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.: PACTR202001841385725 Date of Registration: 31/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Lumber Hyperlordosis Correction on Craniovertebral Angle in Low Back Pain Patients. Randomized Controlled Trial
Official scientific title Effect of Lumber Hyperlordosis Correction on Craniovertebral Angle in Low Back Pain Patients. Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The vertebral column is the main axis in the human body and plays an important role in maintaining an upright posture. Spinal curvature in the sagittal plane, especially lumbar lordosis, is necessary for effective weight bearing, increasing efficiency of paraspinal muscles, and maintaining erect posture.Abnormal curvature of the spine can create increased stress on the body which can, overtime , lead to muscle imbalance. One of the most important postural deformities of the spinal column is lumbar hyperlordosis which means exaggerated curve of lumber spine.Excessive lordosis has been advocated as the major cause of postural pain, facet pain and radiculopathy .All the segments in the axial skeleton and lower limbs, function as parts of a closed chain; movement at one joint will create movement in at least one other linkage in the chain .The relationship between cervical and lumber posture is more complex than is generally acknowledged clinically. As the position of lumber spine move toward extension, the cervical spine move toward flexion, and vice versa. This study is designed to investigate whether lumber hyperlordosis correction is associated with changes in craniovertebral angle which will help in predicting and preventing degenerative changes in cervical spine. Patients will be assigned randomly into 2 groups Group A: 15 patients will receive lumbar hyperlordosis correction by muscle energy technique. Group B: 15 patients will receive no intervention. X-ray will be used to measure the lumbar lordotic angle using cobbs angle Photographic analysis methods will be used to assess Craniovertebral angle . Treatment program will be three sessions per week for four weeks and all measurement will be taken pre and post the treatment period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VAS ROM CVA and MET
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 22/09/2019
Actual trial start date 06/10/2019
Anticipated date of last follow up 22/02/2020
Actual Last follow-up date 22/02/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MET group 3 sessions per week four weeks group A receive muscle energy technique for iliopsoas muscle and lower back muscle . 15
Control Group William group 3 sessions per week four weeks group B received william flexion exercises 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Subjects of both genders with lumber lordosis angle more than 40 degrees. (2) Subjects age is between 20 to 35 years (3) Subjects suffer from chronic low back pain more than 3 months. (1) Bone disease (2) Any underlying disease such as malignancy, infection or systemic disease of the musculoskeletal system (3) Disc lesion, osteophytes (4) Spondylolithesis. (5) Any sensory problems or disturbance (6) Evidence of previous vertebral fractures or major spinal structural abnormality Adult: 18 Year(s)-44 Year(s) 20 Year(s) 35 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 01/09/2019 faculty of physical therapy research ethical comittee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat ,dokki,Giza,Egypt Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 1-improvement trunk flexion ,extension ,side bending, and rotation range of motion . before treatment and after compeletion of treatment .
Secondary Outcome improvement in craniovertebral angle . before treatment and after completion of treatment.
Secondary Outcome improvement in lumber lordosis angle before treatment and after completion of treatment .
Primary Outcome improvement in low back pain level on VAS before treatment and after completion of treatment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy benisuef university Benisuef benisuef Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy Benisuef university Benisuef Benisuef Egypt University
COLLABORATORS
Name Street address City Postal code Country
fatma alzahraa mohamed ali El fayoum Almasla El Fayoum Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma ALzahraa Mohamed Ali fatmaalzahraa_mohamed@yahoo.com 01016953388 ALmasala
City Postal code Country Position/Affiliation
ELFayoum Egypt demonstrator at faculty of physical therapy Benisuef university
Role Name Email Phone Street address
Public Enquiries Awatef labib arabisque2010@yahoo.com 01001454095 EL dokki
City Postal code Country Position/Affiliation
Giza Egypt professor at faculty of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries shimaa Taha dr.shymaelshazly@yahoo.com 01229823327 7 Ahmed EL Zayat ,dokki,Giza
City Postal code Country Position/Affiliation
Giza Egypt lecturer of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries Magda Gaid mangaaa3@yahoo.com 01228721227 7 Ahmed EL Zayat,dokki,giza
City Postal code Country Position/Affiliation
Giza Egypt assistant professor at faculty of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Subjects of both genders with lumber lordosis angle more than 40 degrees,Subjects age is between 20 to 35 years, Subjects suffer from chronic low back pain more than 3 months Study Protocol after 3 months 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