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

Phase 3

Completed

• Conditions: Acute Pain; Low Back Pain, Mechanical
• Interventions: Combination Product: SMT + SSM; Drug: Standard Medical Care (SMC); Other: Spinal Manipulation Therapy (SMT); Behavioral: Supported-Self Management (SSM)

• Registration Number: NCT03581123
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-10
• Study Start: 2018-11-01
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SMT + SSM	SMT + SSM	Spinal Manipulation Therapy + Supported Self-Management
Standard Medical Care (SMC)	Standard Medical Care (SMC)	Standard Medical Care
Spinal Manipulation Therapy (SMT)	Spinal Manipulation Therapy (SMT)	Spinal Manipulation Therapy
Supported-Self management (SSM)	Supported-Self Management (SSM)	Supported-Self management

Primary Outcome Measures

Name	Time	Method
Average disability over one year post-randomization	Measured monthly from enrollment - 52 weeks	Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities.
Average pain intensity over one year post-randomization	Weekly from enrollment - 52 weeks	Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible).
Prevention of chronic low back pain (LBP) that is impactful at 10-12 months follow-up	Months 10 -12	Measured by the LBP impact scale which includes measures of pain intensity, pain interference, and physical function from the PROMIS-29 Profile v2.0. The scale ranges from 8 (least impact) to 50 (greatest impact).

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Measured during treatment and monthly from enrollment - 52 weeks	Any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline, appears to worsen.
Chronic Interference with Daily Activities	Baseline, 6 and 12 months	Assessed using "how often has low back pain interfered with your ability to do regular activities over the past 6 months?" on a 3-item scale (less than half the days in the past 6 months, at least half the days in the past 6 months, every day or nearly every day in the past 6 months).
Visual Trajectory for Pain	Baseline, 12 months	Assessed using 8 different diagrams describing back pain change over the last 12 months
Low Back Pain Frequency	Weekly from enrollment - 52 weeks	Participants report the number of days low back pain has been a problem in the past 7 days.
Productivity loss	Measured monthly from enrollment - 52 weeks	Missed work and reduced productivity while at work will be assessed using questions from the Institute for Medical Technology Assessment's productivity cost questionnaire.
Intervention Barriers	Screening, baseline, 2, 6, 12 months	This qualitative assessment explores barriers to participation in the intervention using open ended questions in an electronic survey.
Sit-to-stand	Baseline and 2 months	Measured by a blinded examiner, in seconds, the amount of time a person requires to stand up and sit down from a chair 5 times without using their arms
The Sock Test	Baseline and 2 months	Measured by a blinded examiner on a scale from 0-3, with 0 being can easily grab the toes with the fingertips of both hands and 3 being can hardly, if at all, reach as far as to the malleoli.
Quebec Task Force	Baseline, 2 months	Measured by a blinded examiner who will classify the participant's spinal disorder as 0) no pain; 1) pain without radiation; 2) pain with radiation to the proximal extremity; 3) pain with radiation to the distal extremity; 4) pain with radiation to the extremity and neurologic signs.
Recovery from acute/sub-acute low back pain	6 months	Measured by the proportion of patients with scores of 0 on the 0-10 pain numeric rating scale (NRS) and a score of less than or equal to 2 on the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities.
Healthcare Utilization	Measured monthly from enrollment - 52 weeks	Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures.
Global Improvement	Baseline, 2, 6, 12 months	Measured using a 9-point scale (completely recovered to vastly worse)
Patient Satisfaction with Treatment	Baseline, 2, 6, 12 months	Measured using a 7-point Likert scale (completely satisfied to completely dissatisfied)
Healing Encounters and Attitudes Lists (HEAL)	Baseline, 2 weeks, and 1, 2, 6, 12 months	Includes patient-provider connection (7-item), healthcare environment (6-item), positive outlook (6-item) and treatment expectancy (6-item) from the HEAL measured on a 5-point scale (not at all to very much)
Intervention Facilitators	Screening, baseline, 2, 6, 12 months	This qualitative assessment explores facilitators to participation in the intervention using open ended questions in an electronic survey.
Risk factors for transitioning to chronic low back pain	Baseline, 2, 6, 12 months	Measured using the STarT Back Screening Tool.
Prevention of chronic low back pain (LBP)	6, 12 Months	Measured by the proportion of patients in each group meeting the definition by the NIH Task Force on Research Standards for Chronic LBP (i.e., ongoing LBP on ≥50% of days over past 6 months).
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	Measured monthly from enrollment - 52 weeks	Includes pain interference with normal activities, physical function, anxiety, depression, fatigue, sleep disturbance and the ability to participate in social roles and activities.
Medication Use	Measured monthly from enrollment - 52 weeks	Over the counter and prescription medication use for low back pain including class and frequency by class.
Covid 19 Impact	Screening, baseline, 2, 6, 12 months	Measured using the 7-item Pain Management Collaboratory (PMC) Coronavirus (COVID-19) Pandemic Measure
Telehealth Usability Questionnaire	Baseline, 1, 2 months	Participants' views of the remote intervention delivery platform will be assessed using items adapted from the Telehealth Usability Questionnaire
Timed Up and Go Test	Baseline and 2 months	Measured by a blinded examiner, in seconds, the time taken by a person to stand up, walk a distance of 10 feet, turn, walk back to the chair and sit down again.

Trial Locations

Locations (3)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States