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.

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

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

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
Pain Intensity	Average over weeks 1-52	Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible). Missing weekly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline pain intensity.
Disability	Average over months 1-12	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. Score ranges from 0 to 24 with higher values indicating more disability. Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline RMDQ.
Low Back Pain (LBP) That is Impactful	Average over 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). Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline LBP impact score.

Secondary Outcome Measures

Name	Time	Method
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.
Low Back Pain Frequency - Percent of Days Over 12 Months	Weeks 1-52	Participants report the number of days that low back pain has been a problem in the past 7 days for 52 weeks. This measure is the percent of days that low back pain has been a problem. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.
Number of Participants Who Received Care For Low Back Pain	Months 1-12	Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures. This is a binary indicator of any care from providers outside the study for low back pain.
Medication Use - Percent of Months 4-12	Months 4-12	Over the counter and prescription medication use for low back pain. Since the MC arm intervention includes medications, only months 4-12 (i.e. after the intervention) are considered for this outcome. The measure is the percent of months 4-12 in which medication was used for low back pain. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.
Bothered by Low Back Pain at Work - Percent of Months	Months 1-12	Participants indicated in monthly follow-ups if they were bothered by low back pain over the last month. This measure is the percent of months that participants were bothered by low back pain at work. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.
Global Improvement	12 months	Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Patient Satisfaction With Treatment	12 months	Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)
Chronic Low Back Pain (LBP)	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).
Number of Participants Who Reported Chronic Interference With Daily Activities	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). Here we dichotomize to "at least half the days in the past 6 months" or more.
Timed Up and Go Test	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.
Sit-to-stand	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	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. Each leg is scored separately with the greater leg score serving as the overall score.
Visual Trajectory for Pain	12 months	Assessed using 8 different diagrams describing back pain change over the last 12 months
Quebec Task Force	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.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression	Baseline and 2, 6, and 12 months	The PROMIS depression scale consists of 4 questions related to depression over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 41.0 - 79.3. Higher scores indicate greater depression. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function	Baseline and 2, 6, and 12 months	The PROMIS physical function scale consists of 4 questions about ability to perform tasks of daily living. The raw score is converted to the T-Score that is reported here. The range of possible scores is 22.6 - 57.0. Higher scores indicate greater physical function. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety	Baseline and 2, 6, and 12 months	The PROMIS anxiety scale consists of 4 questions related to anxiety over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 40.3 - 81.4. Higher scores indicate greater anxiety. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue	Baseline and 2, 6, and 12 months	The PROMIS fatigue scale consists of 4 questions related to fatigue over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 33.7 - 75.8. Higher scores indicate greater fatigue. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance	Baseline and 2, 6, and 12 months	The PROMIS sleep disturbance scale consists of 4 questions related to sleep disturbance over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 32.0 - 73.3. Higher scores indicate greater sleep disturbance. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation	Baseline and 2, 6, and 12 months	The PROMIS participation scale consists of 4 questions related to participation in social activities. The raw score is converted to the T-Score that is reported here. The range of possible scores is 27.5 - 64.2. Higher scores indicate greater ability to participate in social activities. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference	Baseline and 2, 6, and 12 months	The PROMIS participation scale consists of 4 questions related to pain interference in the last 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 41.6 - 75.6. Higher scores indicate greater pain interference. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
STarT Back Risk Classification	12 months	The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4).

Trial Locations

Locations (3): University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Washington
🇺🇸
Seattle, Washington, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States