Study: NCT06533345

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavior Change Coaching
Description: Done by Dr. Hollingsworth or students via consultations with participants. Participant's health behavior aspirations or target outcomes will be clarified, informed by the participant's interactions with other MERCI providers. Behaviors that move the participant towards their aspirations/outcomes will be explored to find target behaviors that the participant is motivated and able to do. Target behaviors and supporting habits will be designed into the participant's existing routine. The Fogg Behavior Model will be used 1) to find the participant's primary motivation for engaging in target behaviors and 2) to make target behaviors easier to do. Implementation intentions - When/then or If/then plans - will be used to form habits and promote behavior engagement. Adopting a growth mindset will also be discussed. Subsequent consultations will focus on troubleshooting, iterative improvements, and incorporation of new aspirations/outcomes, target behaviors, and supporting habits.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavior Change Coaching
Description: Done by Dr. Hollingsworth or students via consultations with participants. Participant's health behavior aspirations or target outcomes will be clarified, informed by the participant's interactions with other MERCI providers. Behaviors that move the participant towards their aspirations/outcomes will be explored to find target behaviors that the participant is motivated and able to do. Target behaviors and supporting habits will be designed into the participant's existing routine. The Fogg Behavior Model will be used 1) to find the participant's primary motivation for engaging in target behaviors and 2) to make target behaviors easier to do. Implementation intentions - When/then or If/then plans - will be used to form habits and promote behavior engagement. Adopting a growth mindset will also be discussed. Subsequent consultations will focus on troubleshooting, iterative improvements, and incorporation of new aspirations/outcomes, target behaviors, and supporting habits.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Nutrition
Description: Nutrition: The nutrition intervention will be conducted as a 12-week protocol with assessment points at baseline, 1 month, and 3 months. Following consent, eligible participants will work through a self-taught educational module detailing the anti-inflammatory dietary program. Once the module is completed, participants will be scheduled for one-on-one counseling sessions with a Registered Dietitian or a supervised Dietetic Intern or Medical Student on the research team to receive personalized guidance on implementation of the dietary intervention. A dietary recall will be conducted via the automated self-administered dietary assessment tool (ASA24®), which takes about 20 minutes to complete. This survey will be conducted on two non-consecutive days at each timepoint (baseline, 1 month, and 3 months).

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Nutrition
Description: Nutrition: The nutrition intervention will be conducted as a 12-week protocol with assessment points at baseline, 1 month, and 3 months. Following consent, eligible participants will work through a self-taught educational module detailing the anti-inflammatory dietary program. Once the module is completed, participants will be scheduled for one-on-one counseling sessions with a Registered Dietitian or a supervised Dietetic Intern or Medical Student on the research team to receive personalized guidance on implementation of the dietary intervention. A dietary recall will be conducted via the automated self-administered dietary assessment tool (ASA24®), which takes about 20 minutes to complete. This survey will be conducted on two non-consecutive days at each timepoint (baseline, 1 month, and 3 months).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Autonomic Recalibration
Description: Participant will be outfitted with the Empatica wrist sensor. An initial history to rule out pathology and document a chief complaint relevant to pain is conducted. An initial head to toe assessment of withdrawal or startle reflex behavior in response to palpation is performed to identify trigger points and establish patterns of sympathetic dominance. The pattern of sympathetic dominance is addressed during treatment by Primal Reflex Release Technique Protocol to inhibit somatic afferent feedback loops and rebalance the autonomic nervous system towards a state of parasympathetic dominance. Day 2 is the same until the initial history and r/o. Here, the history is from the previous day, asking about perception of pain, sleep, digestion, or other pertinent issues brought up on the first visit. Treatment proceeds same as Day 1. Any emotional tags to trigger points are identified and acknowledged. Subjects may be scheduled for follow-up visits if their pain persists.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Autonomic Recalibration
Description: Participant will be outfitted with the Empatica wrist sensor. An initial history to rule out pathology and document a chief complaint relevant to pain is conducted. An initial head to toe assessment of withdrawal or startle reflex behavior in response to palpation is performed to identify trigger points and establish patterns of sympathetic dominance. The pattern of sympathetic dominance is addressed during treatment by Primal Reflex Release Technique Protocol to inhibit somatic afferent feedback loops and rebalance the autonomic nervous system towards a state of parasympathetic dominance. Day 2 is the same until the initial history and r/o. Here, the history is from the previous day, asking about perception of pain, sleep, digestion, or other pertinent issues brought up on the first visit. Treatment proceeds same as Day 1. Any emotional tags to trigger points are identified and acknowledged. Subjects may be scheduled for follow-up visits if their pain persists.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Dry Needling
Description: An initial history to document a chief complaint relevant to pain is conducted and to identify and potential contraindications (infection of overlying skin, patient on anticoagulation drugs, 1st trimester of pregnancy, etc.) A physical exam is performed to identify the trigger points causing pain. The subject is educated about the risks/benefits/indications and alternative treatments. The subject is also educated about dry needling aftercare. The skin over the trigger points is cleaned with 70% isopropyl alcohol. The pertinent trigger points are treated with dry needling (95% of time), direct inhibition (2 - 3% of time) or injection of 1% lidocaine in a fan-like fashion (1 - 2 % of the time). Subject is assessed for any bleeding. An office note, including a procedure note, is documented in the subject's record. Subject is scheduled for additional follow-up meeting.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Dry Needling
Description: An initial history to document a chief complaint relevant to pain is conducted and to identify and potential contraindications (infection of overlying skin, patient on anticoagulation drugs, 1st trimester of pregnancy, etc.) A physical exam is performed to identify the trigger points causing pain. The subject is educated about the risks/benefits/indications and alternative treatments. The subject is also educated about dry needling aftercare. The skin over the trigger points is cleaned with 70% isopropyl alcohol. The pertinent trigger points are treated with dry needling (95% of time), direct inhibition (2 - 3% of time) or injection of 1% lidocaine in a fan-like fashion (1 - 2 % of the time). Subject is assessed for any bleeding. An office note, including a procedure note, is documented in the subject's record. Subject is scheduled for additional follow-up meeting.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Osteopathic Manipulative Treatment
Description: Osteopathic Manipulative Treatment: After inform and consent process, the subject will enter patient room and meet with Dr. Hayes, who will conduct a brief history of patient pain, injuries, and procedures. Subjects will be asked to wear, or change into, athletic shorts or a tank top or loose-fitting T-shirt to facilitate treatment. Subject will undergo a brief somatic dysfunction screen, which involves light tough and manipulation. Once Hayes has diagnosed potential dysfunctions, he will proceed with osteopathic manipulative treatment. Treatment will last anywhere from 15 minutes to 1 hour. At the end of the treatment, subjects will be scheduled for a follow-up visit.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Osteopathic Manipulative Treatment
Description: Osteopathic Manipulative Treatment: After inform and consent process, the subject will enter patient room and meet with Dr. Hayes, who will conduct a brief history of patient pain, injuries, and procedures. Subjects will be asked to wear, or change into, athletic shorts or a tank top or loose-fitting T-shirt to facilitate treatment. Subject will undergo a brief somatic dysfunction screen, which involves light tough and manipulation. Once Hayes has diagnosed potential dysfunctions, he will proceed with osteopathic manipulative treatment. Treatment will last anywhere from 15 minutes to 1 hour. At the end of the treatment, subjects will be scheduled for a follow-up visit.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Counseling Psychology
Description: Psychoeducation Workshop and Counseling: The psychoeducational group intervention will be done according to the standardized Empowered Relief (Darnall et al., 2024) protocol. Empowered Relief is a single-session, 2-hour group workshop (online or in person) that teaches participants pain neuroscience education, mindfulness principles, and cognitive-behavioral skills. During the program, participants will complete a personalized plan to work toward pain relief. This program requires a certified instructor; Marilyn Cornish (Co-I), a licensed psychologist, is certified. After completion, participants can attend up to 4 individual counseling sessions with a counseling psychology doctoral student (supervised by Marilyn Cornish). Sessions will be approximately 50-60 minutes and will occur every other week. Specific in-session interventions will be tailored to the participant's unique needs but will focus on participants' pain relief plan and overall psychological wellbeing of participants.