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.: PACTR202001519121833 Date of Approval: 15/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of proprioceptive training on lower back muscle performance in patients with chronic nonspecific low back pain
Official scientific title Effect of proprioceptive training on lower back muscle performance in patients with chronic nonspecific low back pain
Brief summary describing the background and objectives of the trial Low back pain (LBP) can be described as pain referred to one or both lower limbs that last for at least 1 day. Low back pain is an extremely common problem . It attacks nearly 60% to 80 % of all adults at least once in their lifetime with increasing risk in older subjects. It can affect the individual`s family, community, business, and life style.In most of the cases back pain is considered an ordinary or non specific “back ache”. It is called non-specific due to the inability of orthopedic medicine to determine a definitive diagnosis of pain on the basis of structure, anatomy and biomechanics. Proprioceptive training (PrT) which is an exercise that activates self-receptors of the trunk muscles is popularly applied as preventive or rehabilitative exercise method in various sports and rehabilitation settings. Proprioceptive training teaches patients how to adjust their muscles, thereby triggering muscle plasticity, alleviating pain, and improving muscle strength.Although many therapists and clinicians report successful treatment cases, the exact effect and validity of sensorimotor interventions is still discussed controversially.the focus of many studies was to study the effect of proprioceptive training on pain and function and there is gap of knowledge concerning the effect of proprioceptive training on lower back muscle performance and lumbar repositioning accuracy.so this study will be conducted to investigate the effect of proprioceptive training on lower back muscle performance and lumbar repositioning accuracy in patients with chronic nonspecific low back pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) lbp PrT PPT ODI
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 16/04/2019
Actual trial start date
Anticipated date of last follow up 17/04/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Issuing authority Trial register
not available
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 Group A 3 sessions per week 8 weeks will receive proprioceptive training and conventional treatment 25
Control Group Group B 3 Sessions per week 8 weeks conventional treatment 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- The patients diagnosed as chronic non-specific LBP, diagnostic investigations including X rays failed to show obvious pathological findings (Konstantinovic, 2009). 2- The patient age ranges from 25-40 years old (Hidalgo et el, 2013 and Hussien et al 2017). 3- The patients will be chosen from both sexes. 4-Body Mass Index from 18 to 29 kg/m² (Hussien et al 2017). 5-Patients complaining of signs and symptoms not less than 3 months (Aoki, 2012). 6-Patients should be able to assume at least 40 ° of trunk flexion, to be able to perform the required measurement tasks (30 ° trunk flexion) (Georgy, 2011) 1- Any low back pain due to a definite cause as; arthritis, degenerative joint diseases, disk lesion, inflammation and facet joint disease (Hussien et al 2017). 2- Patients with a history of head trauma or other neurological manifestations (Georgy, 2011). 3- Current inner ear infection or vestibular problem (Georgy, 2011). 4- Obese patients with body mass index (BMI) above 29, and pregnant females Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 17 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 05/05/2019 Faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayad street, Dooki, Giza, Egypt. Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -Muscle performance before and after completion of the intervention
Secondary Outcome repositioning accuracy/pain level/ functional status before and after completion of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo university 7 Ahmed Elzayad street, Dokki, Giza, Egypt Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sahar abdallah abdallah khalifa Talhawien zagazig sharqia zagazig 44779 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university 1 Gamaa street , Giza Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ghada abdelmoniem abdallah Talhawien zagazig 44779 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sahar Abdallah saharalasar88@yahoo.com 00201112881730 Talhawein street
City Postal code Country Position/Affiliation
zagazig 44779 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Maher Ahmed Elkabalawy saharabdallah341@gmail.com 00201001419544 1 Gamaa street
City Postal code Country Position/Affiliation
GIZA Egypt PROF
Role Name Email Phone Street address
Scientific Enquiries Ghada Mousa Ghadar2013@yahoo.com 00201011447393 1 Gamaa street
City Postal code Country Position/Affiliation
Giza Egypt assistant prof at basic science department faculty of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The patients diagnosed as chronic non-specific LBP, diagnostic investigations including X rays failed to show obvious pathological findings (Konstantinovic, 2009).The patient age ranges from 25-40 years old (Hidalgo et el, 2013 and Hussien et al 2017).The patients will be chosen from both sexes.Body Mass Index from 18 to 29 kg/m² (Hussien et al 2017).Patients complaining of signs and symptoms not less than 3 months (Aoki, 2012).Patients should be able to assume at least 40 ° of trunk flexion, to be able to perform the required measurement tasks (30 ° trunk flexion) (Georgy, 2011). Study Protocol 2023 The patients diagnosed as chronic non-specific LBP, diagnostic investigations including X rays failed to show obvious pathological findings (Konstantinovic, 2009).The patient age ranges from 25-40 years old (Hidalgo et el, 2013 and Hussien et al 2017).The patients will be chosen from both sexes.Body Mass Index from 18 to 29 kg/m² (Hussien et al 2017).Patients complaining of signs and symptoms not less than 3 months (Aoki, 2012).Patients should be able to assume at least 40 ° of trunk flexion, to be able to perform the required measurement tasks (30 ° trunk flexion) (Georgy, 2011).
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