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.: PACTR201710002660565 Date of Approval: 02/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of forward head posture correction and lumbar stabilization exercises on lumpopelvic organization
Official scientific title Effect of forward head posture correction added to lumbar stabilization exercises on lumbopelvic organization in mechanical low back pain patients: a randomized clinical trial
Brief summary describing the background and objectives of the trial Because mechanical low back pain (LBP) is a common problem with substantial social and occupational consequences, effective treatment is needed. As the diagnosis of LBP tends to be subject to debate, the important question of identifying its effective treatment modalities is a difficult one. The challenge that clinicians face comes from focusing on pathoanatomy as one of the most common etiologic factors of back pain, ignoring the important role of dysfunction. Recently, there has been a focus on lumbar stabilization exercises that proved to be effective and may be superior to general exercises for LBP management. However, recent reviews recommended further research focusing on the development of new predictions for novel stabilization exercise programs and/or combination of interventions.Differences in the sagittal spinal alignment between normal subjects and those with LBP have been reported. Subject with forward head may has a problem with postural reflexes and the repositioning sense. The mechanical relation may be explained by joints mechanical chain or muscles and fascia structure. given the high incidence of forward head posture, correction of this abnormal posture may improve stabilization programs effects
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied chronic mechanical low back pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 06/11/2017
Actual trial start date 15/11/2017
Anticipated date of last follow up 10/04/2018
Actual Last follow-up date 10/04/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet 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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group lumbar stabilization exercises 3 times per week 12 weeks Involving 3 phases; Segmental control over primary stabilizers, exercises in close chain and exercises in open chain. in addition to problem solving approach 30 Active-Treatment of Control Group
Experimental Group forward head posture correction exercises 3 times per week 12 weeks stretching exercises for neck extensors and protractors in addition to strengthing exercises for deep cervical flexors and retractors 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ CMLBP Patients with symptoms lasting longer than 3 months. ¿ Mild to moderate disability according to the Oswestry Disability Index (ODI) (up to 40%) ¿ The patients will be screened before inclusion in the study by measuring their lateral cervical radiographs for anterior head translation (AHT), and a distance of more than 15 mm was required to be included in the study. ¿ Contracture or surgery affecting lumbar spine. ¿ Current medical treatment or physical therapy for LBP. ¿ Pathologies such as skin diseases, inflammatory diseases, neurological diseases, congenital diseases, fractures, dislocations, neoplasms, and infection. ¿ Visual or auditory problems. 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 01/10/2017 ethics committee center of faculty of physical therapy, cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzayat street cairo 12398 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lumbar lordosis on the same day before first treatment session one day post treatment
Secondary Outcome lumbopelvic sagittal alignment parameters on the same day before first treatment session one day after the last treatment session
Secondary Outcome functional disability on the same day before first treatment session one day after the last treatment session
Secondary Outcome forward head posture on the same day before first treatment session one day after the last treatment session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic of faculty of physical therapy, pharos university elmahmoudia street Alexandria 23679 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
authors own money 5 sabri aboalam street shebin elkoum 21061 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy, cairo university 7 ahmed elzayat street cairo 10985 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Haytham Mohamed Elhafez 7 ahmed elzayat street cairo 24587 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa elabd aliaelabd88@gmail.com 00201069352446 5 sabri aboallam street
City Postal code Country Position/Affiliation
shebin elkoum 25879 Egypt assistant lecturer, basic science department, faculty of physical therapy, pharos university
Role Name Email Phone Street address
Public Enquiries Aliaa elabd aliaelabd88@gmail.com 00201069352446 5 sabri aboallam street
City Postal code Country Position/Affiliation
shebin elkoum 39805 Egypt assistant lecturer, basic science department, faculty of physical therapy, pharos university
Role Name Email Phone Street address
Scientific Enquiries Aliaa elabd aliaelabd88@gmail.com 00201069352446 5 sabri aboallam street
City Postal code Country Position/Affiliation
shebin elkoum 209876 Egypt assistant lecturer, basic science department, faculty of physical therapy, pharos university
REPORTING
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