Clinical trial NCT04355104: Effects of Low Back Pain Knowledge-Related Education on Attitudes and Knowledge in Patients With Low Back Pain
Official title: Effects of Low Back Pain Knowledge-Related Education on Attitudes and Knowledge in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Knowledge
Attitude
Disability
Pain
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain (LBP) is the leading musculoskeletal condition in burden of disease and years lived with disability. This high ranking is in large part due to the high prevalence of LBP. LBP is not only mechanically related to spinal pathophysiology (i.e., postural alterations, articular stiffness, or muscle weakness), but may also be influenced by psychosocial factors such as attitudes and beliefs. Multidisciplinary rehabilitation programs, which include biopsychosocial management, resulted in a better outcome. The aim of this project is to determine if the change in LBP-related knowledge and attitudes toward LBP are correlated with the change in LBP-related pain, disability, fear avoidance, and emotional states of depression, anxiety, and stress after three months. The second aim is to investigate the effect of adding LBP knowledge related education sessions to standard physical therapy treatment on patients' LBP knowledge, attitudes toward LBP, LBP-related pain, disability, fear avoidance, and emotional symptoms in comparison to standard physical therapy alone.

Detailed description: Low back pain (LBP) is the leading musculoskeletal condition in burden of disease and years lived with disability. This high ranking is in large part due to the high prevalence of LBP. LBP is not only mechanically related to spinal pathophysiology (i.e., postural alterations, articular stiffness, or muscle weakness), but may also be influenced by psychosocial factors such as attitudes and beliefs. Multidisciplinary rehabilitation programs, which include biopsychosocial management, resulted in a better outcome. The aim of this project is to determine if the change in LBP-related knowledge and attitudes toward LBP are correlated with the change in LBP-related pain, disability, fear avoidance, and emotional states of depression, anxiety, and stress after three months. Secondly, the investigators will investigate the effect of adding LBP knowledge related education sessions to standard physical therapy treatment on patients' LBP knowledge, attitudes toward LBP, LBP-related pain, disability, fear avoidance, and emotional symptoms in comparison to standard physical therapy alone. 74 patients with LBP receiving standard physical therapy service for the first time will be interviewed and their knowledge and attitude about LBP will be collected at the baseline. After 3 months, the LBP related pain, emotional symptoms, and LBP disability will be collected. The patients will be allocated to "Experimental group" consist of 37 patients will take education sessions in addition to standard physical therapy for 12 sessions or "control group" consist of 37 patients take just standard physical therapy for the same number of sessions without education. Participants will be assessed at baseline and at 3 months follow up. Outcome measures include Arabic version of the Back Pain Attitudes (Back-PAQ), Low Back Pain Knowledge (LKQ) Questionnaires, Arabic version of Oswestry Disability Index (ODI) to assess the function, Visual Analogue Scale for pain intensity, Depression Anxiety Stress Scales (DASS-21) for emotional states, and Fear-Avoidance Beliefs Questionnaire (FABQ) for fear avoidance beliefs. Spearman correlation coefficient r will be used to investigate the correlation between change in LBP knowledge and attitude, and change in pain, disability, fear avoidance and emotional symptoms after three months. Independent sample t-test will be used to compare the knowledge, attitude, VAS, ODI, FABQ, and DASS- between the experimental group and control group.

Eligibility criteria: Inclusion Criteria:

* Patients reported persistent LBP of more than 3/10 in the last 12 weeks.

Exclusion Criteria:

* Subjects with acute low back pain, "red flags" indicating signs of serious pathology, previous back surgery, pregnancy, specific rheumatological diseases, spodylolysis or spondylolisthesis, spinal tumor or spinal fracture, mental disorders, or neurological diseases will be excluded.

Primary outcomes:
measure: Change in Back Pain Attitude Questionnaire from baseline to 4 weeks and 3 months
timeFrame: Change from baseline to 4 weeks and 3 months
measure: Change in Low Back Pain Knowledge questionnaire from baseline to 4 weeks and 3 months
timeFrame: Change from baseline to 4 weeks and 3 months
measure: Change in Oswestry Disability Index from baseline to 4 weeks and 3 months
timeFrame: Change from baseline to 4 weeks and 3 months
measure: Change in Visual analogue scale from baseline to 4 weeks and 3 months
timeFrame: Change from baseline to 4 weeks and 3 months
Secondary outcomes:
measure: Change in Depression Anxiety Stress Scales (DASS-21) from baseline to 4 weeks and 3 months
timeFrame: Change from baseline to 4 weeks and 3 months
measure: Change in Fear-Avoidance Beliefs Questionnaire (FABQ) from baseline to 4 weeks and 3 months.
timeFrame: Change from baseline to 4 weeks and 3 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
Study officials:
affiliation: Jordan University of Science and Technology
name: Saddam F Kanaan, PhD
role: PRINCIPAL_INVESTIGATOR
References: