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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202005581156925 Date of Approval: 08/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF ADDING CONTINUAL VERTICAL DOWNWARD CORRECTION TO DYNAMIC SCAPULAR RECOGNITION EXERCISE ON SCAPULAR DYSKINESIS AND SHOULDER PAIN AND DISABILITY IN PATIENTS WITH FROZEN SHOULDER: A RANDOMIZED CONTROLLED TRIAL
Official scientific title EFFECT OF ADDING CONTINUAL VERTICAL DOWNWARD CORRECTION TO DYNAMIC SCAPULAR RECOGNITION EXERCISE ON SCAPULAR DYSKINESIS AND SHOULDER PAIN AND DISABILITY IN PATIENTS WITH FROZEN SHOULDER: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial OBJECTIVE: This study was conducted to study the effect of adding a continual vertical downward correction to dynamic scapular recognition exercise on scapular dyskinesis and shoulder pain and disability in patients with frozen shoulder. Methods: A double-blinded randomized controlled study design was used. Sixty- seven (67) subjects with unilateral frozen shoulder were distributed into two groups. The intervention group performed the dynamic scapular recognition exercise and continual vertical downward correction using rigid taping with 50%-75% tension. The control group performed a similar dynamic scapular recognition exercise using a wireless biofeedback system and placebo taping. A scapular dyskinesis test with caliper was utilized to measure scapular dyskinesis, a digital inclinometer was utilized to evaluate the scapular upward rotation and shoulder ROMs, and the Shoulder Pain and Disability Index (SPADI) was utilized to evaluate the shoulder pain and disability.
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: Other
Anticipated trial start date 18/11/2018
Actual trial start date
Anticipated date of last follow up 15/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 67
Actual target sample size (number of participants) 67
Recruitment status Completed
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Exercise with Placebo taping 3/week 2 months The control group received continual vertical downward correction using a standardized rigid tape with placebo taping without tension. 33 Placebo
Experimental Group The main intervention 3/week 2 months They received dynamic scapular recognition exercise and a continual vertical downward correction using a standardized rigid tape. A hypoallergenic tape (Hypafix; BSN Medical GmbH, Hamburg, Germany) was used with 50% to 75% tension. Two rigid tapes were applied; the first one is placed from just superior to the midpoint of the superior border of the scapula to the level of T12 and the second tapes were placed from just superior to the superior angle of the scapula to the level of T12. The level of T12 was used as the end of both taps to increase the lever arm of the applied force and to decrease the incidence of peeling off of the tape. No tape was applied from the lateral angle of the scapula because it might impair the upward rotation of the scapula. Both taps were performed after each session and removed immediately prior to the next session. 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The main inclusion criterion was the incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula. More inclusion criteria included a restriction in both passive and active shoulder ROM and the existence of pain that affects performing activities of daily living The exclusion criterion involved the presence of any shoulder problem contraindicated for performing exercises to the shoulder joint, such as active inflammatory disease, cancer, active infection, recent subluxations or dislocations, fractures, and surgeries nearby the shoulder region. Furthermore, the patient was excluded if he/she had no signs of scapular dyskinesis. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 65 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 02/10/2017 The ethicl committee of the Faculty of Physical Therapy at Beni Suef University
Ethics Committee Address
Street address City Postal code Country
New Beni SUef Beni Suef 34563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures were scapular dyskinesis, scapular upward rotation and SPADI 2 months
Secondary Outcome The secondary outcome measures were the ROMs of shoulder flexion, abduction and external rotation 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef University New Beni Suef Beni Suef Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ayman Mohamed New Beni Suef Beni Suef Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ayman Mohamed Cairo Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Motaz Alawna Plastine Tol Karem Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Mohamed dr_ayman_pt@hotmail.com +905550995477 Kristal Sahir
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Motaz Alawna motaz.alawna@gmail.com +906575666333 BaSK SAHIR
City Postal code Country Position/Affiliation
Tol Krem Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Aly Ahmed aly_Ahmed@gmail.com +278755469 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Accountant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Randomized controlled study Study Protocol 2 year N/A
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.clinicaltrials.gov/ct2/show/NCT04369144 Yes After two weeks, there were significant differences between intervention and control groups in scapular dyskinesis, scapular upward rotation, shoulder flexion, and abduction and SPADI (P< .05) and non-significant differences in shoulder external rotation (P>.05). After two and six months, there were significant differences between the intervention and control groups in all dependent outcome measures (P< .05). 31/12/2021 31/12/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.clinicaltrials.gov/ct2/show/NCT04369144
Changes to trial information