- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355104
Effects of Low Back Pain Knowledge-Related Education on Attitudes and Knowledge in Patients With Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Irbid, Jordan, 22110
- King Abdullah University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education+standard physical therapy
Consist of 37 patients will take education sessions in addition to standard physical therapy.
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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.
Two session physical therapy per week for 4 weeks.
The physical therapy will be based on patients case.
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Active Comparator: Standard physical therapy
Consist of 37 patients take just standard physical therapy.
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Two session physical therapy per week for 4 weeks.
The physical therapy will be based on patients case.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Back Pain Attitude Questionnaire from baseline to 4 weeks and 3 months
Time Frame: Change 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.
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Change from baseline to 4 weeks and 3 months
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Change in Low Back Pain Knowledge questionnaire from baseline to 4 weeks and 3 months
Time Frame: Change from baseline to 4 weeks and 3 months
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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.
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Change from baseline to 4 weeks and 3 months
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Change in Oswestry Disability Index from baseline to 4 weeks and 3 months
Time Frame: Change 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 .
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Change from baseline to 4 weeks and 3 months
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Change in Visual analogue scale from baseline to 4 weeks and 3 months
Time Frame: Change from baseline to 4 weeks and 3 months
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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").
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Change from baseline to 4 weeks and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Anxiety Stress Scales (DASS-21) from baseline to 4 weeks and 3 months
Time Frame: Change 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.
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Change from baseline to 4 weeks and 3 months
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Change in Fear-Avoidance Beliefs Questionnaire (FABQ) from baseline to 4 weeks and 3 months.
Time Frame: Change from baseline to 4 weeks and 3 months
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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.
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Change from baseline to 4 weeks and 3 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 810/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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