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Effects of Low Back Pain Knowledge-Related Education on Attitudes and Knowledge in Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Education
Standard physical therapy
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Knowledge, Attitude, Disability, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Abdullah University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Education+standard physical therapy

Standard physical therapy

Arm Description

Consist of 37 patients will take education sessions in addition to standard physical therapy.

Consist of 37 patients take just standard physical therapy.

Outcomes

Primary Outcome Measures

Change in Back Pain Attitude Questionnaire from baseline to 4 weeks and 3 months
Back Pain Attitude Questionnaire is a valid, reliable instrument with acceptable internal consistency (α=0.70; 95% CI 0.66 to 0.73) used to assess beliefs about back pain among the general public, people with back pain and health professionals. It contains 34 items, divided into 6 sections with a five-point Likert scale, and response options ranging from 'False' to 'True' for each one.14 The score range from 0-34 with higher scores indicate a negative attitude toward LBP.
Change in Low Back Pain Knowledge questionnaire from baseline to 4 weeks and 3 months
Low Back Pain Knowledge questionnaire evaluates a person's knowledge of low back pain. It is a valid, reliable and sensitive to change instrument consists of 16 multiple-choice questions divided into three topics: general aspects (Questions 1, 6, 7, 8, 15), with a maximum score of nine, concepts (Questions 2, 3, 4, 5), with a maximum score of four, and treatment (Question 9, 10, 11, 12, 13, 14, 16), with a maximum score of 11. The overall maximum score of the questionnaire was 24.13 The higher score reflects a higher knowledge.
Change in Oswestry Disability Index from baseline to 4 weeks and 3 months
It measures the patient's permanent functional disability due to low back pain. It is a valid, reliable assessment tool with acceptable internal consistency (Cronbach α ranges from .71 to .87) and test-retest reliability ((r=0.83-0.99) vary according to the time interval between measurement), diagnosed to collect information about the effect of low back pain on an individual's ability to manage everyday life. Intraclass correlation coefficient values from (0.84-0.94). It includes 9 sections with a total possible score of 5 for each one. The total score which ranges from 0%-20% represents a minimal disability and from 81%-100% is represent the highest disability .
Change in Visual analogue scale from baseline to 4 weeks and 3 months
It measures the level of pain intensity. It is a valid, reliable, acceptable and sensitive to change unidimensional assessment scale of pain intensity, with acceptable (test-retest reliability (r=0.71-0.94,p<0.001)) and construct validity. The scale consists of an 11 point likert rating scale (with response options from "no pain" "0 score" to "worst pain ever" "10 score").

Secondary Outcome Measures

Change in Depression Anxiety Stress Scales (DASS-21) from baseline to 4 weeks and 3 months
Depression Anxiety Stress Scales (DASS-21) measures the emotional states of depression, anxiety, and stress. It is a valid and reliable assessment tool, includes a set of three self-reports (7 items for each divided into subscales) with five verbal (normal, mild, moderate, severe, and extremely severe) and numeric classifications for each one, designed to measure the emotional states of depression, anxiety, and stress. (Cronbach's α = 0.94, 0.87, 0.91 for depression, anxiety and stress respectively). The higher the score in each subscale reflects higher mental symptoms.
Change in Fear-Avoidance Beliefs Questionnaire (FABQ) from baseline to 4 weeks and 3 months.
It measures the impact of patient's fear-avoidance beliefs about physical activity and work on low back pain and resulting disability. FABQ is a valid and reliable assessment questionnaire (ICC = 0.97) consist of 16 items, divided into two subscales, work (items 6, 7, 9, 10, 11, 12, 15) and physical activity (items 2, 3, 4, 5), with a maximum score of 96. A higher score reflects a higher avoidance.

Full Information

First Posted
March 23, 2020
Last Updated
July 1, 2021
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04355104
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Knowledge, Attitude, Disability, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education+standard physical therapy
Arm Type
Experimental
Arm Description
Consist of 37 patients will take education sessions in addition to standard physical therapy.
Arm Title
Standard physical therapy
Arm Type
Active Comparator
Arm Description
Consist of 37 patients take just standard physical therapy.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
A one hour educational session per week for 4 weeks. In a total of 4 sessions of education, the content based on LBP Clinical Practice Guidelines which recommended that education and counseling strategies for patients with low back pain. Education session will be through video lecturing as a motivated tool of education for all subject who are in experimental group, this video will repeated the same in every educational session and will be sent for all participants. The neuroscience education will be by the therapist using interactive slide show and hand-drawing images. In addition to the education video, slide show, we will specify the education for every patient to give him all that he need, questions and details, mention his case on real spine to explore it and to determine the expected goal from what he need and what we have.
Intervention Type
Behavioral
Intervention Name(s)
Standard physical therapy
Intervention Description
Two session physical therapy per week for 4 weeks. The physical therapy will be based on patients case.
Primary Outcome Measure Information:
Title
Change in Back Pain Attitude Questionnaire from baseline to 4 weeks and 3 months
Description
Back Pain Attitude Questionnaire is a valid, reliable instrument with acceptable internal consistency (α=0.70; 95% CI 0.66 to 0.73) used to assess beliefs about back pain among the general public, people with back pain and health professionals. It contains 34 items, divided into 6 sections with a five-point Likert scale, and response options ranging from 'False' to 'True' for each one.14 The score range from 0-34 with higher scores indicate a negative attitude toward LBP.
Time Frame
Change from baseline to 4 weeks and 3 months
Title
Change in Low Back Pain Knowledge questionnaire from baseline to 4 weeks and 3 months
Description
Low Back Pain Knowledge questionnaire evaluates a person's knowledge of low back pain. It is a valid, reliable and sensitive to change instrument consists of 16 multiple-choice questions divided into three topics: general aspects (Questions 1, 6, 7, 8, 15), with a maximum score of nine, concepts (Questions 2, 3, 4, 5), with a maximum score of four, and treatment (Question 9, 10, 11, 12, 13, 14, 16), with a maximum score of 11. The overall maximum score of the questionnaire was 24.13 The higher score reflects a higher knowledge.
Time Frame
Change from baseline to 4 weeks and 3 months
Title
Change in Oswestry Disability Index from baseline to 4 weeks and 3 months
Description
It measures the patient's permanent functional disability due to low back pain. It is a valid, reliable assessment tool with acceptable internal consistency (Cronbach α ranges from .71 to .87) and test-retest reliability ((r=0.83-0.99) vary according to the time interval between measurement), diagnosed to collect information about the effect of low back pain on an individual's ability to manage everyday life. Intraclass correlation coefficient values from (0.84-0.94). It includes 9 sections with a total possible score of 5 for each one. The total score which ranges from 0%-20% represents a minimal disability and from 81%-100% is represent the highest disability .
Time Frame
Change from baseline to 4 weeks and 3 months
Title
Change in Visual analogue scale from baseline to 4 weeks and 3 months
Description
It measures the level of pain intensity. It is a valid, reliable, acceptable and sensitive to change unidimensional assessment scale of pain intensity, with acceptable (test-retest reliability (r=0.71-0.94,p<0.001)) and construct validity. The scale consists of an 11 point likert rating scale (with response options from "no pain" "0 score" to "worst pain ever" "10 score").
Time Frame
Change from baseline to 4 weeks and 3 months
Secondary Outcome Measure Information:
Title
Change in Depression Anxiety Stress Scales (DASS-21) from baseline to 4 weeks and 3 months
Description
Depression Anxiety Stress Scales (DASS-21) measures the emotional states of depression, anxiety, and stress. It is a valid and reliable assessment tool, includes a set of three self-reports (7 items for each divided into subscales) with five verbal (normal, mild, moderate, severe, and extremely severe) and numeric classifications for each one, designed to measure the emotional states of depression, anxiety, and stress. (Cronbach's α = 0.94, 0.87, 0.91 for depression, anxiety and stress respectively). The higher the score in each subscale reflects higher mental symptoms.
Time Frame
Change from baseline to 4 weeks and 3 months
Title
Change in Fear-Avoidance Beliefs Questionnaire (FABQ) from baseline to 4 weeks and 3 months.
Description
It measures the impact of patient's fear-avoidance beliefs about physical activity and work on low back pain and resulting disability. FABQ is a valid and reliable assessment questionnaire (ICC = 0.97) consist of 16 items, divided into two subscales, work (items 6, 7, 9, 10, 11, 12, 15) and physical activity (items 2, 3, 4, 5), with a maximum score of 96. A higher score reflects a higher avoidance.
Time Frame
Change from baseline to 4 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saddam F Kanaan, PhD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdullah University Hospital
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Low Back Pain Knowledge-Related Education on Attitudes and Knowledge in Patients With Low Back Pain

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