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. 2023 May 25;24(1):415.
doi: 10.1186/s12891-023-06549-w.

Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol

Gert Bronfort  1 , Anthony Delitto  2 , Michael Schneider  3 , Patrick J Heagerty  4 , Roger Chou  5 , John Connett  6 , Roni Evans  7 , Steven George  8 , Ronald M Glick  9 , Carol Greco  10 , Linda Hanson  7 , Francis Keefe  11 , Brent Leininger  7 , John Licciardone  12 , Christine McFarland  3 , Eric Meier  13 , Craig Schulz  7 , Dennis Turk  14
Affiliations

Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol

Gert Bronfort et al. BMC Musculoskelet Disord. .

Abstract

Background: Chronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis.

Methods: We have designed a phase 3 randomized trial with a 2 × 2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10-12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients' intervention assignment.

Discussion: By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem.

Trial registration: ClinicalTrials.gov Identifier: NCT03581123.

Keywords: Low back pain; Medical care; Self-management; Spinal manipulation.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
PACBACK trial mapped to the domains of the PRECIS-2 tool26 (Scores:5 = fully pragmatic,1 = fully explanatory)
Fig. 2
Fig. 2
Trial flow diagram
See this image and copyright information in PMC

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