Table 4 Description of interventions based on the template for intervention description and replication
| Â | Supported biopsychosocial self-management (SBSM) | Medical care |
|---|---|---|
Rationale and goal | Rationale: Back-related leg pain (BRLP) is a complex condition impacted by interrelated physical, psychological, and social risk factors | Rationale: Medications are recommended by evidence-based guidelines for LBP and BRLP; they are used by common front-line providers like physicians and advanced practice providers; it is well suited to serve as a comparison intervention |
Goal: to provide patients the opportunities and resources to develop the capabilities and motivation to engage in healthy pain self-management behaviors | Goal: to reduce BRLP symptoms and provide care as it would typically be delivered in primary care settings | |
Participant materials | Back In Action booklet with educational material regarding the causes, prognosis, and general self-management tips for BRLP | Back In Action booklet with educational material regarding the causes, prognosis, and general self-management tips for BRLP |
Workbook | ||
Website with video and audio recordings | ||
Clinician materials | Manual of operations | Manual of operations |
BPS COM profile for summarizing individual’s BPS strengths and needs elated to guide individualized care | ||
Clinician guide with tools to guide discussions (e.g. Priority & Goal Check In, Wellbeing Wheel worksheets), session checklists and prompts and cues to facilitate delivery of required activities in a supportive manner | Treatment visit forms with session checklists to facilitate delivery of required activities and protocol compliance | |
Treatment visit forms with session checklists to facilitate delivery of required activities and protocol compliance | ||
Procedures | Needs assessment, individualized treatment plan (also see Tailoring and Individualization below) | –Needs assessment, individualized treatment plan |
BPS Self-Management Skills Training including physical exercises; psychological and social strategies | ||
Spinal manipulation therapy (SMT) as indicated to manage symptoms | ||
Enablement as indicated to improve patients’ unhelpful beliefs | Medications (1st line: Non-steroidal anti-inflammatory drugs; 2nd line: systemic corticosteroids, skeletal muscle relaxants, acetaminophen, benzodiazepines, antiseizure medications, lidocaine patches serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, and weak opioids (e.g. Tramadol, Tylenol with Codeine) for participants unable to tolerate or unresponsive to first-line medications | |
Education using evidence-based information about chronic pain, BRLP, biopsychosocial risk factors, and self-management | ||
Persuasion as needed to influence patients BRLP beliefs, optimism, and motivation | ||
Intervention providers and training | Licensed physical therapists, chiropractors | Licensed physicians, nurse practitioners |
3Â years of clinical experience | 3Â years of clinical experience | |
40Â h of initial training; bi-weekly 1Â h group clinician meetings to facilitate address their own capability, opportunity and motivational needs and ensure intervention fidelity; additional refresher training as needed | 2Â h initial training; additional refresher training as needed | |
Mode of delivery | One-to-one | One-to-one |
In person or videoconference | In person or videoconference | |
Telephone visits allowed after 1st visit | ||
Locations | University-affiliated research clinic or by videoconference | University-affiliated research clinic or by videoconference |
Frequency, time period, schedule, and duration, intensity, or dose of intervention | 6 to 12 visits over 12Â weeks | 2 or more visits over 12Â weeks |
Visits typically occurred weekly | Visits did not have a set schedule | |
Each visit lasted between 45–60 min | Each visit 15–30 min long | |
Choice and dosing of mind–body and physical exercises was individualized | Choice and dosing of medications was individualized | |
Tailoring and individualization | Number and frequency of visits depends on needs after minimum of 6 visits reached; release to self-management determined by Priority & Goal Check In worksheet assessing confidence in self-management | Frequency and number of visits depends on needs after minimum of 2 visits reached |
Education: information reiterated, and supplemental information on sleep, communication, physical activity, and tips for pain management or tackling barriers to exercise presented if indicated | ||
Training: home exercise plan including practice of physical exercises and psychological ‘mind–body’ strategies tailored to needs, goals and abilities | Medication(s) prescribed based upon participant’s prior history and preferences and clinician judgment | |
Enablement/support: customized to patients needs related to training goals and general and emotional support | ||
Persuasion: verbal persuasion used as needed to stimulate action | Additional emphasis on information from Back in Action booklet per individual needs | |
Additional emphasis on information from Back in Action booklet per individual needs | ||
Modifications during Study | None | None |
Adherence or fidelity assessments | Review of study treatment visit documentation for completion of required activities | Review of study treatment visit documentation for completion of required activities |
Review of video recordings for a random sample of 10% of study visits | Review of video recordings for a random sample of 10% of study visits |