Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention

NCT03909048 | Completed

• 1 other identifier: 300002878
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain.

Conditions

Chronic Low Back Pain

Keywords

Chronic Pain; Low Back Pain

Outcome Measures

Primary Outcomes (5)

• Pain Intensity as assessed by Numeric Rating Scale

  The Numeric Rating Scale (NRS) measures pain intensity measured via 0-10 numeric rating scale. 0 = No Pain - 10 = Worst Possible Pain Range of scores: 0-10

  Baseline - Final assessment (average 1 week post treatment)

• Present Pain Intensity

  Present Pain Intensity (PPI) assesses present pain intensity on a scale of 0 (no pain) to 5 (excruciating)

  Baseline - Final assessment (average 1 week post treatment)

• Present Pain Rating

  Pain Rating Index (PRI) is assessed by 15 questions assessing pain in the sensory and affective dimensions. Items rate from 0 (none) to 3 (severe) on degree to which the words apply to pain. Score Range: 0-45

  Baseline - Final assessment (average 1 week post treatment)

• Pain Chronicity assessed by the Graded Chronic Pain Scale

  Pain Chronicity is assessed by the Graded Chronic Pain Scale (GCPS). The GCPS is 7 questions with 3 sub-scales (Characteristic pain intensity, disability score, and disability points). Scoring: Characteristic Pain Intensity: is a 0 to 100 score derived from Questions 1 through 3: Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score: is 0 to 100 score derived from Questions 4 through 6: Mean (Daily Activities, Social Activities, Work Activities) X 10 Disability Points: Add the indicated points for Disability Days (Question 7) and for Disability Score (0-6). Items rate from 0 to 10 with 0 referencing no pain/interference/change and 10 referencing pain as bad as could be/unable to carry out any activities/extreme change.

  Baseline - Final assessment (average 1 week post treatment)

• Daily Pain Monitoring: 10 point scale

  Daily pain monitoring defined as daily pain intensity and daily pain interference monitoring is two questions asked daily on a 10 point scale assessing daily pain and how much pain had interfered with day to day activities. Pain: Over the past 24 hours, how would you rate your back pain on average? (0=No Pain; 10=Worst Imaginable Pain) Interference: Over the past 24 hours, how much did pain interfere with your day-to-day activities? (0=No Interference; 10 = A great deal of interference)"

  Baseline - Final assessment (average 1 week post treatment)

Secondary Outcomes (14)

• Back Disability as assessed by the Roland Morris Disability Questionnaire

  Baseline - Final assessment (average 1 week post treatment)

• Depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale

  Baseline - Final assessment (average 1 week post treatment)

• Pain Catastrophizing as assessed by the Pain Catastrophizing Scale

  Baseline - Final assessment (average 1 week post treatment)

• Pain-related fear of movement as assessed by the Tampa Scale Kinesiophobia

  Baseline - Final assessment (average 1 week post treatment)

• Mood and Affect as assessed by the Positive and Negative Affect Scale

  Baseline - Final assessment (average 1 week post treatment)

Study Arms (2)

Interactive Psycho-education

EXPERIMENTAL

Interactive psycho-education using interactive dashboard.

Behavioral: Interactive - Psychoeducation

Psycho-education

PLACEBO COMPARATOR

Non-interactive psycho-education not using interactive dashboard.

Behavioral: Non-interactive Psychoeducation

Interventions

Interactive - Psychoeducation BEHAVIORAL

Individuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes.

Interactive Psycho-education

Non-interactive Psychoeducation BEHAVIORAL

Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.

Psycho-education

Eligibility Criteria

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

You may qualify if:

• report having low back pain for more than three months and at least half the days in the past 6 months
• be 18-65 years of age,
• have scores higher than 37 on the Tampa Scale of Kinesiophobia,

You may not qualify if:

• medical conditions other than back pain that significantly impair movement (e.g., arthritis)
• confirmed/suspected pregnancy
• pending litigation related to an episode of low back pain
• significant impairment in vision

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Chronic Pain; Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant, statistician, and outcomes assessor are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: May 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

US (1)