A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE

The proportion of patients contacted who consent to screening

Retention will be assessed by tracking the percentage of participants who complete their primary endpoint visit

Intervention Satisfaction. Min = 8, Max = 32. Higher score = greater satisfaction.

The proportion of participants completing at least 5 intervention sessions

The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring during the study.

Satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a self-report measure designed to assess satisfaction with health services.

Activities of daily living. Min = 0%, Max = 100%. Higher score = worse outcomes.

Neuropathic Pain. Min = -1, Max = 38. Higher score = worse outcomes.

Pain Intensity. Min = 0, Max = 10. Higher score = worse pain

A questionnaire to assess pain hypersensitivity and allodynia. The CMSI inquires about participants' pain experiences specifically related to hypersensitivity and allodynia to discern whether an individual may experience central sensitization. Currently, no direct measures of self-reported nociplastic pain exist, thus measures of central sensitization can be used as surrogate measures for this construct. The CSI has previously been shown to have strong test-retest reliability in chronic pain patients.

The NPQ is a screening tool designed to identify characteristics of nociplastic pain, which arises from altered nociception without clear evidence of tissue damage or somatosensory system disease. The NPQ assesses symptoms such as widespread pain, fatigue, sleep disturbance, and cognitive difficulties, helping to differentiate nociplastic pain from nociceptive and neuropathic pain mechanisms.

The PGIC is a single-item, patient-reported outcome measure that captures a participant's overall perception of improvement or decline in health status since the start of an intervention. Rated on a 7-point Likert scale ranging from "very much improved" to "very much worse," the PGIC provides a global assessment of treatment effectiveness from the patient's perspective.

This questionnaire will assess whether participants have changed their use or plans for use of pain medication, injection, nerve ablation, or surgery as a result of participation in the study.

The PEG-3 is a brief, 3-item measure derived from the Brief Pain Inventory that assesses pain intensity and its impact on enjoyment of life and general activity. Each item is rated on a 0-10 scale, with higher scores indicating greater pain-related interference. The PEG-3 is a validated tool commonly used in both clinical and research settings to monitor pain outcomes efficiently.

A questionnaire to assess fear of movement. The TSK-11 is designed to assess the presence of fear of movement. This measure has previously been validated in populations of patients with chronic non-specific low back pain and shown to have good reliability.

A questionnaire to assess pain catastrophizing and rumination. The PCS is ubiquitously used to assess pain catastrophizing via its subscales: helplessness, rumination, and magnification. It has primarily been used and validated in patients with low back pain.

The PROMIS Self-Efficacy for Managing Symptoms 8a is an 8-item patient-reported measure assessing an individual's confidence in managing symptoms related to their health conditions. It evaluates domains such as controlling symptoms, performing tasks despite symptoms, and coping with the impact of symptoms on daily life. Higher scores indicate greater self-efficacy in symptom management. This tool helps capture patients' perceived ability to handle their health challenges and is useful for tailoring interventions and tracking progress in clinical research.

A questionnaire to assess social participation. The ability to participate in social roles questionnaire is a PROMIS measure designed to evaluate the impact of a condition on social engagement. It has previously been validated with an additional questionnaire, satisfaction with participation in social activities.

This is a validated patient-reported outcome measure assessing perceived sleep quality and disturbances over the past 7 days. The 6-item Sleep Disturbance short form (6a) evaluates aspects such as difficulty falling asleep, staying asleep, and overall sleep satisfaction, while an additional question captures average sleep duration. Scores provide insight into sleep problems that may affect health and functioning.

The WPHI is a simple self-report survey tool that provides a comprehensive snapshot of a person's health. The WPHI can serve as an anchor or reference point for connecting diverse health data, all while keeping the individual's personal health perspective at its core. The WPHI is based on nine questions developed and validated through a collaboration between the National Center for Complementary and Integrative Health (NCCIH) and the National Center for Health Statistics/Centers for Disease Control and Prevention.

A questionnaire to assess participant agreement with the biopsychosocial model of pain. The PEB is designed to assess patient beliefs about the biopsychosocial model of chronic pain. It has been previously shown to have good internal consistency and reliability and it has been recommended for use in longitudinal study designs for assessing patients' attitudes towards long-term pain management.

The WHOQOL-2 is a brief, validated instrument developed by the WHO to assess an individual's perceived quality of life across multiple domains, including physical health, psychological well-being, social relationships, and environment. It provides a global measure of overall life satisfaction and well-being.

The PHQ-9 is a widely used self-report instrument for assessing the presence and severity of depressive symptoms over the past two weeks. The PHQ-8 excludes the item on suicidal ideation found in the PHQ-9, making it suitable for general population surveys and clinical research where suicide risk assessment is conducted separately.

The GAD-7 is a brief, validated self-report questionnaire used to screen for and assess the severity of generalized anxiety disorder symptoms. It consists of seven items asking respondents how often they have been bothered by anxiety-related problems over the past two weeks. Scores help categorize anxiety severity from minimal to severe and assist clinicians and researchers in monitoring anxiety symptoms and treatment response. The GAD-7 is widely used in both clinical and research settings for its reliability and ease of administration.

The TSRQ is a validated self-report measure designed to assess individuals' motivation behind engaging in health-related behaviors. It evaluates the degree to which behavior change is driven by autonomous (intrinsic) versus controlled (extrinsic) motivation, grounded in Self-Determination Theory. The TSRQ helps identify the reasons patients choose to adhere to or modify treatments, providing insights into their internalization of health goals. It is commonly used in research to understand motivational factors influencing treatment adherence and lifestyle changes.

The IPAQ is a 12-question validated tool designed to capture information about a range of physical activity frequency, intensity, time, and type. The IPAQ has been shown to have high repeatability, with 75% of the Spearman correlation coefficients observed in a 12-country validation study to be above 0.65 and ranging from 0.88 to 0.32. The IPAQ also demonstrated high criterion validity ranging from 0.14 to 0.53, with a median of about 0.30. Reliability and validity have also been assessed in other languages and populations both healthy and unhealthy.

A questionnaire to assess participants trait mindfulness. The FFMQ is a self-report questionnaire that assesses trait mindfulness using five categories of mindfulness: Observing, Describing, Acting with Awareness, Nonjudging of inner experience, and Nonreactivity to inner experience. The FFMQ has demonstrated good construct, discriminant, and predictive validity, as well as its internal consistency.

A questionnaire to assess participants pain reappraisal. The MRPS is a self-report questionnaire designed to quantify mindful reappraisal of pain. This survey is measured on a scale from 0, "never do that," to 6, "always do that". It was found to have good convergent and discriminant validity with various other mindfulness questionnaires and be sensitive to change in participants undergoing mindfulness interventions.

A questionnaire to assess interoception. The MAIA-2 is designed as a tool to assess interoceptive awareness. It is made up of eight subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. It has been previously evaluated with internal consistency, validity, and reliability.

The Purpose in Life Scale is a self-report instrument designed to assess an individual's sense of meaning, purpose, and direction in life. It measures the extent to which a person feels their life has meaning and goals that give motivation and fulfillment. This scale is commonly used in psychological and health research to evaluate well-being, resilience, and overall mental health. Higher scores indicate a stronger sense of life purpose, which is associated with better psychological outcomes and coping abilities.

The PROMIS Physical Functioning Short Form 6b is a brief, validated patient-reported outcome measure that assesses an individual's ability to perform everyday physical activities. It includes six items focused on mobility, self-care, and upper extremity function, capturing the impact of health conditions on physical functioning. Scores provide a standardized assessment of physical capabilities, with higher scores indicating better physical function. This tool is widely used in clinical and research settings to monitor physical health status and track changes over time.

Biometric tracking will take place via the wearing of an actigraphy device. The device will track activity level and several parameters of sleep. This is a research grade actigraphy device. All participant data will be uploaded to a secure platform stored exclusively on a computer at Helfgott Research Institute. Only participant study IDs will be used within the data collection platform.

Visual Stressors will probe mechanisms of global or generalized sensory sensitivity that bypass somatic peripheral receptors and the spinal cord, and are increased in many chronic pain patients. For visual testing, participants will be presented with a flashing annular checkerboard pattern at varying illumination levels as performed previously. Participants will be acclimated to a dark room and exposed to a high resolution, calibrated LED monitor displaying the visual stimulus. Each visual stimulus intensity level and the entire task will be rated on both sensory intensity and unpleasantness scales with overall task ratings and stimulus-response curves generated for analysis. Participants who report being diagnosed with or self-report visual-evoked migraines will not participate in the visual testing.

Objective measure of pain to assess participants' response to pressure. Algometers are designed to quantify and document levels of tenderness via pressure pain threshold measurement and pain sensitivity via pressure pain tolerance measurement. Overall, digital algometers have been shown good validity in patients with migraine and low back pain.

Pinprick testing assesses mechanical pain threshold (MPT), a measure of nociceptive sensitivity to punctate mechanical stimuli. Standardized, weighted pinprick stimulators, 256 millinewtons will be applied perpendicularly to the skin at a non-painful site (volar forearm or upper trapezius, lower back, and the area of most pain). This test is used to evaluate central sensitization. Pinprick testing is non-invasive, well-tolerated, and commonly included in quantitative sensory testing (QST) protocols to assess changes in mechanical pain sensitivity.

The SCWT is used to measure a person's attentional interference or the ability to inhibit the interruption of a second stimulus while continuing to process an original stimulus. The SCWT will be conducted online using the Testable platform. In the SCWT, the words RED, YELLOW, and BLUE will be presented in one of the alternate font colors and the participant will be asked to press the first letter of the font color on a keyboard rather than the color of the word itself.

Motion assessments of the lumbar spine will be performed using the Conity system which uses commercially available IMU sensors that are designed for collecting human kinematics non-invasively.