Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201910650013453 Date of Registration: 21/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title shock wave therapy versus local corticosteroid injection in shoulder impingement syndrome
Official scientific title shock wave versus corticosteroid injection in impingement syndrome
Brief summary describing the background and objectives of the trial this study will conducted to compare the efficacy of shockwave therapy and local corticosteroid injections in shoulder impingement syndrome, Single blind randomized control study and Pretest and posttest design will be used in 3 groups each one will contain 20 patients . \ Group A 20 patients will receive traditional physical therapy program in form of strengthening exercise for rotator cuff muscles and scapular stabilizers and shoulder mobilization exercise( posterior and caudal glide) Group B 20 patients will receive the same traditional physical therapy program in addition to extracorporeal shock¬waves therapy , Swiss DolorClast equipment will be used (figure 9) with a magnitude of 1500 beats at 0.12 mj /mm2 was applied once a week for 3 weeks (Circi E et al.,2018). Group C 20 patients will receive the same traditional physical therapy program in addition to intra-articular corticosteroid injections using was betamethasone dipropionate. ( Huu MN et al 2017) (Barreto RB, et al. 2018).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 30/09/2019
Actual trial start date 01/10/2019
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date 30/01/2020
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group strengthening exercise for rotator cuff muscles and scapular stabilizers and shoulder mobilization 3-4 weeks strengthening exercise for rotator cuff muscles and scapular stabilizers and shoulder mobilization exercise 20 Active-Treatment of Control Group
Experimental Group shock wave 20 patients will receive the same traditional physical therapy program in addition to extracorporeal shock¬waves therapy , Swiss DolorClast equipment will be used with a magnitude of 1500 beats at 0.12 mj /mm2 was applied once a week for 3 weeks (Circi E et al.,2018). 3 weeks 20 patients will receive the same traditional physical therapy program in addition to extracorporeal shock¬waves therapy , Swiss DolorClast equipment will be used with a magnitude of 1500 beats at 0.12 mj /mm2 was applied once a week for 3 weeks (Circi E et al.,2018). 20
Experimental Group corticosteroid injection 20 patients will receive the same traditional physical therapy program in addition to intra-articular corticosteroid injections using was betamethasone dipropionate. ( Huu MN et al 2017) (Barreto RB, et al. 2018). once one shot 20 patients will receive the same traditional physical therapy program in addition to intra-articular corticosteroid injections using was betamethasone dipropionate. ( Huu MN et al 2017) (Barreto RB, et al. 2018). 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
2– Both genders were included (Aktas 2007). 3 –Duration of complaining more than 3 months (Neer ,1983). 4-psitive at least 3 of impingement tests (Neer and Hawkins-Kennedy impingement tests, the painful arc test, Jobe’s test, and the external rotation resistance test (Michener et al., 2009). 5– Pain greater than 5 on VAS. 6–Unilateral shoulder involvement . 7- Impingement syndrome stage II Neer classification. 8-unilateral impingement syndrome. 1 – Frozen shoulders. 2 – Arthritis of the shoulder. 3 - Shoulder instability. 4 – Pregnant women. 5– A pacemaker. 6 – Previous shoulder surgery. 7 – History of dislocation of the shoulder. 8– Internal metallic fixation. 9- Malignancy. 10-previous corticosteroid injection. 11-rheumatoid arthritis 12-full thickness tear of the rotator cuff 13-cervical radiculopathy 14-previous experience with shock wave therapy Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2018 Research ethics committee Faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmed Elziat Giza Giza 0025 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome shoulder ROM The patients were evaluated for these parameters before allocated in their groups then after 4, 8, and 24 weeks later.
Primary Outcome Shoulder Pain and Disability Index The patients were evaluated for these parameters before allocated in their groups then after 4, 8, and 24 weeks later.
Secondary Outcome 3-Diagnostic shoulder ultrasonography before and just after 3 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of Physical Therapy in El Safa hospital Damietta Damietta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ebrahim Elerian 46 B at 77 street . MAADI. Cairo. Egypt . Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Elerian Elmaadi Cairo 0025 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Prof .Dr . Mohamed Elgendi 7 ahmed Elziat Giza 0025 Egypt
Mohamed Mazen 7 ahmed Elziat Giza 0025 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elerian dr_ahmed_elerian77@yahoo.com 002201116752333 Elmaadi
City Postal code Country Position/Affiliation
Cairo 0025 Egypt Ass. Prof. Dr. at Basic science Department. Faculty of physical therapy. Cairo University
Role Name Email Phone Street address
Public Enquiries Ahmed Elerian dr_ahmed_elerian77@yahoo.com 002201116752333 Elmaadi
City Postal code Country Position/Affiliation
Cairo 0025 Egypt Ass.prof.
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elerian dr_ahmed_elerian77@yahoo.com 002201116752333 Elmaadi
City Postal code Country Position/Affiliation
Cairo 0025 Egypt Ass. Prof. Dr. at Basic science Department. Faculty of physical therapy. Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes link to the results summary Study Protocol within 3 years 9/2019- 9/2020 usually open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information