Completed

Psychosocial Intervention for Acute Low Back Pain (ALBP)

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What is being tested

Data Collection

Who is being recruted

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1977
See protocol details

Summary

Principal SponsorIndiana University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1977

Actual date on which the first participant was enrolled.

Acute low back pain (ALBP) is very prevalent in the United States, accounting for substantial morbidity, functional limitations, pain, and health care costs. Psychosocial interventions that target improved symptom control and patient functioning have the potential to improve the outcomes of patients with ALBP. This study evaluates a psychosocial intervention designed to enhance self-efficacy and social support for patients with ALBP. In this randomized, controlled trial, we will randomize eligible patients with ALBP to receive the intervention or usual care. The intervention program consists of: (1) patient education regarding ALBP; (2) explanations and rationales, in layperson's terms, of diagnostic and treatment options for ALBP; (3) discussions regarding the management of negative affect (i.e., depression, anger, fear, hostility, anxiety); (4) methods to involve social support systems; and (5) strategies to involve the primary care physician to reinforce patients' behaviors and progress. We will follow patients for 12 months and assess outcomes at 3 and 12 months. Primary outcomes are health-related quality of life (i.e., functional status, role function, back pain symptoms) and patient satisfaction with care. Secondary outcomes include health care use, direct health care costs, self-efficacy, and social support. We will also estimate the cost-effectiveness of the intervention. We will conduct this investigation among socioeconomically vulnerable patients with ALBP, a group that shoulders a disproportionate burden of disability and morbidity from musculoskeletal conditions and comorbid medical conditions.

Official TitlePsychosocial Intervention for Acute Low Back Pain (ALBP)
NCT00000418
Principal SponsorIndiana University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

211 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Acute low back pain

8 exclusion criteria prevent from participating
Chronic back pain (including surgery)

Disability claim for back pain

Nursing home resident

Severe impairment in hearing, vision, or speech

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Indiana University School of Medicine

Indianapolis, United StatesOpen Indiana University School of Medicine in Google Maps
CompletedOne Study Center