Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)

University of Minnesota (UMN)

Status and phase: Completed; Phase 3

Conditions: Low Back Pain, Mechanical; Acute Pain

Treatments: Other: Spinal Manipulation Therapy (SMT); Combination Product: SMT + SSM; Drug: Standard Medical Care (SMC); Behavioral: Supported-Self Management (SSM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03581123

CSH-2018-26524

Details and patient eligibility

About

This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.

Full description

The long-term goal is to reduce overall low back pain (LBP) burden by evaluating, first-line, non-drug treatment strategies that address the biological, psychological and social aspects of acute LBP and prevent transition to chronic back pain. The study will also assess barriers and facilitators that impact future implementation of the non-drug treatments into clinical practice.

The US faces an unprecedented pain management crisis. LBP is the most common chronic pain condition in adults and one of the leading causes of disability worldwide. Guidelines have recommended non-drug treatments like spinal manipulation and behavioral and selfcare approaches for LBP for nearly a decade, yet uptake and adherence has been poor. Little is known about the role of these treatments in the secondary prevention of chronic LBP, especially for patients at risk of developing severe low back pain. Due to high societal costs, and side effects of commonly used drug treatments, including opioids, there is a critical need for research on how well non-drug treatments work for preventing serious chronic LBP.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Acute or sub-acute low back pain
• Average low back pain severity ≥3 on the 0-10 numerical rating scale over 7 days
• Medium or high risk for persistent disabling back pain according to the STarT Back screening tool
• Ability to read and write fluently in English

Exclusion criteria

• Non-mechanical causes of low back pain
• Contraindications to study treatments (e.g,. surgical fusion of lumbar spine)
• Active management of current episode of low back pain by another healthcare provider
• Serious co-morbid health condition that either requires medical attention or has a risk for general health decline over the next year
• Pregnancy, current or planned during study period and nursing mothers
• Inability or unwillingness to give written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,000 participants in 4 patient groups

Supported-Self management (SSM)

Experimental group

Description:

Supported-Self management

Treatment:

Behavioral: Supported-Self Management (SSM)

Spinal Manipulation Therapy (SMT)

Experimental group

Description:

Spinal Manipulation Therapy

Treatment:

Other: Spinal Manipulation Therapy (SMT)

SMT + SSM

Experimental group

Description:

Spinal Manipulation Therapy + Supported Self-Management

Treatment:

Combination Product: SMT + SSM

Standard Medical Care (SMC)

Active Comparator group

Description:

Standard Medical Care

Treatment:

Drug: Standard Medical Care (SMC)