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

NCT04355104 | Completed

• 1 other identifier: 810/2019
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Knowledge; Attitude; Disability; Pain

Outcome Measures

Primary Outcomes (4)

• 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 from baseline to 4 weeks and 3 months

• 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 from baseline to 4 weeks and 3 months

• 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 from baseline to 4 weeks and 3 months

• 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").

  Change from baseline to 4 weeks and 3 months

Secondary Outcomes (2)

• Change in Depression Anxiety Stress Scales (DASS-21) from baseline to 4 weeks and 3 months

  Change from baseline to 4 weeks and 3 months

• Change in Fear-Avoidance Beliefs Questionnaire (FABQ) from baseline to 4 weeks and 3 months.

  Change from baseline to 4 weeks and 3 months

Study Arms (2)

Education+standard physical therapy

EXPERIMENTAL

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

Behavioral: Education; Behavioral: Standard physical therapy

Standard physical therapy

ACTIVE COMPARATOR

Consist of 37 patients take just standard physical therapy.

Behavioral: Standard physical therapy

Interventions

Education BEHAVIORAL

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.

Education+standard physical therapy

Standard physical therapy BEHAVIORAL

Two session physical therapy per week for 4 weeks. The physical therapy will be based on patients case.

Education+standard physical therapy; Standard physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

King Abdullah University Hospital

Irbid, 22110, Jordan

Location

MeSH Terms

Conditions

Low Back Pain; Behavior; Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Saddam F Kanaan, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 21, 2020
• Study Start: August 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)