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Table 1 Summary of inclusion–exclusion criteria

From: Impact of contextual factors on patient outcomes following conservative low back pain treatment: systematic review

 

Inclusion

Exclusion

Population/Illness

Adult (≥ 18 years) with chronic low back pain (≥ 12 weeks)

Non-human subjects; human objects (e.g., tissues, fMRI, MRI, CT etc.), children and adolescents (< 18 years old); fictitious/actor patients, patients with acute, sub-acute or mixed samples of low back pain

Treatment Setting

Universally accepted/clinically recognised forms of conservative care (i.e., non-pharmacological and non-invasive) occurring in a clinical setting (in-patient or out-patient), primary or secondary healthcare (private or public) or where it was expressly articulated that the site involves regular delivery of therapeutic care (e.g., University clinic, community care centre)

Excluded if treatment related to palliative care, emergency medicine or experimental laboratory environments

Intervention

Conservative care approaches/strategies which potentially alter clinical outcomes through the explicit modulation or measurement of at least one of the five contextual factors relating to the health encounter

Excluding pharmacological or surgical interventions; acupuncture, injections, or invasive procedures; neurological experiments or imaging; interventions targeting adherence to analgesic medication, diet modification/nutritional supplements; interventions involving alternative medicine; online, app-based or telehealth interventions

Comparators

No treatment or intervention (e.g., waiting-list control or natural history group), no control group (i.e., uncontrolled study), standard/usual care, or neutral, negative, or an experimentally dosed and/or opposite or contextually comparative condition

Two-armed trial or two-group design whereby the description indicates a standard placebo-controlled trial (where the comparison group involved a “sham” condition perceived to be an “inert” placebo)

Outcomes

Validated pain or physical functioning/disability measures (e.g., used during routine clinical care)

Non-validated pain or physical functioning/disability measures or sub-scales

Study Design

Randomised Controlled Trials (RCTs); quasi-experimental designs, or prospective longitudinal studies

Retrospective/secondary analyses, qualitative studies, cross-sectional designs, n-of-1 trial; conference abstracts, dissertations, and trial protocols