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

Acute Pain Clinical Trial

— PACBACK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03581123
• Other study ID #: CSH-2018-26524
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 1, 2018
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Behavioral:
• Supported-Self Management (SSM)
Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.

Other:
• Spinal Manipulation Therapy (SMT)
SMT will address the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.

Combination Product:
• SMT + SSM
Combination Treatment

Drug:
• Standard Medical Care (SMC)
Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
University of Minnesota	Duke University, Oregon Health and Science University, University of North Texas Health Science Center, University of Pittsburgh, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-efficacy	Using a 10-100 numerical rating scale (10=very uncertain, 100 = very certain), self-efficacy is measured with the 22-item Chronic Pain Self-Efficacy Scale adapted for acute/sub-acute pain. This is a psychosocial mediating measure.	Baseline, 2, 6, 12 months
Other	Catastrophizing	Measured using the 13-item Pain Catastrophizing Scale; it uses a 5-item point scale (0=not at all, 4 all the time). This is a psychosocial mediating measure.	Baseline, 2, 6, 12 months
Other	Kinesiophobia	Measured using the 11-item Tampa Scale for Kinesiophobia demonstrated to have internal consistency, responsiveness and validity similar to the original 17-item instrument. A four-item scale is used (strongly disagree to strongly agree). This is a psychosocial mediating measure.	Baseline, 2, 6, 12 months
Other	Coping	Measured using an adapted version of the 28-item Brief Coping Orientation to Problems Experienced (COPE) instrument on a 4 point scale (I haven't been doing this at all to I've been doing this a lot). This is a psychosocial mediating measure.	Baseline, 2, 6, 12 months
Primary	Average pain intensity over one year post-randomization	Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible).	Weekly from enrollment - 52 weeks
Primary	Average disability over one year post-randomization	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.	Measured monthly from enrollment - 52 weeks
Primary	Prevention of chronic low back pain (LBP) that is impactful at 10-12 months follow-up	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).	Months 10 -12
Secondary	Recovery from acute/sub-acute low back pain	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.	6 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	Includes pain interference with normal activities, physical function, anxiety, depression, fatigue, sleep disturbance and the ability to participate in social roles and activities.	Measured monthly from enrollment - 52 weeks
Secondary	Low Back Pain Frequency	Participants report the number of days low back pain has been a problem in the past 7 days.	Weekly from enrollment - 52 weeks
Secondary	Healthcare Utilization	Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures.	Measured monthly from enrollment - 52 weeks
Secondary	Medication Use	Over the counter and prescription medication use for low back pain including class and frequency by class.	Measured monthly from enrollment - 52 weeks
Secondary	Productivity loss	Missed work and reduced productivity while at work will be assessed using questions from the Institute for Medical Technology Assessment's productivity cost questionnaire.	Measured monthly from enrollment - 52 weeks
Secondary	Risk factors for transitioning to chronic low back pain	Measured using the STarT Back Screening Tool.	Baseline, 2, 6, 12 months
Secondary	Global Improvement	Measured using a 9-point scale (completely recovered to vastly worse)	Baseline, 2, 6, 12 months
Secondary	Patient Satisfaction with Treatment	Measured using a 7-point Likert scale (completely satisfied to completely dissatisfied)	Baseline, 2, 6, 12 months
Secondary	Healing Encounters and Attitudes Lists (HEAL)	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)	Baseline, 2 weeks, and 1, 2, 6, 12 months
Secondary	Intervention Barriers	This qualitative assessment explores barriers to participation in the intervention using open ended questions in an electronic survey.	Screening, baseline, 2, 6, 12 months
Secondary	Intervention Facilitators	This qualitative assessment explores facilitators to participation in the intervention using open ended questions in an electronic survey.	Screening, baseline, 2, 6, 12 months
Secondary	Covid 19 Impact	Measured using the 7-item Pain Management Collaboratory (PMC) Coronavirus (COVID-19) Pandemic Measure	Screening, baseline, 2, 6, 12 months
Secondary	Telehealth Usability Questionnaire	Participants' views of the remote intervention delivery platform will be assessed using items adapted from the Telehealth Usability Questionnaire	Baseline, 1, 2 months
Secondary	Adverse Events	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.	Measured during treatment and monthly from enrollment - 52 weeks
Secondary	Prevention of chronic low back pain (LBP)	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).	6, 12 Months
Secondary	Timed Up and Go Test	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.	Baseline and 2 months
Secondary	Sit-to-stand	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	Baseline and 2 months
Secondary	The Sock Test	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.	Baseline and 2 months
Secondary	Chronic Interference with Daily Activities	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).	Baseline, 6 and 12 months
Secondary	Visual Trajectory for Pain	Assessed using 8 different diagrams describing back pain change over the last 12 months	Baseline, 12 months
Secondary	Quebec Task Force	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.	Baseline, 2 months