame
6 weeks
Title
Range of motion
Description
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.
Time Frame
Baseline
Title
Range of motion
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dr. Gopal Nambi
City
Al Kharj
State/Province
Riyadh
ZIP/Postal Code
11942
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
In one month

Learn more about this trial

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

We'll reach out to this number within 24 hrs