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.: PACTR202301569800157 Date of Approval: 26/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title leg length inequality and lateral spinal alignment
Official scientific title biomechanical effect of conservative correction of leg length inequality on lateral spinal alignment and human performance
Brief summary describing the background and objectives of the trial Background: leg length discrepancy is a common physical problem that has a great effect on postural symmetry and body balance. Inequality of the lower limb length has both cosmetic and functional problem. It impairs the limb function and the biomechanics of the musculoskeletal system, and significantly reduces the quality of life of the affected patients. Previous studies found that even mild leg length inequality causes significant changes in pelvic position and spinal posture. In a retrospective study done to analyze the radiographs of 106 chiropractic patients with mild leg length inequality of 6 mm or more, it was found that more than 50% of the patients had scoliosis and abnormal lumbar lordosis. That may indicate abnormal weight bearing in the joints of the lumbar spine. Muscular imbalance and the asymmetrical loading caused by mild leg length inequality could negatively influence body alignment. In particular, the misaligned spinal column can cause back pain and negatively impact on body performance. For that, patients with Leg length inequality may find difficulties during physiological and physical activities of their body. Thus, mild leg length inequality treatment may help in preventing disabilities and improving body performance. The use of shoe inserts was found to improve function in participants with leg length inequality and back pain, after total hip arthroplasty, or following orthopedic injury to the ankle, foot or leg. Objectives: The purpose of this study was to investigate the effect of correcting mild structural leg length inequality using a shoe insert on sagittal plane spinal alignment and body performance.
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 31/12/2022
Actual trial start date 29/01/2023
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date 29/04/2023
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group the patients will use inserts for LLD correction only in the shoe corresponding with the short leg. The patients will use shoe inserts while standing or walking The intervention will be applied for an eight-week period The inserts are made of hard foam and constructed of three layers; basic, corrective, and uppermost. The corrective insert is constructed with a height similar to the degree of leg length inequality that reported by the CT scanogram 15
Control Group no intervention eight weeks no intervention 15 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria involved adult patients with structural leg length inequality of 5-20mm. structural leg length inequality was measured using CT scanogram. The body mass index (BMI) was ≤35 kg/m2 as BMI greater than 35 kg/m2 may impede the automatic detection of the bony landmarks by rasterstereography The exclusion criteria were functional leg length inequality any serious medical condition as spine arthritis or disc lesions ligamentous instability of the lower limb. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 60 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 11/09/2022 research ethical committee of faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7ahmed ezzayat street bien el sarayat Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the sagittal plane spinal alignment (kyphotic and lordotic angles) that was assessed using Rasterstereography pre and post intervention
Secondary Outcome Oswestry Disability Index (ODI) is used to assess body performance. Patients will be assessed pre- and post-insert use for eight weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy 7 ahmed ezzayat street bien el sarayat Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Reda sayed Ashour 7 Ahmed Ezzayat streeet Bien El-sarayat Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Reda Sayed Ashour Ali 7ahmed ezzayat street bien el sarayat Giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Yasmine Essam Mohamed 7ahmed ezzayat street bien el sarayat Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reda Ashour redaashour82@yahoo.com +2036717691 7 Ahmed Ezzayat street bien el sarayat
City Postal code Country Position/Affiliation
Giza Egypt lecturer in the Department of Biomechanics Faculty of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Yasmine Mohamed dr.yassminessam@gmail.com +2036717691 7 Ahmed Ezzayat street Bien El-Saraya
City Postal code Country Position/Affiliation
Giza Egypt lecturer in the Department of Biomechanics Faculty of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Reda Ashour redaashour82@yahoo.com +2036717691 7 Ahmed Ezzayat street Bien El-Saryat
City Postal code Country Position/Affiliation
Giza Egypt lecturer in the Department of Biomechanics Faculty of Physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article, after deidentification, will be avaliable Study Protocol beginning 9 months and ending 24 months after publication data are available
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