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.: PACTR202001657839875 Date of Approval: 31/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title lumbopelvic stabilization versus pilates exercises on spatiotemporal gait parameters in chronic nonspecific low back pain: randomized controlled trial
Official scientific title lumbopelvic stabilization versus pilates exercises on spatiotemporal parameters of gait, pain, function and endurance in patients with non-specific chronic low back pain
Brief summary describing the background and objectives of the trial Low back pain (LBP) has been the leading cause of disability worldwide since 1990 (Global Burden of Disease Study, 2013). Low back pain (LBP) is arguably the most prevalent musculoskeletal condition found among both developed and developing nations (Manchikant, 2003; Hoy et al., 2010; Hoy et al., 2012; Froud et al., 2014). Gait is an activity that is repeated frequently throughout the day. The trunk and lumbar spine, however help drive inhuman bipedal gait. It has been suggested that deficiencies in motor control during gait following LBP produce repeated and prolonged stresses on the spine [6, 8].Various studies have reported that patients with CLBP alter their movement pattern and control strategy to avoid painful motion (Bagheri et al,2017). Lumbar stabilization exercises are aimed at improving the neuromuscular control, strength, and endurance of the muscles that are central to maintaining the dynamic spinal and trunk stability.). Pilates focuses on maintaining a ‘neutral spine,’ pelvic and spinal stability, along with activation of transverse abdominals and pelvic floor muscles in combination with controlled breathing
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LBP
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 18/03/2020
Actual trial start date 18/03/2020
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date 30/12/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lumbopelvic stabilization exercise 3 times a week 3 weeks • Segmental control over primary stabilizers (mainly TrA, deep multifidus, pelvic floor and diaphragm) • Exercises in closed chain, with low velocity and low load • Exercises in open chain, with high velocity and load strengthening exercises for the abdominal, back, and hip muscles. 20
Experimental Group Pilates exercises. 3 times a week 3 weeks Pilates focuses on maintaining a ‘neutral spine,’ pelvic and spinal stability, along with activation of transverse abdominals and pelvic floor muscles in combination with controlled breathing strengthening exercises for the abdominal, back, and hip muscles. 20
Control Group exercises 3times a week 3 weeks strengthening exercises for the abdominal, back, and hip muscles. The patients performed an average of three series of ten repetitions of each exercise. Increases in the number of exercises performed in each session (or load progression) occurred according to individual tolerance 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age from 20–30 years (Bhadauria et al., 2017) - Patients with chronic nonspecific LBP (more than12 weeks) - Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line) - Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation. - Signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss and widespread neurologic changes - Any vestibular, visual or neurological dysfunction affecting balance. - Current radiating symptoms (and/or neurological deficit) below the level of the buttock crease - Current pregnancy or breastfeeding - History of spinal surgery, fracture or malignancy - Specific LBP, defined as herniated disc, ankylosing spondylitis, spondylolisthesis or other relevant - Presence of severe postural abnormality or neuromuscular disorder, previous diagnosis of pathology (confirmed by magnetic resonance imaging or radiograph). Adult: 19 Year-44 Year 20 Year(s) 30 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 09/02/2020 faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
7th elzayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Biodex gait trainer 2 TM system (Model 950-380, software version 2.6x, New York) was used to measure spatiotemporal gait parameters. It is a special treadmill designed to monitor and record step length, step speed and right-to-left time distribution (step symmetry). before and after completion of study
Secondary Outcome pain The visual analog scale (VAS) is the VAS, which consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) , to the worst pain that could possibly feel (10) before and after completion of study
Secondary Outcome Modified Oswestry Disability Questionnaire. A well validated, self-reported questionnaire designed for low back containing 10 sections was used to assess the level of disability. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage. before and after completion of study
Secondary Outcome Sorensen test (low back fatigue test). The test, as described by Biering Sorensen involves measuring how many seconds the subject is able to keep the unsupported upper body (from the upper border of the iliac crest) horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest. before and after completion of study
Secondary Outcome 5. Trunk flexion endurance test To measure abdominal muscle endurance, the subjects were placed in a sitting position with flexed knees so that the legs were on the bed and firmly fixed to the bed by a belt. Then, a board with angles of 55 ° relative to the bed was placed behind the subjects and the subject while his hands were on his chest in cross position, flexed his trunk close to the board and kept the position. When the subject lose endurance and touch the board, his time were over and recorded in registration form of the pre-test and post-test . The knee and hip of the subjects were in flexion position of 90 °, and the arms in cross position in front of the chest, and hands on shoulders. An assistant fixed legs in order to keep the position before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7th elzayat street giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
heba el feqy 7th el-zayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo university street giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
haytham el hafez 7th el zayat street giza 12511 Egypt
al shaymaa shaaban 7th el zayat street giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator heba el feqy hebaelfeky61@yahoo.com 01014450994 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries haytham el hafez elhafez@yahoo.com 01001909630 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt professor of physical therapy
Role Name Email Phone Street address
Public Enquiries al shaymaa shaaban shimaashaaban30@yahoo.com 01033771553 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of the trial 1-pain 2-function 3-spatiotemporal parameters 4-endurance test Study Protocol one year the criteria will be accessed by the publication of trials in international journal
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