Table 2 Description of Interventions based on the Template for Intervention Description and Replication (TIDieR [61])
|  | SSM | SSM + SMT | SMT | MC |
|---|---|---|---|---|
Rationale and Goal | Rationale: LBP is a biopsychosocial (BPS) condition; front-line providers like PTs and DCs are well suited to provide support that will encourage adaptive self-management behaviors using multiple BPS-oriented evidence-based modalities Goal: to address the BPS aspects of LBP in an individualized manner so patients have what they need to effectively self-manage | Rationale: as described for SSM and SMT Goals: as described for SSM and SMT | Rationale: SMT is recommended by evidence-based guidelines for LBP; it is a modality used by common front-line providers like PTs and DCs Goal: to address the physical/biological aspects of LBP in an individualized manner, to restore spinal movement and functional ability | Rationale: Medications are recommended by evidence-based guidelines for LBP; they are used by common front-line providers like physicians and advanced practice providers; it is well suited to serve as a pragmatic comparison intervention Goal: to reduce pain symptoms as it would typically be delivered in primary care settings |
Participant materials | -Back In Action booklet -Print workbook summarizing education and training procedures -Audio recordings of progressive muscle relaxation and guided imagery | -Includes patient materials as described for SSM and SMT | -Back In Action booklet | -Back In Action booklet |
Clinician materials | -Manual of operations -Clinician guide with session checklists and other prompts and cues (e.g., suggested language, things to watch for) to facilitate delivery of essential procedures | -Includes clinician materials as described for SSM and SMT | -Manual of operations | -Manual of operations |
Procedures | -Needs assessment, individualized treatment plan (also see Tailoring and Individualization below) -Education related to pain physiology, mind-body connection, etc. -Training in physical exercises (postural, strength, stabilization and mobility); psychological ‘mind-body’ strategies (relaxed breathing, progressive muscle relaxation, guided imagery, cognitive restructuring); and social strategies (pleasant activity planning and communication techniques for navigating social roles) -Empowerment and support to enhance facilitators and reduce barriers through goal setting and review; problem solving; action planning; general and emotional social support -Persuasion using patient-centered communication to foster therapeutic alliance | -Includes needs assessment, individualized treatment plan, and procedures as described for SSM and SMT | -Needs assessment, individualized treatment plan (also see Tailoring and Individualization below) -Spinal manipulation (Grades 1–4 mobilization, manipulation) -Supportive modalities (soft-tissue techniques, lumbar neural mobilization, heat) | -Needs assessment, individualized treatment plan -Medications (1st line: NSAIDs, skeletal muscle relaxants; 2nd line: acetaminophen, lidocaine patches, benzodiazepines, antiseizure medications, tricyclic antidepressants and selective serotonin reuptake inhibitors and/or serotonin norepinephrine reuptake inhibitors -Supportive modalities (heat, recommendations for massage, and acupuncture) |
Clinicians and Training | -Physical therapists, chiropractors -minimum 3 years of experience -20 hours initial training; monthly 1 hour group clinician meetings to facilitate fidelity; additional refresher training as needed | -Physical therapists, chiropractors -minimum 3 years of experience -includes training as described for SSM and SMT | -Physical therapists, chiropractors -minimum 3 years of experience -4 hours initial training; monthly 1 hour group clinician meetings to facilitate fidelity; additional refresher training as needed. | -Medical physicians, nurse practitioners -minimum 3 years of experience -4 hours initial training; monthly 0.5-hour group clinician meetings to facilitate fidelity; additional refresher training as needed. |
Format | -One-to-one -In person or via videoconference | -One-to-one -In person or via videoconference (SSM portion only) | -One-to-one -In person | -One-to-one -In person or via videoconference or telephone (after 1st visit) |
Tailoring and individualization | -Number and frequency of visits depends on needs after minimum of 4 reached; determined by Self-Reliance check in assessing confidence in self-management, and Wellbeing Wheel -Education: information reiterated, and supplemental sleep, communication and physical activity information presented if indicated -Training: home exercise plan including practice of physical exercises and psychological ‘mind-body’ strategies tailored to needs, goals and abilities -Empowerment/support: customized to patients needs related to training goals and general and emotional support. -Persuasion: communication based on patient needs for to stimulate action -Additional emphasis on information from Back in Action booklet per individual needs | -Includes tailoring as described for SSM and SMT | -Frequency and number of visits after minimum of 2 reached. -Spinal levels treated, choice of grades 1–4 mobilization and/or manipulation based on clinical presentation, patient tolerance. -Additional emphasis on information from Back in Action booklet per individual needs | -Frequency and number of visits after minimum of 2 reached. -Medication(s) prescribed based upon participant’s prior history and preferences and clinician judgment. -Additional emphasis on information from Back in Action booklet per individual needs |
Frequency, Duration | -4-8 visits over 8 weeks -up to 60 min | -4-8 SSM and ≥ 2 SMT visits over 8 weeks -up to 60 min | -≥ 2 visits over 8 weeks -15–20 min | -≥ 2 visits over 8 weeks -30 min |
Locations | Physical Therapy Clinical and Translational Research Center (PT-CTRC) in Pittsburgh, PA, and the Epidemiology Clinical Research Center and Berman Center for Outcomes and Clinical Research in Minneapolis, MN. HIPAA compliant telemedicine SSM and MC sessions allowed prior to, during, and after COVID restrictions. | |||
Modifications | -Enrollment to two of the interventions (SSM + SMT, SMT) suspended temporarily due to COVID impacts on in-person clinic activity; other two interventions (SSM, MC) transitioned to videoconference delivery until in-person clinic activities could be safely resumed. -Additional clinician training (~ 2 h) for delivery of SSM and MC via videoconference during COVID restricted period | |||
Fidelity | Planned Fidelity Assessment: Review of structured treatment notes for required, allowed and prohibited intervention procedures and random assessment of video recordings monthly for each provider for 6 months, then quarterly thereafter. If concerns arise, investigators will reinstate monthly fidelity checks and/or additional training as needed. | |||