Radial Shockwave Versus Ultrasound Phonophoresis

Radial Shockwave Versus Ultrasound Phonophoresis in Management of Chronic Supraspinatus Tendinitis

Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy)

Study Overview

• Status: Not yet recruiting
• Conditions: Supraspinatus Tendinitis
• Intervention / Treatment: Other: Electro Therapy

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shady Alkadry; Phone Number: +201128398533; Email: shad.bahaa@gmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University
    • Contact: Shady Alkadry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:- BMI 18.5-24.9

• 18 years to 60
• with Unilateral Chronic Supraspinatus Tendinitis.
• Tenderness is found over the supraspinatus as it passes sub-acrominal and anterolateral.
• The patient reported with positive Jobe's test (empty can test)
• The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and overhead playing athletes).
• The patient reported pain with resisted isometric abduction

Exclusion Criteria:

• Case reports, treatments after surgery, did not meet our specified outcome parameters, traumatic incidents,
• Partial tears at surgery
• Massive retracted tears at surgery
• Frozen shoulder.
• Rotator cuff tear.
• Glenohumeral or acromioclavicular arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group 1; 23 subjects will Receive radial shockwave by ( Storz Medical /SN:BS.3517 ) for 3 sessions one session per week for four consecutive weeks and conventional physical therapy	Other: Electro Therapy; radial shockwave 3 sessions one session per week for four consecutive weeks ,receive Ultrasound phonophoresis using diclofenac Na+ 12 session, 3 sessions per week and conventional physical therapy modalities in the form of 3 sessions every week for 8 weeks
Experimental: Experimental group 2; 23 subjects will receive Ultrasound phonophoresis using diclofenac Na+( voltaren) by ( Sonopuls 490 / SN : 36 602 ) for 12 session, 3 sessions per week and same conventional physical therapy	Other: Electro Therapy; radial shockwave 3 sessions one session per week for four consecutive weeks ,receive Ultrasound phonophoresis using diclofenac Na+ 12 session, 3 sessions per week and conventional physical therapy modalities in the form of 3 sessions every week for 8 weeks
Other: Control group; 23 subjects will receive conventional physical therapy modalities in the for 3 sessions per week for 4 weeks in form of Stretching Exercise in form of exercise of posterior shoulder capsule, strengthening exercises all have been recommended as essential for any shoulder rehabilitation program. These exercise include shoulder flexion, scaption. ,Tens applied for 20 minutes per session using (Enraf Nonius (Endomed 482) SN : 36853 )	Other: Electro Therapy; radial shockwave 3 sessions one session per week for four consecutive weeks ,receive Ultrasound phonophoresis using diclofenac Na+ 12 session, 3 sessions per week and conventional physical therapy modalities in the form of 3 sessions every week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the thickness of supraspinatus tendon	Ultrasonography	before start of treatment and 4 weeks following end of treatment
change in pain intesity	VAS ( visual analog scale score)	before start of treatment and 4 weeks following end of treatment , score from 0-10 ,0=no pain , 10= unbearable pain
Change in shoulder range of motion	electro goniometer	before start of treatment and 4 weeks following end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function of the Upper Limb	Quick DASH Questionnaire score	before start of treatment and 4 weeks following end of treatment, it measure the disability/symptom section (11 items, scored 1-5)
measure weight in kg and height in cm	Weight and height scale for determining BMI	before starting the assessment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Shockwave , phonophoresis , supraspinatus tendinitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: P.T.REC/012/005075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No