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.: PACTR202204802502473 Date of Approval: 19/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of diaphragm strength in mechanical low Back pain
Official scientific title Role of diaphragm strength in mechanical low Back pain
Brief summary describing the background and objectives of the trial Increasing attention is being drawn towards the involvement of systems other than the musculoskeletal one in the presence of low back pain (LBP). Recent evidence suggests that cognitive and respiratory functions affect low back pain patients. (Gosheha et all,2017) •objective:-Investigate the effect of diaphragm strength in mechanical low back pain
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 08/05/2022
Actual trial start date
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not 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 a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group power lung device training patients will receive training by the power lung device (trainer) for six successive weeks, 3 times per week. Plus, traditional back pain exercises in form of core stability exercises; Curl-Up, Side-Bridge, and Bird-Dog. six successive weeks, 3 times per week. patients will receive training by the power lung device (trainer) for six successive weeks, 3 times per week. Plus, traditional back pain exercises in form of core stability exercises; Curl-Up, Side-Bridge, and Bird-Dog. 30
Control Group Traditional back pain exercises for six successive weeks, 3 times per week. Traditional back pain exercises in form of core stability exercises; Curl-Up, Side-Bridge, and Bird-Dog. for six successive weeks, 3 times per week. patients will receive traditional back pain exercises in form of core stability exercises; Curl-Up, Side-Bridge, and Bird-Dog. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Subject’s age will range from 20to 40 years old. (Chul et all,2016). 2. In the initial clinical examination, the subject complained of mechanical LBP for more than three months. 3. referred by out clinic of Kasr-AL.Ainy. 4. All subjects' body mass index was <30 Kg/m2. 1. Patients with acute /chronic disc prolapse. 2. Spondylolisthesis with or without disc prolapse. 3. Post laminectomy syndrome. 4. Other neurological, orthopedic conditions 5. Patients with mental disorders make cooperation impossible. 6. Any chest problem and/or disease Adult: 19 Year-44 Year 20 Year(s) 40 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 27/12/2021 faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat street Giza 11511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome FVC (forced vital capacity), FEV1(forced expiratory volume in the first second), FEV1/FVC (forced expiratory volume in the first second /forced vital capacity ratio), PEF (peak expiratory flow), and (MVV)maximum voluntary ventilation. before and after intervention
Secondary Outcome Pain assessment by Numerical pain rating scale before and after intervention
Secondary Outcome The functional disability of each patient was assessed by the Oswestry disability questionnaire. before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr EL Ainy hospital Kasr EL-Ainy street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Shimaa Ahmed Eid 7 Kasr ELAiny street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasr EL Ainy hospital 1 Kasr EL Ainy street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shimaa Ahmed Eid Ahmed Dr.shaimaa.eid@gmail.com 00201009572360 7 Kasr EL Ainy
City Postal code Country Position/Affiliation
Cairo Egypt Physical therapy specialist at Kasr EL Ainy hospital
Role Name Email Phone Street address
Public Enquiries Magda Ramadan Zahran magdaramadan2000@yahoo.com 01025891348 28 Faysal street
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of Physical Therapy Department of Basic Science Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Hussein Elgendy prof.mgendy@hotmail.com 00201005747169 20 of 6 October city motamiz street
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy Department of Basic Science Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data thatunderlie the results reported inthis article, afterdeidentification (text, tables,figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months period time after publication Controlling access to data
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