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

NCT ID: NCT05951322

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-08
• Study Completion Date: 2023-06-08

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.

Conditions

Sub Acromial Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Shockwave therapy

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)

Group Type: EXPERIMENTAL

Shockwave therapy

Intervention Type: DEVICE

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

Phonophoresis

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.

Group Type: ACTIVE_COMPARATOR

Phonophoresis

Intervention Type: 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.

Interventions

Shockwave therapy

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

Intervention Type: DEVICE

Phonophoresis

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

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Gopal Nambi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr. Gopal Nambi

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

ECM#2023-1102

Identifier Type: -

Identifier Source: org_study_id