Chronic Mechanical Low Back PainNCT06810128
Predictors For the Prognosis of CMLBP Among Healthcare Professions
An observational study of Chronic Mechanical Low Back Pain, run by Alaa shaker Mohamed Mohamed at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 49 years
- Conditions the study is for
- Chronic Mechanical Low Back Pain
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: 1. One hundred and thirty male and female participants aged between 30 and 49 years. 2. Health care professions (Nurses, Physiotherapists, Dentists, Doctors, surgeons, technicians), have years of experience (at least 5 years up to more than 15 years). 3. Participants have CMLBP for at least 3 months. 4. Chronic mechanical Low back pain (CMLBP) will be assessed by Arabic Version visual analogue scale (VAS). 5. Functional performance will be assessed by Arabic Version Oswestery questionnaire (ODI). 6. Fear avoidance behavior will be assessed by Arabic Version Tampa scale (TSK).
Who may be able to join
None listed.
Who cannot join
- If investigated individuals with specific LBP (eg, infections, fracture, traumatic injuries, cancer, major systemic diseases, or congenital diseases).(Wong et al., 2022).
- Radiculopathy/cauda equina syndrome Segmental pain
- paresthesia in area of pain
- loss of strength (grade 3 or less)
- sudden loss of bladder/ bowel function
- perianal/perineal hypaesthesia
- death of nerve root.(Steinmetz, 2022).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ethical research review of faculty of physical therapy Cairo university
Cairo
About this study
Official title: CLINICAL PREDICTION RULE IN PROGNOSIS OF CHRONIC MECHANICAL LOW BACK PAIN AMONG HEALTH CARE PROFESSIONS
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.
Read the detailed description
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:
- Statistical analysis will be conducted using SPSS Version 15.0 statistical software package (SPSS Inc, Chicago, IL, USA) to determine whether any potential prognostic variables among health care progressions with low back pain.
- Demographic data will be expressed as mean ± standard deviation for all continuous variables and Chi square for gender distribution between groups.
- Prior to final analysis, data will be screened for normality assumption, homogeneity of variance, and presence of extreme scores.
- Tests of normality including Shapiro Wilk test and Kolmogorov-Smirnov test will be used.
- Sensitivity, specificity, and positive likelihood ratios will be calculated for each potential predictor variable. To determine the most accurate set of variables for prediction of prognosis of mechanical low back pain , potential predictor variables will be entered into a step-wise logistic regression model (p<0.05).
- Conditions
- Chronic Mechanical Low Back Pain
- Keywords
- CMLBP among healthcare professions
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticipating prognosis of pain intensity and level of disability of mechanical low back pain among health care professions by identifying clinical predictors .
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Oct 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mechanical Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa shaker Mohamed Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa shaker Mohamed Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810128
- Sponsor's protocol ID
- Predictors For CMLBP Prognosis
- Status last verified
- May 2025
- First submitted
- 7 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL PREDICTION RULE IN PROGNOSIS OF CHRONIC MECHANICAL LOW BACK PAIN AMONG HEALTH CARE PROFESSIONS
- ClinicalTrials.gov ID
- NCT06810128
- Acronym / sponsor ID
- Predictors For CMLBP Prognosis
- Conditions
- Chronic Mechanical Low Back Pain
- Keywords
- CMLBP among healthcare professions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Alaa shaker Mohamed MohamedUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Statistical analysis will be conducted using SPSS Version 15.0 statistical software package (SPSS Inc, Chicago, IL, USA) to determine whether any potential prognostic variables among health care progressions with low back pain.
- Demographic data will be expressed as mean ± standard deviation for all continuous variables and Chi square for gender distribution between groups.
- Prior to final analysis, data will be screened for normality assumption, homogeneity of variance, and presence of extreme scores.
- Tests of normality including Shapiro Wilk test and Kolmogorov-Smirnov test will be used.
- Sensitivity, specificity, and positive likelihood ratios will be calculated for each potential predictor variable. To determine the most accurate set of variables for prediction of prognosis of mechanical low back pain , potential predictor variables will be entered into a step-wise logistic regression model (p<0.05).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 1. One hundred and thirty male and female participants aged between 30 and 49 years. 2. Health care professions (Nurses, Physiotherapists, Dentists, Doctors, surgeons, technicians), have years of experience (at least 5 years up to more than 15 years). 3. Participants have CMLBP for at least 3 months. 4. Chronic mechanical Low back pain (CMLBP) will be assessed by Arabic Version visual analogue scale (VAS). 5. Functional performance will be assessed by Arabic Version Oswestery questionnaire (ODI). 6. Fear avoidance behavior will be assessed by Arabic Version Tampa scale (TSK).
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- If investigated individuals with specific LBP (eg, infections, fracture, traumatic injuries, cancer, major systemic diseases, or congenital diseases).(Wong et al., 2022).
- Radiculopathy/cauda equina syndrome Segmental pain
- paresthesia in area of pain
- loss of strength (grade 3 or less)
- sudden loss of bladder/ bowel function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anticipating prognosis of pain intensity and level of disability of mechanical low back pain among health care professions by identifying clinical predictors .
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Mechanical Low Back Pain, run by Alaa shaker Mohamed Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticipating prognosis of pain intensity and level of disability of mechanical low back pain among health care professions by identifying clinical predictors . (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.