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

NCT05951322 | Completed Phase 3 DMC

• 1 other identifier: ECM#2023-1102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sub Acromial Impingement Syndrome

Keywords

Extra corporeal shock wave; phonophoresis; sub acromial impingement syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• 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.

  6 weeks

Secondary Outcomes (4)

• Functional disability

  Baseline

• Functional disability

  6 weeks

• Range of motion

  Baseline

• Range of motion

  6 weeks

Study Arms (2)

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)

Device: Shockwave therapy

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.

Device: Phonophoresis

Interventions

Shockwave therapy DEVICE

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

Shockwave therapy

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.

Phonophoresis

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Phonophoresis

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Drug Administration Routes; Drug Therapy

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome asseser is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 19, 2023
• Study Start: January 8, 2023
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: In one month

Locations

SA (1)