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.: PACTR201710002659137 Date of Approval: 02/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adding cervical posture correction to lumbar stabilization exercises for mechanical low back pain
Official scientific title Efficacy of integrating cervical posture correction with lumber stabilization exercises on mechanical low back pain: a randomized blinded clinical trial
Brief summary describing the background and objectives of the trial Because low back pain is a common problem with substantial social and occupational consequences, effective treatment is needed. As the diagnosis of chronic LBP tends to be subject to debate, the important question of identifying effective treatment modalities for this problem 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. Lumbar stabilization exercises have been proved as one of the most effective treatment modalities. However recent evidence suggests that integrating approaches may has better effects. Because global sagittal spinal alignment has a role in development of LBP, maintaining appropriate alignment and correcting deformities may help to relieve LBP. This study will be conducted to examine whether integrating forward head posture correction exercises with lumber stabilization exercises would have more beneficial outcomes related to pain, disability, lumbo-pelvic sagittal alignment and lumbar intervertebral movements in patients with MLBP.
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 15/10/2017
Actual trial start date 15/10/2017
Anticipated date of last follow up 22/03/2018
Actual Last follow-up date 15/03/2018
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 Concealed allocation will be performed using a computer generated randomized table of numbers created prior to the start of data collection by a researcher who will be not involved in recruitment or treatment of the patients. Individually, sequentially numbered index cards containing the randomly assigned intervention group will be folded and placed in sealed, opaque envelopes. A second therapist, blinded to baseline examination findings, will open the envelope and proceed with the treatment according to the group assignment. Simple randomisation using a radomisation table created by a computer software program 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 Will be performed for all groups. Involving 3 phases; Segmental control over primary stabilizers, exercises in close chain and exercises in open chain. in addition to problem solving approach 25 Active-Treatment of Control Group
Experimental Group cervical posture correction exercises 3 times per week 12 weeks will begen concurrently with the start of phase 1 lumbar stabilization program. The corrective exercise program in the form of two strengthening (deep cervical flexors and shoulder retractors) and two stretching (cervical extensors and pectoral muscles) exercises. In addition to postural correction instructions. 25
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. 18 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 02/10/2017 ethics committee of faculty of physical therapy, cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed alzayat street cairo 22672 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain at the same day of first treatment session one day post treatment
Secondary Outcome rotational and translational segmental intervertebral movement at the same day of first treatment session one day post treatment
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 12334 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
author own money 5 sabri abo allam street shebin elkoum 203457 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 22672 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Haytham Mohamed Elhafez 7 ahmed elzayat street cairo 23679 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa Elabd aliaelabd88@gmail.com 00201069352446 5 sabri abo allam street
City Postal code Country Position/Affiliation
shebin elkoum 32768 Egypt assisstant lecturer, faculty of physical therapy, pharos university
Role Name Email Phone Street address
Public Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 5 sabri abo allam street
City Postal code Country Position/Affiliation
shebin elkoum 32768 Egypt assisstant lecturer, faculty of physical therapy, pharos university
Role Name Email Phone Street address
Scientific Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 5 sabri abo allam street
City Postal code Country Position/Affiliation
shebin elkoum 32768 Egypt assisstant lecturer, faculty of physical therapy, pharos university
REPORTING
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