Ethical research review of faculty of physical therapy Cairo university
Cairo, Egypt
NCT Number: NCT06810128
Identifying clinical predictors that anticipate the prognosis of pain intensity and level of disability of mechanical low back pain among healthcare professions.It will be hypothesized that:There will be no statistical significance correlation between the prognosis of chronic mechanical low back considering pain intensity, function disability and the independant variables.
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Notify Me30 year–49 year
All sexes
Observational
Cairo, Egypt
The annual incidence of CMLBP among healthcare professions has been found to be 26% with a high yearly recurrence. Chronic mechanical Low back pain is the leading cause of years lived with disability worldwide. There are individual factors that can increase the risk of pain chronicity such as biomechanical, psychological, social, environmental, lifestyle, and personal factors. Therefore the main objective of the current study will be to investigate the anticipated clinical predictors that may help the prognosis of chronic mechanical LBP among health care professions. Up to author's knowledge, no studies have been carried on to identify anticipating factors related to CMLBP among healthcare professions. Studies simply identify the factors related to chronicity, they do not however study whether the presence of 1 factor is sufficient or whether a certain mix of factor is required. Therefore, the present study will be carried on to develop more comprehensive model including connections between multiple factors, in addition to consider which factors are truly important.The study procedures were explained in detail to every patient before the assessment. All patients were informed about the purpose and nature of the study, and written consent was obtained before participation in the study.
Sample size calculation is based on power analysis using the G*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany). The sample size calculation is depended on a pilot study including 10 patients diagnosed with chronic mechanical low back pain to study multi-regression between dependent variable and independent variables. The squared multiple correlation (R2) for this pilot study = 0.140. Sample size calculation based on F tests (Linear multiple regression: Fixed model, R² deviation from zero), Type I error (α) = 0.05, power (1-β error probability) = 0.80, and Effect size f2= 0.1627907 with a total sample size for 118 participants. Considering a 10% drop out rate, the appropriate minimum sample size for this study will be 130 participants diagnosed with chronic mechanical low back pain. The sample size calculation was depended on a pilot study including 10 patients diagnosed with chronic mechanical low back pain to study multi-regression between dependent variable and independent variables . The squared multiple correlation (R2) for this pilot study = 0.140. Sample size calculation based on F tests (Linear multiple regression: Fixed model, R² deviation from zero), Type I error (α) = 0.05, power (1-β error probability) = 0.80, and Effect size f2= 0.1627907 with a total sample size for 118 participants. Considering a 10% drop out rate, the appropriate minimum sample size for this study will be 130 participants diagnosed with chronic mechanical low back pain.
Statistical Analysis:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subject selection based on the following criteria:
Exclusion criteria
Time frame: 1 year
The predictors
1-Age2-Gender 3-BMI 4-Life style5-Duration of pain 6-Intensity of pain 7-Occupation 8-Years of experience 9-Duty/Load hours 10-ODI 11-Work related frequent position12-Fear avoidance behavior Methods: 1-pain intensity will be assessed by Arabic Version(VAS).2-functional disability will be assessed by the Arabic version of (ODI ) 3-psychological status by Arabic version of Tampa scale.4-Assessment of physical activity by six-point grade.5-weight and height scale to measure weight in(kg),Height in(m). 6-BMI:weight in(kg),height in (m) will combined to measure BMI in (kg/m²)Demographic data (age, gender, occupation) will be taken .Participants will be asked about :-Duration of pain .-Years of work experience: at least 5 years, 5-10 years, 10-15 years and more than 15 years.-Duty /Load hours -Work related frequent positions (sitting, standing, squatting, slopping,, and rotation, side bending,kneeling
Alaa shaker Mohamed Mohamed
Other
CLINICAL PREDICTION RULE IN PROGNOSIS OF CHRONIC MECHANICAL LOW BACK PAIN AMONG HEALTH CARE PROFESSIONS
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