Radial Shockwave Versus Ultrasound Phonophoresis
1 other identifier
interventional
69
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 26, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedApril 26, 2024
April 1, 2024
2 months
April 17, 2024
April 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Function of the Upper Limb
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
before starting the assessment
Study Arms (3)
Experimental group 1
EXPERIMENTAL23 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
Experimental group 2
EXPERIMENTAL23 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
Control group
OTHER23 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 )
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university
Giza, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical therapist
Study Record Dates
First Submitted
April 17, 2024
First Posted
April 26, 2024
Study Start
May 1, 2024
Primary Completion
July 1, 2024
Study Completion
September 1, 2024
Last Updated
April 26, 2024
Record last verified: 2024-04