NCT06386926

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 17, 2024

Last Update Submit

April 24, 2024

Conditions

Keywords

Shockwave , phonophoresis , supraspinatus tendinitis

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

EXPERIMENTAL

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

Experimental group 2

EXPERIMENTAL

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

Control group

OTHER

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

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

Control groupExperimental group 1Experimental group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Cairo university

Giza, Egypt

Location

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

Locations